| Austria |
|
20 voting members:
3 academics 10 from sickness funds 2 from physicians associations 2 from economic chamber 2 from federal chamber of labour 1 from Austrian chamber of pharmacists
|
Manufacturer submits application for reimbursement to Association of Austrian Social Security Institutions Internal staff (Department of Pharmaceutical Affairs) prepare evaluation of application (pharmacological and therapeutic) based on evidence presented in application, and assigns pharmaceutical to 1 of 6 categories of therapeutic value – pharmaceuticals classified into categories 5 or 6 can request price above average European Union price Health economics team evaluates cost effectiveness of pharmaceutical relative to comparable alternatives Pharmaceutical Evaluation Board deliberates over both evaluation reports and prepares report Pharmaceutical Evaluation Board sends report to manufacturer for comment Pharmaceutical Evaluation Board prepares reimbursement recommendation, taking into account responses received from manufacturer Deputy director of Association of Austrian Social Security Institutions reviews recommendations and makes final decision21,56,58 |
No21
|
180 days (includes pricing and reimbursement decision)58
|
|
| Belgium |
|
31 members (23 voting including chair):
Nonvoting:
2 from pharmaceutical industry 1 from generic pharmaceutical industry -
4 from Ministries of Public Health, Social Affairs, and Economic Affairs, and Federal
Public Service Budget
1 from National Institute for Health and Disability Insurance62
|
Manufacturer submits application for reimbursement to Secretariat of Drug Reimbursement Committee Includes incremental cost-effectiveness ratio (ICER) if Class I claim (added therapeutic value compared to existing alternatives) and simultaneously submits pricing dossier to Federal Public Service economy Brief overview report of product characteristics prepared Staff within Bureau of Drug Reimbursement Committee, supported by experts, prepare evaluation of pharmaceutical’s safety, efficacy, effectiveness, applicability, and convenience based on evidence submitted by manufacturer; pricing commission simultaneously examines pricing dossier, determines maximum price, and notifies manufacturer Drug Reimbursement Committee discusses and approves evaluation report Drug Reimbursement Committee sends report to manufacturer Staff prepare draft recommendations, taking into account evaluation report, price from manufacturer, and responses received from manufacturer Drug Reimbursement Committee discusses and approves (by 2/3 majority vote) draft recommendations Drug Reimbursement Committee sends draft recommendations to manufacturer, who must reply within 10 days; manufacturer may request a hearing Drug Reimbursement Committee prepares final recommendations, taking into account responses received from manufacturer Minister receives recommendations, seeks advice from Minister of Budget and financial administration, and makes final decision9,17,21,62,175 |
No62
|
150 days (includes pricing and reimbursement)21
|
|
| Czech Republic |
|
No information found |
Manufacturer submits application for reimbursement to State Institute for Drug Control Internal staff (Department for Price and Reimbursement Regulation) consult with medical experts, health economists, and patient groups, and prepare evaluation report; assess safety, efficacy, and clinical use first, and then financial aspects State Institute for Drug Control makes decision on price and level of reimbursement, based on evaluation report176–180 |
No138
|
75 days (includes pricing and reimbursement decision) |
|
| Denmark |
Danish Medicines Agency (decisions)68,69,121 Reimbursement Committee (recommendations)68,121 |
Maximum of 7 members: Must include:
|
Manufacturer submits application for reimbursement to Danish Medicines Agency Internal staff, supported by external experts (if necessary) prepare evaluation report based on evidence submitted by manufacturer; clinical effect and safety profile compared to already reimbursed pharmaceutical and non-pharmaceutical products for same indication Danish Medicines Agency simultaneously prepares price survey Health economics expert(s) evaluate(s) economic analysis, if submitted Reimbursement Committee reviews evaluation report, price survey, and review of economic analysis and makes reimbursement recommendation to Danish Medicines Agency If negative, Danish Medicines Agency sends draft recommendations to manufacturer Danish Medicines Agency Board makes final decision 21,68,69 |
No68
|
90 days after receipt of “adequate application”38
|
|
| Estonia |
|
No information found |
No information found |
No information found |
No information found |
No information found |
| Finland |
Pharmaceuticals Pricing Board (decisions)73,74,76 Pharmaceuticals Pricing Board Expert Group (recommendations)75 |
7 members of Pharmaceuticals Pricing Board:
2 from Ministry of Social Affairs and Health 2 from Social Insurance Institution (Kela) 1 from Ministry of Finance 1 from National Agency for Medicines 1 from National Research and Development Centre for Welfare and Health
7 members of Expert Group:
Includes individuals with medical, pharmacological, health economics, and social insurance expertise75,181
|
