OBJECTIVES : Belimumab and emerging biologics targeting systemic lupus erythematosus (SLE) must compete to convince the cost-constrained EU5 (France, Germany, Italy, Spain, UK) that they are worthy of use. This research explored the evolving reimbursement and prescribing landscape for current and emerging SLE biologics as they seek optimal market access.

METHODS : Across the EU5, 10 payers who influence reimbursement nationally or regionally were interviewed, and 254 rheumatologists were surveyed.

RESULTS : All interviewed payers demand unequivocal proof of added benefit from new agents for favorable reimbursement terms, particularly in a heavily genericized market like SLE, where there are relatively few high-cost treatments available. Those in Germany highlight the G-BA’s determination of considerable added benefit for belimumab (GlaxoSmithKline’s Benlysta), despite IQWiG’s reluctance, to exemplify the importance of absolute risk reduction (ARR). The importance of clinically relevant end-points is also stressed across countries, with the SLE Responder Index (SRI) specifically mentioned. Likewise, 20% (Italy) to 59% (Spain) of surveyed rheumatologists selected efficacy profiles as their top prescribing driver, beating out non-clinical factors such as national-level guidelines. In all countries, while clinical performance trumps treatment cost among surveyed physicians’ prescribing drivers overall, interviewed payers nevertheless seek substantial price discounts or managed entry agreements at national and subnational levels in exchange for optimal reimbursement and positioning. The importance of positive pharmacoeconomic data is also pinpointed, particularly with the availability of biosimilar rituximab (a commonly used off-label SLE treatment). 38% of surveyed physicians indicated that regional/hospital/local budgets were a barrier to prescribing belimumab.

CONCLUSIONS : Emerging SLE biologics face the modern day EU5 market access reality of frugal payers increasingly reliant on health technology assessment and pharmacoeconomic results as a lever to stringent reimbursement negotiations, and increasingly seeking cost-cutting opportunities. Meaningful discounts/managed-entry-agreements, well-designed clinical trials, and persuasive pharmacoeconomic data will help optimize P&R terms and have a positive impact on uptake.