Treatment of psoriatic arthritis (PsA) has historically been challenged by relatively low levels of awareness and by disease-modifying antirheumatic drug (DMARD) treatment. The tumor necrosis factor-alpha (TNF-α) inhibitors have revolutionized treatment standards and elevated sales, and new therapies are expected to substantially expand the market further in the next few years. Two agents have recently received approval for PsA: UCB’s Cimzia (certolizumab pegol) brings the total number of TNF-α inhibitors for PsA to five, while Janssen’s Stelara (ustekinumab) represents the first-in-class interleukin (IL)-12/23 inhibitor approved for this indication. Emerging therapies with novel mechanisms of action are also in late-stage development for PsA, including Celgene’s oral phosphodiesterase-4 (PDE-4) inhibitor apremilast and Novartis’s IL-17 inhibitor secukinumab. Additionally, biosimilar versions of infliximab and etanercept, branded as Remicade (Merck) and Enbrel (Pfizer), respectively, are expected to be available by the end of 2016. In an increasingly cost-conscious reimbursement environment, EU5 payers and prescribers are challenged with incorporating these novel agents into medical practice. This report explores the levers and barriers that will promote or restrict access for emerging therapies, including the implications for biosimilar entry on the pricing and reimbursement environment across the EU5.
Decision Resources’ European Physician & Payer Forum report “Moving Beyond the TNF-α Inhibitor Class in Psoriatic Arthritis in Europe: How Will Payers and Prescribers React to an Expanding Array of Treatment Options?” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of PsA 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 a 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.