Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nulojix 250 mg vial. The Plan did not grant this request. We received this caseto conduct an independent review.Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeledindications and approval for marketing by the FDA. The Medicare Part B rules state that parenteralBelatacept (Nulojix) is not proven to be safe when administered in the home setting, and therefore will bedenied under Medicare Part B as not medically necessary when provided in that setting. The case recordindicates that Nulojix will be administered in the home. Nulojix would therefore not be eligible forcoverage under Medicare Part B in this case. Thus, Nulojix may be eligible for coverage under MedicarePart D. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Nulojix 250 mg vial.Nulojix 250 mg vial is requested for ongoing prevention of renal transplant rejection. The plan deniedcoverage of Nulojix 250 mg. The plan's denial letter states that their coverage criteria require that theenrollee must be using Nulojix in combination with basiliximab induction and corticosteroids, ANDbecause Nulojix must not be administered in the home setting. It is noted that the enrollee underwent aliving donor transplant in August 2014, her current immunosuppression regimen includes the requesteddrug in combination with Mycophenolate delayed release tablet, and that she is stable on the notedimmunosuppression regimen. Additionally, the prescriber has stated that the enrollee has tolerated inoffice/hospital administration of Nulojix without problems, and that it would be safer from an infectionstandpoint for the enrollee to receive treatment at home rather than coming to the hospital.For coverage 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. Thefollowing is noted in DRUGDEX, in the Adult Dosing section (Quick Answers view only) for therequested drug: Orphan drug designation: Prophylaxis of organ rejection in renal allograft recipients. Thereis no stipulation as to whether other specific drugs need to be used in combination with the requested drug.Therefore, the requested drug is being prescribed for a medically accepted indication.The plan's safety concerns have been addressed, and 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 formulary exceptioncriteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore,the Plan is required to cover Nulojix.