Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calquence. 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 Calquence. The drug is requested to treat Waldenstrom's macroglobulinemia (WM), which is an off-label (non-FDA approved) use.  The enrollee is a 69-year-old man with WM. He has been treated with Carfilzomib, Methylprednisone, Rituximab, stem cell transplant with Melphalan, and Ibrutinib. He has continued on Ibrutinib as maintenance therapy. His IgM level on 5/20/20 was 1013 and on 8/19/20 935. M-spike on both days was 0.6. The office note from 8/19/20 states the investigations show the best hemoglobin since diagnosis and the prescriber thinks the paraprotein parameters are going to be unchanged. The last IgM had increased compared to the one before that, but it is far from a concerning level. He states the newer drug, Calquence may be slightly more potent than Ibrutinib. The prescriber requests Ibrutinib to treat him. A journal article was submitted in support of the request and was reviewed.  The drug is not FDA approved for WM. The NCCN compendium supports the use for previously treated disease that does not respond to primary therapy or for progressive or relapsed disease. The submitted documentation does not support that the enrollee has progression of the WM. Therefore, the requested use is not a medically accepted indication.  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 Calquence 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 Calquence.  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.