Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Intron A, Sterile Water, Benzyl Alcohol, and Sodium Chloride. The Plan did not grant this request. We received this case to conduct an independent review.Intron AWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Intron A. The drug is requested to treat intraepithelial squamous cell neoplasia of the conjunctiva, which is an off-label (non-FDA approved) use.The enrollee is an 82 year old man with biopsy confirmed conjunctival intraepithelial neoplasia. He was started on compounded eye drops with Intron A, Sterile water, Benzyl alcohol and Sodium chloride for injection on 1/8/2020. The prescriber requests the drug to ensure all potentially malignant cells are treated to prevent metastatic disease.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Intron A, Sterile Water, Benzyl Alcohol, and Sodium Chloride 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 Intron A, Sterile Water, Benzyl Alcohol, and Sodium Chloride. 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.Sterile Water, Benzyl Alcohol, and Sodium ChlorideFor coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Sterile Water, Benzyl Alcohol, and Sodium Chloride are used as a dilutant in the reconstitution of the Interferon Alfa Compound. Sterile Water, Benzyl Alcohol, and Sodium Chloride use in this instance is not therapeutic. Thus, Sterile Water, Benzyl Alcohol, and Sodium Chloride do not meet the definition of a Part D drugs. Therefore, the Plan is not required to cover Sterile Water, Benzyl Alcohol, and Sodium Chloride.Since no parts of the compound can be covered under Medicare Part D, the subsequent request for reimbursement has not been evaluated at this time.