Therapeutic Update: 5 Questions on FDA Hearing for Tofacitinib in PsA Save
Therapeutic updates are periodic reports that feature commentary, insight and review from leading experts on advances in therapeutics in rheumatology. These updates may feature new drug approvals or indications; product label or safety updates, new important clinical trial results, new treatment guidelines or disease management reviews.
In this Therapeutic Update Drs. Cush and Gibofsky answer 5 questions regarding the August 3rd FDA Arthritis Advisory Committee meeting that reviewed the potential approval of tofacitinib (Xeljanz) in patients with active psoriatic arthritis (PsA). The panel was nearly unanimous (10-1) in favor of the efficacy and safety profile of of tofacitinib and similarly voted 10-1 to approve this drug for use in PsA. Final decisions on these recommendations from the AAC panel will be made at a later date by the FDA.
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Jack, as a former reviewer for "medical necessity" for drugs needing prior authorization, I would like to share with you what I told the insurance companies and PBMs trying to stop the request due to lack of an FDA approval for a specific indication. The role of the FDA not only includes safety but also efficacy for a specific indication. This is purely (legally) a regulatory decision that limits marketing ONLY and does not over-rule medical necessity based on published scientific literature as well as standard of care. Once a drug is approved, lack of FDA approval for a specific indication prevents marketing for that indication only. The requested drug remains medically necessary based on medical evidence even if not FDA approved for a specific indication. The FDA regulates marketing, not medical necessity especially for off-label use. Let the appeals begin!
Disclosures
The author has received research/grant financial support on this subject
The author has received compensation as an advisor or consultant on this subject
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