Table 3.

Overview of the characteristics of CED programmes for medical devices in Europe

	England	France	Germany	Netherlands	Spain	Switzerland	Belgium
Name of the CED Policy	Commissioning through Evaluation	Forfeit Innovation (FI)/Post-Registration Studies (PRS) (études post-inscription sur les technologies de santé)	Evaluation of medical examination and treatment methods (§ 137e SGB V)	Conditional admission (Voorwaardelijke toelating)a	Postlaunch evidence-generation studies (Estudios de Monitorización”)	Services in evaluation (Leistungen in Evaluation)	Limited clinical application (Beperkte klinische toepassing)
Desirability of schemes
Technology selection	Proposals for new schemes are co-ordinated by NHS England’s CRGs during a ‘Topic Selection’ phase and assessed by the Clinical Panel that determines which schemes go forward for implementation	FI package: proposals are submitted by manufacturers alone or in partnership with physician’s associations PRS: if, during the assessment of a request for inscription in the LPPR, the CNEDiMTS identifies remaining uncertainties on the technology’s short or long-term outcomes, it can require collection of new data through a PRS	During the evaluation procedure of a diagnostic and therapeutic method, if the opinion of the IQWIG reports that the benefit has not been confirmed, but the method offers the potential of being a treatment alternative. Requests for the evaluation of methods may be put forward by 1) stakeholders organizations for inpatient (§ 137c, SGB V) and outpatient (§ 135 SGB V) care, 2) directly by manufacturers (§ 137e SGB V) or 3) by hospitals, submitting a first request for NUB payment to the InEK (§ 137 h SGB V)	Technologies can be identified in 2 ways: 1) a bottom-up process where parties can submit their own application once a year; and 2) a top down process, where the ZIN recommends, in any negative view following an assessment, whether an intervention can be eligible for conditional admission	Technologies are identified by the National Commission of Provision, Insurance and Financing (CPAF) of the Ministry of Health and selected by the Directorate General of the common portfolio of services of the National Health System (NHS) and Pharmacy (DGPSPh). Topics are usually identified from previous HTA reports from the Spanish Network for Health Technology Assessment and Services of the NHS (RedETS)	Technologies can be identified in 2 ways: 1) following a request for verification that a medical service is effective, appropriate and efficient (WZW criteria), if during the assessment the EAMGK/CFAMA issues a “Yes in evaluation” recommendation; 2) following a direct request from manufacturers or providers for medical devices that need to be listed under the medical device aid list	CED schemes can be initiated top-down following a technology appraisal by the CTIIMH of the RIZIV. Bottom-up requests for the initiation of CED schemes can be submitted by scientist or participating hospitals; however, these schemes can formally only be initiated by the CTIIMH of the RIZIV
Criteria for eligibility and prioritization	The following eligibility criteria must be met: 1) Technology falls within NHS England’s direct commissioning responsibilities 2) The treatment or care pathway shows significant promise; 3) a clinical commissioning policy is published confirming that the technology is not routinely commissioned, or there are significant remaining questions of clinical or cost-effectiveness, and/or outcomes in the routine clinical setting. 4) existing uncertainties will not be answered by current or planned clinical trials. 5) Meaningful new outcome data can be gathered within the likely timescale of a scheme (1–2 years)	FI: requests are accepted if the device is expected to be innovative (4 criteria: 1) the novelty of the device, 2) early dissemination phase, 3) acceptable risk for patients, and 4) promise of significant health improvements or reduction in healthcare costs; and the protocol is considered adequate to answer the identified research questions (article 165.1.1 of the French social security code) PRS: A request for a PRS is done whenever the CNEDiMTS outlines relevant remaining uncertainties (no prioritization)	The new method must have positive promise of benefit, as defined in the German code of procedures: 1) potential replacement of more complex methods; 2) fewer expected side effects, 3) higher expected clinical benefits	10 primary criteria for admissibility to a scheme (yes/no answers, all to be satisfied), and 5 secondary criteria for prioritization (score from 1 to 10). Prioritization criteria include: 1) Disease burden, 2) existence of clinical alternatives, 3) the expected added value of the intervention (health benefits/ economic/organizational/social/ethical impact) 4) existence of other (similar) studies ongoing or planned and 5) The level of evidence of the proposed study (RCTs, observational design, comparative or not-comparative studies)	A quantitative prioritization tool is used. Criteria are defined across 4 domains: 1) Population/end users (e.g., disease burden, frequency of use); 2) Technology (innovativeness, different expectations of use); 3) Safety/adverse effects (e.g., safety issues, undetected adverse effects); 4) organization/costs and other implications (e.g., learning curve, financial impact, organizational or structural impact)	An explicit checklist is used for technology selection and prioritization. Main criteria are: 1) existence of a relevant evidence gap regarding efficiency, safety, cost-effectiveness and conditions of use; 2) interest for the technology (e.g., disease burden, existence of treatment alternatives, significant economic impact); 3) existence of ongoing studies 4) the research proposal can answer the evidence gaps 5) feasibility of a CED scheme for the technology 6) expected positive cost–benefit ratio; and 7) capacity of the new findings to affect coverage decisions	Main criteria used are: 1) the innovativeness of the technology; 2) feasibility of answering the identified research questions within the timeframe of the study
Research design
Type of CED schemeb	Only in research	FI: Only in research, PRS: Only with research	Only with research for Inpatient care, Only in research for outpatient care	Only in researchc	Only with research (in selected healthcare centres identified at the regional level)	Only with research	Only in research
Types of study design	Mainly prospective observational studies using data collected from existing clinical databases, or by setting up a new registry	FI: Highest level of evidence preferred (e.g., RCTs) PRS: Mainly single-arm, registry based, observational studies	Highest level of evidence preferred (e.g., RCTs)	Highest level of evidence preferred (e.g., RCTs). Furthermore, a supplementary (observational) study may be initiated after the enrolment of the preferred study is completed	Prospective, single-arm observational studies; focus on designs which minimize data collection effort	Preferably RCTs, other designs may be also considered (before-and-after comparisons, case series or comparisons with historical controls)	Prospective observational studies, based on registry data
