On March 21, 2025, the Swiss parliament has adopted a new Cost Containment Package ("CCP2") in response to the continuing rise of healthcare costs, in particular the premiums of the compulsory health insurance. This most recent revision of the law on compulsory health insurance forms part of the Federal Government's broader cost reduction program, under which two initial Cost Containment Packages (CCP1a and CCP1b) have already been enacted in the years 2019 and 2022.
At the heart of the CCP2 are two new provisions authorising the Federal Office of Public Health ("FOPH") to decree so-called pricing models when determining the price of medicinal products. This new type of condition for an inclusion in the so-called List of Specialties ("SL") is likely to have a significant impact on reimbursement and the associated economic consequences for manufacturers. However, neither the details regarding the pricing models nor the date of entry into force of the CCP2 have yet been determined.
Since long, the prices of medicinal products in Switzerland have been set by the FOPH. The prices of every medicinal product covered by the compulsory health insurance are included in the SL. Medicinal products are added to the SL following an administrative procedure initiated by the manufacturer by submitting an application to the FOPH. In this procedure, the FOPH determines the price to be reimbursed by means of a legally defined therapeutic cross-comparison ("TQV") and an international price comparison ("APV"). Both comparisons ultimately ensure that prices remain economically efficient. However, the future pricing models will enable the FOPH to modify the standard pricing procedure by imposing additional conditions regarding, e.g., sales volume, cost or quantitative limits.
Recently, the FOPH has taken the position that pricing models already constitute permissible conditions in pricing procedures, although the aforementioned provisions of the CCP2 have not yet entered into force. Taking into account the principle of legality and pertinent case law, this position most likely bears no merit. The Federal Administrative Court has not yet rendered a decision regarding the current practices of the FOPH. However, the publicly accessible overview of pricing models by FOPH contains valuable guidance on what manufacturers may have to expect with regards to future pricing procedures. FOPH considers the following price models: (i) Reimbursements on the published price (ii) cost or quantity limits at patient level (iii) quantity limits per medicinal product (iv) advance payment models (v) pay-for-performance at patient level (vi) pay-forperformance at population level.
The provisions of the CCP2, which will provide the legal basis for pricing models, partly reflect these specific pricing models. Manufacturers may be required to reimburse a predetermined portion of the price of the medicinal product or the costs incurred. Moreover, once a medicinal product reaches a defined market volume in Switzerland, manufacturers may be required to reimburse a portion of the additional turnover.
The implementing ordinances have yet to be drafted. In our view, the legally defined pricing mechanism of TQV and APV may not be completely undermined by such models and it is clear that the constitutional principles of proportionality and equal treatment must be respected at ordinance level as well.
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