Market accesS Services
MARKET ACCESS CONSULTANCY SERVICES
Vivactis HM3A is a consultancy agency specialized in market access and health economics for pharmaceuticals, biotech products, medical devices and digital health, diagnostics, vaccines, and nutrinomics.
We are part of the Vivactis group and offer an international coverage.
WHAT CAN WE DO FOR YOU ?
Pricing and reimbursement Dossiers,
managed entry agreements
Health economic modelling and analysis
Global Value Dossiers,
Health Technology Assessments
OVERVIEW OF COUNTRIES
MARKET ACCESS IN BELGIUM
The Belgian system for P&R for medicines and medical devices is centralized and based on two arms: the Ministry of Economy for pricing and INAMI/RIZIV (National Institute for Health and Disability) for reimbursement advice to the Minister of Social Affairs through the CRM/CTG (reimbursement committee). It is also the HTA body for medicines in Belgium. The Minister decides whether or not the drug will be reimbursed. This is a central, unique decision. All medicines, reimbursed or not, are under price regulation.
MARKET ACCESS IN NETHERLANDS
ZIN (Zorginstituut, National Healthcare Institute) is the centralized HTA body for medicines in The Netherlands. It assesses whether extramural medicines and expensive specialist intramural medicines are eligible for reimbursement. Based on the assessment, ZIN sends its advice to the Minister of Health, Welfare and Sport (VWS). The Minister decides whether or not the drug will be reimbursed from the basic package. Farmatec centrally sets the maximum price for reimbursed medicines.
MARKET ACCESS IN LUXEMBOURG
The Luxembourg system for P&R for medicines is based on two arms: the Ministry of Social Affairs for pricing and CNS (National Institute for Health) for reimbursement advice to the Minister of Social Affairs. The Minister decides whether or not the drug will be reimbursed. This is a central, unique decision. Pricing is fully referenced to the country of origin which must have a packaging in French and/or German, hence usually Belgium.
MARKET ACCESS IN FRANCE
The French system for P&R for medicines is centralized and based on two arms : HAS Transparency Committee (HTA) for therapeutic added value and CEPS (Comité économique des Produits de Santé) for pricing. After obtaining a marketing authorization, a pharmaceutical company can freely set the price of a medicine. For a medicine to be reimbursed by Social Security, it must submit a request to both HAS Transparency Commission, and to the Comité économique des produits de santé (CEPS) as well as to the Union nationale des caisses d’assurance maladie (UNCAM). CEPS is where pricing negotiations take place. The final reimbursement decision is made by the Ministers of Health and Social Security. This is a central, unique decision.
MARKET ACCESS IN SPAIN
The Spanish system for P&R for medicines and medical devices is decentralized and split across national, regional and local. Levels. In Spain, reimbursement decision precedes pricing decision as only reimbursed products are subject to price regulation.
MARKET ACCESS IN ITALY
The Italian system for P&R for medicines and medical devices is decentralized and split across AIFA (Italian Medicines Agency), regional and local level health authorities. AIFA is responsible for the regulatory process as well as governance of medicines’ spending. Pricing is part of the reimbursement process with P&R interlinked.
MARKET ACCESS IN OTHER EU COUNTRIES
Contact us for more information about other countries.
How do we bring value to our clients ?
- Part of the Vivactis Group with reach in major European markets
- Unique team with physicians, pharmacists, science PhDs and health economists.
- In depth understanding of healthcare systems and decision makers as well as pricing and reimbursement processes.
- Expertise across healthcare industries: pharma, biotech and medtech.
- Thorough situation analysis capabilities with expertise in the interpretation of complex data sets.
- Health economics capabilities with access to health service costing and activity data.