Zurich Social Security Court, Decision KV.2018.00057 of 29 January 2019

8 April 2019 – The Zurich Social Security Court decided that SWICA Krankenversicherung AG, within the framework of the compulsory health insurance, shall cover the costs of an off-label use of the medication Imbruvica® for the treatment of blood cancer (CNS lymphoma in relapse of diffuse large cell B-cell lymphoma, stage IVA). According to art. 71a(1) of the Ordinance on Health Insurance, compulsory health insurance covers the cost of a medicinal product included in the list of pharmaceutical specialties (“Spezialitätenliste”) for use outside the information approved by Swissmedic or outside the limits laid down in the list of pharmaceutical specialties, if the use of the medicinal product is expected to have a major therapeutic benefit against a disease which is fatal for the patient or may result in serious and chronic health impairments, and no other effective and approved treatment method is available due to the lack of therapeutic alternatives. In the present case, it was controversial whether the use of Imbruvica® could be expected to have a major therapeutic benefit against the patient’s blood cancer disease - proven by clinical studies or published, scientifically verifiable findings on effectiveness of the medication in the field of application. The court concluded that, due to the individual clinical progress of the disease as well as the presented medical literature, the prerequisite of the high therapeutic benefit is fulfilled in the individual case. The court stated that in case of off-label use, it cannot be a question of assessing whether the use of a medicinal product should generally be included in the list of pharmaceutical specialties, but rather whether it is necessary to deviate from the list in an individual case. Passing the decision, the court took into account that the medical opinion of the treating doctor could partly substitute missing scientific findings in the present context and in the absence of existing studies and, furthermore, that the freedom of therapy (art. 27 of the Swiss Constitution) protects the right of a doctor to apply the therapy which he considers to be most suitable in the context of his duty of care.