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["ELECTRONIC SUPPLEMENTARY MATERIAL 4 - CED SCHEMES FOR DEVICES OPERATED IN THE LAST 5 YEARS IN EUROPE"]
["Country","Medical device","Manufacturer(s) involved:","Year of initiation of scheme","Description of the product(s) and/or procedure(s) involved","Disease/Indication(s) included in the scheme:","Actual status of the scheme ","National programme /type of scheme","How was this MD selected for the scheme","Agency(ies) running the scheme","Purpose of scheme ","Agreed length of scheme (years)","Description of the agreement","Key sources of uncertainty at scheme initiation ","Design of the study ","Outcomes being measured in the scheme: ","Source of funding","Results (if scheme completed)","Public source of evidence about the scheme","Comments/NOTES"]
["Belgium","Proclaim DRG","Abbott Medical Belgium",2019,"Implant: Dorsal Root Ganglion Stimulation","Complex regional pain syndrome (CRPS) of inferior limbs","Data collection active","CED","Bottom-up (requested by manufacturer)","NIHDI (National Institute for Health and Disability Insurance)","To confirm reimbursement status at the end of the scheme (e.g. if effectiveness or cost-effectiveness are confirmed, the technology will receive an unconditional reimbursement); To confirm use of the device for specific subpopulations and/or indication; To ensure appropriateness and quality of care","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care; The effects on long-term patient relevant outcomes; The risks of adverse events and/or adherence problems; Uncertainties relating to the true cost-effectiveness of the technology","Set up of a registry","Short- and longterm analgetic effect of DRG stimulation, effect of DRG stimulation on functional rehabilitation and reintegration of the patients, impact of DRG stimulation on quality of life (EQ-5D-5L score), risk of adverse events, longterm safety, functioning of device over time (absence of problems for patients, e.g. displacement of electrodes, loss of effectiveness, occurance of bleedings or fybrosis etc.), cost-effectiveness, retrospective analysis of direct medical costs, comparison of cumulative costs in the year before and after the DBS implantation (costs associated with: number of visits to A&E department, general practitioner/neurologist, number and dose of anti-epileptic pharmaceuticals), as well as just before the implantation (consultation, diagnostic tests, evaluation of implantation, implanatation, hospitalisation). Costs to be assessed: costs associated with implant procedure,  costs associated with treatment of most important acute/pre/post procedural adverse events and costs associated with revisions,  costs associated with re-hospitalisations","NIHDI (National Institute for Health and Disability Insurance)","1) Conventional reimbursement via the list; 2) scientific report","Interview (and validated by interviewee); RIZIV website","NA"]
["Belgium","Mitraclip","Abbott Medical Belgium",2016,"Implant: Percutaneous mitral valve leaflet repair for mitral regurgitation ","Mitral valve regurgitation","Data collection active","CED","Bottom-up (requested by manufacturer)","NIHDI (National Institute for Health and Disability Insurance)","To confirm use of the device for specific subpopulations and/or indications","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The relative efficiacy/effectivness in the real target population and/or in different population subgroups; The effects on long-term patient relevant outcomes; The risk of adverse events and/or adherence problems; Uncertainties related to the trye budget impact of introducing the technology; Uncertainties related to the organizational impact of the technology","Set up of a registry","Number, age, and STS/Euroscore of treated patients, number of deaths and severe side effects, loss of follow up, number of registered implants for which no reimbursement was requested, ratio between functional mitralis regurgitation (FMR) and degenerative mitralis regurgitation (DMR), change in MR and NYHA scores over time,  retrospective analysis of direct medical costs just before the implantation (consultation, diagnostical tests and evaluation before implantation, implantation and hospitalisation), costs in the year before and the years after the  implantation (costs associated with: number and costs of visits to A&E department, general practitioner/cardiologist, number, dose, and costs of pharmaceuticals, costs associated with the analysis). ","NIHDI (National Institute for Health and Disability Insurance)","1) Conventional reimbursement via the list; 2) scientific report; overall impression on failure aspects of the scheme: registry not compliant with legal requirements/agreements between parties involved; things to do different: better agreements between parties before start of the CED scheme","Interview (and validated by interviewee); RIZIV website","NA"]
["Belgium","Artificial heart","Abbott Medical Belgium; HeartWare (Medtronic)",2016,"Implant: Ventrical assist devices","Bridge to transplant and to decision patients","Completed. Decision: indications \"bridge to transplant\" and \"bridge to decision\" from public funding (added to reimbursement list)  \nindication \"destination therapy\": reimbursement strategy  in development","CED","Top-down (by the RIZIV); devices available on market, restriction on the numbers because of high price","NIHDI (National Institute for Health and Disability Insurance)","To confirm reimbursement status at the end of the scheme (e.g. if effectiveness or cost-effectiveness are confirmed, the technology will receive an unconditional reimbursement); To confirm use of the device for specific subpopulations and/or indications","2 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The relative efficiacy/effectivness in the real target population and/or in different population subgroups; The effects on long-term patient relevant outcomes; The risk of adverse events and/or adherence problems; Uncertainties related to the true cost-effectiveness of the technology","Set up of a registry","Number of implants, type of cardiopathology, demografic characteristics patients, use of materials, outcome: weaning, transplantation, death, date of discharge after implantation, duration of support for weaning, transplantation or death","NS","1) Conventional reimbursement via the list, destination therapy under consideration; 2) scientific report, yearly rise of the numbers confirmed by CED scheme ","Interview (and validated by interviewee); RIZIV website","NA"]
["Belgium","Eversense XL Transmitter","Roche Diagnostics Belgium (legal manufacturer: Senseonics)",2019,"Implant","Diabetes type 1, transdermal glucose monitoring system","Data collection active","CED","Bottom-up (requested by manufacturer)","NIHDI (National Institute for Health and Disability Insurance)","To confirm use of the device for specific subpopulations and/or indications","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care; The risk of adverse events and/or adherence problems","Set up of a registry","Number of patients, parameters at follow-up or during sensor replacement (e.g. adverse events linked to the system and sensor life), percentage of patients with a rightful claim who have stopped treatment with the implantable sensor and the reason, the number of premature replacements of implantable sensors and transmitters and the reason, Patients using an implantable sensor show similar results to those using other transdermal sensors for the continuous measurement of glucose values ​​in interstitial fluid in terms of: HbA1c/time spent in hypoglycemia, normoglycemia and hyperglycemia/hospitalizations as a result of hypoglycemia and ketoacidosis/absence from work/improving the quality of life, development of allergies for the adhesive material, direct and indirect costs. Retrospective analysis of direct medical costs, comparison of cumulative costs in the year before and after the implantation  as well as just before the implantation (consultation, diagnostic tests, implanatation). Costs to be assessed: costs associated with implant and replacement procedures, costs associated with treatment of adverse events during and after implantations, costs associated with hospitalisations.","NS","1) Conventional reimbursement via the list; 2) scientific report,","Interview (and validated by interviewee); RIZIV website","https://ondpanon.riziv.fgov.be/IRREQPublic/nl/?id=174370&date=30%2F03%2F2020"]
["Belgium","Watchman; Amplatzer","Boston Scientific Benelux; Abbott Medical Belgium",2017,"Implant: Percutaneous closure of the left atrial appendage","Non-valvular atrial fibrillation","Data collection active","CED","Bottom-up (requested by manufacturer)","NIHDI (National Institute for Health and Disability Insurance)","To confirm reimbursement status at the end of the scheme (e.g. if effectiveness or cost-effectiveness are confirmed, the technology will receive an unconditional reimbursement); To confirm use of the device for specific subpopulations and/or indications","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The relative efficiacy/effectivness in the real target population and/or in different population subgroups; The effects on long-term patient relevant outcomes; The risk of adverse events and/or adherence problems; Uncertainties related to the budget impact of introducing the technology; Uncertainties related to the true cost-effectiveness of the technology; Uncertainties related to the organizational impact of the technology","Set up of a registry","Number of treated patients, CHA2DS2-VASc and HASBLED population scores, contra-indication for anticagulation, number of severe peri-procedural side effects (days 0-7): death, stroke, systemic embolism, major bleeding, tamponade, implant migration, percentage of missing follow-up two months after the anticipated follow-up times, per nursing institution, serious “adverse events” at follow-up, percentage of technical success, antithrombotic therapy since device placement, cost-effectiveness, an analysis of the patient population in the registry, including at least: demographic data/an overview of the criteria that led to the decision to use the implant/procedural data/procedural safety and success/impact on stroke prevention (compared to the expected rate of stroke evaluated via the CHA2DS2-VASc score)/bleeding rate (compared to the expected risk calculated by the HASBLED score)/total and “event-free” survival/similarities and differences between nursing institutions with regard to the selection of the patients/the number of implantations per center/a discussion of this analysis, including a comparison of these results with those in the literature (clinical studies and registries), an analysis of the collected follow-up data. This includes at least: the deaths, with causes/the prevention of several important side effects up to one year after implantation or longer follow-up, if available/a discussion of this analysis, including a comparison of these results with those in the literature (clinical studies and registries), a retrospective analysis of direct medical costs, one year before implantation, before implantation itself (consultation, diagnostic testing and evaluation for implantation, implantation and hospitalization) and for each full year after implantation. The following costs are analyzed: number, duration and costs of admissions to a nursing institution due to closure of the left heart earpiece. The technical investigations related to diagnostics or treatment are included/number of visits and emergency costs/number of visits and costs at the GP or cardiologist/number, dose and cost of antithrombotic medications (ATC B01) and antihemorrhagics (ATC B02)/a discussion of this analysis/re-hospitalizations and the costs involved/percentage of missing follow-up two months after the anticipated follow-up times, per nursing institution/serious “adverse events” at follow-up/percentage of technical success/antithrombotic therapy since device placement","NS","2) NA; Overall impression of failure aspects of the scheme: problems with privacy committee and set-up of the registry; anything you would do differently: too early to come to conclusions","Interview (and validated by interviewee); RIZIV website","NA"]
