BURLINGTON, Mass., Oct. 15, 2014 /PRNewswire/ -- Decision Resources Group finds that although use of biologics in SLE has increased in the past three years, largely due to uptake of GlaxoSmithKline's Benlysta, overall physician-reported patient share of biologics remains modest. Less than half of SLE patients considered to be candidates for biological therapy actually receive the biologics. Reimbursement restrictions limit use of these agents in SLE patients. Approval of novel SLE therapies is expected to increase biologics' patient share in the SLE market, but these emerging agents will need to overcome significant reimbursement hurdles. Surveyed physicians indicate that when considering a new drug for SLE they will be looking for agents that are effective in preventing acute flares of the disease, offer good efficacy in treating severe manifestations and allow reduction in concomitant corticosteroid use.
Other key findings from the U.S. Physician and Payer Forum report entitled What Market Access Challenges and Opportunities Lie Ahead for Emerging SLE Biologics:
- Opportunities and challenges for emerging agents: Despite indicating interest in emerging SLE therapies, over two-thirds of physicians do not believe that drugs in the late stage SLE pipeline will address all unmet needs in SLE. Surveyed managed care organizations' (MCO) pharmacy and medical directors are very cautious regarding inclusion and tier positioning of emerging agents for SLE. The majority of respondents expect to either place these novel drugs on non-preferred tiers or completely exclude the drugs from coverage.
- Opportunity for emerging agents in lupus nephritis: The presence of lupus nephritis drives rheumatologists' treatment decisions in a high percentage of moderate and severe SLE patients. Benlysta, the only biologic approved by the U.S. Food and Drug Administration, is not recommended for use in patients with lupus nephritis, and a therapy for this patient subpopulation is cited by rheumatologists among the top unmet needs.
- Impact of biosimilar rituximab: Despite lack of clinical trial data in SLE, surveyed rheumatologists and MCO directors have a positive view regarding use of biosimilar rituximab in SLE, but the price of the biosimilar will have a significant impact on its reimbursement.
Comments from Decision Resources Group Analyst Elena Kozhemyakina, Ph.D.:
"Physicians will welcome the approval and launch of self-administered SC Benlysta because the current intravenous route of administration of Benlysta requires 13 infusion clinic visits per year. The inconvenience that patients face coupled with Benlysta's modest efficacy deters patients from committing to this drug. However, pricing of SC Benlysta will be the key factor for patient access to the drug, as surveyed MCO directors demonstrate a high level of price sensitivity."
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