23.4.2026

SL Insight Newsletter #30

Prevalence criterion: Discretion rather than methodology

Marcel Boller

As part of Cost Containment Package 2 (KP2), the FOPH is introducing a third pricing element in addition to the TQV and the APV: the prevalence criterion (Art. 65b para. 3ter nKVV). It allows the FOPH to determine the ex-factory price by comparing it with other drugs used to treat diseases with comparable prevalence.

Discretion as a systemic feature—or a systemic flaw?

In its report, the FOPH presents the new criterion as a bridge intended to make new therapies accessible. While this framing is understandable from an industry perspective, it is misleading: The Dittli motion (19.3703) explicitly called for price-setting to take into account not only the unit price but also the expected total costs, with a view to prevalence.

What does this mean in practice?

The new criterion is not subject to any specific methodological requirements. The FOPH determines what constitutes “comparable prevalence,” which drugs are included in the comparison group, and when a TQV result should be classified as “very low”—without any binding requirements at the regulatory level.

Click here for the Dittli motion (19.3703)