["Belgium","Activa PC","Medtronic",2015,"Implant: Deep Brain Stimulation","Refractory epilepsy","Completed, re-assessment done - proposition for extension of BKT under slightly modified conditions","CED","Top-down (by the RIZIV)","NIHDI (National Institute for Health and Disability Insurance)","Literature: Uncertainty about effectiveness, safety, or condition of use; Interview: To confirm reimbursement status at the end of the scheme (e.g. if effectiveness or cost-effectiveness are confirmed, the technology will receive an unconditional reimbursement); To ensure appropriateness and quality of care","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care; The effects on long-term patient relevant outcomes; The risks of adverse events and/or adherence problems; Uncertainties relating to the true cost-effectiveness of the technology","Set up of a registry","Change in severity and frequenty of epileptic seizures, respons ratio (decrease of >= 50% in frequency of seizures), change in pharmaceutical treatment, change in hospitalization rate/consultation/visits to the accidents & emergency (A&E) department per year), improvement of functional skills, improvement of quality of life, side effects and adverse events, retrospective analysis of direct medical costs, comparison of cumulative costs in the years before and after the DBS implantation (costs associated with: number of visits to A&E department, general practitioner/neurologist, number and dose of anti-epileptic pharmaceuticals), indirect costs","NIHDI (National Institute for Health and Disability Insurance)","1) Conventional reimbursement via the list; 2) scientific report (peer-reviewed)","Carbonneil et al. (2009); Interview (and validated by interviewee); RIZIV website","NA"]
["Belgium","Activa PC; Activa SC","Medtronic",2016,"Implant: Deep Brain Stimulation","Obsessive compulsive disorder","Data collection active","CED","Top-down (by the RIZIV)","NIHDI (National Institute for Health and Disability Insurance)","To confirm reimbursement status at the end of the scheme (e.g. if effectiveness or cost-effectiveness are confirmed, the technology will receive an unconditional reimbursement); To confirm use of the device for specific subpopulations and/or indication","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care; The relative efficacy/effectiveness in the real target population and/or in different population subgroups; The effects on long-term patient relevant outcomes; The risks of adverse events and/or adherence problems; Uncertainties relating to the true cost-effectiveness of the technology","Set up of a registry","GAF score, Y-BOCS score, change in pharmaceutical treatment, quality and quantity of obsessions and compulsions, effect on psychiatric indicators, quality of life (side effects/adverse events, complications, and effect of DBS with device), type of device and type/number of electrodes, direct and indirect costs","NIHDI (National Institute for Health and Disability Insurance)","1) Conventional reimbursement via the list; 2) scientific report","Interview (and validated by interviewee); RIZIV website","NA"]
["Belgium","MARS; Prometheus","Baxter Gambro",2015,"Therapeutic","Acute-on-chronic liver failure ","Data collected, re-assessment being done","CED","Top-down (by the RIZIV)","NIHDI (National Institute for Health and Disability Insurance)","To confirm reimbursement status at the end of the scheme (e.g. if effectiveness or cost-effectiveness are confirmed, the technology will receive an unconditional reimbursement)","5 years","Temporary reimbursement from public funding. Based on results of the scheme the RIZIV committee will decide on permanent reimbursement of medical device.","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care; The relative efficacy/effectiveness in the real target population and/or in different population subgroups; differences in efficacy/effectiveness between the two devices","Set up of a registry","Type of device used, indications, number of patients and number of sessions per indication, number of transplants, adverse events, 3-month and 6-month survival and survival at the end of the CED scheme as well as cause of death","NIHDI (National Institute for Health and Disability Insurance)","1) Conventional reimbursement via the list; 2) scientific report; overall impression on failure aspects of the scheme: too little data to be able to obtain a final conclusion","Interview (and validated by interviewee); RIZIV website","NA"]
["England","Amplazer, GORE CARDIOFORM Septal Occluder and Figulla Flex","ST JUDE MEDICAL (now owned by ABBOTT) (Amplazer range), GORE (GORE CARDIOFORM Septal occluder, Occlutech (Figulla flex range)",2014,"Closure of patent foramen ovale (PFO closure) - a procedure which involves closing a hole, or potential hole, between the two upper (atrial) chambers of the heart with the aim of preventing recurrent cryptogenic stroke (stroke occurring in the absence of other known causes such as cardiac, pulmonary, vascular or neurological causes). The procedure is described in NICE IPG472","Patients who had had a confirmed ischaemic stroke presumed to be due to paradoxical embolism","Data collected, reassessment done","Commissioning through evaluation (CtE), OIR","A structured process exists for topic selection within the Commissoning through evaluation programme, involving the Clinical review groups, the Programme of Care Board the Clinical Panel and NICE. ","NHS England","To ensure effective and/or cost-effective use of the device in clinical practice (e.g., payment or reimbursement linked to individual patients’ outcomes)","3 years","No initial agreement on the decision rule at the end of the schemes are defined. After the scheme evaluation report is produced and published, will feed into NHS \"business as usual\" England’s process for the development of Clinical Commissioning Policies for directly commissioned specialised services. ","The relative efficacy/effectiveness in the real target population and/or in different population subgroups; the effects on long-term patient relevant outcomes (versus surrogates outcomes used in clinical studies); uncertainties related to the true budget impact of introducing the technology ","Set up of a registry","Primary outcomes: successful device implantation; in-hospital major complications (defined as death, neurological event of ischaemic, haemorrhagic or undetermined origin, device embolization, cardiac structural complications, major vascular problems, endocarditis, oesophageal rupture, major bleed, and additional surgery); in-hospital minor complications; post-discharge major and minor complications; confirmed PFO closure on contrast echocardiography. Secondary outcomes: death, neurological event, device embolization, major cardiac structural complications, myocardial infarction (MI), major vascular complications, endocarditis, oesophageal rupture, major bleed, additional surgery/intervention, device malfunction, device malposition, rhythm complications, minor cardiac structural complication, transient ST-elevation (no MI), minor embolic events, minor vascular complications, migraine/worsening migraine, oesophageal trauma, nickel allergy and minor bleeds.","NHS England Commissioning through Evaluation Programme","NHS England has updated its clinical commissioning policy for the intervention.","https://www.nice.org.uk/guidance/ipg472/chapter/3-The-procedure ","ID of the scheme NHSCB/A09/PS/a "]
["England","WATCHMAN; AMPLATZER Cardiac Plug (ACP); AMPLATZER Amulet","Boston Scientific (WATCHMAN); ST JUDE MEDICAL (Now owned by Abbott) (Amplatzer range)",2014,"Left atrial appendage occlusion (LAAO)  -  aims to reduce the risk of thromboembolic stroke by mechanically blocking the entrance to the appendage of the left atrium, which is known to be a frequent source of thromboembolism in patients with atrial fibrillation (AF).","Patients with AF with absolute or relative contraindications to anticoagulation and considered to be at high risk of thromboembolic events","data collected, reassessment to be done","Commissioning through evaluation (CtE), OIR","A structured process exists for topic selection within the Commissoning through evaluation programme, involving the Clinical review groups, the Programme of Care Board the Clinical Panel and NICE. Selection of MDs was informed by availability in the UK","NHS England","To ensure effective and/or cost-effective use of the device in clinical practice (e.g., payment or reimbursement linked to individual patients’ outcomes)","3 years ","No initial agreement on the decision rule at the end of the schemes are defined. After the scheme evaluation report is produced and published, will feed into NHS \"business as usual\" England’s process for the development of Clinical Commissioning Policies for directly commissioned specialised services. ","The relative efficacy/effectiveness in the real target population and/or in different population subgroups; Uncertainties related to the true cost-effectiveness of the technology","Set up of a registry","Primary outcomes: Device implanted, in-hospital major complications, in-hospital minor complications, extended length of stay (2 or more nights in hospital), post-discharge clinical failure, post-discharge major complications and post-discharge minor complications. Secondary outcomes: death, neurological event, pericardial effusion, embolization, additional intervention, major vascular complication, major bleeding complication, myocardial infarction (MI), acute kidney injury (AKI), endocarditis, device malfunction, device malposition, minor vascular complication, pericardial effusion (conservatively treated), procedural-related arrhythmia, minor bleeding complication, peripheral embolism and oesophageal damage","NHS England Commissioning through Evaluation Programme","As a result of the scheme, treatment with LAAO will be routinely funded","https://www.england.nhs.uk/publication/left-atrial-appendage-occlusion-commissioning-through-evaluation-report/"]
["England","Mitraclip","Abbott Medical",2013,"implant - Percutaneous mitral valve leaflet repair for mitral regurgitation ","Patients with severe grade 3 or 4 mitral regurgitation, deemed by an Multi-disciplinary team to be at too high risk or at high risk for conventional mitral valve surgery","data collected, reassessment done","Commissioning through evaluation (CtE), OIR","A structured process exists for topic selection within the Commissoning through evaluation programme, involving the Clinical review groups, the Programme of Care Board the Clinical Panel and NICE. ","NHS England. Scheme proposed by  Specialised Cardiology CRG, and run by Newcastle and York External Assessment Centre (EAC)","To ensure effective and/or cost-effective use of the device in clinical practice (e.g., payment or reimbursement linked to individual patients’ outcomes); to provide data on the safety, efficacy and costs of MitraClip in a real-world setting, and specifically to answer 11 pragmatic questions defined in the original scheme protocol","2 years","No initial agreement on the decision rule at the end of the schemes are defined. After the scheme evaluation report is produced and published, will feed into NHS \"business as usual\" England’s process for the development of Clinical Commissioning Policies for directly commissioned specialised services. ","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care; The relative efficacy/effectiveness in the real target population and/or in different population subgroups; The effects on long-term patient relevant outcomes (versus surrogates outcomes used in clinical studies); Uncertainties related to the true cost-effectiveness of the technology. The existing uncertainties were declined in 11 pragamatic questions in the scheme protocol. ","Set up of a single armed registry","Primary outcome measures included: device implantation, in-hospital major complications, in-hospital minor complications, new requirement for pacemaker, post-discharge major complications, post-discharge minor complications and mitral regurgitation over time. Secondary outcome measures included: death, embolisation, requirement for additional intervention, myocardial infarction (MI), pericardial effusion or tamponade requiring intervention, major vascular complication requiring intervention, mitral valve complication, neurological event, cardiogenic shock, major bleed, acute kidney injury (AKI) stage 1/2/3, endocarditis, oesophageal damage, device failure, partial detachment, pericardial effusion or tamponade treated conservatively, thrombus, new moderate or severe mitral stenosis, minor bleed, minor vascular complication","NHS England Commissioning through Evaluation Programme","NHSE has updated its commissioning policy for the procedure. ","https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2019/04/Percutaneous-mitral-valve-leaflet-repair-for-mitral-regurgitation-Commissioning-through-Evaluation-Report.pdf","ID of the scheme: NHSCB/A09/PS/b. \nNHS England commissioned a total of 180 MitraClip procedures in the cardiac CtE scheme. Each of the 3 centres was required to do no more than 40 procedures per financial year. As CtE commenced on 01/10/2014, each centre could do no more than 20 MitraClip procedures in those last 6 months of 2014/15. Funding was made available by NHS England for each centre to do 40 procedures in 2015/16, making 60 procedures per centre in total. Owing to slower than anticipated roll-out of the programme, centres were permitted, by NHS England Specialised Services Circular SSC 1669 (November 2016), to carry on with their 2015/16 activity plans in financial year 2016/17, up to the contracted number of 180 procedures in total for the MitraClip CtE programme."]
