Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zejula. The Plan did not grant this request. We received this case to conduct anindependent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Zejula 100 mg; 60/30.The drug is requested to treat progressive primary peritoneal/ovarian cancer that is Platinum resistant. Theenrollee is a 65 year old woman with primary peritoneal/ovarian cancer involving peritoneum, adnexa, andliver serosa. She has been treated with Carboplatin, Taxol, surgery, Doxil, and Avastin. Her CA-125 isrising and the prescriber states she has progressive cancer that is Platinum resistant. She does not have aBRCA mutation. The tumor does not have HRD positive status. The prescriber requests Zejula to be givenwith Pembrolizumab to treat her. The prescriber states there are no other treatment options. The prescribersubmitted press releases, reference to an abstract and information of the ongoing clinical trial,NCT02657899, and journal articles from CMS and non-CMS approved journals in support of the request.These were reviewed.The article in Annals of Translational Medicine is not a CMS-approved journal and cannot be used todetermine medically accepted use. Abstracts cannot be used to determine medically accepted use. Thearticle by Vinayak (JAMA Oncol. 2019 Jun 13. doi: 10.1001/jamaoncol.2019.1029) concludes that thecombination warrants further investigation. The article by Konstantinopolous (JAMA Oncol. 2019 Jun 13.doi: 10.1001/jamaoncol.2019.1048) states the results will need to be validated in a larger trial. Thereforethe requested treatment is investigational.The use of Zejula to treat progressive primary peritoneal/ovarian cancer that is Platinum resistant is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. There was no peerreviewed,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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 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 Zejula 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 Zejula.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.