Benlysta (GlaxoSmithKline) is not only the first drug approved for systemic lupus erythematosus (SLE) in more than 50 years, but also the first biologic approved for the indication. However, uptake of Benlysta has been tempered by its relatively high price in a largely generic market coupled with physicians’ perception of its modest efficacy, slow onset to action, and inability to be used in patients with severe, life-threatening organ involvement. Several biological therapies (including blisibimod, epratuzumab, rigerimod, SC Benlysta, tabalumab) are in late-stage development for SLE; however, for those drugs that have available clinical trial data, their demonstrated effect on disease activity is not substantially differentiated from Benlysta. It is unclear to what extent physicians and payers will accept novel biological therapies with premium prices as well as emerging biosimilar versions of Rituxan (Biogen Idec/Roche/Genentech).

Questions Answered in This Report:

  • SLE is a heterogeneous disease affecting various organ systems; it varies greatly in severity and is characterized by flares of activity interspersed by periods of improvement or remission. What factors drive rheumatologists’ treatment decisions and what are the preferred first-line agents for the treatment of acute flares in disease activity and for maintenance?

  • Physicians use both approved and off-label therapies for SLE. How are agents commonly used to treat SLE, including Benlysta and Rituxan, currently positioned on payers’ formularies and what is their reimbursement status for SLE?

  • Several biological therapies with various mechanisms of action are in late-stage development for SLE. Which mechanisms of action do rheumatologists view as the most promising for the treatment of SLE?

  • The emerging biologic therapies for SLE are expected to carry a high price tag, while the biosimilar version of rituximab will offer a lower price than Rituxan. What will be the likely tier positioning of new SLE biologics and biosimilar rituximab, and what are the likely cost controls payers expect to implement on these agents?

Scope:

Markets covered: United States.

Primary research: Surveys of 103 rheumatologists and 31 MCO pharmacy and medical directors.

Emerging therapies: blisibimod, epratuzumab, rigerimod, SC Benlysta, tabalumab.

Author(s): Elena Kozhemyakina, Ph.D.