SIPULEUCEL-T (PROVENGE®)- AUTOPSY OF AN INNOVATIVE CHANGE OF PARADIGM IN CANCER TREATMENT

Author(s)

Jaroslawski S1, Caban A1, Toumi M2
1Creativ-Ceutical, Krakow, Poland, 2University of Marseille, Marseille, France

OBJECTIVES: Approved by the Food and Drug Administration (FDA) in 2010, sipuleucel-T was the first personalised “cancer vaccine” to treat prostate cancer in the metastatic, non-symptomatic population of 30,000 men in the US. Sipuleucel-T is prepared individually for each patient and infused in three sessions over one-month. In 2015, sipuleucel-T’s owner, Dendreon, filed for bankruptcy. This search aimed to review how this innovative product failed to achieve commercial success. METHODS: PubMed and internet search focused on pricing, reimbursement and market access. RESULTS: Sipuleucel-T’s FDA approval was delayed by 3 years, reportedly because of the vaccine’s new mechanism of action. Sipuleucel-Twas cleared by the European Medicines Agency two years later, but other locations were not approached. It was priced at $93,000 for a course of treatment. The high price combined with the company’s late management of reimbursement of the vaccine by the US Centers for Medicare & Medicaid Services (CMS) resulted in another year of delay in accessing the market. In spite of positive recommendation by the National Comprehensive Cancer Network, sipuleucel-T’s complex administration, high price and uncertainty about the reimbursement status deterred doctors from the product. Further, the vaccine’s supply was limited during the first year of launch, due to small manufacturing capacity. Two oral metastatic prostate cancer drugs with similar survival benefit reached the US market one and two years after sipuleucel-T. Even though Dendreon’s market capitalization topped $7.5 billion following FDA’s approval sipuleucel-T, this value degraded gradually until the firm’s bankruptcy five years later. CONCLUSIONS: The bankruptcy of Dendreon was largely due to the delay in reaching FDA approval and CMS coverage and the high cost that had to be incurred by providers up-front. Licensing sipuleucel-T to a Pharma company more experienced in the market access pathway may have saved the company and the product.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN275

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Oncology

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×