Pricing and reimbursement

Price regulation

To what extent is the market price of a medicinal product or medical device governed by law or regulation?

Medicinal products that are reimbursed by the basic health insurance are subject to government price control. The prices of non-reimbursed products are free and are not government-controlled.

A ready-to-use medicinal product (whether prescription-only or non-prescription) must, in principle, be listed on the speciality list (SL) established by the Federal Office of Public Health to be reimbursed in the basic health insurance (unless it is paid by hospitals out of a diagnosis-related group flat-rate). When deciding on the admission of a medicinal product to the SL, the Federal Office of Public Health determines its list price. This price is the maximum price that can be invoiced by healthcare providers and that will be reimbursed by health insurance companies. About 80 per cent of the sales of pharmaceutical products in Switzerland relate to products listed on the SL.

If a medicinal product is not listed on the SL or is listed on the SL but is used off-label or outside a limitation of reimbursement, it must be taken over by the health insurance companies in basic health insurance if there is no effective and authorised treatment alternative against a fatal or severe and chronic illness, and a high therapeutic benefit can be expected from its use. In this situation, the health insurance companies determine the reimbursed amount and negotiate a cost participation with the pharmaceutical company concerned.

For medical devices used or applied by patients themselves or persons supporting in a non-professional capacity or by healthcare providers providing nursing services, the health insurance companies pay a certain fixed amount per device that is listed in the list of aids and equipment independently of the price of the specific medical device in question. For medical devices applied by medicinal healthcare professionals or hospitals not for nursing services, the reimbursement is governed by the tariff agreements regulating the reimbursement of their healthcare services.

Negotiations between manufacturers and providers

Must pharmaceutical and medical device manufacturers negotiate the prices of their products with public healthcare providers?

For reimbursed medicinal products, the SL established by the Federal Office of Public Health lists the maximum ex-factory price and the SL price. Healthcare providers can negotiate a lower price than the ex-factory price with the pharmaceutical manufacturers. Sometimes rebates are granted, namely to hospitals. Prices of medical devices can also be negotiated. For non-reimbursed products, prices can be negotiated among pharmaceutical manufacturers and healthcare providers.

Reimbursement

In which circumstances will the national health insurance system reimburse the cost of medicines?

Under the basic health insurance, health insurance companies pay or reimburse ready-to-use medicinal products prescribed by physicians for outpatient treatment (or, under certain circumstances, chiropractors) that are listed on the SL if they are used within their indication. The SL listing may be accompanied with limitations regarding reimbursement.

In two exceptional situations, the costs of a product that is either not listed on the SL, or is listed on the SL but used off-label or outside a limitation of reimbursement, are taken over by the basic health insurance: in a situation when there is no effective and authorised treatment alternative against a fatal or severe and chronic illness and a high therapeutic benefit can be expected from its use, and in the situation of a ‘treatment complex’ (ie, when there is a very narrow connection between medical services that are reimbursed and services that are not or are only partially reimbursed when the non-reimbursed services are a necessary condition for the treatment, or are of considerable importance for the success of the treatment). In both situations, the physician of confidence of the respective health insurance company has to be consulted, and the health insurance company has to approve reimbursement in advance and determines the extent of reimbursement after having negotiated a cost-contribution with the manufacturer.

In the inpatient sector, the costs of medicines are mainly paid through, and included in, flat-rate payments per case. For certain medicines, separate supplementary fees can be invoiced by the hospital to the health insurance companies.

Optional additional private insurance may also cover certain authorised medicinal products that are not listed in the SL.

Price adjudication

If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?

The competent body is the Swiss Federal Office of Public Health. It decides on the admission of finished medicinal products to the SL. A medicinal product is only admitted to the SL if the applicant can show its efficacy, usefulness and economy. The relevant criteria for fixing the SL price of an original product are the prices of drugs in Switzerland with the same indication or a similar mode of action and the average price of the product in other countries. Currently, the prices in nine reference countries – Germany, Denmark, England, the Netherlands, France, Austria, Belgium, Finland and Sweden – are used for this comparison. For determining the SL price, the Federal Office of Public Health adds a distribution margin to the ex-factory price determined according to the two criteria described above. The fulfilment of the conditions for admission to the SL is, in principle, reviewed every three years. A review of the conditions for admission to the SL also takes place immediately after the expiration of the patent protection, as well as in the following situations: authorisation of a new indication by Swissmedic, restriction of an indication by Swissmedic, request for changing a limitation and request for a price increase. The SL prices of generics are determined in the function of the prices of their reference products.

Discount

Are manufacturers or distributors of medicinal products statutorily obliged to give a discount to health insurance schemes or third parties?

There are no statutory rules obliging manufacturers or distributors of medicinal products to give certain discounts. Healthcare providers must pass on discounts that they have received on medicinal products or in relation to services reimbursed by the basic health insurance to the debtor of the healthcare product or service (insurance or patient).