Implementation
Funding of the research	NHS England provides funds for service provision to the participating centres and NICE to oversee the scheme. NICE directly commissions an External Assessment Centre for data collection and data analysis	FI: a forfeit payment for the procedure and the associated hospital costs is established at the start of the scheme. Costs of data collection and analysis fall on the scheme applicant PRS: Following the CNEDiMTS appraisal, the device is temporarily listed in LPPR and covered by the social health insurance. Costs of data collection and analysis fall on the manufacturers	G-BA coordinates all phases of the design and implementation of the scheme. The diagnostic and therapeutic method under evaluation is covered by the health insurance. Overheads of the study can be financed by the manufacturer of the device being evaluated or are financed by statutory health insurance via G-BA	The care provided is covered by the basic insurance package. The reimbursement rate is negotiated between the health insurance companies and the participating hospitals and included in a covenant agreement signed by all parties involved in the scheme. The costs of data collection and analysis are covered by the scheme applicants. However, there is the possibility to apply for a research grant at ZonMw	Regional HTA agencies receive funding for data collection, analysis and reporting from the central Ministry of Health. The price of the device is negotiated individually by the regions participating in the scheme. Participating hospitals do not receive extra funding for data collection	The reimbursement of the procedure is covered by the health insurance. Costs of data collection and analysis falls on the manufacturer	Following the recommendation of the CTIIMH to initiate a scheme, the minister of health takes a decision regarding the temporary reimbursement of the care service and the reimbursement methods to be applied. Participating hospitals do not receive any funding for data collection and analysis
Definition of study protocol	The study protocol is developed by the External Assessment Centre in partnership with NICE	FI: The study protocol is directly submitted by the scheme applicant and evaluated by the HAS PRS: The responsibility of defining the protocol falls on the scheme applicants. Authorities only provide broad indications on the type of uncertainties that must be addressed by the scheme, and approve the final version of the study protocol	The key aspects of the study are defined in the directive approving the scheme. The protocol is then refined by the research institution that conducts the study	Development of the study protocol is a direct responsibility of the scheme applicant. ZIN assesses the study proposal in collaboration with the Scientific Advisory Council (WAR) and ZonMw	The study protocol is defined by the regional HTA agencies participating in the data collection	The design of the protocol is a responsibility of the scheme applicant. The proposal is then evaluated and approved by the FOPH	The relevant questions to be answered in the scheme and the set-up of the registry are proposed by the CTIIMH and discussed with the stakeholders involved, to obtain an agreement. Outcomes to be considered are discussed between the expert scientific community and the CTIIMH which also approves the final version of the protocol
Data collection, monitoring. and analysis	The data collection is overseen by the appointed steering group, and supported by the External Assessment Centre. Periodic checks and follow ups are done on the quality and validity of data submitted to ensure meaningful data is being collected. Analysis of the data is done by the external assessment centre and reviewed by NICE	FI and PRS: The responsibility for both the data collection and analysis falls on the manufacturer only. For PRS studies, the CNeDMTs evaluate the quality of the new evidence provided at the time of the planned re-appraisal of the technology	Data collection and analysis are done by an external research institution which has been appointed by G-BA through a public tender, if the overheads are financed via G-BA	The scheme applicant has the main responsibility for data collection and monitoring. The ZIN monitors the course of the scheme and reports it annually to the Minister of Health. ZIN assesses the new evidence provided at the time of the planned assessment of the technology	Data collection and analysis is coordinated by the Regional HTA agencies participating in the scheme. Tasks include checking data completeness and quality, safety surveillance, and yearly reporting to the CPAF on the progress of the scheme	The applicant (provider and/or manufacturer) are the sole responsible for data collection and analysis. Yearly reports have to be reported to the FOPH, showing how the study is proceeding. These reports may inform changes to the scheme or even cause early termination, if issues arise with data collection (e.g., poor quality of the data, slow recruitment)	Data collection is a responsibility of the hospitals that have signed the agreement to participate in the scheme. Depending on the agreement, the hospitals or an external peer-review group/scientific association are responsible for the scientific report
Evaluation
Existence of ex-ante decision rules for the scheme linking the results of the scheme to a decision on price, reimbursement or use	No	No (both FI and PRS)	No	Agreements regarding the uptake of the intervention, in case of a positive coverage decision at the end of the scheme, or exit strategies in case of a negative opinion (e.g., because the intervention is not effective, or the data quality is considered insufficient to take a decision) are defined in the convenant agreement prior to the start of the scheme	No	No	No
Types of decisions informed by the scheme	Results of the scheme are used for the development of Clinical Commissioning policy for NHS England’s directly commissioned specialised services	FI: Conditional reimbursement is provided only for the duration of the scheme, then devices enter usual evaluation pathways (e.g., a new request by the manufacturer for inscription in the LPPR) PRS: confirmation of the device in the LPPR and refinements of the conditions of use. Financial penalties on the price of the device may be applied in case of poor data quality at reassessment	Confirmation of the reimbursement status	Confirmation of the reimbursement status	Confirmation of reimbursement status under the same conditions of use, changes to the conditions of use or withdrawal of the technology from the benefit package	Confirmation of the reimbursement status, refinements of conditions of use, and changes in the maximum reimbursement rate for the technology or procedure	Confirmation of the reimbursement status