Manufacturer submits application for reimbursement to Pharmaceuticals Pricing Board secretariat Internal staff, with support from Expert Group, prepare evaluation report based on evidence submitted by manufacturer Expert Group reviews report and formulates opinions Pharmaceuticals Pricing Board Secretariat presents summary of report and opinions, along with written statement regarding the potential impact of the pharmaceutical on its budget provided by Kela, to Pharmaceuticals Pricing Board Pharmaceuticals Pricing Board formulates recommendations If negative, Pharmaceuticals Pricing Board sends recommendations to manufacturer, who may choose to lower price or provide additional evidence Pharmaceuticals Pricing Board makes final decision74,122,181,182 |
No181
|
180 days (includes pricing and reimbursement decision)181
|
|
| France |
Ministry for Health and Social Security (decisions)20,78 French National Authority for Health (recommendations)78 |
Transparency Committee within French National Authority for Health: 20 voting members (includes chair):
4 from “public institutions” 3 from main health insurance fund 1 from pharmaceutical industry 12 with medical and pharmacological expertise78,184
7 Specialist subcommittees of clinical experts |
Single technology appraisals
Manufacturer submits application for reimbursement to French National Authority for Health secretariat Internal staff prepare evaluation report based on evidence submitted by manufacturer (focuses on clinical effectiveness, target population, conditions of use, and already reimbursed technologies) External clinical and methodological experts review evaluation report Commission d’Evaluation des Medicaments reviews evaluation report and expert opinions to appraise the “medical benefit” of the pharmaceutical (on a 5 point scale; I – major to V – insufficient to justify reimbursement) Minister makes final decision on the medical benefit level/score Commission d’Evaluation des Medicaments then performs comparative assessment of pharmaceutical with already reimbursed alternatives to appraise the “improvement in medical benefit” (on a 6 point scale; 1 – major innovation to VI – negative opinion regarding inclusion on benefit list) Transparency Commission considers advice received from Commission d’Evaluation des Medicaments and assigns an “improvement in medical benefit” classification to the pharmaceutical Once positive reimbursement recommendation is received, the Comite Economique des produits de Sante = negotiates price with manufacturer and the Union Nationale des Caisses d’Assurance Maladie fixes the reimbursement rate Minister for Health and Social Security makes final decision on reimbursement level and price16,20–23
Multiple technology appraisals
French National Authority for Health approves technology topic for multiple technology appraisals French National Authority for Health conducts consultations with relevant stakeholders and the Interdisciplinary Economic Evaluation and Public Health Committee to define scope and protocol for multiple technology appraisals Internal staff and/or independent academic group prepares assessment report (includes clinical review and economic analysis) Interdisciplinary Economic Evaluation and Public Health Committee and external experts review assessment report Stakeholders receive assessment report for comment Stakeholders also consulted through working group meetings Appropriate health technology assessment specialist subcommittee appraises report and comments and formulates recommendations French National Authority for Health Board reviews and approves recommendations21,185
|
No20
|
|
May appeal recommendation to French National Authority for Health, requesting a hearing or providing written comments Once decision has been made, may appeal to administrative court20 |
| Germany |
|
13 members including representatives from:
Associations of physicians, dentists, and physiotherapists Hospital associations Sickness funds Patient organizations (nonvoting)18,19
|
Federal Joint Committee makes decision to assess technology and notifies Institute for Quality and Efficiency in Health Care Institute for Quality and Efficiency in Health Care appoints internal staff to manage and/or conduct assessment Institute for Quality and Efficiency in Health Care carries out consultations with external clinical experts and patient/carer organizations to define assessment scope and protocol Institute for Quality and Efficiency in Health Care posts draft scope and protocol on website for public comment Internal staff, supported by external experts, prepare assessment, first considering clinical benefit or innovativeness (ie, is the first active ingredient or offers therapeutic improvement); if deemed noninnovative, technology is assigned to 1 of 3 groups (1: identical active ingredient; 2: therapeutically comparable and one active ingredient; 3: therapeutically comparable and two active ingredients); technologies with similar efficacy/effectiveness must demonstrate comparable efficiency through findings from efficiency frontier analysis119; if deemed innovative (ie, offers added therapeutic value over already reimbursed alternatives), “cost-benefit” analysis is performed to set maximum reimbursable amount; if technology treats life-threatening condition for which there are no alternatives, cost must not be considered18,19 Institute for Quality and Efficiency in Health Care steering committee reviews draft report and recommendations for quality assurance Institute for Quality and Efficiency in Health Care posts draft report and recommendations on website for public comment Staff prepare final report, incorporating comments received and recommendations, and submit it to the Institute for Quality and Efficiency in Health Care steering committee for final quality assurance review and then to the Board for final approval Board sends recommendations to Federal Joint Committee, who makes final decision19,24,124,144 |