["England","NA","NA",2016,"Therapeutic - Stereotactic Ablative Body Radiotherapy (SBRT/ SABR) - precise irradiation of an image defined extra cranial lesion and is associated with the use of a high radiation dose delivered in a small number of fractions","Patients with Oligometastic Disease or Hepatocellular carcinoma, or undergoing re-irradiation of pelvis and spine","Reports submitted. Awaiting NHSE policy update","Commissioning through evaluation (CtE), OIR","A structured process exists for topic selection within the Commissoning through evaluation programme, involving the Clinical review groups, the Programme of Care Board the Clinical Panel and NICE. ","NHS England","NA","3 years","No initial agreement on the decision rule at the end of the schemes are defined. After the scheme evaluation report is produced and published, will feed into NHS \"business as usual\" England’s process for the development of Clinical Commissioning Policies for directly commissioned specialised services. ","Lack of comparator data","Cohort study","Overall survival (OS), progression free survival (PFS)\nPFS (LPS), health related quality of life and safety.","NHS England Commissioning through Evaluation Programme","NA","https://www.england.nhs.uk/commissioning/spec-services/npc-crg/comm-eval/","The web page on commissioning through evaluation programme in the NHS England site only provides info on the centres participating in the scheme and refer to the previous Clinical Commissioning Policy for Stereotactic Ablative Body Radiotherapy for NonSmall-Cell Lung Cancer (Adult). No other information are provided. "]
["England","NA","NA",2014,"Therapeutic - Selective Internal Radiation Therapy (SIRT) ","Patients with unresectable colorectal cancer liver\nmetastases or primary intrahepatic cholangiocarcinoma which has\nprogressed following standard chemotherapy","Data collected, re-assessment done","Commissioning through evaluation (CtE), OIR","A structured process exists for topic selection within the Commissoning through evaluation programme, involving the Clinical review groups, the Programme of Care Board the Clinical Panel and NICE. ","NHS England; External assessment centres: Birmingham and Brunel consortium then hand-overed to Cedar EAC","To ensure effective and/or cost-effective use of the device in clinical practice (e.g., payment or reimbursement linked to individual patients’ outcomes); to provide data on the safety, efficacy and costs of MitraClip in a real-world setting, and specifically to answer 11 pragmatic questions defined in the original scheme protocol","3 years","No initial agreement on the decision rule at the end of the schemes are defined. After the scheme evaluation report is produced and published, will feed into NHS \"business as usual\" England’s process for the development of Clinical Commissioning Policies for directly commissioned specialised services. ","The main uncertainties were declined in 7 pragmatic questions to be answered: 1. Does treatment with SIRT for the clinical indications covered within the CtE scheme increase overall survival? 2. Does treatment with SIRT for the clinical indications covered within the CtE scheme increase liver and wider progression free survival? 3. What is the patient experience of treatment with SIRT for the clinical indications covered within the CtE programme? 4. What is the actual cost, and relative cost-effectiveness, of treatment with SIRT for the clinical indications covered within the CtE programme? 5. Does the data suggest any differential benefit for particular cohorts of patients within the wider clinical indications covered within the scheme? 6. Are there any factors from the experience of provision within centres participating in the scheme that should be taken into account in terms of future service provision, should the service become routinely commissioned by the NHS? 7. Are there any research findings that have become available during the course of the CtE scheme that should be considered alongside the evaluative findings of the CtE scheme?","Set up of a registry","Overall survival (OS), progression free survival (PFS), liver-specific\nPFS (LPS), health related quality of life (HRQoL), and safety.","NHS England Commissioning through Evaluation Programme","NICE has now completed its independent evaluation of the SIRT CtE scheme.  The evaluation will support a planned review of the currently published NHS England clinical commissioning policy statement for the use of SIRT.","https://www.england.nhs.uk/publication/independent-evaluation-of-the-selective-internal-radiation-therapy-commissioning-through-evaluation-scheme/"]
["France","Ablatherm (HIFU)","EDAP-TMS",2014,"Therapeutic - high-intensity focused ultrasound (HIFU) device for the nonsurgical and noninvasive treatment of localized prostate cancer","Patients with the following characteristics: a) localized adenocarcinoma of the prostate in a patient aged 70 years or more, with a life expectancy estimated to be greater than five years;\nb) after local recurrence in a patient treated in first curative intention by external radiotherapy for a localized tumor initially accessible to surgical treatment, whose recurrence is proven histologically.","Data collection presumed active ","Forfeit innovation package, OIR","A dossier is submitted by the promoter of the study (industry, distributor, a national professional council et.). The forfait innovation is granted if the technology is considered innovative (Art 165-63 of the French Social Security code)  and the study protocol submitted is considered pertinent to the aim of the study. ","HAS; Minister for Solidarity and Health","NA","six years (2.5 years for inclusion period, 2.5 years of follow-up period and 1 year of data analysis period)","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Confirmation of the expected service (service attendu) and improvement in the expected service (ameloration du service attendu)","Observational study comparing HIFU to the reference treatment with radical prostatectomy","NA","The amount of the care package as defined in article L. 165-1-1 of the social security code including the procedure  and the associated hospital costs is fixed at 6,047 euros per patient. ","NA","https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000028927989&categorieLien=id","The total number of patients likely to benefit from the treatment is fixed at 5,100, including 2,550 patients for the study during its inclusion phase and, after all of the inclusions have been completed, 2,550 additional patients not included in the study, during the monitoring and data analysis phases."]
["France","Argus II","SecondSight",2014,"Therapeutic - Retinal Prosthesis System","Patients with the following characteristics: age ≥ 25 years; suffering from severe to deep external retinal degeneration; benefiting from a residual perception of light for both eyes. If there is no residual light perception, the retina must be able to respond to electrical stimulation; having had a useful vision of forms in the past.","Data collected, reassessment done","Forfeit innovation package, OIR","A dossier is submitted by the promoter of the study (industry, distributor, a national professional council et.). The forfait innovation is granted if the technology is considered innovative (Art 165-63 of the French Social Security code)  and the study protocol submitted is considered pertinent to the aim of the study. ","HAS; Minister for Solidarity and Health","To prove sufficient levels of expected service (service attendu) and improvement in the expected service (Amelioration du service attendu)","five years (two years of inclusion period, two years of follow-up period and one year of data analysis period)","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","A previous report from CNEDiMTS outlined a poor level of  clinical evidence, not sufficient to confirm a satisfactory level of Expected service  (service attendu)","Controlled, prospective, multi-centre, single-arm  study. Control will consist of three different matched comparisons: 1) Post vs. pre-implantation (Baseline) data. 2) Prospective within-subject comparisons (implanted vs. non implanted eye) 3) Prospective subjects' visual performance Argus II System ON vs Argus II System OFF - presumed ClinicalTrials.gov Identifier: NCT02303288","Functional vision and quality of life) as measured by the Functional Low-vision Observer Rated Assessment (FLORA); Incidence of procedure- and device-related adverse events; Patient Satisfaction and ease of use of the System through a questionnaire; Visual Function in terms of square location, directino of motion, grating visual activity; explantation rates ","The amount of the care package as defined in article L. 165-1-1 of the social security code including the procedure  and the associated hospital costs is fixed at €95,897 euros per patient. ","As the result of the study, in a subsequent report (2019),  the CNEDiMTS evaluated the expected service (service attendu) as sufficient and a level of  improvement in the expected service (Amelioration du Service attendu ASA) equal to III. Eventually the CNEDiMTS recommended the inscription of ARGUS II in the list of products and services qualifying for reimbursement for 5 years. Note that further evidence was required for the reassessment at the end of the 5 years inlcuding changes in quality of life (according to the IVI-VLV scale), evolution of functional vision (according to the ULV-VFQ scale). and log term outcomes","https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000029359406\nhttps://clinicaltrials.gov/ct2/show/NCT02303288?term=argus+II&draw=2&rank=4","The total number of patients likely to benefit from the treatment is set at 36, including 18 patients for the study during its inclusion phase and, after all of the inclusions have been completed. , 18 additional patients not included in the study, during the monitoring and data analysis phases"]
["France","Iris II","Pixium Vision",2017,"Implant - replaces the failing photoreceptor cells by stimulating by a beam of 150 electrodes of the retina cells. The generated signal is transmitted to the visual cortex by the optic nerve and the result is the patient's perception of phosphenes (luminous sensations).","Patients suffering from severe to deep peripheral retinal degeneration, benefiting or not from a residual perception of light and having had a useful view of the forms in the past","NA","Forfeit innovation package, OIR","This scheme is innovative because it meets all four criteria set out in Article R. 165-63 of the Social Security Code: 1) the device is new and would allow patients to be cared for in a therapeutic impasse. 2) the device is in the early stages of dissemination and does not warrant sufficient expected service given the available clinical studies; in addition It is not and has never been publicly taken into public support in the claimed indications; 3) Risks to patients were explored by the follow-up of small cohorts of medium-term patients implanted with the current or previous generations of devices; 4.\tPreliminary results from two clinical studies(Clinical.Trials.gov: NCT01864486, NCT02670980) indicate that IRIS II is likely to provide a significant clinical benefit in terms of therapeutic effect to meet an uncovered or under-covered medical need for patients with rare medical conditions.","HAS; Minister for Solidarity and Health","To demonstrate the clinical benefit of the IRIS II prosthesis ","2 years","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","clinical benefit of the device","NA","A validated scale forpatients with very low vision (ULV-VFQ scale). ","NA","NA","https://www.has-sante.fr/upload/docs/application/pdf/2017-09/ac_2017_0077_innov_5_iris_ii_cd_2017_09_20_vd.pdf","Only positive opinion from the HAS. National decree still to be published on the Government ufficial journal\n\nA previous application for the scheme was presented in 2017 and rejected by the HAS (https://www.has-sante.fr/upload/docs/application/pdf/2017-05/dir19/ac_2017_0055_forfait_inov_5_iris_ii_cd_2017_05_03_vd.pdf)"]
["France","Retina Implant Alpha AMS","Retina Implant",2017,"Implant - A microchip similar to a camera chip is implanted in the macula region, between the outer retinal layer and the retinal pigment epithelium. The chip's 1,600 pixel cells capture light and convert it into electrical impulses and stimulate the layer of bipolar nerve cells. The generated signal is transmitted to the visual cortex via the optic nerve, resulting in the perception of phosphenes (light points)","Patients suffering from severe to deep peripheral retinal degeneration, benefiting or not from a residual perception of light and having had a useful view of the forms in the past","Study presumably stopped (as per update in clinicaltrials.org)","Forfeit innovation package, OIR","This scheme is innovative because it meets all four criteria set out in Article R. 165-63 of the Social Security Code: 1) the device is new and would allow patients to be cared for in a therapeutic impasse. 2) the device is in the early stages of dissemination and does not warrant sufficient expected service given the available clinical studies; in addition It is not and has never been publicly taken into public support in the claimed indications; 3) Risks to patients were explored by the follow-up of small cohorts of medium-term patients implanted with the current or previous generations of devices; preliminary results from three clinical studies(Clinical.Trials.gov: NCT00515814, NCT01024803, NCT0149779) indicate that RETINA IMPLANT ALPHA AMS is likely to provide significant clinical benefit in terms of therapeutic effect to meet an uncovered or insufficiently covered medical need for patients with rare conditions.","HAS; Minister for Solidarity and Health","to evaluate the efficacy of RETINA IMPLANT ALPHA AMS ","2 years","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Effects on patients daily life, safety","Single arm, open label, prospective study - presumed ClinicalTrials.gov Identifier: NCT03561922","Change in functional vision through the tool Instrumental Activities of Daily Living; Vision Related Quality of Life through the validated patient reported outcome questionnaire, IVI-VLV; Visual Function through the validated questionnaire ULV-VFQ; Number, nature and severity of device-related and implantation-related adverse events. ","The amount of the care package as defined in Article L. 165-1-1 of the Social Security Code, including the care of the act and the associated hospital costs, is thus set per patient at 35,820 €. For additional patients when enrollment will be completed the price will be 123,291€","Study presumibly stopped in April 2019","https://www.has-sante.fr/upload/docs/application/pdf/2017-09/ac_2017_0078_innov_7_retina_implant_alpha_ams_cd_2017_09_20_vd.pdf\nhttps://www.legifrance.gouv.fr/eli/arrete/2018/6/1/SSAH1815270A/jo/texte/fr\nhttps://clinicaltrials.gov/ct2/show/study/NCT03561922?term=RETINA+IMPLANT&draw=2&rank=1\n","A study on Clinicaltirals.org presumably related to the scheme was identified and information retrieved"]
