Treatment for the wet (exudative, neovascular) form of age-related macular degeneration (AMD) in Europe is characterized by several current therapies targeting vascular endothelial growth factor (VEGF). Notable agents, administered via intravitreal (eye) injections, include Lucentis (Novartis), Eylea (Bayer), and compounded Avastin (Roche/Genentech/Chugai). However, the cost-constrained European health authorities are increasingly questioning the value of these agents, especially when compared with the VEGF inhibitor Avastin, which does not have marketing approval for the treatment of wet AMD, but which is priced significantly lower than Lucentis or Eylea. Because emerging agents offering novel mechanisms of action, greater convenience, or enhanced efficacy through adjunctive therapy are expected to launch in coming years, this report examines levers to optimize market access in the EU5 (France, Germany, Italy, Spain, United Kingdom).

Questions Answered in This Report:

  • Impact of reimbursement and payer policy on current prescribing trends in wet AMD: How does reimbursement of approved wet AMD therapies vary between countries? How do product labeling labeling and/or local, regional, or institutional prescribing differentially impact uptake and prescribing patterns for key wet AMD brands by country? What have been the main cost/clinical constraints to the uptake of the most recent entrant to the European wet AMD market, Eylea? How are recently approved wet AMD agents faring in increasingly convoluted health technology assessments and P&R negotiations?

  • Payer and physician perspectives on emerging agents for wet AMD: What are payers’ reactions to Fovista, a PEGylated aptamer inhibitor of PDGF-B that is in development as adjunctive IVT therapy to an anti-VEGF agent in patients with wet AMD? How do these reactions compare with those for abicipar pegol, squalamine, and sonepcizumab? What clinical advantages could secure reimbursement for emerging agents? What role will head-to-head and pharmacoeconomic outcomes play in differentiating the reimbursement of emerging agents versus current mainstays? To what degree will emerging anti-VEGF biosimilars impact the use of the originator drug and other branded therapies in wet AMD in the EU5? 

  • Market access outlook for emerging wet AMD therapies: How might evolving healthcare reforms and cost-containment strategies affect reimbursement of novel agents? What market access levers can drug developers take advantage of to better position new wet AMD products in the EU5? How will prescribing patterns change with the launch of new agents, a long-acting formulation of Lucentis, and biosimilar anti-VEGF drugs? 

Scope:

Decision Resources Group’s European Physician & Payer Forum report “The Anti-VEGF Era and Beyond in Wet AMD: The Impact of Clinical Attributes and Market Access Status on Current and Future Prescribing Decisions Among Retinal Specialists in the EU5” explores the many clinical features that impact treatment of wet AMD and analyzes the market access challenges faced by current and emerging agents as competition and cost-sensitivity intensify. It draws on insights from 251 surveyed retinal specialists 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: Hospital pharmacy director and regional (Paris-Ile de France region) hospital formulary committee member who is an advisor to the Commission de la Transparence (CT; Transparency Commission); pharmacist director and member of the formulary committee for hospitals, Rhône-Alpes region; and payor/advisor, Economic Committee for Health Products (Paris) and consultant to the Haute Autorité de Santé (HAS; National Health Authority).

- Germany: Member, National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung); drug division head at a statutory health insurance association and member of the GBA (Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds); drug division head, health fund advisory association (GWQ Service Plus AG).

- Italy: Advisor to Agenzia Italiana del Farmaco (AIFA) and PTO/PTOR member (Rome), responsible of drug access decisions and drug assessment; AIFA advisor, PTOR and PTO committee member (Palermo), responsible of drug access decisions and drug assessment; AIFA committee member, Turin.

- Spain: Consultant to the Ministry of Health and AEMPS (Spanish Medicines Agency) member, economics professor; national-level payer, Sevilla, Genesis Group for Innovation, Assessment, Standardisation and Research in the Selection of Drugs, and member, Spanish Society of Hospital Pharmacists); health system advisor/regional formulary committee member (Madrid) involved in the pharmacy and therapeutic commission at the Madrid Autonomous Community, advisor for therapy inclusion in Madrid’s hospital, head of the department of pharmacy at a public university.

- United Kingdom: Clinical commissioning group (CCG) member and hospital pharmacy director, Sussex; CCG member and hospital formulary committee member, London; CSU/Primary Care Trust (PCT) hospital budget holder (Liverpool) with a significant role in the commissioning of services for wet AMD within PCT/CCGs.

Author(s): Laurie DiModica, M.S.
Virginia Schobel, M.Sc.