BURLINGTON, Mass., Nov. 18, 2014 /PRNewswire/ -- Decision Resources Group finds that Johnson & Johnson/Janssen Biotech/Janssen Cilag/AstraZeneca's Zytiga is the clear agent of choice for second-line treatment of metastatic castrate-resistant prostate cancer (mCRPC) patients, according to surveyed oncologists from France, Germany, Italy, Spain, and the United Kingdom (EU5). The average reported patient share of Medivation/Astellas Pharma's Xtandi in the second-line mCRPC setting is comparable across the EU5 with the exceptions of Italy and Spain, where Xtandi is yet to complete pricing and reimbursement negotiations. Dendreon's Provenge and Bayer HealthCare's Xofigo received European approval in 2013, but have not yet completed pricing and reimbursement negotiations across all European countries; interviewed payers cite long delays in completing these negotiations, particularly in cost-constrained countries.
Other key findings from the European Physician and Payer Forum report entitled The Metastatic Castrate-Resistant Prostate Cancer Patient Journey: EU5 Prescribing Preferences and Payer Strategy as Options Diversify:
- Market access hurdles for new therapies: Authorities in Germany found that the level of additional benefit offered by Xofigo and Xtandi to patients who are still eligible for docetaxel was not proven. In the United Kingdom, NICE was similarly critical of Xofigo (and also Zytiga in the chemotherapy-naive mCRPC setting) and did not recommend its use in the National Health Service. These unfavorable market access decisions can restrict uptake of these therapies in clinical practice, unless drug developers offer rebates on these therapies or they can be accessed through other funds (e.g. the Cancer Drugs Fund in the United Kingdom).
- Increasing payer monitoring of physician prescribing: Across the EU5, monitoring of physician prescribing for costly oncology drugs restricts their use. Sanofi's Jevtana and Zytiga are currently included in the Italian online registry of drugs subject to monitoring; Italian payers anticipate that the additional prostate cancer therapies will also be monitored in this fashion in the future. This is important because the majority of surveyed oncologists in Italy consider payer monitoring to somewhat or severely restrict their use of oncology drugs.
- Optimizing pivotal trial design as a key market access lever: Interviewed payers stress the importance of demonstrating a clear efficacy advantage over a clinically relevant existing therapy in order to secure a price premium and rapid inclusion in clinical treatment guidelines.
Comments from Decision Resources Group Business Insights Analyst Sehrish Rafique, Ph.D., M.Sc.:
- "Patient access schemes (PAS) are crucial for ensuring that expensive oncology drugs secure positive health technology assessment reviews. For example, interviewed payers from the United Kingdom tell us that the PAS for Zytiga was crucial to securing a positive NICE recommendation."
- "Emerging therapies for mCRPC will need to demonstrate significant efficacy over an active comparator in order to justify a price premium over existing therapies, though interviewed payers from the EU5 cite that the maximum price has already been reached. Likely, drug manufacturers will need to use a cost-sharing scheme to help new therapies gain market access – particularly in the more cost constrained markets (Italy and Spain)."
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