Key finding: Efficacy (in treating severe manifestations of SLE and in treat lupus nephritis), as well as safety and tolerability, will be the key factors impacting the prescribing of emerging targeted therapies according to rheumatologists surveyed by DRG. Physicians in some EU5 countries, notably in the U.K., also considered clinical guidelines recommendations to be among the most influential prescribing factors.

What do payers say? Interviewed payers similarly believed that proven clinical efficacy and safety, especially against the Benlysta, would be crucial for securing favorable HTA reviews and optimizing market access, including fewer prescriber restrictions.

 The “so what” for strategists: Given the reliance on low-cost generics as first-line treatments for SLE and the entrenched use of off-label MabThera and biosimilar rituximab, high-cost branded agents will face pressure to demonstrate superior efficacy relative to Benlysta. Proving demonstrable efficacy, particularly in severe populations, could tip the scales in achieving favorable HTA and P&R among payers and in uptake with rheumatologists.

 

What else matters for payer decisions around emerging SLE treatments?

 

See what’s covered in the full report: SLE | Access & Reimbursement | EU5

Key questions answered in the analysis:s

  • How do reimbursement terms for Benlysta IV and Benlysta SC vary across the EU5? How do payers regulate use of these premium-priced agents?
  • How do prescribing patterns for key SLE therapies differ between and within EU5 countries, and to what extent does payer policy impact uptake?
  • What restrictions are imposed on SLE therapies and how, if at all, do these restrictions impact physician prescribing practices?
  • What key market access challenges do emerging SLE agents face? What lessons have been learnt, and what market access levers can drug developers take advantage of to optimize the positioning of their products?

 

Markets covered: EU5 (France, Germany, Italy, Spain, United Kingdom)

Methodology: Survey of 253 rheumatologists in the EU5, in addition to interviewing 10 payers (2 per EU5 country).

Indication coverage: Systemic lupus erythematosus and lupus nephritis

Key drugs covered: Benlysta, MabThera, Orencia, hydroxychloroquine, CellCept, Myfortic, anifrolumab, atacicept, voclosporin

Key companies mentioned: GlaxoSmithKline, Biogen/Roche/Genentech, Bristol-Myers Squibb, Aurinia Pharmaceuticals, AstraZeneca, Merck KGaA

 

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