Rheumatoid Arthritis | Access and Reimbursement | EU5 | 2017

The lucrative EU5 rheumatoid arthritis market is dominated by biologics, including five tumor necrosis factor (TNF)-α inhibitors and four biologics with alternative mechanisms of action. The TNF-α inhibitors are the most widely prescribed biologics in RA patients refractory to conventional DMARDs, and the non-TNF-α biologics largely compete for use in TNF-refractory patients. However, the premium-priced branded TNF-α inhibitors face a competitive threat from the recent launch of biosimilars, including biosimilar infliximab and biosimilar etanercept, which provide cost-effective alternatives. In addition, Jak inhibitors Xeljanz (Pfizer’s tofacitinib) and Olumiant (Eli Lily/Incyte’s baricitinib) received EC marketing authorization for use in RA in the first quarter of 2017. With the impending entry of additional IL-6 inhibitors and Jak inhibitors, and biosimilars of several other TNF and non-TNF biologics, marketers are faced with fierce competition as EU5 payers and prescribers balance clinical need with budgetary constraints.

Questions Answered:

•  What clinical and cost-related factors most strongly influence and restrict prescribing of key RA therapies? How do these differ across the EU5?
• What factors will determine the success of recently approved and emerging Jak and IL-6 inhibitors, including Sanofi/Regeneron’s sarilumab and Janssen’s sirukumab? How do payers intend to reimburse emerging agents? To what extent will payer policy impact prescribing of them?
• What can manufacturers do to achieve favorable pricing and reimbursement terms, maximize uptake and, therefore, optimize market access?

Scope:

• Markets covered: France, Germany, Italy, Spain, United Kingdom.
• Methodology: Surveys of 252 dermatologists and 10 country-specific interviews with European payers.
• Indication coverage: Rheumatoid arthritis.
• Key drugs covered: Enbrel, Humira, Remicade, Simponi, Cimzia, Orencia, RoActemra, MabThera, Xeljanz, Olumiant, Inflectra, Remsima, Flixabi, Benepali, Truxima, Amgevita, sarilumab, sirukumab, ABT-494.
• Key companies mentioned: Pfizer, Merck, AbbVie, UCB, Roche, Bristol-Myers Squibb, Janssen, Eli Lilly, Sanofi, Regeneron, Hospira, Celltrion, Biogen.