The entrenched positioning of biologics (in particular, tumor necrosis factor-alpha [TNF-α] inhibitors) to treat moderate to severe rheumatoid arthritis (RA) has generated a lucrative market. However, the barriers to entry are high given the number of effective biological therapies already marketed, including five TNF-α inhibitors, Bristol-Myers Squibb’s selective costimulation modulator Orencia (abatacept), Roche’s MabThera (rituximab), and the interleukin-6 (IL-6) inhibitor RoActemra (tocilizumab) from Roche. Currently, Orencia, Rituxan, and RoActemra compete for use largely in TNF-refractory patients. A subcutaneous (SC) version of Orencia continues to launch across Europe, and SC RoActemra is expected to launch in 2014, both offering the convenience of self-injection. Oral kinase inhibitors have the potential to shift the treatment algorithm to delay initiation of biological therapy. However, the Committee for Medicinal Products for Human Use (CHMP) refused to grant marketing authorization to Pfizer’s Janus kinase (Jak) inhibitor tofacitinib for use in RA in 2013, causing a significant delay in the agent’s expected launch in Europe. Nevertheless, tofacitinib’s convenience (twice-daily oral) and efficacy profile, similar on several key outcome criteria to that of biologics, will make it a compelling option for RA patients if ultimately approved, although its safety profile (e.g., risk of serious infection and malignancy) remains a concern for rheumatologists. Biosimilar versions of Merck's Remicade (infliximab), Pfizer’s Enbrel (etanercept), and MabThera are also expected to be available by the end of 2016. Competition in this market will, therefore, become increasingly fierce as EU5 payers and prescribers balance clinical need with budgetary constraints. At a time when nationalized healthcare systems are striving to cut drug costs, this report explores dynamics that affect sales of biologics for RA, and examines the levers and barriers that will promote or restrict access for emerging oral kinase inhibitors, biologics, and biosimilars.
Questions Answered in This Report:
Impact of reimbursement and payer policy on use of current RA biologics:
How do prescribing patterns vary between EU5 countries? Which non-TNF biologic is the leading treatment of choice for TNF-refractory patients in each EU5 country? Are there differences in reimbursement constraints between these three brands? What are the key market access challenges in each country? How do healthcare authorities monitor prescribing? What will be the impact of biosimilar versions of Remicade, Enbrel, and MabThera on reimbursement and uptake of branded forms of each molecule and on other therapies?
Payer and physician perspectives on emerging agents for RA:
As the number of therapies grows, what patient-specific and drug-specific factors will most influence prescribing decisions? What percentage of surveyed European rheumatologists’ prescriptions for tofacitinib will be in biologics-naive versus biologics-experienced RA patients? How will rheumatologists’ prescribing of established biologics by line of therapy shift following the entry of these oral agents? How might evolving healthcare reforms and increasing cost-containment strategies affect reimbursement and uptake of novel agents?
Decision Resources’ European Physician & Payer Forum report “Rheumatoid Arthritis: How Will Payers and Prescribers React to the Launches of Oral Kinase Inhibitors, Subcutaneous Orencia and RoActemra, and Biosimilars in the Cost-Constrained EU5?” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of RA agents. It draws on insights from 254 surveyed rheumatologists in the EU5 and from interviews with 15 European payers, all of whom have influence at a national or regional level. Interviewed payers include the following:
France: A national payer and past member of the Transparency Commission (CT), hospital pharmacy directors.
Germany: A member of the Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen (GBA; Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds), a member of the Federal Pharmacy Association and hospital pharmacy director, a chairman of hospital formulary committee.
Italy: Regional hospital formulary (PTOR) members with responsibility for assessing new drugs for formulary inclusion, an Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) advisor, an ex-AIFA member.
Spain: A Dirección General de Farmacia y Productos Sanitarios (DGFPS; General Directorate of Pharmacy and Health Products) advisor, a professor at the Institut de Salut Pública de Catalunya (Public Health Institute of Catalonia), a pharmacy director.
United Kingdom: A National Institute for Health and Care Excellence (NICE) advisor, a Clinical Commissioning Group (CCG) formulary committee member, chief pharmacist on a health board, also a member of the AWMSG (All Wales Medicines Strategy Group) and head pharmacist.