Prior to 2011, there was a lack of effective treatment options available for metastatic castrate-resistant prostate cancer (mCRPC) patients who had previously received docetaxel (i.e., second- and subsequent-line settings). However, after a long period of stagnation, intense R&D activity has come to fruition, making 2011 a landmark year for drug approvals in this patient population. Sanofi’s Jevtana (cabazitaxel) and Johnson & Johnson/Janssen Biotech/Janssen Cilag’s Zytiga (abiraterone) were approved by the European Medicines Agency for mCRPC previously treated with docetaxel-containing chemotherapy in March 2011 and September 2011 and have now launched across the EU5 (except for Zytiga in Italy). European first-line label extension for the use of Zytiga in asymptomatic or minimally symptomatic chemotherapy-naive mCRPC followed in January 2013.
Continuing the wave of drug development activity in the prostate cancer space, multiple market authorization applications of novel mCRPC drugs were made in 2012: Dendreon’s Provenge (sipuleucel-T), Medivation/Astellas Pharma’s Xtandi (enzalutamide), and Algeta/Bayer’s radium-223 (formerly Alpharadin). The mCRPC market is therefore poised to become increasingly crowded and competitive. As the EU5 countries continue to tighten their healthcare belt, payers are charged with balancing clinical need with diminishing budgets, and physicians will be challenged in making economical prescribing decisions and determining the optimal sequence of treatments. In this cost-constrained environment, what market access hurdles are Jevtana and Zytiga encountering, how might these evolve, and how can emerging agents hoping to compete in the prostate cancer market by the end of 2015 secure optimal pricing and reimbursement, and maximal uptake?
Decision Resources’ European Physician & Payer Forum report “The Dynamic Prostate Cancer Landscape: How Will European Payer and Prescriber Attitudes Shape This Competitive Market?” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of Jevtana and Zytiga in France, Germany, Italy, Spain, and the United Kingdom, as well as the dynamics that will influence reimbursement, pricing, and overall market access of key emerging agents. The report is based on a survey of 250 medical oncologists in the EU5, as well as 31 urologists in Germany only, and on interviews with 15 European payers. Interviewed payers have influence at a national or regional level and include the following:
- France: Advisers to the Comité Economique des Produits de Santé (CEPS; Economic Committee). Hospital Pharmacy Director.
- Germany: Member of the Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen (GBA; Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds); Key opinion leaders and chief hospital pharmacists involved in hospital tendering process and drug formulary review boards.
- Italy: Prontuario terapeutico ospedaliero regionale (PTOR; Regional Hospital Formulary) committee members; member of regional ethics committee board, and Aziende sanitarie locali (ASL; local health authorities) coordinator
- Spain: Consultant to the Spanish Ministry of Health and member of the Dirección General de Farmacia y Productos Sanitarios (DGFPS; General Directorate of Pharmacy and Health Products); a key opinion leader and university economics professor; regional hospital Pharmacy Director and member of regional formulary committee.
- United Kingdom: Regional Program Director and National Institute of Health and Clinical Excellence (NICE) technology appraisal (TA) committee member; Chief Health Board and member of the All Wales Medicines Strategy Group (AWMSG); KOL and NICE reviewer.