No18
|
No information found |
|
| Greece |
|
7 members including representatives from:
|
Manufacturer submits application for reimbursement to Transparency Committee in the Reimbursement and Medicinal Products Transparency Committee in the Reimbursement and Medicinal Products recommends classification of pharmaceutical into pre-existing therapeutic category based on “therapeutic and pharmacoeconomic effectiveness” Transparency Committee in the Reimbursement and Medicinal Products sends classification recommendation to Ministry of Health and Social Security for approval Price set taking into account products already included in assigned category or average of the 3 lowest European prices186 |
No information found |
90 days (includes pricing and reimbursement decision)186
|
No information found |
| Hungary |
Ministers of Health and Finance National Health Insurance Fund Administration Technology Appraisal Committee (recommendations)88,89 |
Technology Appraisal Committee: includes members delegated by stakeholder groups102
|
Manufacturer submits application for reimbursement to Transparency Secretariat of National Health Insurance Fund Administration (pharmaceutical division) Transparency Secretariat registers and checks application for completeness and then determines whether application should undergo simplified procedure or normal procedure; normal procedure applies to new agents, indications, routes of administration, and combinations National Health Insurance Fund Administration Department of Pharmaceuticals prepares a preliminary evaluation If application is assigned to normal procedure, Transparency Secretariat transfers it to Technology Assessment Office of the National Institute for Strategic Health Research Assessment Office prepares assessment report comprising a systematic review of clinical evidence and economic analysis Technology Appraisal Committee deliberates over report, preliminary evaluation of pharmaceutical department, and advice from professional colleges, and formulates a recommendation Director of pharmaceutical division approves recommendation and forwards it to the Ministers of Health and Finance90,102,187 |
No information found |
No information found |
Decision may be appealed to Appeals Committee Includes representatives from:
|
| Ireland |
|
No information found |
1. Products Committee of Health Service Executive selects technology for assessment OR manufacturer submits application for reimbursement to Health Service Executive 2a. If Products Committee selects technology, Health Service Executive notifies manufacturer of referral to National Centre for Pharmacoeconomics 2b. If manufacturer submits application, staff prepare preliminary evaluation report based on evidence from manufacturer 3a. Staff within National Centre for Pharmacoeconomics appointed to comprise review group 3b. Products Committee reviews evaluation report and decides whether to refer technology to National Centre for Pharmacoeconomics for formal pharmacoeconomic evaluation or recommend reimbursement 4a. Review group meets with manufacturer to determine scope and requirements for evaluation 4b. If referred, National Centre for Pharmacoeconomics conducts pharmacoeconomic evaluation 5a. Manufacturer prepares pharmacoeconomic submission, which includes cost-effectiveness and budget impact analyses 5b. National Centre for Pharmacoeconomics sends pharmacoeconomic evaluation to manufacturer for comment 6a. Review group prepares evaluation report based on manufacturer’s submission 6b. National Centre for Pharmacoeconomics prepares final pharmacoeconomic evaluation, incorporating manufacturer’s comments 7a. National Centre for Pharmacoeconomics sends report to manufacturer for comment 7b. National Centre for Pharmacoeconomics sends evaluation to Products Committee, who makes reimbursement decision 8a. Review group prepares final evaluation report, incorporating manufacturer’s comments 9a. National Centre for Pharmacoeconomics sends report to Products Committee, who makes reimbursement decision91,93,125,147 |
No fixed threshold, but €45,000/QALY used as a guide91,125,165
|
90 days (for reimbursement decision)93
|
Decision may be appealed to designated expert committee91
|
| Italy |
|
Technical Scientific Committee: Includes 17 members:
|
