Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Humira (CF) 80 mg/0.8 ml pen. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Humira (CF) 80 mg/0.8 ml pen. Humira (CF) 80 mg/0.8 ml pen is requested for treatment of scleritis.The Plan concluded that the requested drug is not being prescribed for a medically accepted indication. Forcoverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition. In the Non-FDA uses section of DRUGDEX, Inflammatory disorder of the eye, there is a link to the Drug Consultstitled, Inflammatory Disorders of the Eye - Anti-TNF Biologics Therapy. The following reference is cited:Levy-Clarke G, Jabs DA, Read RW, et al: Expert panel recommendations for the use of anti-tumor necrosisfactor biologic agents in patients with ocular inflammatory disorders. Ophthalmology 2014; 121(3):785-796.e3, a systematic review of the literature performed by the American Uveitis Society. Conclusions notedinclude that Infliximab and adalimumab can be considered as potential second-line immunomodulatoryagents for the treatment of severe ocular inflammatory conditions including posterior uveitis, panuveitis,severe uveitis associated with seronegative spondyloarthropathy, and scleritis in patients requiringimmunomodulation in patients who have failed or who are not candidates for antimetabolite or calcineurininhibitor immunomodulation. You have indicated that the enrollee has tried and had adverse effects toMethotrexate. Therefore, the requested drug is being prescribed for a medically accepted indication. Theenrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorizationcriteria 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 ofHumira (CF) 80 mg/0.8 ml pen for the diagnosed condition. As a result, Humira (CF) 80 mg/0.8 ml pen isbeing 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 aremet. Therefore, our decision is the Plan is required to cover Humira (CF) 80 mg/0.8 ml pen.Please note that if the Plan does not agree with our decision, they can askus to open a case again. We only open a case again if we believe there was a mistake or if there is newinformation to review. The health plan has to show us the mistake and/or send us the new information. Thisdoes not happen often. If we decide to open the case again, we will notify you in writing that the case isbeing reviewed again and the outcome of the reopening.