The EU5 Market for Respiratory Drugs is Becoming Increasingly Crowded and Price-Sensitive

BURLINGTON, Mass., July 5, 2016 /PRNewswire/ -- Decision Resources Group finds that access and reimbursement for both chronic obstructive pulmonary disease (COPD) and asthma are becoming increasingly challenging as European payers grow more price sensitive. The bulk of new therapies entering the European COPD market within the next three years are likely to be new fixed-dose combinations (FDCs) of molecules currently marketed as monotherapies or already included in alternative FDCs. Most notably, the first triple therapies (long-acting beta 2 agonist [LABA]/long-acting muscarinic antagonist [LAMA]/inhaled corticosteroid [ICS] FDCs) are forecast to reach the market as soon as 2017. However, the launch of branded-generic/generic versions of market-leading drugs such as GlaxoSmithKline's Seretide, AstraZeneca's Symbicort, and Boehringer Ingelheim's Spiriva following patent expiries for these agents across the EU5 (France, Germany, Italy, Spain, and the United Kingdom) coupled with the current availability of FDC components in separate inhalers are likely to impose pricing pressures on these new combinations despite the convenience they offer and contribute to an already competitive reimbursement environment.  In the European asthma market, in addition to growing competition within the LABA/ICS FDCs class, the near-term availability of several new—and likely premium priced—biologics for severe, refractory asthma will add further complexity to the market landscape. Interviewed payers expect that these biologics will face growing market access challenges in the EU5 as health authorities continue to tighten controls on pricing and reimbursement in response to increasing pressure to curb pharmaceutical expenditure.

Other key findings from the Chronic Obstructive Pulmonary Disease | Access and Reimbursement | EU5, and Asthma | Access and Reimbursement | EU5 analyses include:

• Surveyed pulmonologists anticipate robust uptake of both LABA/LAMA and LABA/LAMA/ICS FDCs for their COPD patients, although in some markets these agents will be reserved for later lines of therapy.
• For both the asthma and COPD markets, interviewed payers indicate that branded therapies offering favorable discounts or rebates will be able to secure/retain preferred reimbursement status, while physicians report that device and dosing frequency are drivers of prescribing.
• Additionally, for emerging asthma and COPD therapies, demonstrating superior efficacy over the current standard of care in head-to-head trials will be crucial for favorable reimbursement.
• Among novel biologics for severe, refractory asthma, surveyed pulmonologists expect clinical efficacy to drive their choice of treatment; however, payers—given increasing competition in this patient segment—are likely to base reimbursement decisions on the comparative overall cost of treatment.

Comments from Decision Resources Group Analysts:

• "Although all EU5 markets respond to EMA approval with national-level reimbursement negotiations, there can be considerable market access variation at the regional level within these markets. Marketing to physicians and negotiating local discounts will be critical to increase uptake of newer therapies." Kristine Mackin, Ph.D.
• "Germany's HTA review of Nucala (GlaxoSmithKline) underscores the importance of demonstrating superiority to existing treatments. While the emerging asthma biologics will compete for share of the underserved severe, refractory market, Xolair (Roche/Novartis) and all new biologics are perceived to target a largely overlapping patient population, and thus in the absence of head-to-head trials, their developers will have difficulty in negotiating price premiums relative to the competitor brands. Too high a premium is likely to result in stringent payer-imposed controls and possible exclusion from reimbursement." Elena Kozhemyakina, Ph.D.

Additional Resources:

• Kristine Mackin, Ph.D. has written a blog on Nucala pricing.
• Laura Vinuesa, D.V.M., M.Sc., has written a blog on EU market access evolution.
• Laurie DiModica, M.S., has written a blog on potential EU adaptation to outcomes-based drug pricing.

About Decision Resources Group

Decision Resources Group offers best-in-class, high-value data, analytics and insights products and services to the healthcare industry, delivered by more than 1,000 employees across 17 global locations. DRG provides the pharmaceutical, biotech, medical device, financial services and payer industries with the tools, insights and advice they need to compete and thrive in an increasingly complex and value-based marketplace. DecisionResourcesGroup.com.

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SOURCE Decision Resources Group

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