["France","Embotrap II","Johnson and Johnson Medical SAS",2018,"Implant, stent retriever","Management of patients with acute ischemic stroke related to proximal occlusion of a large intracranial artery, visible on imaging, within 6 hours of the onset of symptoms, used immediately with intravenous thrombolysis. It can also be used as a remedy in case of failure of intravenous thrombolysis treatment or alone in case of contraindication to thrombolysis  ","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","Study should be conducted and results reported by the time of reassessment for the inclusion  of the device in the list of products and services qualifying for reimbursement. The reassessment is set at 3 years from the first coverage decision. ","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The adverse events related to the procedure and the device;  the indications in which this device is used and the conditions of use. ","Registry","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/application/pdf/2019-02/embotrap_ii.pdf\n"]
["France","Exem Foam (preparation kit for hyperechoic product)","IQ-Medical Ventures. Demand in France submitted by MEDIPHA SANTE ",2018,"Diagnostic - Single-use unit kit containing the following 3 sterile elements: 1) 10 ml syringe containing 5 ml of ExEm Gel; 2) 10 ml syringe containing 5 ml of ExEm Water,: 3) 1 coupling device \n","Visualization of tubal permeability with ultrasound through endocaviary foam injection (hystero-salpingo-sonography-foam [HyFoSy]),  as part of an infertility check-up.","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","3 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The Commission subordinates the renewal of registration to the transmission of data under real-world conditions documenting the interest of the Hystero-salpingo-Foam-Sonography (HyFoSy) exploration procedure associated with ExEmFoam Kit in the course infertility assessment: this interest will be appreciated in light of the impact on reference tubal exploration examinations and the complications identified.","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/evamed/CEPP-5596_EXEM%20FOAM%20KIT%20FK05_18_d%C3%A9cembre_2018_(5596)_avis.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2019-02/exem_foam_kit_fk05_transcription_du_6_novembre_2018.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2019-02/exem_foam_kit_fk05_transcription_du_18_decembre_2018_pc.pdf"]
["France","Theraclion ","Echopulse",2017,"Therapeutic -  robotic application of high-intensity focused ultrasound (HIFU) with ultrasound guidance","Patients with breast fibroadenomas","Data collection presumed active ","Forfeit innovation package, OIR","The device considered innovative because it meets all four criteria set out in Article R. 165-63 of the Social Security Code","HAS; Minister for Solidarity and Health","To demonstrate that \"the treatment of breast fibroadenomas with guided echo focused ultrasound is less expensive and as effective as surgery.\"","Four years (one year of inclusion, one and a half years of follow-up period, six months of data analysis period and one year for reassessment processes by the High Health Authority and , if a sufficient expected service is obtained, pricing by the CEPS or Health Insurance","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Confirmation of the expected service (service attendu) and improvement in the expected service (ameloration du service attendu)","Multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective - presumed ClinicalTrials.gov Identifier: NCT03742401","Difference in cost between the HIFU procedure and conventional surgery; Evaluation of the clinical effectiveness in both arms (No improvement on vas anxiety; No improvement on vas pain; No volume regression); Rate of corrective surgical procedure after non effective HIFU procedure up to 18 months; Number of and severity of adverse events in both arms. ","The amount of the care package as defined in Article L. 165-1-1 of the Social Security Code, including the care of the act and the associated hospital costs, is thus set per patient at 35,820 €. For additional patients when enrollment will be completed the price will be 1,300€","NA","https://www.has-sante.fr/upload/docs/application/pdf/2016-06/a_2016_0043_college_ineligibilite_echopulse_07062016_post_college.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2016-12/ac_2016_0076_favorable_forfait_innovation_echopulse_cd_2016_12_07_vd_2016-12-14_12-39-24_66.pdf\nhttps://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000035070633&categorieLien=id\nhttps://clinicaltrials.gov/ct2/show/NCT03742401?term=echopulse&draw=2&rank=9","The total number of patients eligible to the procedure with echopulse is set at 600, including 150 patients under the study during its inclusion phase and, after all inclusions have been completed, and 450 additional patients not included in the study, during the follow-up, data analysis and reassessment phases by the High Health Authority and then pricing by the CEPS or Health Insurance if necessary. \n\nA previous application for the scheme was presented in 2016 and rejected by the HAS"]
["France","Bluepro","BLUESOM ",2018,"Therapeutic - mandibular advanced orthotic","Adult patients with obstructive sleep apnea/hypopnea and at least three of the following symptoms: daytime drowsiness, severe and daily snoring, feelings of suffocation or suffocation during sleep, daytime fatigue, nycturia, morning headaches.","Presumed active","Forfeit innovation package, OIR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment after 5 years","Study should be conducted and results reported by the time of reassessment for the inclusion  of the device in the list of products and services qualifying for reimbursement. The reassessment is set at 5 years from the first coverage decision. ","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The proportion of patients moving towards a bespoke OAM at 6 months and the duration of the test period","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/evamed/CEPP-5616_BLUEPRO_17_juillet_2018_(5616)_avis.pdf"]
["France","PICSO system","MIRACOR MEDICAL S.A",2018,"Therapeutic -  The system is intended to perform intermittent occlusion of the coronary venous sinus with the aim of reducing the size of myocardial infarction","Acute coronary syndromes with ST segment over-shift (SCA ST), in patients with lesions of the left coronary arteries","NA","Forfeit innovation package, OIR","The technology is considered innovative (Art 165-63 of the French Social Security code) because there is no technique with an equivalent mode of action used routinely in the claimed indication. The PICSO system has never been publicly supported in the indication described. It is in the early phase of dissemination and does not justify a sufficient expected service given the available clinical studies (5 specific feasibility studies of the PICSO system). The risks associated with the use of the PICSO system have been previously characterized. ","HAS; Minister for Solidarity and Health","To collect evidence as necessary to assess the improvement in the expected service. ","NA","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Confirmation of the expected service (service attendu) and improvement in the expected service (ameloration du service attendu)","Comparative study ","NA","NA","NA","https://www.has-sante.fr/jcms/c_2870256/fr/avis-n-2018-0032/ac/sed-du-18-juillet-2018-du-college-de-la-haute-autorite-de-sante-relatif-a-la-prise-en-charge-derogatoire-de-picso-en-application-de-l-article-l-165-1-1-du-code-de-la-securite-sociale","Only positive commentary from the HAS. National decree on the Government ufficial journal not found"]
["France","Brain Port Vision Pro","WICAB",2019,"Therapeutic - non-implantable electronic assistance device that allows the transmission of images captured by a digital camera in the form of electro-tactile signals on the patient's tongue. Electrical impulses are different depending on the intensity of the light and the location of the objects","Adult or child patients (aged at least 8 years) with blindness regardless of etiology","Data collection presumed active ","Forfeit innovation package, OIR","Device considered innovative according to the criteria set in Art 165-63 of the French Social Security code: there is no technique with an equivalent mode of action used routinely in the claimed indication; the device has never been publicly supported in the indication described; it is in the early phase of dissemination and does not justify a sufficient expected service given the available clinical studies (5 feasibility studies specific to the previous generation BRAINPORT V100 system whose results are extrapolable to the BRAINPORT VISION PRO generation); the risks associated with the use of the BRAINPORT VISION PRO system have been previously characterized. ","HAS; Minister for Solidarity and Health","To prove sufficient levels of expected service (service attendu) and improvement in the expected service (Amelioration du service attendu)","3 years (two years of inclusion and follow-up period, one year of data analysis and reassessment by the HAS and, if obtaining a sufficient expected service, pricing as the case by the CEPS or the assurance maladie) ","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Proof of expected service (service attendu)","Longitudinal, prospective, non-randomized, open and multicenter clinical study ","NA","The amount of the care package as defined in article L. 165-1-1 of the social security code including the procedure  and the associated hospital costs is fixed at €11,265 euros per patient. ","NA","https://www.has-sante.fr/upload/docs/application/pdf/2018-09/ac_2018_0035_innov_17_brainport_vision_pro_cd_2018_09_12_vd.pdf\nhttps://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000039699229&categorieLien=id","The total number of patients eligible for treatment  is set at 185, including 125 patients under the study, and, when all inclusions are completed, an additional 60 patients are not included in the study, during the follow-up phases, analysis of the data and reassessment by the HAS and then pricing by the CEPS or assurance maladie if necessary.\n"]
["France","dNERVA","NUVAIRA ",2019,"Therapeutic - targeted lung denervation catheter ","Patients with GOLD D stage COPD despite optimal medical management","NA","Forfeit innovation package, OIR","The technology is considered innovative (Art 165-63 of the French Social Security code) because there is no technique with an equivalent mode of action used routinely in the claimed indication. The submitted study protocol was considered pertinent to the aim of the study. ","French National Authority for Health (HAS) ","To collect missing data identified as necessary to assess the improvement in expected service","NA","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Confirmation of the expected service (service attendu) and improvement in the expected service (ameloration du service attendu)","French arm of a prospective and multi-center international trial validated by the US Food and Drug Administration - 8 French investigational centres are involved (Strasbourg, Grenoble, Reims, Paris, Toulouse, Montpellier, Nantes and Nice) ","NA","The study is funded by the company","NA","https://www.has-sante.fr/upload/docs/application/pdf/2019-04/ac_2019_0021_forfait_innovation_dnerva_cd_2019_04_10_vd.pdf","Only positive opinion from the HAS. National decree still to be published on the Government ufficial journal"]
["France","Istent inject ","GLAUKOS",2018,"Implant - micro-invasive glaucoma surgery (MIGS),  trabecular micro-bypass containing 2 stents","Patients with cataracts eligible for phacoemulsification and chronic open angle glaucoma of mild to moderate grade poorly balanced by hypotonizing drug treatments (bi- or tritherapy) or being intolerant to them.","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","Long term effects on safety (rate of obstruction of the device)  and efficacy (reduction in intraocular pressure)","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/application/pdf/2018-08/istent_transcription_du_29_mai_2018.pdf\nhttps://www.has-sante.fr/upload/docs/evamed/CEPP-5629_iSTENT%20INJECT_12_juin_2018_(5629)_avis_occultation.pdf\n\n"]
["France","WISE CRT","EBR systems",2019,"Implant - cardiac resynchronization medical device ","Patients with persistent symptomatic heart failure despite optimal drug treatment, meeting the current criteria for eligibility for cardiac resynchronization therapy (CRT) but considered \"non-responders\" to conventional cardiac resynchronization devices","Data collection presumed active ","Forfeit innovation package, OIR","Device present a novelty character because there is no technique with an equivalent mode of action used routinely in the claimed indication. The study protocol submitted by the promoter is deemed adecuate","HAS; Minister for Solidarity and Health","To collect evidence as necessary to assess the improvement in the expected service. ","48 months","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Evidence on  the efficacy and safety of the device and associated procedure. ","Prospective, multi-center, randomized, randomized clinical study ","NA","The amount of the care package as defined in article L. 165-1-1 of the social security code including the procedure  and the associated hospital costs is fixed at €25,600 euros per patient. ","NA","https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000038133641&categorieLien=id\nhttps://www.has-sante.fr/upload/docs/application/pdf/2018-09/ac_2018_0037_innov_19_wise_crt_cd_2018_09_12_vd.pdf\n"]
