In Europe, multiple myeloma (MM) treatment is centered on the use of three major agents—Janssen’s Velcade (bortezomib), Celgene’s Revlimid (lenalidomide), and Celgene’s Thalidomide (thalidomide)—while the treatment for non-Hodgkin’s lymphoma (NHL) has Roche’s MabThera (rituximab) as a central player. All of these drugs have demonstrated clear improvements in clinical practice and have achieved significant commercial success within their indications. Multiple emerging agents spanning several different dug classes are in development for MM and NHL. Although many of these emerging therapies appear clinically promising, they face considerable competition from currently available therapies. The presence of several promising agents in development, coupled with dynamic markets, make the MM and NHL indications very exciting from a commercial, as well as a clinical point of view.
Questions Answered in This Report:
- What are the main agents used in the treatment of MM and NHL in the EU5, and how do prescribing patterns vary by country?
- How do European product labeling and/or local, regional, or institutional prescribing restrictions differentially impact use of MM and NHL agents?
- What have been the main clinical as well as budgetary/reimbursement-related constraints to the uptake of Revlimid, Velcade, Thalidomide, and MabThera?
- How will hematological oncologists embrace new MM market entrants Imnovid, Kyprolis, ixazomib citrate, panobinostat, elotuzumab, and daratumumab?
- How will hematological oncologists embrace new NHL market entrants Imbruvica, idelalisib, Gazyva, and biosimilar rituximab?
- How does reimbursement of approved MM and NHL therapies vary between countries? How do national, regional, and local healthcare authorities regulate the prescribing of these agents?
- How are increasingly convoluted health technology assessments and pricing and reimbursement processes in the EU5 impacting patient access to these new market entrants?
- What clinical advantages could secure reimbursement for emerging agents?
- What role will head-to-head and pharmacoeconomic outcomes play in differentiating the reimbursement of novel, high-cost agents versus current mainstays?
- What are hematological oncologists’ and payers’ reactions to biosimilar rituximab and subcutaneously delivered MabThera for NHL?
- How might evolving healthcare reforms and cost-containment strategies affect reimbursement of novel agents, and to what degree will prescribing constraints present a future hurdle for emerging therapies in the EU5?
- What market access levers can drug developers take advantage of to better position new MM and NHL products in the EU5?
Decision Resources Group’s European Physician & Payer Forum report “The Impact of EU5 Payer Policy on Prescribing in Non-Hodgkin’s Lymphoma and Multiple Myeloma” explores reimbursement and additional payer policies that influence prescribing trends for approved targeted agents in MM and NHL. The report assesses levers and barriers that will promote or restrict market access for premium-priced novel agents across the cost-constrained EU5 (France, Germany, Italy, Spain, and the United Kingdom). It draws on insights from 251 surveyed hematological oncologists 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 directors, members of the local formulary committee, and advisors to the Haute Autorité de Santé (HAS; National Health Authority) from northern and southeastern France; hospital pharmacy director and member of the local formulary committee from northern France.
- Germany: ex-Krankenkassen (health insurance funds) member; GBA (Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds) member; member of national boards and ex-GBA member.
- Italy: advisor to the Agenzia Italiana del Farmaco (Italian Medicines Agency) and member of the Prontuario Terapeutico Ospedaliero Regionale (PTO/PTOR; [regional] hospital pharmaceutical formulary) committee in southern Italy; AIFA member from northern Italy; PTO/PTOR member from central Italy.
- Spain: hospital/regional formulary committee members from central, eastern, and southwestern Spain.
- United Kingdom: Clinical commissioning group (CCG) advisor and formulary committee member; CCG advisor and ex-CCG commissioner; CCG advisor and ex-advisor to the National Institute for Health and Care Excellence (NICE).