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). Dr. Michael Zürcher, partner of the Healthcare Shapers network and CEO of Swizzard Pharma AG is helping pharmaceutical companies to get access to the Swiss healthcare market much faster.
First step: Get approval by Swissmedic
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 (1).
There are several paths to drug reimbursement for patients in Switzerland. Michael Zuercher is introducing the most popular: the specialties list (SL).
Enter the Specialties list (SL) to get your products reimbursed
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 (2).
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”).
Innovations are getting premium price
If a drug is considered innovative, a premium of up to 20 Percent 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.
Dr. Michael Zürcher and his team at Swizzard Pharma can help pharmaceutical companies to get access to the Swiss healthcare market – faster. By providing critical expertise and customized go-to-market-strategies, he enables pharmaceutical companies to settle in without any unnecessary delays. His approach is based on deep experience of the price-setting process and price strategies. Besides supporting companies with their SL submission, Michael and the team of Swizzard Pharma are also able to negotiate directly on behalf of customers.
For further information please contact Dr. Michael Zürcher.
(1) Swissmedic – More about organization, Mission and Duties https://www.swizzard-pharma.com/post/swizzard-insight-no-1-swissmedic
(2) Specialties list (SL) published by the FOPH on https://www.spezialitätenliste.ch