Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Acitretin 10 mg. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Acitretin 10 mg. Acitretin 10 mg is requested for treatment of Darier's disease. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition. The following citation is noted inthe Non-FDA Uses section under the discussion of Darier's disease and is based on the medical studiesnoted below: Complete clearing of Darier disease was reported in 3 of 13 patients treated with oralAcitretin. Marked improvement was seen in 7 patients and slight improvement in 3. Acitretin wasadministered initially in doses of 30 mg once daily for 8 weeks, followed by doses of 10 to 30 mg/day forthe remaining 8 weeks. However, despite the adequate clinical responses observed, ultrastructuralimprovement (evaluated by electron microscopy) was incomplete in the 3 patients studied. The size andnumber of desmosomes remained reduced and normal stratification did not occur [7]. In another report, 2patients with Darier disease treated with Acitretin experienced remission. Therefore, the requested drug isbeing prescribed for a medically accepted indication.The prescriber has discussed the enrollee's clinical history and why the requested drug is the best option forthe enrollee. Additionally, although the plan's notes indicate that the enrollee has persistently elevatedlipids, the prescriber has provided laboratory data to the contrary. The documentation indicates that theenrollee does not have any of the plan's exclusion criteria for coverage of the requested drug. The enrolleedoes not satisfy the Plan's coverage criteria. However, the prescriber has indicated why all alternativesrequired by the Plan would likely not be as effective as the requested drug for the enrollee, and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorizationexception criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofAcitretin for the diagnosed condition. As a result, Acitretin is being prescribed for a medically acceptedindication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Planis required to cover Acitretin.