["France","Ponto ","OTICON MEDICAL AB (Sweden), applicant: PRODITION (France)",2018,"Implant - integrated osteo hearing aid","Patients with transmission deafness or mixed deafness for which mid-ear surgery cannot be performed and traditional aerial or bone apparatus are ineffective or impossible; or Patients with at least severe unilateral neurosensory deafness ","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","Short and medium-term complications; hearing quality for sensorineural hearing loss, in terms of auditory comfort, improved spatial location and\n understanding in noise","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","The first assessment of PONTO devices occurred in 2012 but the CNEDiMTS voted for a not sufficient expected clinical benefit (Service attendu, SA), which was granted in a second application in 2014. The approval in 2014 was made conditional to the conduction of a post registration study to confirm the benefit, tolerance and compliance of the device. However, the evidence provided by the manufacturer at the time of the renewal of the registration in the List of products and services qualifying for reimbursement was deemed incomplete by the CNEDiMTS and not sufficient to issue an unconditional reimbursement opinion, mainly because of the limited followup of patients. Therefore the requirements of a new post-registration study was issued again in the 2018 assessment. ","https://www.has-sante.fr/upload/docs/evamed/CEPP-4601_PONTO_08_avril_2014_(4601)_avis.pdf\nhttps://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-5993_PONTO%204_02_juillet_2019_(5993)_avis.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2018-04/ponto_transcription_du_19_decembre_2017.pdf\n"]
["France","Ranger ","Boston Scientific",2017,"Therapeutic - Paclitaxel eluting balloon","Patients with peripheral artery disease before critical limb ischemia stage or with intermittent claudication due to a de novo lesion (lenght of the stenosis between 20 mm and 150 mm and rate of occlusion higher thatn 70% (less or equal 10 cm) of the femoropopliteal artery above the knee and with a reference diameter between  4 and 7 mm","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","Lack of specific data for French clinical practice. Effects on clinically meaningful outcomes including limb rescue,  improvement in walking, pain relief, overall survival, re-intervention rate and number of implanted endoprothses. ","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/jcms/c_2801851/fr/ranger"]
["France","PULSANTE","Autonomic Technologies Inc",2019,"Therapeutic - pain management by performing a neuromodulation of thesphenopalatin lymph node ","Patients suffering from cluster headaches ","Data collection presumed active ","Forfeit innovation package, OIR","The college considered that PULSANTE was innovative in relation to the four eligibility criteria set out in Article R. 165-63 of the Social Security Code. ","HAS; Minister for Solidarity and Health","To assess the expected service improvement in a manner relevant to other ongoing clinical studies.","Three years and four months (two years and four months of inclusion and follow-up period, one year of data analysis and reassessment by the HAS and, if obtaining an expected service, pricing according to the CEPS or health insurance","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","Confirmation of the expected service (service attendu) and improvement in the expected service (ameloration du service attendu)","Multicenter, randomized cross-over  double-blind study comparing the use of the medical device system when ON versus system when OFF","NA","The amount of the care package as defined in Article L. 165-1-1 of the Social Security Code, including the care of the act and the associated hospital costs, is thus set per patient at 35,820 €. For additional patients when enrollment will be completed the price will be 29,670 €","NA","https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000038033955&categorieLien=id\nhttps://www.has-sante.fr/upload/docs/application/pdf/2018-03/ac_2018_0008_innov_09_pulsante_cd_2018_02_21_vd.pdf\n","The total number of patients eligible for the care mentioned in Article 1 of this order is set at 180, including 60 patients under the study during its inclusion phase and, when all inclusions are completed, 120 patients additional studies, during the follow-up, data analysis and y reassessment by the HAS and then pricing by the CEPS or assurance maladie if necessary.\n\nA previous application for the scheme was presented in 2017 and rejected by the HAS (https://www.has-sante.fr/jcms/c_2792605/fr/avis-n-2017-0075/ac/sed-du-6-septembre-2017-du-college-de-la-haute-autorite-de-sante-relatif-a-la-prise-en-charge-derogatoire-prevue-a-l-article-l-165-1-1-du-code-de-la-securite-sociale-de-pulsante)"]
["France","Reveal linq ","Medtronic ",2015,"Implant - etiological diagnosis of recurrent unexplained syncope after initial clinical evaluation, and \netiological diagnosis of cerebral ischemic accidents","Several criteria defined in the CNEDiMTS notice,  which must be verified by an ad hoc multidisciplinary team involving a neurovascular neurologist and a rhythmologist. The REVEAL LINQ device is not indicated in patients fitted with a pacemaker with ear probe and whose programming is adapted to the detection of atrial fibrillation.","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","In the first 2015 assessment, the duration of the temporary registration in the LPPT was aligned to the one of the previous generation of the device (REVEAL XT), in the subsequent re-assessment in 2018, the duration of the registration was set at 5 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The CNEDiMTS has accepted the generalization of other data from the previous version of the device (REVEAL XT). The therapeutic changes and the occurrence of transient strokes/ischemic accidents 3 years after implantation of the REVEAL heart monitor in a real life setting were still considering missing. ","Follow up study","The assessment of therapeutic changes and the occurrence of strokes/transient ischemic accidents at least at 1 year for all patients enrolled","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","in the 2018 re-assessment no evidence from the post-registration study was provided and the committee renewed its request for the study to be done. ","https://www.has-sante.fr/upload/docs/evamed/CEPP-4799_REVEAL%20LINQ_16_juin_2015_(4799)_avis.pdf\nhttps://www.has-sante.fr/upload/docs/evamed/CEPP-5470_REVEAL%20LINQ_18_d%C3%A9cembre_2018_(5470)_avis_occultation.pdf"]
["France","CARMAT - total bioprosthetic orthotopic artificial heart","CARMAT",2020,"Implant - Total artificial heart","Patients with advanced biventricular heart failure waiting for a heart transplant and who do not respond to optimal medical management","Scheme to be initiated: the sponsor received positive opinion on the eligibility of the device to the scheme. Comments were made for modifications of the study protocol. ","Forfeit innovation package, OIR","The device was considered to have a novelty character linked to technological developments made compared to other available bi-quantum assistance, including the use of biological materials for surfaces in contact with blood, the device ability to self-regulate and the provision of lighter and quieter external equipment (consoles and batteries). Also the study protocol submitted is considered pertinent to the aim of the study (conditional of required modifications to the protocol)","HAS; Minister for Solidarity and Health","To collect evidence on the expected service (Service attendu) and expected service improvement  (Amélioration du service attendu) of the device","NA","NS (No agreement at the end of the study is forseen with Forfait Innovation schemes)","The device does not currently warrant sufficient expected service in light of the available clinical data on a feasibility study and an ongoing study for CE marking. The risks associated with the use of the CARMAT TAH device have been characterized. Indeed, the results in the 2 available studies reported high rates of serious adverse events and some technical dysfunctions encountered during the studies led to incremental modifications of the device to improve its reliability","A non-randomized, multi-center prospective study with external comparator submitted by the company was  considered appropriate to gather required clinical data. A RCT was not deemed feasibile because, given the size of the target population it cannot include within a reasonable time the number of subjects needed for this type of study. ","Survival rate at 180 days after implantation without debilitating stroke or up to heart transplantation","NA","NA","https://www.has-sante.fr/upload/docs/application/pdf/2020-02/ac_2020_0012_forfait_innovation_carmat_cd_2020_02_12_vd.pdf","Only positive opinion from the HAS. National decree still to be published on the Government ufficial journal"]
["France","SOFIA and SOFIA PLUS","MicroVention",2019,"Therapeutic - distal access catheters used with a manual suction system (syringe) ","Patients with acute ischemic stroke, in relation to a proximal occlusion of a large-caliber intracranial artery, visible to imaging ","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","3 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The eligibility criteria (clinical, imaging) of patients for thrombectomy","Registry","Rate of adverse events related to the procedure and the device, the indications in which this device is used and the methods of use","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/application/pdf/2020-03/sofia_sofia_plus_17_decembre_2019_6076_6131_avis.pdf"]
["France","DBLG1","DIABELOOP",2020,"Therapeutic - external medical device that connects 3 components: a continuous glucose monitor (CGM), an insulin patch pump and a locked-down handset that hosts the Diabeloop decision-making algorithm","Patients with Type 1 diabetes whose glycemic balance is insufficient despite a well conducted insulin therapy by continuous subcutaneous infusion of insulin for more than 6 months and a multi-daily self-monitoring glycemic surveillance","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","3 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The impact in the target population of the DBLG1 system on the glycemic balance and quality of life of patients in the medium term; the absence of risk associated with the use of the system, especially on the occurrence of episodes of severe hypoglycemies. The need for data on the real  rate of use of the semi-closed loop system. ","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-5998_DBLG1%205998_occultation.pdf","The Sesame form completed by the company DIABELOOP at HAS shows that the company does not not claim a particular impact of its product DBLG1 ™ SYSTEM on the organization of care, professional practices or conditions for taking care of the sick. In addition, the turnover of the product DBLG1 ™ SYSTEM, as defined in article 1 of the decision 2013.0111 / DC / SEESP, is less than twenty million euros. As a result, the product DBLG1 ™ SYSTEM is not likely to have a significant impact on the expenses of health insurance within the meaning of article R.161-71-1, I, 2 ° of the social security code. There are no specific comments on the draft decision. The college unanimously adopts the decision noting that there is no significant impact DBLG1 ™ SYSTEM product on health insurance expenses. "]
["France","BHR","Midland Mechanical Technologies in the 2004 notice from CNEDiMTS; Smith and Nephew Orthopaedics in all subsequent notices. ",2004,"Implant - total hip replacement","Young and active patients with coxarthritis - BHR is indicated in patients: 1) under the age of 50 (this age limit is indicative); having (practicing) a physically demanding professional (sporting) activity before the intervention; whose life plan after the intervention involves the pursuit of this type of physically demanding activities, and; whose physiological state (bone quality in particular) and morphology (diameter of native femoral head greater than or equal to 48 mm, in particular) are compatible with the implantation of a total resurfacing prosthesis. [Indication as reported from 2015 onwards after modifications compared to previous notices]","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years after the first assessment in 2004; 5 years period in the renewal by CNEDiMTS in 2008; 3 years in 2011; 5 years in 2015 and 3 years in 2019","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","In 2004, main uncertainties outlined included: rate of implant migration, frequency of dislocations, and implant revision rate. In the 2008 renewal of the registration of BHR in the list of product and services eligible for rimbursement, the CNEDiMTS required a post-registration study reporting on: the survival rate of the implants; a description of the complications; an evaluation of the likelihood of recovery (surgery time, blood losses, inpatient stay); and the dosage of chromium and cobalt metal ions released in implanted patients in the long term. In the 2011 renewal, 5 more studies were submitted. These confirmed the interest in the technology, but raised more concerns about the risk of resurfacing prostheses in terms of surgical recovery and safety (releasing metal ions by metal on metal hip prostheses that include resurfacing prostheses). In the 2013 following an overall assessment of metal on metal hip prostheses and a re-evaluation of all products of this type registered in the list of product and services eligible for reimbursement uncertainties were reported on the superiority of metal on metal hip implant compared to metal on polyethylene hip resurfacing, in terms of implant survival rate, and functional performance. In the 2019 assessment the CNEDiMTS noted that data documenting the long-term survival of the BHR implant in the French context, as well as data confirming the functional value of the BHR resurfacing prosthesis; the early recovery of physically demanding  professional and/or sport activities, the likelihood of recovery from surgery; and the dosage of chromium and cobalt metal ions released in implanted patients were still missing. ","A 10 years follow up study with an interim update at 4 years was requested in 2004 by the CNEDiMTS in the first assessment. In the 2008 renewal of the registration in the list of products and services eligible for reimbursemen the CNEDiMTS conditioned reimbursement to the inclusion of BHR in the registry of hip replacements set up by the French Society of Orthopaedic and Trauma Surgery (SOFCOT). No information are available for the design of the required post-registration study. ","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","In the 2011 renewal the CNEDiMTS regretted not having at least the study protocol of the post-registration study requested in 2008, and insisted for receiving a yearly update on the status of the study. The commission also complained a lack of completeness of the data reported in the national register of hip replacements set up by the SOFCOT. In the 2015 renewal, updated data was provided from the national registres from UK, Australia and New Zealand, but the intermediate data from the requested post-registration study were not provided. Various versions of the protocol have been discussed in 2014 in tripartite consultation meetings between HAS, CEPS and the manufacturer, but not yet finalized at the time of the assessment. In the 2019 assessment new studies were submitted as evidence, including the preliminary results of the French resurfacing registry. Average FU was 10.2 months which was considered insufficient to allow the interpretation of the results, especially in terms of the survival rate of the prosthesis. In addition the CNEDiMTS outlined poor reporting also for other endpoints including the included functional scores, information on metal ion dosages and recovery of physically demanding sport and professional activities.","https://www.has-sante.fr/jcms/c_398611/fr/bhr-birmingham-hip-resurfacing\nhttps://www.has-sante.fr/jcms/c_676088/fr/bhr\nhttps://www.has-sante.fr/jcms/c_1054314/fr/bhr-27-septembre-2011-3267-avis\nhttps://www.has-sante.fr/jcms/c_1614977/fr/bhr-prothese-totale-de-hanche-de-resurfacage\nhttps://www.has-sante.fr/jcms/c_2006722/fr/bhr-birmingham-hip-resurfacing\nhttps://www.has-sante.fr/jcms/p_3145936/fr/bhr-birmingham-hip-resurfacing"]
