The Municipal Court in Prague has ruled that the insurance company is obliged to approve an extraordinary reimbursement for the client's treatment with the medicinal product Besremi. At the same time, in his judgment, he explained the relationship between on-label and off-label treatment.
In a dispute with VZP, we represented a client who requested an extraordinary reimbursement for the treatment of his oncological disease pursuant to Section 16 of the Public Health Insurance Act. The client submitted a total of three requests for extraordinary payment. All applications were rejected by the insurance company. We appealed against the last decision. That too was rejected. We therefore filed a lawsuit against the insurance company's decision, stating that the decision is illegal. We saw the illegality in the fact that VZP misinterpreted the fulfillment of the conditions for extraordinary reimbursement - the condition of uniqueness of treatment with the medicinal product Besremi and the condition of exceptionality.
The case was interesting in fact and in law, and we succeeded on both levels. In assessing the uniqueness of Besremi treatment, the court took into account in the specific case that the patient is middle-aged, the indicated treatment allows a near-recovery condition, and the insurance options provided by the insurance company are intended for elderly patients, are carcinogenic or unavailable for a long time.
The central issue in the dispute was the legal issue of the relationship between on-label and off-label indication of a medicinal product. VZP argued that in the case of the client, the condition of uniqueness of treatment with the medicinal product Besremi is not met, as there is a medicinal product Pegasys, which is even covered by the public health insurance system. The main legal difference between these medicinal products was that, according to the summary of product characteristics, Besremi is indicated specifically for the treatment of the client's oncological disease. Pegasys, on the other hand, is not indicated for the treatment of this disease. In other words, Besremi is an on-label treatment in this case, while Pegasys is an off-label treatment. Interestingly, although Besremi treatment is an on-label treatment for the client's illness, reimbursement from the public health insurance system was set for off-label treatment with Pegasys. Thus, a patient who needs Besremi treatment has no choice but to ask the insurance company for an extraordinary reimbursement of treatment pursuant to Section 16 of the Public Health Insurance Act. The Medicines Act stipulates that if on-label treatment is available for the patient's treatment, the doctor may not use off-label treatment, even if it is reimbursed.
The court clearly stated that the requirement of preferential use of on-label treatment should be followed, even in the case where off-label treatment, unlike on-label treatment, is reimbursed. A different interpretation would force the attending physician to take a procedure which is contrary to the Law on Medicinal Products and, in addition, exposes the doctor to liability for the damage suffered.
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