By Year-End 2015, Surveyed European Rheumatologists Anticipate That the Launches of Biosimilar Etanercept and Infliximab Will Sustain Total Patient Shares of These Molecules at the Expense of Humira in the Rheumatoid Arthritis Drug Market

In Addition to Potential EU5 Payer Restrictions on Patient Candidates for Tofacitinib, Physicians’ Prescribing Practices Will Also Determine Tofacitinib’s Place in RA Treatment Algorithms, According to Findings from Decision Resources

December 5, 2012-Burlington, Mass. –Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that by year-end 2015, surveyed rheumatologists in the EU5 (France, Germany, Italy, Spain and the United Kingdom) anticipate that the launches of biosimilar etanercept (Amgen/Pfizer/Takeda’s Enbrel) and infliximab (Janssen Biotech/Merck/Mitsubishi Tanabe’s Remicade) will sustain these molecules’ total patient shares at the expense of Abbott/Eisai’s Humira in the rheumatoid arthritis (RA) drug market. The two newer TNF-alpha inhibitors, UCB/Astellas’s Cimzia and Janssen Biotech/Merck/Mitsubishi Tanabe/Janssen’s Simponi will fail to achieve patient shares at the same level of the more established drugs in this class.

The new European Physician & Payer Forum report entitled How Will the Launches of Oral Immunomodulators and Biosimilars Shape the EU5 Prescribing and Reimbursement Landscape for Current and Emerging Biologics in Rheumatoid Arthritis? also finds that Roche/Chugai's Actemra/RoActemra, the most recently launched biologic for the treatment of RA, has gained significant patient share since its approval in Europe in 2009 as survey responses show that it receives similar or greater use than the longer-marketed Orencia (Bristol-Myers Squibb/Ono Pharmaceuticals) and Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera among respondents’ patients in most EU5 countries. By year-end 2015, the expected launches of subcutaneous (SC) formulations of Orencia and RoActemra will increase these brands’ current patient shares, and in the case of Orencia, the share of the SC formulation will surpass that of the IV version in all markets under study by year-end 2015.

“Patient shares of the TNF-alpha inhibitors will decline by year-end 2015 despite the availability of discounted biosimilar etanercept and infliximab,” said Decision Resources Analyst Iva Holder, Ph.D. “On the strength of their efficacy data and mode of administration, surveyed rheumatologists estimate that 5 to 14 percent of their patients will be treated with tofacitinib (Pfizer/Takeda’s Xeljanz), with slightly lower estimates for the second-to-market fostamatinib disodium (AstraZeneca).”

The report also finds that, in addition to potential payer restrictions on patient candidates for Pfizer/Takeda’s tofacitinib, physicians’ prescribing practices will also determine tofacitinib’s place in RA treatment algorithms across the EU5. Despite convincing efficacy data in biologic-naive patients (albeit not from head-to-head trials), more surveyed EU5 rheumatologists will use tofacitinib in patients who have failed treatment with one or two biological agents, than in biologic-naive patients within the first two years following the drug’s launch for RA. The 15 percent of surveyed rheumatologists across the EU5 (mostly in Germany and the United Kingdom) who do not expect to prescribe tofacitinib within the first two years of its launch cited a variety of reasons for this decision. Among them, the need for more convincing data on tofacitinib’s effect on structural damage is highlighted by 39 percent of these respondents, while 37 percent of anticipated non-prescribers expect to encounter difficulties with funding or reimbursement of the drug in their respective countries. The risk of malignancy, serious and/or opportunistic infections, and lymphopenia feature prominently among physicians’ safety-related reasons for not prescribing tofacitinib.

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