["France","NEURX DPS RA4","Synapse Biomedical",2009,"Implant - intradiaphragmatic phrenic nerve stimulation device","Patients dependent on external mechanical ventilation in the following indications: high traumatic spinal lesions (strictly above C4); congenital or acquired central alveolar hypoventilation.","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years renewal time in the first assessment in 2009, and renewed in 2016 and 2019","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","In 2009, the main sources of uncertainty related to improvements in quality of life and morbidity and mortality with NEURX RA/4, including: deaths, quality of life, episodes of respiratory infections; hospitalization rates (regardless of the reason); use of technical resources. For patients with central hypoventilation, data on sleep recording, 3 months after implementation, and during the annual monitoring report were also required","Database set up by the manufacturer ","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","In the 2016 renewal the manufacturer provided more studies to support the device, but the CNEDiMTS reported that no results relating to the post-registration study requested in 2009 had been submitted, and thereore still conditioned the renewal of the registration of the device to the submission of the same study requested in 2009. The same issue was reported in the 2019 renewal.  ","https://www.has-sante.fr/jcms/c_2622939/fr/neurx-dps-ra/4\nhttps://www.has-sante.fr/jcms/c_2675255/fr/neurx-dps-ra/4\nhttps://www.has-sante.fr/jcms/p_3143747/fr/neurx-dps-ra/4"]
["France","ZILVER PTX","Cook ",2010,"Implant - Drug-Eluting Peripheral Stent","Treatment of symptomatic lower limb arteriopathy attributable to lesions (length <14 cm) of the femoro-popliteal arteries above the knee, with a reference diameter between 4 and 7 mm, after failure of the balloon angioplasty. ","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years conditional registration for the first assessment in 2010, 3 years in the following reassessment in 2016 and 5 years in 2019. ","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","In 2010, the main sources of uncertainty were about the medium and long term  efficacy and tolerance of ZILVER PTX based on clinical and velocimetric criteria, in a  real conditions of use of these endoprotheses . ","The CNEDiMTS recommended in 2010 a study representative of the target population, possibly providing subgroup analyses. Prospective, multicentre observational study, enrolling about 120 patients. ","The primary endpoint will be the absence of revascularization of the target lesion (RLC) at 12 months","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","In the 2016 renewal the manufacturer provided more studies to support the device, including the preliminary results of the post-registration study. However, these were considered too preliminary to be taken into consideration, and the requirement of providing the final results of the study was renovated. By the following reassessment the study reported results 119 patients, 113 of whom were followed at 24 months of age, although the committee still required the definitive results of the study originally requested in 2010. ","https://www.has-sante.fr/upload/docs/application/pdf/2011-09/zilver-09_novembre_2010_2807_avis.pdf\nhttps://www.has-sante.fr/jcms/c_2677779/fr/zilver-ptx\nhttps://www.has-sante.fr/jcms/p_3145957/fr/zilver-ptx\n","In the 2010 notice, the CNEDiMTS ecplicitly states that the post-registratino study should be implemented no later than one year after the publication of the committee opinion, and that an annual communication of the results of the study would be required. The evaluation of the results may result in the continuation or removal of the inclusion of the device in the list of products and services eligible for reimbursement. "]
["France","TAVI (PORTICO device)","ST JUDE MEDICAL",2019,"Implant - minimally invasive surgical procedure wedging a replacement valve into the aortic valve's place","Patient with symptomatic severe aortic stenosis (indexed aortic valve surface 0.5 cm2/m2) either: 1) contraindicated to aortic valve replacement surgery. The contraindication is characterized by a logistic Euroscore greater or equal to 20% or a STS score greater or equal to 10%. 2) High risk. The high risk is characterized by an STS score between 8 and 10% and a risk of mortality or irreversible surgical morbidity (up to 30 days post-operative) greater than 15%. Patients with a life expectancy of less than 1 year due to extracardiac factors (comorbidities) are not eligible for the technique.","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","Beyond requiring an update of the ongoing studies, including , the pivotal study for FDA market authorization, and the French  transcatheter aortic valve implantation (TAVI) registry, the CNEDiMTS opinion also included a request for additional evidence related to: the symptomatology and quality of life of patients (on validated scales); the durability (valve thrombosis, endocarditis, non-structural valve dysfunction, moderate to severe structural valve dysfunction, failure of the prosthetic valve according to the standardized definitions of the current EAPCI-ESC-EACTS consensus), in the long term (5 years then 10 and 15 years). \n","NA","NA","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/jcms/p_3135956/fr/portico"]
["France","INTERSTIM II","Medtronic",2008,"Implant - system which electrically stimulates the sacral nerve which is thought to normalize neural communication between the bladder and brain and between the bowel and brain (second generation of the device)","Urinary indications: Chronic urinary retention with hypertonia of the sphincter streak, without detecable urological cause (\"so-called retentionist disorders\"), not respondent to conservative treatments, or debilitating pollakiuria with or without incontinence caused by imperiositis (urgent) and debilitating imperiositis (so-called \"irritatory\" disorders), not responent to conservative treatments. Fecal indications (since 2009): Fecal incontinence, not respondent to conservative treatments, with a sphincter functional anal defined as follows: Sphincter anal intact (without lesion or after sphincter repair); or altered sphincter, if the size of the lesion does not justify a sphincter repair.","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","5 years for the urinary indications in 2005, extended for other 3 years in 2010 and 5 years in 2013 and 2019. Two years for the fecal indications in 2009, extended for other 5 years in 2013 and 2019. ","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The first version of the device in the CNEDiMTS opinion in 2005 lacked clear evidence on the long term clinical benefit,  complication rates and the lifetime of the device. A post-registration study was therefore required for renewal of the registratino for the urinary indications. The request was extended to the second version of INTERSTIM in the CNEDiMTS opinion in 2008. In 2009 the indication for fecal incontinence was added. Uncertainties for this indication regarded the effectiveness of sacral neuromodulation, the rate of device explants, and re-interventions as well as complication rates and adverse events. ","Urinary indications: post registration study SOUNDS. A Multicentric (n=25 sites) prospectic observational study. The objective was to evaluate the effectiveness and safety of the INTERSTIM device with a follow up of up to 5 years. \nFecal indications: post registration study French fecal registry. A Multicentric (n=16 sites) prospectic observational study. The objective was to evaluate the effectiveness and safety of the INTERSTIM device for patients with fecal incontinence. ","Urinary indications: the outcomes measured included urinary discomfort, urination, leakage, quality of life, urinary symptoms, faecal incontinence, adverse events (not categorized as primary and secondary endpoints). Fecal indications: The primary endpoints were the proportion of patients with a reduction of at least 50% in the number of weekly leaks at the 2nd follow-up visit (4-8 months after implantation), and the proportion without serious adverse event, nor any event or serious adverse reaction related to the device following the test phase. Other secondary endpoints include the Wexner score to estimate severity of incontinence, quality of life measured through the Faecal Incontinence Quality of Life (FIQL) measure; patients satisfaction assessed by patients on a scale ranging from -5 (lack of satisfaction) to 5 (maximum satisfaction).\n.","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","Urinary indications: the 2010 renewal of the registration of INTERSTIM I and II in the LPPT didn't accept the results of the post-registration study required in 2005 and 2008 because of potentially biases in the estimates (the data covered only one third of patients implanted in half of the centres where the study was set up, opening to concerns on the representativeness of the results for the current practice in France). The committee made again the renewal of the registration conditional to the submission of data about the effectiveness of INTERSTIM in the medium and long term, the procedure related morbitity and the rate of revisions. In the 2013 assessment no data on the post-registration studies were provided. In the 2019 assessment the intermediate results have been submitted and were considered satisfactory and scientifically sound. The CNEDiMTS still conditioned further renewal of registration to the submission of the final results of the post-registration study. Fecal indications: in the 2013 assessment no data on the post-registration studies were provided. These were provided in the 2019 assessment and considered satisfactory and scientifically sound. No furthwer post-registration studies were required for the next renewal. ","https://www.has-sante.fr/upload/docs/application/pdf/pp020402.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2008-06/cepp-1762interstim.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2009-12/cnedimts-2132-interstim.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2010-11/interstim-23_novembre_2010_2783_avis.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2013-12/interstim_i_et_ii.pdf\nhttps://www.has-sante.fr/upload/docs/application/pdf/2019-11/interstim_ii.pdf\n"]
["France","SYNCHRONY","MED-EL ELEKTROMEDIZINISCHE GESELLSCHAFT M.B.H ",2019,"Implant - cochlear implant","Patients with severe bilateral Sensorineural hearing loss after the failure or inefficiency of conventional acoustic equipments","Presumed active","Post Registration Study, OWR","The conditions for confirmation of the reimbursement status of the device are defined by the CNEDiMTS based on available evidence","HAS; Minister for Solidarity and Health","To confirm inscription in the list of products and services qualifying for reimbursement at the time of the reassessment ","In line with the end of the registration period for the Cochlear implant systems of the SYNCHRONY 2 range (February 28, 2021). ","The responsibility for implementing these studies rests with the manufacturers concerned with the device for which a request for a post-registration study is made; if these studies are not carried out, sanctions may be taken, whether regulatory or financial. In general, the requests for a further study are subject to a conventional clause between CEPS and the company. ","The keys uncertainties for the range of implants SYNCHRONY were the same as all the other cochlear implants registered in the LPPT. Since the first assessment of a cochlear implant system in 2007 (MED-EL range) the committee has asked each manufacturer to  set up post-registratino study in the form of a registry of implanted patients, aimed at providing evidence on  perceptive gains, complications and the follow up of implanted patients. These requirements applied also to the Synchrony range of implants","Registry EPIIC (Post-registration study of Cochlear Implant and Brainstem Systems), multi-center longitudinal study, with prospective data collection, to assess the efficacy and safety of long-term cochlear implant and brainstem systems","The outcomes relate to tests on perceptive results, complications, types of surgery (unilaterally or bilaterally implanted cochlear implants) and length of hospitalization, as well as the follow up of implanted patients. ","The product is temporarily registered in the List of products and Services qualifying for reimbursement. The extra costs related to the study are paid by the sponsor. ","NA","https://www.has-sante.fr/upload/docs/application/pdf/2019-08/mi1200_synchrony-mi1200_synchrony_pin_5874_opus2_5910_sonnet-sonnet_eas_5911_rondo-rondo2_5912_23_avril_2019_avis.pdf"]
["Germany","Fluorodeoxyglucose - PET (FDG-PET) scan","NA",2016,"Diagnostic","Colorectal cancer"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","Federal Joint Committee (G-BA)","To confirm the potential of PET to correctly diagnose the involvement of Bone Marrow in patients with early stage malignant lymphoma, avoiding other more invasive procedures. ","NA","NA","NA","NA","NA","NA","NA","https://www.g-ba.de/downloads/40-268-3561/2016-01-21_Einl_Beratungsverfahren-Erp-RL-PET-mal-Lymph_TrG.pdf"]
