Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Imbruvica, 140 mg capsule, 120 per 30 days. The Plan did not grant thisrequest. 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 requestfor Imbruvica 140 mg; 120/30.The drug is requested to treat primary central nervous system (CNS) lymphoma, which is an off-label (non-FDA approved) use. The enrollee is a 77 year old woman with newly diagnosed CNS lymphoma, diffuselarge B-cell type. She has not been treated. The prescriber requests Imbruvica to be given with Rituxan totreat her. The prescriber states that the enrollee is not a candidate for standard immuno-chemotherapyincluding high dose Methotrexate and stem cell transplant.The prescriber submitted citations to support the request and notes the NCCN supports the use in primaryCNS lymphoma. The citations relate to relapsed or refractory primary CNS lymphoma and the NCCNcompendium also supports use in patients with relapse or refractory disease including after radiationtherapy. The enrollee does not have relapsed or refractory disease. Therefore she does not meet thesupported use.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medicalliterature from an approved journal submitted to support this appeal. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Imbruvica, 140 mg capsule, 120 per 30 days for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forImbruvica, 140 mg capsule, 120 per 30 days.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.