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.
Questions Answered in This Report:
Determine the impact of reimbursement and payer policy on use of current PsA biologics:
What proportion of PsA patients have peripheral versus axial disease? How many treatment lines do PsA patients with axial or peripheral disease typically fail prior to biological therapy? How do prescribing patterns vary between EU5 countries? How do healthcare authorities monitor prescribing? What are the key market access challenges in each country? Are there differences in reimbursement constraints between approved biologics and for different manifestations? What will be the impact of biosimilar versions of Remicade and Enbrel on reimbursement and uptake of branded forms of each molecule and on other therapies?
Analyze payer and physician perspectives on emerging agents for PsA:
In which lines of therapy are physicians most likely to prescribe apremilast, Stelara, and Cimzia? Given that apremilast is an oral, with potential to be priced at a meaningful discount to biologics, how will different pricing scenarios for the drug influence its likelihood to be used before biologics according to physicians and interviewed payers? What is surveyed rheumatologists’ expected uptake of each drug? How might evolving healthcare reforms and increasing cost-containment strategies affect reimbursement and uptake of novel agents?
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.