Market Access in Switzerland represents a great opportunity in improving patient access in a pharmaceutical hub
Unlike other European healthcare systems, Switzerland does not have a free state-run healthcare system. Instead, health insurance is compulsory and is run primarily by the private sector.
Insurers must provide every Swiss citizen and resident with basic health insurance and are not allowed to make a profit from basic healthcare. However, insurers are allowed to make a profit from supplementary care plans.
Who is responsible?
It is the role of the country’s Federal Office of Public Health (FOPH) to maintain and develop a framework for biomedical research and technology, ensuring that the population benefits from the achievements of biomedicine with affordable access to the latest biomedical products. The FOPH is responsible for the legal framework (for example in relation to clinical research, therapeutic products, cancer registries and e-patient dossiers) and is charged with ensuring that the healthcare system remains high quality, effective and affordable.
Swissmedic is the national authorisation and supervisory authority for drugs and medical products, and is responsible for granting marketing authorisation.
What are the stages of market access in Switzerland?
In Switzerland, there are two stages to the market access process. First, the product must obtain market authorisation through Swissmedic. The process can take anywhere between 140 days and 500 days, depending on the data available or whether a product is going through the Fast-Track Process (FTP) application. Swissmedic will assess the efficacy, safety and quality of the drug product. The product will receive a price for reimbursement from the FOPH, which takes up to an additional 150 days. The reimbursement price is based on the assessed value of the product from an economic perspective (therapeutic reference, international reference pricing and health economics), efficacy and the usefulness of the drug.
The second stage is health technology assessment (HTA). Switzerland does not have a specialised HTA institution like the National Institute for Health and Care Excellence (NICE) in the UK or Haute Autorité de Santé (HAS) in France. Instead, HTA submissions are carried out by external partners overseen by the FOPH. An HTA report will then be submitted to a review group. This has created an inconsistent HTA process that can vary in scope and criteria depending on the body carrying out the HTA, posing challenges for pharmaceutical manufacturers.
Medicines can only be reimbursed by health insurance providers if the FOPH places the medicine on its List of Pharmaceutical Specialties (LS). Inclusion on this list depends on meeting the criteria for effectiveness, appropriateness and cost-effectiveness. The verdict on inclusion will be taken by the FOPH at the recommendation of the Federal Medicines Commission.
The price of drugs is set using two criteria: comparison with prices charged abroad and therapeutic comparison. The results of these two comparisons are equally important in setting the price of the drug. If a drug demonstrates significant therapeutic progress, the FOPH can grant an innovation bonus within the framework of the therapeutic comparison.
What does this mean for my medicinal product?
Market access in Switzerland presents unique challenges to companies that are planning to launch their products. As Switzerland is not part of the EU market, authorisation is not within the scope of the European Medicines Agency. Additionally, with HTA evaluations undertaken by external partners, there are inconsistencies in HTA opinions.
Nevertheless, Switzerland represents one of the largest pharmaceutical markets in Europe that represents over 5% of its Gross Domestic Product (GDP). Switzerland is a great place to launch products with its highly developed pharmaceutical market. Switzerland is only behind Germany when it comes to Research and Development investment in Europe. Launching in Switzerland can help achieve better patient access in Europe and allow more people in need to be treated faster and effectively.