In the EU5, Zelboraf Has Heavily Penetrated Surveyed Oncologists’ First-Line Treatment of BRAF Mutation-Positive Unresectable and Metastatic Malignant Melanoma

In the EU5, Zelboraf Has Heavily Penetrated Surveyed Oncologists’ First-Line Treatment of BRAF Mutation-Positive Unresectable and Metastatic Malignant Melanoma

Decision Resources

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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that in the EU5 (France, Germany, Italy, Spain and the United Kingdom), despite ongoing pricing and reimbursement negotiations in some countries, Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf has heavily penetrated surveyed oncologists’ first-line treatment of mutation-positive unresectable and metastatic malignant melanoma. Bristol-Myers Squibb’s Yervoy, in accordance with its European label which specifies pretreatment, is most commonly used as a second-line treatment among survey respondents, primarily for their mutation-negative patients, reflecting that tumors with this molecular characteristic are not treated with Zelboraf.

The European Physician & Payer Forum report entitled finds that uptake of both Zelboraf and Yervoy among surveyed oncologists is highest in the U.K., despite the lack of a positive recommendation from the National Institute for Health and Clinical Excellence (NICE) at the time the survey was fielded. Respondents in the U.K. identify the interim Cancer Drugs Fund as their primary source of funding prior to recommendations from NICE for these agents. Uptake of both drugs is least in Italy and Spain, underlining the prolonged and ongoing pricing and reimbursement negotiations for Zelboraf in both countries and for Yervoy in Italy.

“Interviewed payers believe that drug pricing discussions are causing the delay in admission to reimbursement for these agents, as the healthcare systems in Italy and Spain especially struggle to work within rapidly shrinking budgets,” said Decision Resources Analyst Niamh Buckley, Ph.D. “Payers in Italy also indicate that while availability of Yervoy and Zelboraf via compassionate programs has allowed prescribers to become familiar with them, it may also have allowed reimbursement regulators to drag their heels somewhat.”

The report also finds that robust survival advantages over well-chosen comparators in head-to-head trials will help optimize pricing and reimbursement conditions for emerging premium-priced malignant melanoma agents - incremental improvements in survival, and indirect comparisons and Phase III against placebo or an inappropriate comparator will, at best, limit reimbursement price. Therapeutic innovation, a well-defined niche patient population and demonstrable downstream cost savings are additional market access levers that will encourage EU5 payers to think beyond the price tag.

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