A CROSS EUROPEAN COMPARISON OF ERIBULIN REIMBURSEMENT DECISIONS

Author(s)

Walker SA1, Ando G21IHS, London, United Kingdom, 2IHS Global Insight, London, United Kingdom

OBJECTIVES: Eribulin mesylate (Eisai, Japan) was approved by the European Commission in March 2011 for the treatment of locally advanced or metastatic breast cancer in patients who had progressed after at least two chemotherapeutic regimens. The approval, which was granted through the centralised process, was based on results of the Phase III EMBRACE Trial which demonstrated a statistically significant increase in overall survival (OS) for the eribulin study arm versus the "treatment of physician's choice" (TPC) arm. This study aims to discern how reimbursement bodies in key European countries have assessed the drug, with its high price, since its approval. METHODS: We reviewed the reimbursement guidance on eribulin in key European markets and determined whether the decisions were positive or negative, and how those decisions reflect different weightings of clinical versus economic (or other) evidence in the assessments. RESULTS: German authorities concluded that eribulin had additional benefits over existing therapies, despite an initial negative decision by IQWiG, allowing Eisai to enter pricing negotiations. The Italian Medicines Agency and France's Transparency Commission both positively recommended the drug for approval in January 2012 and October 2011 respectively. The United Kingdom's NICE as well as the Scottish Medicines Consortium (SMC) rejected eribulin in April 2012 and October 2011 respectively. CONCLUSIONS: Despite eribulin's centralised approval process, reimbursement decisions on the drug have varied widely among European countries. Although there has been movement towards greater alignment between European reimbursement agencies regarding funding decisions, this still has not come to pass as the Eurozone's financial crises threaten to further stymie reimbursement decision harmonisation. The positive assessments highlight the clinical efficacy of the drug and strength of the clinical evidence, though questions remain over the economic case.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PCN147

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Oncology

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