Manufacturer submits application for reimbursement to Italian Medicines Agency Technical Scientific Committee reviews submission and formulates advice on clinical value, assigning it to one of three reimbursement classes: A – fully reimbursable – essential products and those intended for chronic diseases; H – Fully reimbursable in hospitals; and C – non-reimbursable. Pharmaceuticals in classes A and H are further assigned to one of three classes: I – treatments for serious diseases; II – treatments to reduce or eliminate risk of serious diseases; and III – treatments for non-serious diseases Technical Scientific Committee then assesses the degree of innovation offered by the technology, considering 2 factors: 1) availability of existing treatments and 2) extent of therapeutic benefit; scores on each factor are combined to determine if pharmaceutical represents “important,” “moderate,” or “modest therapeutic innovation” Submission and Technical Scientific Committee evaluation are sent to Pricing and Reimbursement Committee Pricing and Reimbursement Committee reviews advice and contacts manufacturer to negotiate reimbursement status and price Pricing and Reimbursement Committee submits report containing negotiation outcomes to Technical Scientific Committee, who makes final decision 26,27,126 |
No126
|
180 days (includes pricing and reimbursement decision)188
|
No information found |
| Norway |
Norwegian Medicines Agency (recommendations/decisions)34,98 Ministry of Health and Care Services (recommendations/decisions) Department of Pharmacoeconomics (recommendations)98 |
No information found |
Process depends on anticipated budget impact of pharmaceutical: If <5 million Krone/year:
Manufacturer submits application for reimbursement to Norwegian Medicines Agency Norwegian Medicines Agency Department of Pharmacoeconomics staff prepare evaluation report based on evidence submitted by manufacturer Norwegian Medicines Agency reviews evaluation report and makes reimbursement decision If > 5 million Krone/year:
Manufacturer submits application for reimbursement to Norwegian Medicines Agency Norwegian Medicines Agency Department of Pharmacoeconomics staff prepare evaluation report based on evidence submitted by manufacturer Norwegian Medicines Agency reviews evaluation report and consults with National Advisory Committee for Drug Reimbursement Norwegian Medicines Agency sends evaluation report to Ministry of Health and Care Services Ministry consults with National Council for Health Care Priorities to determine whether pharmaceutical would be viewed as” money well spent” Ministry formulates recommendation; if positive, it is sent to Parliament for approval34,98,189
|
No34
|
180 days (includes pricing and reimbursement decision)34
|
No information found |
| Poland |
|
Consultative Council: 12 voting members including representatives from:
Ministry of Health (7) Polish Chamber of Physicians (1) Chief Pharmaceutical Council (1) Supreme Council of Nurses and Midwives National Health Fund127
Drug Management Team: Includes representatives of:
|
Manufacturer submits application for reimbursement to Ministry of Health Ministry of Health sends application to the Agency for Health Technology Assessment Agency for Health Technology Assessment staff prepare evaluation report based on evidence from the submission and information received from invited experts Agency for Health Technology Assessment Consultative Council meets to review report, hear from experts, and formulate recommendations Director of Agency for Health Technology Assessment issues reimbursement recommendation to Minister of Health Drug Management Team within Ministry of Health negotiates maximum reimbursement price Ministry of Health makes final decision on reimbursement and price100,127,190 |
No information found |
180 days (includes pricing and reimbursement decision)100
|
None127
|
| Portugal |
|
No information found |
Manufacturer submits application for reimbursement to INFARMED following approval of maximum price by Directorate General of Economic Activities External experts prepare evaluation report based on evidence submitted by manufacturer (includes pharmacotherapeutic and pharmacoeconomic information demonstrating added therapeutic value and proposed reimbursement price) and assigns “grade” of innovation and added therapeutic value (compared to already reimbursed alternatives) Economists analyze pharmacotherapeutic information from manufacturer to determine “economic advantage”; if pharmaceutical offers added therapeutic value or treats a condition for which there are no alternative therapies, economic advantage should be demonstrated through formal Using findings from both reports, INFARMED formulates reimbursement recommendation If negative, INFARMED contacts manufacturer, who may present additional information INFARMED submits recommendations to Minister, who makes final decision36,101,191 |
No information found |
90 days (includes pricing and reimbursement decision)36
|
|
| Scotland |
|
No information found |
Manufacturer submits application for reimbursement to Scottish Medicines Consortium Internal staff (“assessment team”), supported by clinical and economic experts, prepare evaluation report based on evidence submitted by manufacturer New Drugs Committee reviews report and prepares draft recommendations for the Scottish Medicines Consortium New Drugs Committee also sends draft recommendations to manufacturer for comment Manufacturer sends comments to Scottish Medicines Consortium, which also considers submissions received from patient interest groups Scottish Medicines Consortium formulates final recommendations and forwards them to the National Health Service Boards, Area Drug and Therapeutics Committees, manufacturer, and competitor(s)30,128 |
