SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
fix the ex-factory and public price, but only sets the maximum reimbursement amount. In princi- ple, higher prices may be charged and the differ- ence is borne by the patient. There are specific provisions governing the application for inclu- sion on the LIT. The FDHA decides upon consul- tation of the Federal Commission for Analyses, 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 medicinal products included in the SL, the FOPH relies on the following comparisons: a therapeutic comparison in which the effective- ness 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 compari- son is carried out according to the guidance of the EAK, taking into account foreign countries whose pharmaceuticals sector is economically comparable with that of Switzerland. 8.3 Pharmaceuticals and Medical Devices: 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 maxi- mum amount set out therein. The reimbursement may be restricted to specific indications, quanti-
ties or durations. Reimbursement is, in general, only granted for listed medicinal 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 authorised, not yet included in the SL, or used outside their marketing authori- sation (Articles 71b-d of the HIO). Medical devices applied by the patient are reim- bursed 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 indica- tions, quantities or durations. Case law has not yet addressed the question of whether the provi- sions of Article 71a-d of the HIO are also appli- cable to medical devices by analogy. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices 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 periodi- cally 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-effectiveness, including the respective comparisons with other medicinal
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