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!