How payers choose to adopt and promote biosimilars will be highly impactful in determining the future commercial opportunity for biosimilars in the United States and across Europe. We conducted primary market research with surveyed MCO pharmacy and medical directors in the United States and interviewed key payer advisers in Europe to understand their perspectives on biosimilars and their expectations and experience with biosimilar market access and reimbursement. We determined payer biosimilar pricing expectations, the strategies payers will undertake to promote biosimilars, and how these strategies will depend on the net cost of biosimilars. We also investigated payers’ attitudes towards the level of clinical testing that should be required for biosimilars and their thoughts on indication extrapolation, as well as how they intend to choose between biosimilars of the same reference product. We also examined the impact that next-generation biologics will have on payers’ reimbursement decisions for biosimilars.

This payer perspectives report is part of the Biosimilars Advisory Service. The Biosimilars Advisory Service provides insight and analysis that is vital to successful business planning in the rapidly evolving biosimilars space. Quarterly webinars detailing major developments, analyst insight addressing key market changes, therapeutic-area-specific primary research, and forecasting modules are all included in a subscription to the Biosimilars Advisory Service. Rely on Decision Resources Group to keep you up-to-date on the biosimilars landscape and poised to maximize opportunities for your business.

Questions Answered in This Report:

  • Understand the current level of awareness of biosimilars among surveyed payers.What methods do surveyed payers report are most frequently used and most valuable in controlling reimbursement of biologics? Which biologic drug classes do payers perceive as presenting the greatest cost burden? How similar do payers believe biosimilars will be to their reference brand? What is the opinion of payers on biosimilar nomenclature?

  • Understand the expected pricing and reimbursement strategies for biosimilars according to payers. What level of clinical trial data do payers want to see before they are comfortable making reimbursement decisions? What are US payers’ perspectives on interchangeable biosimilars, and how do payers view automatic substitution? What do payers expect the net cost of biosimilars to be compared with the reference product? What strategies are being used to promote biosimilar adoption in Europe? Which formulary management methods do payers expect to use to stimulate uptake of biosimilars at various price points? How do payers view indication extrapolation, and how will they manage a biosimilar not granted full indication extrapolation? What level of contact have surveyed US payers had with biosimilar manufacturers to date?

  • Understand the drivers and constraints of biosimilar use. According to payers, which factors stimulate uptake of biosimilars? What factors most constrain biosimilar uptake? How important is the manufacturer of the biosimilar with respect to gaining payer trust? Which types of company gain greatest trust with payers? Respectively, how comfortable do payers believe physicians and patients will be in prescribing and taking biosimilars? Which non-commercial groups do payers expect to influence them when they make reimbursement decisions for biosimilars?

Scope:

Markets covered: United States and Europe.

Primary research: Online quantitative survey of 59 MCO pharmacy and medical directors in the United States and interviews with 10 European payer advisers (from France, Germany, Italy, Spain, and the United Kingdom).

To qualify for participation, surveyed MCO Pharmacy and Medical Directors had to meet the following criteria:

- Worked in pharmacy and therapeutics committees or formulary management for a minimum of 2 years and a maximum of 30 years.

- Work for an MCO that manages more than 100,000 covered lives.

- Be directly involved in reimbursement decisions.

- Be familiar with the following biologic agents: TNF-alpha inhibitors: Enbrel, Remicade, and Humira; Monoclonal antibodies in oncology: Rituxan and Herceptin; Erythropoiesis-stimulating agents (ESAs): Epogen, Procrit, and Aranesp; Granulocyte colony-stimulating factors (G-CSFs): Neupogen and Neulasta; Interferon-alphas: Intron A, Roferon A, Pegasys, and PegIntron; Somatropin (hGH): Humatrope, Genotropin, and Omnitrope; Insulins: Lantus, Humalog, NovoLog, and Levemir; Interferon–beta: Avonex, Rebif, Betaseron, and Extavia; Follitropin-alfa/beta – Gonal-F and Puregon/Follistim.

Author(s): Anees Malik, M.Pharm, M.Phil.