Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Sildenafil 20 mg. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Sildenafil 20 mg. Sildenafil 20 mg is requested for treatment of Raynaud disease complicated by gangrene associated with systemic sclerosis. It is noted that the enrollee had adverse effects to Nifedipine, and insufficient results with Norvasc. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Drugdex states the following in the discussion of the use of Sildenafil for treatment or secondary Raynaud's in the non-FDA uses section for Sildenafil: In a systematic review and meta-analysis of 244 patients with secondary Raynaud phenomenon, mostly related to systemic sclerosis, phosphdiesterase-5 (PDE-5) inhibitors moderately decreased mean Raynaud's Condition Score, daily frequency of Raynaud attacks, and duration of attacks. The citation referenced is Roustit M, Blaise S, Allanore Y, et al: Phosphodiesterase-5 inhibitors for the treatment of secondary Raynaud's phenomenon: systematic review and meta-analysis of randomized trials. Ann Rheum Dis 2013; 72(10):1696-1699. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Of note, generic Sildenafil 20 mg (Revatio) is FDA approved for treatment of pulmonary arterial hypertension. As such, Sildenafil 20 mg is not considered an erectile dysfunction drug; therefore Sildenafil 20 mg is eligible for coverage under Medicare Part D for off-label (non-FDA) uses cited in the Medicare approved compendia.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Sildenafil 20 mg for the diagnosed condition. As a result, Sildenafil 20 mg is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Sildenafil 20 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.