1. Introduction
Before a drug finds its way onto the Swiss market, permission to import must be obtained in accordance with the Therapeutic Products Act (HMG) and approval gained from Swissmedic, the independent Swiss Agency for Therapeutic Products. Read more about Swissmedic and its approval process in our Swizzard Insight No. 1 Swissmedic.
As soon as a new pharmaceutical is approved by Swissmedic, it can be prescribed by physicians. However, after approval, compulsory health insurance in Switzerland does not automatically reimburse the drug. There are several ways for a drug to become reimbursable in Switzerland. The most important is inclusion on the Specialties List (SL), see our Insight No. 6 on the Specialties List. Another option is the reimbursement of pharmaceuticals in individual cases.
2. Case-by-case reimbursement
Case-by-case reimbursement is a Swiss peculiarity enabling reimbursement of drugs that are on the list of specialties (SL) but outside the approved summary of product characteristics or limit; that are already approved but are not (yet) on the SL list; or that are not (yet) approved in Switzerland. The legal basis for this is Art. 71a-d of the Health Insurance Ordinance (KVV). In exceptional cases, such therapies can be covered if the criteria listed in Art. 71a-d KVV are met.
Art. 71a KVV regulates the assumption of the costs of a drug on the specialties list but outside the summary of product characteristics or limitation approved by Swissmedic. Costs can be assumed under two alternative conditions. First, if the use of the pharmaceutical product is an indispensable prerequisite for the performance of another service covered by compulsory health insurance (Art. 71a para. 1 lit. a KVV). Second, the obligation to assume the costs may arise if the use of the drug can be expected to have a major therapeutic benefit against a disease that can be fatal or result in severe and chronic health impairments and no other effective and approved treatment method is available due to a lack of therapeutic alternatives (Art. 71a para. 1 lit. b KVV).
Art. 71b KVV stipulates the conditions for assuming the costs of a ready-to-use medicinal product approved by Swissmedic that is not included in the list of specialties, for an application within or outside the summary of product characteristics. For costs to be covered, the provisions of Art. 71a para. 1 lit. a or b KVV must also be met.
Finally, Art. 71c KVV regulates when costs will be assumed for a ready-to-use medicinal product that has not been approved by Swissmedic, which may be imported into Switzerland in accordance with the Therapeutic Products Act and is approved for the corresponding indication in an approval system recognized as equivalent by Swissmedic. Again, the provisions of Art. 71a para. 1 lit. a or b KVV must also be met in order for costs to be covered.
Art. 71d KVV obliges the health insurer to consult its medical officer before assuming the costs and to check whether the costs assumed are in reasonable proportion to the therapeutic benefit. If a request is complete, the health insurance company must reach a decision on the case within two weeks. The service provider invoices the health insurer for the actual costs. For drugs covered in accordance with Art. 71a KVV, the maximum price in the SL may be invoiced; products covered by Art. 71b KVV and Art. 71c KVV are charged at the price at which the drug is obtained from the service provider. Before any costs are covered, the insurer is obliged to consult the medical officer (Ordinance on Health Insurance, KVV, SR 832.102).
Do you have questions about Art. 71a-d KVV? Contact us for answers.
Email: michael@swizzard-pharma.com
About Swizzard Pharma
Swizzard Pharma AG is a provider of support services for biotech and pharma companies in Switzerland. As part of the company’s mission to enable healthy lives in Switzerland, Swizzard helps clients maximize the value of their breakthroughs in the Swiss market. Swizzard offers a range of services, drawing a vast experience and exceptional connections to deliver fast and lean settle-in, market preparation and commercialization solutions. CEO of Swizzard is Michael Zürcher, an experienced general manager in the life sciences industry.