Life Sciences 2026

SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd

8.3 Reimbursement From Public Funds Under the compulsory health insurance, insurers must reimburse costs for prescribed medicinal products listed in the SL and the LMT at the maximum amount set out therein. The reimbursement may be restricted to specific indications, quantities or durations. Reim- bursement is, in general, only granted for listed medic- inal products under the condition that they are used in connection with indications approved by Swissmedic and within approved quantities. Exceptions from this general rule apply on a case-by-case basis subject to the conditions set out in Article 71a of the HIO. In addition, there is also room for reimbursement in individual cases of medicinal products not yet author- ised, not yet included in the SL, or used outside their marketing authorisation (Articles 71b-d of the HIO). Medical devices applied by the patient are reimbursed under the condition that they belong to a specific group of medical devices in the LIT, are prescribed by a physician or chiropractor, and are dispensed by an authorised provider. The reimbursement of listed medical devices may be restricted to specific medical indications, quantities or durations. Case law has not yet addressed the question of whether the provisions of Article 71a-d of the HIO are also applicable to medi- cal devices by analogy. 8.4 Cost-Benefit Analyses Among the conditions for the inclusion of medicinal products on the SL are their efficacy, appropriateness and cost-effectiveness, and the existence of these conditions must be periodically reviewed (Article 32 of the HIA). Medicinal products that no longer meet these criteria are removed from the SL by the FOPH. The same applies to medical devices (to be) included in the LIT. It is usually undisputed that an authorised medicinal product is effective and appropriate. In practice, the main focus is therefore on the criterion of cost-effec- tiveness, including the respective comparisons with other medicinal products and markets (see 8.2 Price Levels of Pharmaceuticals or Medical Devices ). On 18 February 2026, the Federal Council submit- ted amendments to the HIO and the OBHI for public consultation, introducing, inter alia, a differentiated

if the criteria of efficacy, appropriateness and cost- effectiveness are met (Article 32 paragraph 1 of the HIA). The prices are reviewed every three years (Arti- cle 65d of the HIO) and additional reviews take place upon patent expiry and in the event of the authorisa- tion of further indications. On 21 March 2025, the Swiss Parliament adopted new provisions providing for provisional reimburse- ment of medicinal products from the date of marketing authorisation by Swissmedic (“Day 0”) – ie, prior to their formal inclusion in the SL (cf. Article 52d of the nHIA; expected to enter into force in early 2027). The List of Items and Tools (LIT) determines which devices are covered by the compulsory health insur- ance. Unlike the SL, the LIT does not fix the ex-factory and public price, but only sets the maximum reim- bursement amount. In principle, higher prices may be charged and the difference is borne by the patient. There are specific provisions governing the applica- tion for inclusion on the LIT. The FDHA decides upon consultation of the Federal Commission for Analy- ses, Instruments and Tools (FCAIT) on the addition, change, or delisting (cf Articles 21 et seq of the OBHI). The criteria of efficacy, appropriateness and cost- effectiveness also apply to medical devices. 8.2 Price Levels of Pharmaceuticals or Medical Devices When setting and reviewing the prices of the medici- nal products included in the SL, the FOPH relies on the following comparisons: a therapeutic comparison in which the effectiveness of the medicinal products is assessed in relation to other medicinal products used for the same indication (Article 65b paragraph 1 lit a of the HIO); and a price comparison with the same medicinal product abroad (cf Article 34a of the OBHI and Article 34b of the OBHI). The two comparisons are given the same weight. The latter comparison is carried out accord- ing to the guidance of the EAK, taking into account foreign countries whose pharmaceuticals sector is economically comparable with that of Switzerland.

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