["Germany","Magnetic resonance imaging-controlled highly focused ultrasound therapy for the treatment of uterine myoma","NA","2017-03-09","Therapeutic","Women with symptomatic uterine fibroid myomas who score at least 40 on the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QoL) Severity Score (SSS)"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA"," To confirm use of the device for specific subpopulations and/or indications; ","NA","NA","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care ","Randomized Control Trial ","Primary: Time to return to normal activities, \nSeverity of symptoms based on the SSS of the UFS-QoL\n\nSecondary: length of hospital stay, pain, adverse events, number of reinterventions, health-related quality of life, sexuality-related parameters, number of pregnancies and live births","NA","NA","NA"]
["Germany","Stem cell transplantation for multiple myeloma","NA","2017-04-13","Therapeutic","Multiple myeloma diagnosis,\n- Recurrence or progress of multiple myeloma under or after systemic first-line therapy,\n- no pre-treatment with allogenic SZT,"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA"," To confirm use of the device for specific subpopulations and/or indications; ","NA","NA","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care ","Randomized Control Trial ","Primary: Survival, Progression-free or recurrence-free survival after three years \n\nSecondary: Progression-free or recurrence-free survival, Response Rate, Recurrence Rate, Non-recurrent mortality (NRM), Rate and type of undesirable effects, Quality of life ","NA","NA","NA"]
["Germany","Transcorneal electrostimulation in retinopathy pigmentosa","NA","2017-10-07","Therapeutic","Patients with a form of retinopath pigmentosa "," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA"," To confirm use of the device for specific subpopulations and/or indications; ","NA","NA","The relative efficacy/effectiveness in the real target population and/or in different population subgroups","Randomized Control Trial ","Primary: a change in the visual field area that can be justified as clinically relevant \n\nSecondary: Visual acuity, colour perception, contrast perception, health-related quality of life, adverse events ","NA","NA","NA"]
["Germany","Measurement and monitoring of pulmonary arterial pressure using an implanted sensor to optimize therapy in stage NYHA III heart failure","NA","2018-01-13","Diagnostic ","Patients with; \n- heart failure,\n- a resulting prior hospitalization within the last 12 months,\n- suitable for invasive pulmonary pressure measurement, \n- have received optimal treatment at the time of randomisation,\n- have no contraindications to the trial intervention"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA"," To confirm use of the device for specific subpopulations and/or indications; ","NA","NA","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care ","Randomized Control Trial ","Primary: Combined indicator of Survival and Unplanned hospitalization due to heart failure\n\nSecondary: cardiac mortality and all-cause mortality, frequency and severity of symptoms of heart failure, frequency and severity of adverse events, number and duration of unplanned hospitalisations due to heart failure, health-related quality of life of patients ","NA","NA","NA"]
["Germany","Liposuction for lipedema","NA","2018-04-10","Therapeutic ","Patients with confirmed lipoedema of the legs in stage I, II or III"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA"," To confirm use of the device for specific subpopulations and/or indications; ","NA","NA","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care ","Randomized Control Trial ","Primary: Pain \n\nSecondary: Health-related quality of life, hematoma tendency, physical therapy, leg circumference, restricted mobility, body fat percentage, recurrent surgery","NA","NA","NA"]
["Germany","Tonsillotomy in recurrent acute tonsillitis","NA","2018-12-14","Therapeutic ","Children, Teenagers and adults wirh acute tonsillitis who need surgery "," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA"," To confirm use of the device for specific subpopulations and/or indications; ","NA","NA","The efficacy/effectiveness of the technology in a tested population as compared to current standard of care ","Randomized Control Trial ","Primary: Number of symptomatic inflammations of the throat within 24 months after the procedure\n\nSecondary: Number of symptomatic inflammations of the throat within 12 months after surgery,  number of necessary re-operations after surgery, intra- and post-operative complications ","NA","NA","NA"]
["Germany","Amyloid positron emission tomography (PET)","NA",2020,"Diagnostic ","Mild and moderate Dementia of unknown etiology with possible Alzheimer's disease"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA","Utility evaluation of the amyloid PET method","NA","NA","Utility of the method","Randomized Control Trial ","Cognitive abilities, health-specific quality of life, occurence of serious adverse events; duration of unscheduled hospitalisations; mortality; adjustment of the diagnostic management","NA","NA","NA"]
["Germany","Active motion knee splint","NA",2019,"Therapeutic","patients with rupture of the anterior cruciate ligament who have undergone an operation/are treated conservatively"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA","Utility evaluation","NA","NA","Whether the utilization of the splint among patients with rupture of the anterior cruciate ligament during the standartized physical rehabilitation is associated with higher utility","Randomized Control Trial ","Primary: joint function; secondary: health-specific quality of life, frequency and severity of adverse events","NA","NA","NA"]
["Germany","Pulsing electromagnetic fields (PEMF)","NA",2019,"Therapeutic","Bone healing malfunction of the long hollow bones"," Scheme agreed, data collection to be initiated; ","CED( Erprobung von neuen Untersuchungs- und Behandlungsmethoden §137e)","NA","NA","Utility evaluation","NA","NA","The utility of the therapy when applied in addition to the conservative standard treatment (compared to the standard treatment alone)","Randomized Control Trial ","Bone healing that is associated with clinically relevant reduction of the complaints caused by the bone healing malfunction ","NA","NA","NA"]
["Ireland","Freestyle LIBRE","Abbott",2019,"Diagnostic - Glucose Monitoring System \n","children and young adults with Type 1 diabetes","Presumed active","NA","NA","Health Service Executive (HSE)","To revise current restrictions on use (only children and young adults with type 1 diabetes) ","1 year","Reimbursement was provided only for children and young adults. However, it was agreed that after twelve months, the situation including historical reimbursement data would be reviewed to inform next steps.","cost-effectiveness and budget impact; ","Collection of historical reimbursement data from HSE funded patients ","Reimbursement data on strip usage for persons approved for\nFreestyle;  Reasons for exceptional approvals of use of Freestyle libre.  ","NA","NA","https://www.hse.ie/eng/about/personalpq/pq/2019-pq-responses/october-2019/pq-39292-19-brendan-howlin.pdf"]
["Spain","Sacral root stimulation for the treatment of fecal incontinence ","NA","NA","Therapeuric - low‐voltage stimulation of the sacral nerve roots, termed sacral nerve stimulation (SNS)","Patientes with faecal incontinence (FI) ","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). Topics are usually identified from previous HTA reports from the Spanish Network for Health Technology Assessment\nand Services of the NHS (RedETS)","Spanish regional HTA units","NA","NA","NA","NA","Registry","NA","HTA agencies involved in the scheme receive funding for overseeing the process","Recommendation to review derivation circuits to solve\naccessibility problems.","https://www.ncbi.nlm.nih.gov/pubmed/22980706"]
["Spain","Albumin Dialysis and Molecular Adsorbent Recirculating System (MARS) ","NA","NA","Therapeutic - form of artificial liver support that functions on a base of albumin dialysis","Patients with liver failure","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","Spanish regional HTA units","NA","NA","NA","NA","Registry","NA","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://www.ncbi.nlm.nih.gov/pubmed/22980706"]
["Spain","TAVI - \ntranscatheter aortic valve implantation","NA","NA","Implant - minimally invasive surgical procedure wedging a replacement valve into the aortic valve's place","Patients with severe stenosis of the aortic valve ","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","Spanish regional HTA units","NA","NA","NA","NA","Registry","NA","HTA agencies involved in the scheme receive funding for overseeing the process","Recommendation to policy makers to review authorized indications to optimize patient selection.; Recommendation for the creation of multidisciplinary Hospital Commissions within each authorized hospital to consensuate; TAVI implantation. Recommendation to analyze implantation variability not attributed to geographical differences.","https://www.slideshare.net/HtaiBilbao/post-introductiona-htai2012finallogo?from_action=save; https://www.ncbi.nlm.nih.gov/pubmed/22980706"]
["Switzerland","TAVI - \ntranscatheter aortic valve implantation","NA ","2013\n(Extended 01.01.2019)","Implant - minimally invasive surgical procedure wedging a replacement valve into the aortic valve's place","Patients with severe stenosis of the aortic valve "," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA"," 7 years (30.06.2020)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Multigen test for breast carcinoma (breast cancer assay) ","NA","2011-01-01","Diagnostic","Primary, invasive breast carcinoma with the following characteristics:\n- The estrogen receptor is positive.\n- The human epidermal growth factor2 receptor is negative (HER2-).\n- Up to 3 loco-regional lymph nodes are affected.\n- Conventional findings do not allow a clear adjuvant chemotherapy decision."," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","13 years ( 1.12.2023)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Ambulatory stereotactic radiotherapy (photons) of wet age-related macular degeneration","NA","2018-01-01","Therapeutic ","Choroidal neovascularization (CNV) with activity signs such as intraretinal fluid or bleeding\n\nOngoing anti-VEGF therapy over a period of at least 6 months \n\nNo change in the activity status of CNV despite intensive injection therapy\n\nDiameter of the CNV maximum 4 mm"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","2,5 years (30.6.2020) ","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Autologous chondrocyte transplantation","NA","2017\n(Extended 1.1.2020)","Therapeutic ","Treatment of post-traumatic cartilage lesions of the knee joint"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","4 years (31.12.2020)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Autologous fat grafting for postoperative reconstruction of the mamma (breast)","NA","2018-07-01","Therapeutic ","Complementary measure to the an operative breast reconstruction"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","5 years (30.06.2023)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Extracorporeal photopheresis","NA","2009-01-01","Therapeutic ","After a lung transplantation only in bronchiolitis obliterans syndrome, if augmented immunosuppression and a treatment attempt with macrolides were unsuccessful"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","13 years (31.12.2021)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Focused ultrasound therapy in the pallidum, thalamus and subthalamus","NA","2015-07-15","Therapeutic ","Tremor with established diagnosis of idiopathic Parkinson's disease\n\nEstablished diagnosis of non-Parkinsonian tremor,\n \nTreatment of severe chronic refractory neuropathic pain"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","5 years (30.6.2020)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Haematopoietic stem cell transplantation - autologous","NA","2018\n","Therapeutic ","Patients with multiple sclerosis "," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","6 years (30.06.2024)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Positron-Emission-Tomography (PET, PET/CT) 18F-Flourocholine","NA","2018-07-01","Diagnostic ","For the preoperative localization of parathyroid-\nadenomas in primary hyperparathyroidism\nafter negative or inclusive conventional imaging\n(sestamibi scintigraphy or -SPECT/CT)."," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","2 years (30.6.2020)\n","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Multigene expression test for breast carcinoma ","NA","2019-01-01","Diagnostic","Examination of tumour tissue of a primary invasive breast carcinoma with the following characteristics:\n- Estrogen receptor status is positive.\n- The HER2 receptor status is negative\n- Up to 3 loco-regional lymph nodes are affected.\n"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","5 years (31.12.2023)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","wearable cardioverter defibrillator","NA",2018,"Therapeutic","As a temporary therapeutic measure when implantation of an implantable cardioverted defibrillator (ICD) is not possible immediately or in patients with a planned heart transplant and at high risk of sudden cardiac arrest, particularly in ventricular dysfunction, cardiomyopathy, status after myocardial infarction, myocarditis, patients after surgery or percutaneous revascularization, a left ventricular ejection fraction (LVEF) <35%"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","4 yeras (31.12.2021)","NA","NA","NA","NA","NA","NA","NA"]
["Switzerland","Flash Glucose Monitoring System","NA",2017,"Diagnostic","\nFor people with diabetes mellitus under intensive insulin therapy"," Data collection active; ","CED (Leistund in Evaluation)","NA","NA","NA","4.5 years (31.12.2021)","NA","NA","NA","NA","NA","NA","NA"]
["The Netherlands","CardioMEMS","Abbott Medical",2019,"Implant for arteria pulmonalis (PA) monitoring","Patients with chronic heart failure NYHA class III","Data collection active","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Bottom-up","Dutch Health Care Institute (ZIN)","Collect evidence on effectiveness, cost-effectiveness, adverse events, quality of life, budget impact and some other outcome measures","4 years","Implant is conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Effectiveness","RCT","Primary outcomes: efficacy (evidence of average increase of 6 points in quality of life measured with the KCCQ); Secondary outcomes: quality of life measured with the EQ-5D-5L, number of hospital admissions due to heart failure, device and system-related complications and/or sensor failures, mortality (regardless of the cause), budget impact and cost-effectiveness.\n","Treatment funded through public health insurance; Research privately funded, if necessary supplemented by the Netherlands Organisation for Health Research and Development (ZonMW)","n.a.","Interview (and validated by interviewee); ZIN website","https://www.zorginstituutnederland.nl/over-ons/publicaties/rapport/2018/05/30/voorwaardelijke-toelating-tot-het-basispakket-2019 https://www.zorginstituutnederland.nl/werkagenda/spijsvertering-en-mondzorg/voorwaardelijke-toelating-sacrale-neuromodulatie-bij-therapieresistente-functionele-obstipatie-met-vertraagde-darmpassage"]
