BURLINGTON, Mass., July 24, 2014 /PRNewswire/ -- Decision Resources Group finds that, for the treatment of asthma, pulmonologists in the EU5 countries (France, Germany, Italy, Spain and the United Kingdom) hold a generally positive view of the first once-daily long-acting beta2 agonist/inhaled corticosteroid (LABA/ICS) fixed-dose combination (FDC), Relvar (GlaxoSmithKline/Theravance). EU5 pulmonologists expect robust uptake of Relvar as a first-line LABA/ICS FDC in the treatment of asthma with one-quarter to half of surveyed pulmonologists considering the drug as a first-line maintenance therapy for treatment-naive persistent asthma patients. However, interviewed payers across EU5 countries caution that in order for Relvar to secure premium pricing, superior efficacy data over Seretide (GlaxoSmithKline) would be required. Thus, despite its lower dosing frequency, the existing noninferiority data for Relvar will most likely drive an equivalent price to that of currently available twice-daily LABA/ICS FDCs.
Other key findings from the European Physician and Payer Forum report entitled Asthma in the EU5: What Are the Expectations for Optimal Positioning of New and Emerging Inhaled and Biological Therapies in Market Access Systems?:
- Market-access hurdles for emerging biologics: Interviewed payers and surveyed pulmonologists across the EU5 view the ability to identify likely responders as a benefit for the emerging anti-IL-5 therapies -- Cinquil (Cephalon/Teva), Bosatria (GlaxoSmithKline) and benralizumab (MedImmune/AstraZeneca). However, payers anticipate the cost of such diagnostic testing could be a hurdle for reimbursement and uptake.
- Impact of emerging generics and biosimilar omalizumab: Interviewed EU5 payers agree that the use of generic or branded-generic versions of LABA/ICS FDCs, Seretide and Symbicort (AstraZeneca), and biosimilar omalizumab are likely to be promoted. Surveyed pulmonologists indicate that concerns regarding safety and bioequivalency of biosimilar omalizumab to Xolair (Genentech/Novartis) need to be addressed before they would consider prescribing the drug.
Comments from Decision Resources Group Analyst Eun-Jin Yang, Ph.D.:
- "In these times of austerity, payers across the EU5 emphasize that for an emerging therapy to secure favorable terms in reimbursement and pricing negotiations, the drug has to demonstrate superiority in efficacy in head-to-head trials against an appropriate comparator. Thus, given the non-inferiority efficacy profile in asthma indication, Relvar's pricing will be key for its favorable placement in the treatment guideline and for driving uptake."
- "Even though payers across the EU5 have only a modest cost-saving expectation for generic LABA/ICS FDCs and for biosimilar omalizumab, they indicate a strong interest in promoting the usage of these agents, particularly for treatment-naive patients. However, they are less enthusiastic for biosimilar omalizumab, likely due to the lack of experience with biosimilars to date which contributes to payer and physician uncertainty regarding biosimilar omalizumab's safety and bioequivalency to Xolair. This could be mitigated by biosimilar omalizumab demonstrating a robust safety and bioequivalency profile compared to Xolair."
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