15.7.2025
SL Insight Newsletter #4
Stricter limits - FOPH sends a clear price signal
Werder Viganò
Recently, there have been increasing indications that the FOPH is pursuing a much more restrictive inclusion and limitation practice for new medicinal products - especially if the price charged is considered too high in relation to the additional clinical benefit.
What does this mean for current SL applications?
Cancer therapy without SL status, despite Swissmedic approval:
The FOPH compared the new product with a 20-year-old standard therapy - and derived such a low price from this that the manufacturer refused to include it. The therapy now remains unavailable in Switzerland, while it is reimbursed in other countries.
Asthma biologic with radical limitation:
reimbursement only for a very small subgroup, price around 1/30 of the European average. Here too, the FOPH opted for a clearly conservative benefit assessment.
Trend towards price signal policy:
The message is clear - if there is no additional benefit (or insufficient documentation), the FOPH will not shy away from low prices or complete non-inclusion.
Takeaway:
Anyone currently submitting an SL application must expect a much tougher approach, particularly in oncology and orphan drugs. A solid benefit argumentation and differentiated comparative therapy are more important than ever. Otherwise there is a risk of withdrawal or listing under conditions that are hardly economically viable.
Click here for the press release.
