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.

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Discretion as a systemic feature—or a systemic flaw?

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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.

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What does this mean in practice?

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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.

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Click here for the Dittli motion (19.3703)

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