Switzerland has formalised how added clinical benefit is assessed when manufacturers seek an innovation premium for oncology medicines. From 1 July, applications for premiums in solid and haematological cancers must use new structured models that link the assessed therapeutic advance to the maximum premium available.
On 2 July the Federal Office of Public Health (Bundesamt für Gesundheit, FOPH) announced the requirement for use of the models, adding further detail to an existing part of the Swiss pricing system. Since the 2015 pricing reforms, FOPH has been able to award an innovation premium according to the degree of therapeutic advance, which is already classified into five categories. A ‘very large’ therapeutic advance can support a premium of up to 20%, while a ‘large’ advance can support up to 10%. Moderate, small or absent added benefit receives no premium.
Assessment starts from clinical evidence, normally a peer-reviewed phase III study demonstrating statistically significant superiority over an appropriate comparator. Overall survival and progression-free survival are central outcomes. The initial rating can then be adjusted for factors including quality of life, toxicity and study design. The approach draws substantially on the European Society for Medical Oncology Magnitude of Clinical Benefit Scale.
The July 2026 change provides oncology-specific scoring tools and makes their submission mandatory when a premium is requested.
Swiss reimbursement prices are normally derived equally from a therapeutic price comparison and an international price comparison. Where an innovation premium is justified, it increases the result of the therapeutic comparison before the two price comparisons are combined.
FOPH has not announced a timetable for equivalent mandatory models in other therapeutic areas.
Source: Federal Office of Public Health
Link: Rundschreiben zum Nutzenbewertungsmodell Onkologie (Solide Tumore und Hämatologische Tumore) (Circular on the oncology benefit-assessment model for solid and haematological tumours)
Date: 2 July 2026
Source: Federal Office of Public Health
Link: Handbuch betreffend die Spezialitätenliste und die Geburtsgebrechen-Spezialitätenliste (Handbook concerning the Specialities List and the Congenital Infirmities Specialities List)
Date: 1 January 2025
Source: Federal Office of Public Health
Link: Preisfestsetzung von Arzneimitteln: Mehr Transparenz und bessere Nutzenbewertung (Medicine price-setting: more transparency and better benefit assessment)
Date: 29 April 2015