No fixed threshold, but range of £20,000–£30,000/QALY used as a guide30
|
No information found |
Decisions may be appealed on process-related and scientific grounds For process-related appeals: Manufacturer contacts Scottish Medicines Consortium secretariat, Chair, or New Drugs Committee to resolve issues through discussion For scientific disputes: May resubmit or convene independent panel appointed by Scottish Medicines Consortium |
| Slovakia |
Ministry of Health (decisions) Reimbursement Committee for Medicinal Products (recommendations)105,107 |
Reimbursement Committee:
Includes 11 members representing:
|
Manufacturer submits application for reimbursement, including proposed maximum retail price, to Ministry of Health Staff evaluate pharmaceutical using evidence from manufacturer to determine where its ICER lies in the accepted ICER threshold range One of 22 specialist working groups then evaluates the pharmaceutical according to its anatomic and therapeutic classification A separate working group evaluates pharmacoeconomic data Evaluations from both working groups are forwarded to the Reimbursement Committee The Reimbursement Committee reviews the reports and formulates a reimbursement decision102,106,107,131,169 |
No fixed threshold, but range of €20,000–€26,500/QALY used as a guide105
|
No information found |
|
| Spain |
|
Inter-Ministerial Pricing Commission: Includes representatives from:
Ministry of Health Ministry of Economy Ministry of Industry132
|
Ministry of Health initiates reimbursement decision-making process upon receipt of notice of market approval for new pharmaceutical Ministry of Health invites manufacturer to provide all relevant information to Inter-Ministerial Pricing Commission Internal staff of Ministry of Health prepare evaluation report Inter-Ministerial Pricing Commission reviews report and makes reimbursement and pricing decision108,132 |
No132
|
180 days (includes pricing and reimbursement decision)132
|
No information found |
| Sweden |
|
Expert Board: Includes 11 members and a chair:
|
Manufacturer submits application for reimbursement Internal staff (executive officer, health economist, and legal expert) review submission to determine if application contains sufficient evidence Dental and Pharmaceutical Benefits Board sends copy of application to Pharmaceutical Benefits Group for County Councils for review Internal staff prepare evaluation report and draft recommendations in the form of a “memorandum” Dental and Pharmaceutical Benefits Board sends copy of memorandum to manufacturer for review Manufacturer may request a meeting with the Board, during which it can present case, dispute arguments which form the basis of recommendations, and refute factual errors Meeting of Expert Board held – memorandum, manufacturer’s comments, and any feedback received from the Pharmaceutical Benefits Group are reviewed; external experts may be invited to participate in deliberations; Expert Board makes final reimbursement decision33,192 |
No fixed threshold, but €45,000/QALY used as a guide35
|
180 days (includes pricing and reimbursement decision)192
|
Decision may be appealed on procedurals grounds only15,33,192 Board may reconsider decision before appeal is heard by administrative court192 |
| Switzerland |
|
Federal Drug Commission: Includes 25 voting members representing:
|
Manufacturer submits application for reimbursement Federal Drug Commission reviews application and makes a classification recommendation: pharmaceutical may be classified into one of five categories of relative effectiveness:
Federal Office of Public Health makes final decision, based on Federal Drug Commission’s recommendation, assessment by Swiss Agency for Therapeutic Products for market authorization and internal and external price referencing If Federal Office of Public Health plans to make a negative decision, the manufacturer is informed prior to issuing the final decision; manufacturer may apply for re-evaluation on the basis of price adjustments or availability of additional data114 |
No information found |
No information found |
|
| The Netherlands |
Ministry of Health, Welfare and Sport (decisions) Dutch Healthcare Insurance Board Committee (CHF) (recommendations)26 |
Committee of the Dutch Healthcare Insurance Board: Includes:
A maximum of 24 members with expertise in various medical disciplines, health sciences and economics 2–3 nonvoting members from the Ministry21,117
Includes:
|
For outpatient pharmaceuticals:
Manufacturer submits application for reimbursement to Minister of Health Internal staff prepare evaluation, which includes 4 draft reports (summary, pharmacotherapeutic, pharmacoeconomic, and budget impact assessments based on evidence from manufacturer, as well as independently conducted literature review); if deemed necessary, staff may consult with manufacturer, external experts, and stakeholders CHF reviews report and consults with manufacturer and other stakeholders Staff revise report, incorporating results of CHF deliberations and comments from manufacturer and other stakeholders Dutch Healthcare Insurance Board sends revised report to manufacturer and stakeholders for comment CHF meets to discuss revised report and comments received and prepare final advice Dutch Healthcare Insurance Board board of directors receives final report, which is also sent to manufacturer and stakeholders appointed by Dutch Healthcare Insurance Board for comment Dutch Healthcare Insurance Board board of directors meet to discuss final report and comments received and formulate recommendations; may consult with the Appraisal Committee Alternatively, Steps 7 and 8 may be skipped, with the Board chair drafting a recommendation Dutch Healthcare Insurance Board sends final recommendations to the Minister of Healthcare, Welfare, and Sport Minister makes final reimbursement decision, which includes classifying the pharmaceutical into one of three categories:
