By February 2014, European marketing authorizations were granted for three new disease-modifying therapies (DMTs) for the treatment of multiple sclerosis (MS)—Aubagio (Sanofi/Genzyme), Lemtrada (Sanofi/Genzyme/Bayer HealthCare), and Tecfidera (Biogen Idec). Together with forthcoming market entrants, which include oral and nonoral DMTs, reformulations, and new molecular entities, novel agents have the potential to overcome shortcomings in efficacy and/or delivery among current mainstays of treatment. However, while expanding therapeutic choice, these new options will also complicate treatment decision making in MS. This report will examine the factors that influence prescribing patterns for current DMTs across the EU5 (France, Germany, Italy, Spain, the United Kingdom), and explore how physicians and payers will grapple with the influx of potentially costly DMT alternatives, each offering a unique blend of benefits and risks, against a backdrop of increasingly stringent cost-containment measures and market access challenges.
Questions Answered in This Report:
- Impact of reimbursement and payer policy on use of current MS DMTs: How does reimbursement of MS therapies vary among countries? How do national, regional, and local healthcare authorities regulate the prescribing of MS DMTs in the EU5? What have been the main cost/clinical constraints to the uptake of the early-line platform DMTs, available orals, and later-line alternatives?
- Payer and physician perspectives on emerging agents for MS: How will neurologists and payers embrace new market entrants and key late-stage emerging brands? What clinical advantages are needed to secure reimbursement for emerging agents, according to payers? How might evolving healthcare reforms and cost-containment strategies affect reimbursement of future entrants? What market access levers can drug developers take advantage of to better position new MS products in the EU5? How will prescribing patterns change with the launch of new brands? Biosimilar interferon-beta therapies? Generic versions of glatiramer acetate (Teva’s Copaxone)?
Decision Resources’ European Physician & Payer Forum report “A New Era for Multiple Sclerosis Disease-Modifying Therapy: EU5 Prescriber and Payer Perspectives on Current Mainstays, Recent Market Entrants, and Late-Stage Pipeline Products” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of MS DMTs. It draws on insights from 251 surveyed neurologists 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: Pharmacy director, member of hospital formulary committee, regional payer, and national adviser for the Haute Autorité de Santé (HAS); HAS-advising key opinion leader; pharmacy director, member of hospital formulary committee, and advisor to the HAS.
- Germany: National-level expert in evaluation of public healthcare and quality control, director of a sickness fund; head of Drug Division of State Doctor’s Association and member of the Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen (G-BA; Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds); member of the Drug Commission of the German Medical Association.
- Italy: Prontuario terapeutico ospedaliero (PTO) and prontuario terapeutico ospedaliero regionale (PTOR) member; PTO and PTOR member, advisor to Agenzia Italiana del Farmaco (AIFA); physician and Ex-AIFA member.
- Spain: Hospital/local/regional formulary committee members and pharmacy directors; national and regional payer, member of Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos (GENESIS).
- United Kingdom: Pharmacy director; Clinical Commissioning Group (CCG) hospital budget holder, and member of the regional drugs and therapeutics committee; pharmacy director; CCG hospital budget holder; advisor to the National Health Service (NHS); pharmacy director and NHS advisor.