Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover Venclexta 100 mg, 200 mg and 500 mg. 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 Vencelxta 100 mg; 120/30. The drug is requested to treat myelodysplastic syndrome (MDS).The enrollee is a 71 year old man with newly diagnosed MDS with R-IPSS intermediate risk. Hemoglobin was 6.1 and platelets were 95,000 on 4/15/20. He has dyspnea on exertion. He has not been treated. You are requesting Venclexta to be given with Vidaza to treat him. Per Drug-Dex, Venclexta has orphan drug status for treatment of myelodysplastic syndrome. Per CMS rules, orphan drug status is a medically accepted use. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. 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. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Venclexta 100 mg for the diagnosed condition. As a result, Venclexta 100 mg is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Venclexta 100 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.We are dismissing the request for Venclexta 200 mg and 500 mg. We received your letter asking for an appeal of the Plan's unfavorable determination for Venclexta 200 mg and 500 mg. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time.If you do not agree with usYou may have rights to a Hearing with an Administrative Law Judge. For more information on how to appeal, see the page entitled Important Information About Your Appeal Rights. You must file your appeal, in writing, within 60 days of receipt of this letter.