^aStarting from 2019, conditional admission schemes have started to be gradually replaced by schemes within the new Promising Care Subsidy Fund (PCSF). The main difference between the two programmes concerns the way care provision is reimbursed during a scheme, i.e., directly subsidized in the PCSF rather than covered by the statutory health insurance as in conditional admission schemes. The schemes already ongoing will be completed according to the VT programme described in the Table

^{b “}Only in research” are defined as schemes in which a device or procedure is reimbursed only for patients who enrol in a clinical study, whereas “Only with research” schemes are defined as schemes in which a device or procedure is reimbursed for all indicated patients while data are collected in a subset of patients

^cConditionally approved care is only covered if the patient participates in the main study. However, patients who are not able to participate can claim the conditionally approved care if they participate in a supplementary ancillary study. CNEDiMTS, French Medical Device and Health Technology Evaluation Committee; CRGs, Clinical Reference Groups (England); CTIIMH, Belgium Implant and Invasive Medical Device Reimbursement Committee;; FOPH, Swiss Federal Office of Public Health; G-BA, German Federal Joint Committee; InEK, German Institute for the Hospital Remuneration System; IQWiG, German Institute for the Hospital Remuneration System; LPPR, List of Products and Services qualifying for Reimbursement (France); RCTs, Randomized Controlled Trials; RIZIV, Belgian Medicines Verification Organisation; ZIN, Netherlands National Health Care Institute; ZonMW, Netherlands organisation for Health Research and Development, Implant and Invasive Medical Device Reimbursement Committee