Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hizentra. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Medicare Part B pays for the rental or purchase of DME if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. Medicare Part B local policy states that an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. In this case, Hizentra is being used to treat immune mediated neuropathy/autonomic neuropathy/autoimmune gastrointestinal dysmotility/autoimmune dysautonomia which is not a covered Medicare B diagnosis. We therefore, sent this to our Physician Reviewer to determine if Hizentra can be covered under Medicare D.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Hizentra 10/50 mL. The drug is requested to treat immune mediated neuropathy/autonomic neuropathy/autoimmune gastrointestinal dysmotility/autoimmune dysautonomia, which is an off-label (non-FDA approved) use. 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.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 Hizentra 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 Hizentra. 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.