Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil.    Mycophenolate Mofetil is requested for ongoing treatment of lichen planus (oral and diffuse cutaneous), which is an off-label (non-FDA approved) use. You have discussed the enrollee's clinical course, and have cited medical references which support the use of the requested drug for treatment of the noted condition; however the Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.  Of note, with the request for reconsideration, you have included medical records.  It is stated in an addendum on September 16, 2020 that the enrollee has improved after taking the requested drug for approximately 3-4 weeks. You also stated in the addendum that the enrollee has a past history of Rheumatoid arthritis, the enrollee developed the lichen planus since stopping triple DMARD (Disease-modifying anti-rheumatic drug) therapy, and that perhaps the enrollee's rheumatoid arthritis treatment was keeping the lichen planus at bay.  You state in the medical record that given active symptoms, which are clearly autoimmune medicated, will process mycophenolate under dx of RA.  There is insufficient documentation that the requested drug is being specifically requested to treat rheumatoid arthritis or that the enrollee's biopsy proven lichen planus is a manifestation of her rheumatoid arthritis.  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 no citations in the Medicare approved compendia that support the use of Mycophenolate Mofetil for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Mycophenolate Mofetil.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.