Annex 1A – Therapeutic equivalent value; Annex 1B – Therapeutic added value; and Annex 2 – Conditional reimbursement
For high-cost inpatient pharmaceuticals:
Dutch Federation of University Hospitals, Dutch Hospitals Association, Medical Specialists Association, and Dutch Health Insurance Organization may submit reimbursement application (in the form of additional funding) for high cost inpatient pharmaceuticals Dutch Healthcare Insurance Board prepares evaluation report, which includes evidence on therapeutic value, projected budget impact, and plan for collecting pharmacoeconomic information in daily practice, and formulates recommendations (process similar to that described above) Dutch Healthcare Insurance Board sends final report and recommendations to the Dutch Healthcare Authority Dutch Healthcare Authority formulates recommendation on whether pharmaceutical should be provisionally added to the Expensive Drug List Minister of Health, Welfare, and Sport makes final decision21,31,49,116,117,193
|
No fixed threshold, but €20,000/QALY used as a guide 31
|
|
|
| United Kingdom |
|
Includes:
Academics (eg, health economists) Health care providers in National Health Service Representatives from patient and carer organizations Manufacturers29
|
Single technology appraisal
Topics selection panel selects technology for review National Institute for Health and Clinical Excellence invites stakeholders (ie, consultees and commentators (cannot make a submission or appeal recommendation)) to participate Nonmanufacturer consultees invited to nominate clinical and/or patient experts to take part in Technology Appraisals Committee meetings Manufacturer completes evidence submission (assessment) Independent academic group commissioned to review submission, along with information received from consultees and nominated experts, and prepare evaluation report Technology Appraisals Committee meets to review evaluation report and hear from nominated clinical and patient experts Technology Appraisals Committee formulates draft recommendations, which are presented in appraisal consultation document Appraisal consultation document made available to stakeholders for comment Technology Appraisals Committee meets to consider comments and formulate final recommendations (final appraisal determination) Technology Appraisals Committee submits final recommendations to Guidance Executive Guidance Executive makes final reimbursement decision29,194,195
Multiple technology appraisal
Same as single technology appraisal process except:
1) Formal scoping process to develop review protocol is required; 2) Independent academic group conducts assessment (rather than the manufacturer); 3) Independent academic group attends Technology Appraisals Committee meetings13
|
No fixed threshold, but range of £20,000–£30,000/QALY used as a guide37,196,197
|
Single technology appraisal approximately 39 weeks29
|
Final recommendations may be appealed on procedural grounds only Appeals may only be initiated by consultees identified at the beginning of the assessment and who are not representing National Health Service trusts or local boards Appeal is heard by Appeals Panel appointed by National Institute for Health and Clinical Excellence board39 |
| Wales |
|
Includes:
|
Manufacturer submits application for reimbursement (“Form A”) to All Wales Medicines Strategy Group All Wales Medicines Strategy Group determines whether application requires full appraisal; if yes, manufacturer must submit “Form B” All Wales Medicines Strategy Group identifies and invites clinical experts and patient organizations to submit written statements Internal staff prepare evaluation report, which includes Form A, Form B, and additional relevant information Report sent to manufacturer for comment All Wales Medicines Strategy Group New Medicines Group meets to review evaluation report and comments received and formulate draft recommendations Staff prepare final report and draft recommendations (ie, preliminary appraisal), which is sent to manufacturer and posted on website New Medicines Group meets to deliberate over final report, recommendations, and manufacturer’s response New Medicines Group formulates final recommendation, which is included in final appraisal Minister makes reimbursement decision, based on final appraisal from New Medicines Group28,120 |
No fixed threshold, £20,000/QALY used as a guide28
|
No information found |
Decisions may be appealed on process-related and scientific grounds For process-related appeals: Appeals submitted to Welsh Medicines Partnership, who discusses case with All Wales Medicines Strategy Group Chair and senior staff For scientific disputes: Independent review process initiated198 |
