EU5 Market Access Opportunities and Challenges for Current and Emerging Rheumatoid Arthritis Agents Amid the Launches of Oral Jak Inhibitors and Biosimilars | Physician & Payer Forum | EU5 | 2014

Publish date: January 2015

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Rheumatoid arthritis (RA) is a complex autoimmune condition characterized by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue damage. Biological therapies can effectively treat the symptoms of RA and slow joint destruction, but these agents are very expensive and may lose effect over time. Over the next few years, less expensive biosimilars for some of the leading RA biologics will reach the European markets, drastically changing the dynamics in this high-priced market. New disease-modifying antirheumatic drugs (DMARDs) entering the market during this time will offer improved convenience but not necessarily greater efficacy, a fact that will severely limit their market penetration unless they can compete with current RA therapies on price. This report analyzes European physicians’ and payers’ expectations and attitudes regarding the changing RA market through year-end 2017.

Questions Answered in This Report:

  • Subcutaneous formulations of the non-TNF biologics Orencia and RoActemra are now available in the EU5. Will these largely replace their respective IV formulations? Will the availability of SC forms increase overall use of these two biologics for RA? Will payers encourage use of the SC forms over the IV? To what percentage of DMARD-treated RA patients do physicians expect to prescribe these two agents in 2017?

  • The first RA biosimilar—infliximab (Merck’s Remicade)—will reach the EU5 markets by early 2015, followed by biosimilar etanercept (Pfizer’s Enbrel) and rituximab (Roche’s MabThera) in 2016. How will launches of biosimilars change the RA market dynamics? Will payers require use of the biosimilars in newly treated patients? Will they encourage switching? What are physicians’ attitudes toward biosimilars for RA? What are physicians’ expectations for biosimilar uptake by year-end 2017? What are payers’ expectations? 

  • The first oral biologic for RA—Pfizer’s kinase inhibitor tofacitinib—may reach the European markets by 2016. How will this agent fit into physicians’ treatment armamentarium for RA? Will it be used in DMARD-refractory or reserved for TNF-refractory RA patients? How will price factor into this agent’s use? Will oral delivery be a market access lever in the absence of improved efficacy (compared with marketed biologics)? Will lingering safety concerns limit physician uptake of tofacitinib?

  • Risk sharing agreements are becoming an increasingly common strategy for optimizing market access for expensive new RA biologics. In which European countries have these been the most successful? Which particular biologics have benefited from risk sharing agreements, and in which countries? In which countries might these types of agreements be most effective in the future (for new RA therapies)? 

Scope:

Markets covered: France, Germany, Italy, Spain, United Kingdom.

Primary research: We surveyed 253 rheumatologists and conducted 15 country-specific interviews with European payers.

Author(s): Courtney Stanton, Ph.D.