Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calquence. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Calquence. The drug is requested to treat Waldenstrom's macroglobulinemia (WM), which is an offlabel(non-FDA approved) use.The enrollee is a 72 year old woman with WM who has been treated with Ibrutinib. She is responding withdecreased axillary lymphadenopathy. She has had bradycardia with heart rates in the 40's. The bradycardiais attributed to the Ibrutinib. You request Calquence to treat her stating it has fewer side effects. You cited anews brief from the JAMA and an abstract from the 2018 American Society of Clinical Oncology meeting.The study described in the abstract has been published in Lancet Haematology. 2020; Feb; 7 (2): e 112-e121. The study required no prior treatment with Bruton tyrosine-kinase inhibitor therapy. Ibrutinib is aBruton kinase inhibitor. Thus, the enrollee would not have met the study criteria. Furthermore, the authorsconclude that further studies are needed to establish the efficacy of Acalabrutinib against current standardtreatments and to investigate whether outcomes can be improved with combination therapies. Therefore, inthe opinion of this reviewer, the requested use is investigational.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 Calquence for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 paymentcan be made under the Medicare Part D benefit.