The Beneluxa Initiative members described below undertake HTA of pharmaceuticals following an application by a manufacturer for reimbursement. In the descriptions below the Beneluxa Initiative members have given a brief statement on how HTA of pharmaceuticals is done in the individual countries Austria, Belgium, Ireland and the Netherlands. The agencies are committed to align timelines, methodology and content of HTA within the Beneluxa Initiative. The descriptions hereunder and the pilots completed so far have proven that cross-border collaboration is feasible. Pilots conducted within the Beneluxa Initiative on joint HTA can be found on this webpage.
If you are interested in having a joint HTA done for your product or would like to discuss what products might be a candidate for a joint procedure please let us know by contacting email@example.com.
Responsible institution for HTA: Austrian Social Insurance (Dachverband der österreichischen Sozialversicherungen – DVSV)
Lead for Beneluxa Initiative: Dr. Anna Nachtnebel, MSc
Code of reimbursement: https://www.sozialversicherung.at/oeko/views/index.xhtml
Brief statement on HTA procedure in Austria: DVSV is the strategic and coordinating entity of the statutory health insurance, pension funds and workers' compensation board in Austria. DVSV publishes the code of reimbursement (called Erstattungskodex, EKO) i.e. a positive list including all pharmaceuticals regularly reimbursed in the outpatient sector.
The evaluation process of a drug is initiated with an application submitted by the marketing authorization holder. An interdisciplinary team conducts a pharmacological, medical-therapeutic and economic evaluation (assessment) at the department of pharmaceutical affairs (VPM). In case of a possibly negative reimbursement decision, the marketing authorization holder gets the opportunity to comment on the assessment and to modify his offer.
An advisory board consisting of representatives from different stakeholders (independent science representatives of universities, the Social Security Institutions, the Austrian Chamber of Commerce, the Federal Labor Board, the Austrian Medical Association, the Austrian Chamber of Pharmacists and the Federal States) issues a recommendation on reimbursement as well as on specific criteria for use. The final decision by DVSV is based on the recommendation by the advisory board. Due to the transparency directive, a final decision has to be made within 180 days.
The legal basis for the evaluations is the General Austrian Social Insurance Act (ASVG), supplemented by the rules of procedure for the code of reimbursement.
Responsible institution for HTA: National Health Insurance and Disability Institute
Lead for Beneluxa Initiative: Dr. Marc Van de Casteele
- French: https://www.inami.fgov.be/fr/programmes-web/Pages/default.aspx - Rapports CRM
- Dutch: https://www.inami.fgov.be/nl/toepassingen/Paginas/default.aspx- CTG rapporten
Brief statement on HTA procedure in Belgium: Experts from the pharmaceutical policy department at the INAMI-RIZIV (National Health Insurance and Disability Institute) conduct the health technology assessment of pharmaceutical products and make recommendations for reimbursement. These are based on the efficacy, safety, applicability, ease of use, place in practice and need, cost, budget impact as well as on therapeutic added value compared to existing alternatives in Belgium. If an added value is recognized, cost-effectiveness plays a role in the proposal of reimbursement . If it is not recognized, the pharmaceutical company cannot price the new drug higher than an adequate comparator. HTA for medical devices are made in a different department of the INAMI-RIZIV using different procedures.
Conclusions of the HTA and recommendations (including for price) are presented to a panel of stakeholders independent from INAMI-RIZIV (health care providers, academics, health insurers) . This body – Commission for the Reimbursement of Medicines, or CRM/CTG – adopts reports and makes final recommendations to the Minister of Social Affairs. The Minister of Social Affairs takes the final decision, sometimes deviating from the advices of the Commission CRM/CTG.
Summary of the experts’ HTA reports (in one of two national languages – Dutch or French according to the language of the manufacturer) are available online since January 2019 on the INAMI-RIZIV website, coupled with the final decision of the Minister regarding reimbursement.
Responsible institution for HTA: The National Centre for Pharmacoeconomics (NCPE)
Lead for Beneluxa Initiative: Dr. Roisín Adams
Brief statement on HTA procedure in Ireland: The National Centre for Pharmacoeconomics (NCPE) conducts the HTA of pharmaceutical products for the Health Service Executive (HSE) in Ireland and makes recommendations for reimbursement based on cost effectiveness and budget impact analysis. The Health Service Executive (HSE) is the body responsible for provision and payment of treatments for the Department of Health. The work of the NCPE is underpinned by legislation (Health (Pricing and Supply of Medical Goods) Act 2013) and Framework Agreements with the pharmaceutical industry (https://www.hse.ie/eng/about/who/cpu/iphaagreement2016.pdf).
The HSE reserves the right to assess all products seeking reimbursed and this assessment can take the form of a full pharmacoeconomic assessment (up to 90days) or a more rapid assessment (2-4weeks). A recommendation on reimbursement is made by the NCPE to the HSE. After review by a Drugs Committee and approval by senior leadership of the HSE a decision on reimbursement is made.
Products across both hospitals and community setting are assessed. The thresholds considered for cost effectiveness ICERs are €20,000/QALY and €45,000/QALY and this are considered alongside the five year budget impact. Nine criteria are used for decision making and are laid down in the Health Act 2013 (http://www.irishstatutebook.ie/eli/2013/act/14/enacted/en/pdf).
The NCPE publishes a summary of its reports on its website. A full technical report is provided to the HSE.
Responsible institution for HTA: National Health Care Institute
Lead for Beneluxa Initiative: Dr. Lonneke Timmers
Brief statement on HTA procedure in The Netherlands: The National Health Care Institute (Zorginstituut Nederland, ZIN) conducts the health technology assessment of pharmaceutical products in the Netherlands and makes recommendations for reimbursement in order to manage the basic health care package and to ensure that it contains all necessary care, but no more than is required.
Whether pharmaceuticals are part of the basic package is assessed on the basis of our four package criteria: necessity, effectiveness, cost-effectiveness and feasibility. Through a 'deliberative' process all relevant facts, positions and interests are collected and weighed. The process usually starts with a request from the manufacturer. Before the official dossier is submitted often a draft dossier is discussed. From the submission of a complete final dossier to the reimbursement decision takes usually 90 days for outpatient drugs, 4 months for hospital drugs within the lock procedure. Experts of the National Health Care Institute write a report that is submitted for advice to the scientific advisory board (WAR). Other concerned parties such as health insurers, physicians and patient groups are also consulted. Based on the comments the report is adjusted and mostly discussed for a second time in the WAR. If a major impact on the health care budget or a major social effect is expected, the appraisal committee (ACP) will make a weighting from societal perspective as well. Thereafter, the Board of the National Health Care Institute sends a recommendation on reimbursement to the Minister of Health, Welfare and Sport (VWS) who makes the final reimbursement decision. Pharmaceutical products dispensed in community pharmacies are always assessed, in hospital setting this process is limited to products with a major budget impact. The National Health Care Institute can also make a statement whether a care intervention, including pharmaceutical products, should be reimbursed by national insurance companies in a so-called position paper (duiding).