Market Access in Switzerland – or how to include medical breakthroughs on the specialties list
Updated: Apr 20
The Swiss healthcare market is one of the most lucrative in Europe. Thanks to solid financing, a healthy mix of private sector and state, and safe access to healthcare for Swiss residents, Switzerland ranks high in international comparisons (OECD).
For a drug to make its way onto the Swiss market, a company must first obtain its Pharmaceutical Establishment License in accordance with the Therapeutic Products Act and then receive regulatory approval from Swissmedic, the independent Swiss Agency for Therapeutic Products. Read more about Swissmedic and its approval process in our Swizzard Insight No. 2 Swissmedic.
There are several paths to drug reimbursement for patients in Switzerland. Here, we introduce the most popular: the specialties list (SL).
2. Overview of the specialties list
The reimbursement obligation for Swiss health insurers only applies to medicinal products that are included on the SL. To bring a reimbursable drug onto the market, most marketing authorization holders therefore apply for a pricing procedure at the Federal Office of Public Health (FOPH), with the aim of getting the drug on the SL.
The SL is an exhaustive list compiled by the FOPH and is binding for compulsory health insurers. It lists pharmaceutical specialties and pre-packaged drugs including price and coverage limitations. To be included on the SL, the Marketing Authorization Holder must submit an application and a reimbursement dossier for the corresponding drug. The FOPH examines whether to include the product based on the criteria of efficacy, appropriateness and cost-effectiveness. This procedure is regulated in Art. 64a et seq. of the Health Insurance Ordinance (KVV).
The FOPH is advised in this process by the Federal Drug Commission (FDC), consisting of representatives of service providers (physicians, hospitals, pharmacists), insurers, insured persons, the cantons, Swissmedic, industry, and faculties of medicine and pharmacy. The SL is published by the FOPH and can be found on an official, publicly accessible online platform (https://www.spezialitätenliste.ch).
The FOPH may restrict listing, e.g. to a certain patient population or a pre-defined time period. Apart from the discussion on the defined and covered patient population, the price setting process is governed by the FOPH according to a fixed formula. This includes the average of the reference price of the drug from nine European reference countries (“Auslandspreisvergleich”), and a basket of drugs within the same therapeutic basket (“therapeutischer Quervergleich”).
If a drug is considered innovative, a premium of up 20% may be granted. The SL includes more than 3,000 reimbursed drugs, mostly prescription medicine for the outpatient setting, and sets the maximum selling price as imposed by the FOPH. The standard timeline from Swissmedic approval to SL listing is 60 days; however, it can take significantly longer until the innovator and health authorities agree on a satisfactory price.
3. Swizzard Pharma’s mission
Swizzard Pharma can help pharmaceutical companies access the Swiss healthcare market – faster. By providing critical expertise and customized go-to-market-strategies, Swizzard enables pharmaceutical companies to settle in without any unnecessary delays. Swizzard’s approach is based on deep experience of the price-setting process and price strategies. Besides supporting companies with their SL submission, Swizzard is also able to negotiate directly on behalf of customers.
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Swizzard Pharma AG
About Swizzard Pharma
Swizzard Pharma AG is a provider of support services for biotech and pharma companies in Switzerland. As part of the company’s mission to enable healthy lives in Switzerland, Swizzard helps clients maximize the value of their breakthroughs in the Swiss market. Swizzard offers a range of services, drawing a vast experience and exceptional connections to deliver fast and lean settle-in, market preparation and commercialization solutions. CEO of Swizzard is Michael Zürcher, an experienced general manager in the life sciences industry.