In 2011, GlaxoSmithKline’s Benlysta became the first biological treatment ever approved for systemic lupus erythematosus (SLE) and the first drug approved for SLE in more than 50 years. However, its uptake in the cost-constrained EU5 (France, Germany, Italy, Spain, and the United Kingdom) has been tempered by its relatively high price in a largely generic market, coupled with physician perception of modest efficacy, slow onset of action, and inability to be used in patients with severe, life-threatening organ involvement. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) does not sanction Benlysta’s use for SLE. Several other premium-priced biologics are also in late-stage development for SLE, but thus far, their demonstrated effect on disease activity has not been significantly different from that of Benlysta, resulting in difficult pricing and reimbursement negotiations following ever-more-stringent health technology assessments in all five countries. Decision Resources’ European Physician & Payer Forum—What Market Access Levers and Barriers Will Emerging Biologics for SLE Face in Europe? A Study of EU5 Prescribers and Payers report explores how physicians and payers plan to accommodate the entry of novel, premium-priced SLE biologics against a backdrop of tightening budgets and increasingly aggressive cost-containment measures.

Questions Answered in This Report:

  • Explore current and evolving prescribing trends: What are the treatment rates and dominant therapies in SLE patients with various disease severities? What role does Benlysta play in treatment, and how do prescribing patterns vary by country? To what extent are MabThera and Orencia used off-label for SLE in each market? How do European product labeling and/or local, regional, or institutional prescribing restrictions differentially affect the use of key brands in SLE? What are the drivers and constraints of Benlysta prescribing? How will the availability of biosimilar rituximab and new biological entrants affect physicians’ prescribing decisions? How is recently approved Benlysta faring in health technology assessments and P&R negotiations?

  • Assess payer attitudes toward current and emerging SLE therapies: How does reimbursement of therapies used for SLE vary between countries? How do payers perceive recently approved Benlysta? How and to what extent is prescribing of all brands used for SLE monitored by payers in each EU5 market? How might this practice evolve given the late-stage pipeline? What health technology assessment hurdles and reimbursement restrictions do payers expect to encounter with novel SLE biologics?


Markets covered: France, Germany, Italy, Spain, and the United Kingdom.

Primary research: surveys of 253 rheumatologists and interview with 15 payers, all of whom have influence at a national or regional level. Interviewed payers include the following:

- France: Consultant in the Haute Autorité de Santé (HAS); pharmacy director and member of regional hospital’s formulary committee who advises the HAS; and pharmacy director and member of hospital formulary committee who advises the HAS.

- Germany: Head of drug division at Association of Statutory Health Insurance (Kassenärztliche Vereinigung) and member of the Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen (GBA); member of National Associations of Statutory Health Insurance (Kassenärztliche Bundesvereinigung) and active member of National Board; and head of drug division at GKV-Spitzenverband who consults national sick funds and authorities as head of the Department for Generic Medicine.

- Italy: Prontuario terapeutico ospedaliero (PTO) and prontuario terapeutico ospedaliero regionale (PTOR) member; Agenzia Italiana del Farmaco (AIFA) member; and adviser to AIFA and PTO/PTOR member.

- Spain: Regional formulary commission member and member of Genesis group (Group for Innovation, Assessment, Standardisation, and Research in the Selection of Drugs of the Spanish Society of Hospital Pharmacists); Health system adviser, Head of Department of Pharmacy in a public university hospital, and advisor to a regional pharmacy and therapeutic commission; Health System Advisor, Pharmacy Director, and Hospital/ Regional formulary commission member, responsible for budget management and pricing and reimbursement negotiation.

- United Kingdom: Head of medicines management for a large NHS trust, clinical commissioning group (CCG) member, member of CCG’s medicines management committees, and member of hospital and sector formulary; hospital associate chief pharmacist responsible for formulary entry and CCG commissioner; commission supporting unit (CSU) member and primary care trust (PCT) member.

Author(s): Eun-Jin Yang, Ph.D.

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