Key finding: Head-to-head trial data demonstrating a drug is at least as efficacious as Benlysta – the only targeted therapy approved for systemic lupus erythematosus (SLE) – will be a key determiner of favorable reimbursement of emerging targeted therapies, according to insurer-based pharmacy and medical directors surveyed by DRG. A direct comparison was more influential than separate Phase III trial data indirectly comparing a therapy’s SLE Responder Index (SRI) rates to Benlysta’s trial results.

What do rheumatologists say? Surveyed specialists similarly said a documented reduction in SLE disease activity would be the most influential factor affecting their choice of a new SLE therapy.

 The “so what” for decision makers: Given the reliance on low-cost generic immunosuppressants and corticosteroids as first-line treatments for SLE and five targeted therapies preparing to enter this dynamic market by 2021, high-cost branded agents will face pressure to demonstrate superior efficacy relative to Benlysta. Achieving better disease reduction scores in H2H trials could tip the scales in achieving favorable formulary positioning among payers and in gaining market uptake with rheumatologists.


Learn what else matters for payer decisions around emerging SLE treatments and impact on prescribing:


Key questions answered in the analysis:

  • What is the extent of MCO coverage of Benlysta, as well as off-label branded therapies, including Rituxan, used for SLE, and how do the coverage policies affect rheumatologist prescribing?
  • What is the potential for indication-specific pricing and will MCOs vary formulary coverage of emerging SLE therapies by the specific populations they treat: general SLE and active LN?
  • How receptive are MCOs and rheumatologists to the introduction of biosimilars of Rituxan and to what extent will these less-expensive biologic alternatives disrupt the SLE market?
  • What is the potential reimbursement picture for emerging therapies, including the first oral drug in development for SLE?

Markets covered: United States.

Methodology: Survey of 27 hepatologists and 73 gastroenterologists in the United States in addition to 30 managed care organization (MCO) pharmacy and medical directors (PDs/MDs).

Indication coverage: Systemic lupus erythematosus

Key drugs covered: Current therapies: Benlysta IV and SC, Rituxan, CellCept, Orencia. Emerging therapies: voclosporin, anifrolumab, atacicept

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

Key ESMO Highlights 2020

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