Package advice on avelumab (Bavencio®) for treating urothelial cell carcinoma

Zorginstituut Nederland has completed its assessment whether avelumab (Bavencio®) can be included in the insured package. Avelumab is indicated as monotherapy for the primary-care maintenance treatment of adult patients with locally advanced or metastatic urothelial cell carcinoma. The reason for this advice was the placing of this medicinal product in the so-called package lock procedure or ‘sluice’ for expensive medications.The Zorginstituut advises the Minister to include avelumab in the health care package for the above-mentioned indication if a price reduction of at least 30% can be achieved.

Registered indication

Avelumab is indicated as monotherapy for the primary-care maintenance treatment of adult patients with locally advanced or metastatic urothelial cell carcinoma who are progression-free after platinum-based chemotherapy.

Zorginstuut's advice

Based on the considerations mentioned in the report, the Zorginstituut concludes that avelumab meets the statutory criterion of ‘established medical science and medical practice’ for the indication mentioned. This is an effective medicine that significantly prolongs patients’ lives. However, the budgetary impact is high and unfavourable in terms of cost-effectiveness. The Zorginstituut therefore recommends the Minister to include avelumab in the health care package for the mentioned indication if a price reduction of at least 30% can be achieved.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.