["The Netherlands","Intra-arterial thrombolysis/thrombectomy","Various (overview not available)",2013,"Therapeutic","Patients in a stroke unit","Data collection and re-assessment completed","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Top-down (by ZIN)","Dutch Health Care Institute (ZIN)","Collect evidence on effectiveness","4 years","Conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Effectiveness","RCT","Primary outcome: demonstrate 10% more patients with a favorable outcome (functioning independently or preventing disability death) three months after treatment, i.e. a 1-point reduction or an absolut risk-difference of 10% compared to the control group as measured on the modified Rankin Scale (mRS). Secondary outcomes: long-term neurological outcome, quality of life, cost-effectiveness ","Treatment funded through public health insurance; Research privately funded, if necessary supplemented by the Netherlands Organisation for Health Research and Development (ZonMW)","Positive decision; however, only reimbursed if offered in specialised medical centers","Brügger (2014); ZIN website; validated by interviewee","https://www.zorginstituutnederland.nl/publicaties/standpunten/2007/05/09/intra-arteriele-trombolyse-bij-een-herseninfarct-behoort-nog-niet-tot-te-verzekeren-prestaties https://www.zorginstituutnederland.nl/publicaties/rapport/2015/06/30/voorwaardelijke-toelating-tot-het-basispakket-voortgangsrapportage-2015"]
["The Netherlands","Occipital neurostimulation","Medtronic Trading NL BV",2016,"Therapeutic","Patients with untreatable cluster headache ","Data collection and re-assessment completed","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Bottom-up (requested by multiple medical centers)","Dutch Health Care Institute (ZIN)","Collect evidence on effectiveness, cost-effectiveness, adverse events, patient satisfaction and some other outcome measures","4 years","Conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Effectiveness","RCT","Primary outcome: effectiveness (measured as an average reduction of at least 30% in baseline seizures  in the intervention group, after 6 months, and if there is a significant decrease in the seizure frequency in the intervention group compared to the control group. Secondary outcomes are: average attack frequency during follow-up, average pain intensity of the attacks, number of responders to treatment, use of acute attack medication, patient satisfaction, complications and cost-effectiveness.","Treatment funded through public health insurance; Research privately funded, if necessary supplemented by the Netherlands Organisation for Health Research and Development (ZonMW)","Positive decision, occipital neurostimulation permanently included in basis health-insurance package from 2020 onwards","Interview (and validated by interviewee); ZIN website","https://www.zorginstituutnederland.nl/werkagenda/zenuwstelsel/occipitale-zenuwstimulatie-bij-medicamenteus-onbehandelbare-chronische-clusterhoofdpijn "]
["The Netherlands","Renal denervation","Medtronic; Abbott (was St Jude)",2013,"Therapeutic","Patients with treatment-resistant hypertension","Data collection and re-assessment completed","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Top-down (by ZIN)","Dutch Health Care Institute (ZIN)","Collect evidence on effectiveness","4 years","Conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Long-term effectiveness and cost-effectiveness","RCT","Primary outcomes: composite outcome measure of cardiovascular events (cerebral infarction; myocardial infarction; other), mortality (all causes), blood pressure (24-hour SBP and DBP, and to support the consultation room SBP and DBP), complications of the treatment (measured as serious and all complications; eGFR)\n","Treatment: funded through public health insurance; Research: funded by Medtronic, the Nierstichting (Kidney Foundation), and the Netherlands Organisation for Health Research and Development (ZonMW) ","Negative decision, renal denervation no longer included in basic health-insurance package from 2017 onwards","Brügger (2014); ZIN website; validated by interviewee","https://www.zorginstituutnederland.nl/publicaties/standpunten/2011/06/24/renale-denervatie-bij-therapieresistente-hypertensie https://www.zorginstituutnederland.nl/publicaties/standpunten/2016/12/05/renale-denervatie-bij-therapieresistente-essentiele-hypertensie"]
["The Netherlands","Sacral neuromodulation","Medtronic Netherlands",2016,"Therapeutic","Patients with therapy-resistant functional constipation with delayed bowel passage","Data collection active","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Top-down (by ZIN)","Dutch Health Care Institute (ZIN)","Collect evidence on effectiveness, cost-effectiveness, adverse events, quality of life and some other outcome measures","5 years and 3 months","Conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Effectiveness","RCT","Primary outcome: effectiveness (measured as: 30 percent higher success rate in patient group who received sacral neuromodulation than in patient group who received the usual treatment. Succesfull treatment is defined as an average defecation frequency of >= 3 per week, measured over four weeks); Secondary outcomes: e.g. defecation frequency as a continuous outcome measure, pressing during defecation, defecations with a feeling of incomplete emptying, degree (severity) of constipation, fatique, quality of life, complications and cost-effectiveness.","Details on funding of this specific scheme not published. In general, treatment part of the scheme is funded through public health insurance and research part is privately funded (if necessary supplemented by the Netherlands Organisation for Health Research and Development (ZonMW)","n.a.","Interview (and validated by interviewee); ZIN website","https://www.zorginstituutnederland.nl/werkagenda/spijsvertering-en-mondzorg/voorwaardelijke-toelating-sacrale-neuromodulatie-bij-therapieresistente-functionele-obstipatie-met-vertraagde-darmpassage file:///C:/Users/vivia/AppData/Local/Temp/Voortgangsrapportage+voorwaardelijke+toelating+tot+het+basispakket+verslagjaar+2018.pdf https://www.zorginstituutnederland.nl/publicaties/standpunten/2014/11/24/standpunt-sacrale-neurostimulatie-bij-kinderen-en-volwassenen-met-therapieresistente-functionele-obstipatie"]
["The Netherlands","Spinal cord stimulation","Medtronic",1999,"Implant","Patients with chronic non-oncological pain","Data collection and re-assessment completed","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Bottom-up (requested by the Dutch Neuromodulation Group)","Dutch Health Care Institute (ZIN)","Uncertainty over quality of care and reimbursement of SCS as the implant was not yet structurally embedded in publicly financed healthcare system","3 years","Implant is conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Quality of care, costs","Government provided funding for SCS between 1999 and 2001 to hospitals that agreed to participate in a continuous quality improvement system for monitoring quality and costs (specialists and hospitals received fixed amount per patient)","Primary outcome: pain relief and costs, secondary outcomes: long-term effectiveness and safety","Details on funding of this specific scheme not published. In general, treatment part of the scheme is funded through public health insurance and research part is privately funded (if necessary supplemented by the Netherlands Organisation for Health Research and Development (ZonMW))","Spinal cord stimulation is permanently included in basic health-insurance package for some, but not all, medical indications","Stafinski et al. (2010); Beersen et al. 2005 (cited by Stafinski et al. 2010); ZIN website; not validated by interviewee (this scheme was not known to her)","https://www.zorginstituutnederland.nl/publicaties/standpunten/2007/02/02/neurostimulatie-behoort-tot-de-gebruikelijke-zorg-bij-die-patienten-die-geindiceerd-zijn-volgens-het-protocol-nederlandse-kwaliteitssysteem"]
["The Netherlands","Transluminal endoscopic step-up approach","Unknown (endoscopes and stents were already in use by the hospitals)",2014,"Therapeutic","Patients with infected pancreatic necrosis","Data collection and re-assessment completed","CED (OIR; Voorwaarderlijke toelating tot het basispakket)","Bottom-up (requested by Pancreatitis Werkgroep Nederland)","Dutch Health Care Institute (ZIN)","Collect evidence on effectiveness and cost-effectiveness","4 years","Conditionally included in the basic health-insurance package, if efficacy is proven after CED scheme it will be permanently included","Effectiveness","RCT","Primary outcomes: mortality, serious complications (new organ failure, bleeding/perforation/enterocutaneous fistulation for which reintervention is nmecessary), scar fracture, combined: mortality and serious complications, success of treatment, need for other interventions (necessity necrosectomy (step 2), switch to/additional intervention other arm, open necrosectomy), quality of life; Secondary outcomes: other complications (pancreatic fistulas, exocrine and endocrine pancreatic insufficiency, wound infections), number of interventions (drainage or necrosectomy), duration of admission(s) (intensive care unit, clinical department)\n","Details on funding of this specific scheme not published. In general, treatment part of the scheme is funded through public health insurance and research part is privately funded (if necessary supplemented by the Netherlands Organisation for Health Research and Development (ZonMW))","Positive decision, transluminal endoscopic step-up approach permanently included in basis health-insurance package from 2017 onwards","Brügger (2014); ZIN website; validated by interviewee","https://www.zorginstituutnederland.nl/publicaties/standpunten/2017/11/27/standpunt-endoscopische-transluminale-step-up-benadering-van-geinfecteerde-pancreasnecrose"]
["Spain","Endobronchial valve\n","NA","2015 (approval date), 2017 initiation","NA","Patients with persistent\nair leak after surgery,\ntrauma, or other\nunderlying lung diseases","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","SESCS","NA","3 years","NA","NA","Registry - single arm","• Effectiveness of leak resolution\n• Times from implantation to resolution,\ndrain removal, and hospital discharge\n• Safety: overall mortality and\ncomplication rates\n• Resource use","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://pubmed.ncbi.nlm.nih.gov/33942712/"]
["Spain","Biodegradable\nesophageal stent","NA","2015 (approval date), 2017 initiation","NA","patients with bening esophageal stenosis","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","AETS-ISCIII","NA","4.5 years ","NA","NA","Registry - single arm","• Effectiveness of dysphagia control\n• Reduction in the number of esophageal\ndilatations\n• Safety: overall mortality and\ncomplication rates","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://pubmed.ncbi.nlm.nih.gov/33942712/"]
["Spain","Percutaneous mitral valve\nrepair system by clip\n(MitraClip)","NA","2015 (approval date), 2017 initiation","NA","Patients with severe symptomatic mitral regurgitation refractory to medical treatment","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","OSTEBA","NA","3.5 years","NA","NA","Registry - single arm","• Severity reduction of valve insufficiency\nto grade ≤ 2 at discharge and 30 days.\n• Readmission rates for heart failure and\nchanges in functional capacity at 30\ndays.\n• Changes in outcomes according to\nvolume and learning curve\n• Safety: major adverse cardiovascular\nevents at discharge and 30 day","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://pubmed.ncbi.nlm.nih.gov/33942712/"]
["Spain","Left Atrial Appendage\nClosure Device","NA","2015 (approval date), 2017 initiation","NA","Patients with atrial\nfibrillation and risk\nfactors for stroke, with\ncontraindication to oral\nanticoagulation therapy","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","AETS-ISCIII","NA","4 years","NA","NA","Registry - single arm","• Effectiveness of the reduction of\ncardiovascular events and mortality\n• Changes in outcomes according to\nvolume and learning curve\n• Safety: overall mortality and\ncomplication rates","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://pubmed.ncbi.nlm.nih.gov/33942712/"]
["Spain","Sensor-based glucose\nmonitoring systems\n(Flash type)","NA","August 2018 (approval date). April 2019 initiation","NA","Children\n4–17 years with type 1\ndiabetes mellitus\nrequiring multiple insulin\ndoses","Data collected, reassessment done","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","SESCS","NA","2 years","NA","NA","Registry - single arm","• Effectiveness of glycemic control\n(HbA1c)\n• Reduction of events and time in\nbiochemical hypoglycemia\n• Safety: complication rates\n• Resource use\n• Patients’ experiences","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://pubmed.ncbi.nlm.nih.gov/33942712/"]
["Spain","Left ventricular assist\ndevices (DAVI)","NA","October 2020 (approval)","NA","Patients with advanced heart failure ineligible to transplant (destination therapy)","Ongoing","Post-introduction monitoring","Technologies are identified by the National Commission of\nProvision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the\nNational Health System (NHS) and Pharmacy (DGPSPh). ","Avalia-t","NA","NA","NA","NA","Registry - single arm","• Effectiveness: Overall survival; Survival\nfree from adverse events\n(cardiovascular events or stroke);\nSurvival free from LVAD replacement or\nexplant and Quality of life; Patients´\nsubgroup with best clinical outcomes\nfrom DAVI; Changes in outcomes\naccording to volume and learning curve\n• Safety: In-hospital death; Cardiac\nadverse events (i.e., right heart\nfailure…); Neurological adverse events\n(i.e., stroke…); LVAD device-related\nadverse events\n• Resource use and organizational\nimpact: Length of stay in hospital/ICU;\nLength of stay in readmission\n• Patients’ experiences","HTA agencies involved in the scheme receive funding for overseeing the process","NA","https://pubmed.ncbi.nlm.nih.gov/33942712/"]

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["Belgium"]
["England"]
["France"]
["Germany"]
["Ireland"]
["Spain"]
["Switzerland"]
["The Netherlands"]