Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ninlaro. 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 Ninlaro 3 mg; March 21. The drug is requested to treat multiple myeloma as monotherapy, which is an off-label (non-FDA approved) use. The enrollee is a 76 year old woman with multiple myeloma. She has been treated with Revlimid, Velcade and Dexamethasone. Velcade was stopped due to grade 4 neuropathy.  She achieved a very good partial response and was on Revlimid maintenance. Revlimid was stopped due to grade 3/4 diarrhea.  The prescriber requests Ninlaro to treat her as monotherapy.  The initial information included an undated prior authorization form faxed on October 15, 2020 indicated the drug was for relapse/refractory disease and was not for maintenance following autologous stem cell transplant and was not being used in combination with Lenalidomide and Dexamethasone.  A request for information was requested to include medical records. Medical records were not sent. The prescriber supplied the above noted clinical information.  An article from Lancet was submitted in support of the request. The article relates to post-transplant use. The information submitted does not indicate the enrollee has had a stem cell transplant. Similarly a page from the NCCN Guidelines Version 2.2021 was submitted. The page relates to therapy for transplant candidates. The information submitted does not indicate she is a transplant candidate. 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 Ninlaro 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 Ninlaro.  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.