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FOPH evaluation on the topic of “medicines in off-label use”

For a medicine to be reimbursed by the compulsory health insurance, it has to be authorised, prescribed by a doctor and be on the list of pharmaceutical specialities managed by the FOPH. In individual cases, however, articles 71a-71d of the KVV (Health Insurance Ordinance) provide for an exception: under certain conditions, reimbursement can be made through the health insurance funds by means of cost approvals. Because most of the medicines used for children with cancer are actually only approved for adults, most of their costs are covered by this exception. In this context, paediatric oncologists and parents report protracted and tough reimbursement processes, up to and including the refusal of reimbursement in individual cases. The FOPH has fundamentally re-evaluated the provisions on the reimbursement of these medicines in so-called off-label use. Childhood Cancer Switzerland was given a permanent seat in the evaluation’s support group and was thus able to represent the specific interests of paediatric oncology with paediatric oncologist Pierluigi Brazzola. The following findings were obtained in the course of the evaluation, which has now been completed:

Conclusion: Even though the exemption regulation is welcomed in principle, there is an urgent need for optimisation. In particular with regard to the high administrative effort involved in the applications as well as the unequal treatment of insured persons due to substantial differences in the approval rates of the individual insurers.

Recommendations: In order to improve the situation in the future, various recommendations were drawn up as part of the evaluation. These include the creation of a central digital platform for simplified and more efficient processing of future applications, increased transparency in the case of negative decisions on the part of insurers, and the assessment of the benefits by an independent panel of experts in complex cases.