Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Imbruvica. The Plan did not grant this request. 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 request for Imbruvica 420 mg; 28/28. The drug is requested to treat treatment naive mantle cell lymphoma, which is an off-label (non-FDA approved) use. The enrollee is an 87 year old woman with mantle cell lymphoma. She was diagnosed in 2015 and did not require therapy. In 5/2020 she developed constipation and hematochezia. Colonoscopic biopsies found mantle cell lymphoma of the colon and rectum. You are requesting Imbruvica to be given as monotherapy. You stated conventional first line treatment would be too toxic. The office note indicates that Rituxan (Rituximab) could be added or used alone if Imbruvica doesn't work. Imbruvica is FDA indicated and supported for use to treat mantle cell lymphoma that has been previously treated. The enrollee has not had any treatment. The NCCN Guidelines Version 1.2020 Mantle Cell Lymphoma page MANT-A 1 of 4 lists multiple less aggressive therapy options for first line treatment including oral agents with Rituximab. You stated that Rituximab would be considered to treat the enrollee therefore indicating that Rituximab would not be too toxic for her.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. This reviewer did not find any citations to support the use of the drug as first line treatment of mantle cell lymphoma. 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 Imbruvica 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 Imbruvica. 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.