Appeal type: Prescription Drug
Decision: Partially Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Promacta, 25 mg tablet. You asked the Plan to provide a tiering exception for Promacta, 25 mg tablet. 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 Promacta, 25 mg tablet; 30/30.The drug is requested to treat chronic idiopathic thrombocytopenia purpura (ITP). The enrollee is a 73 year old man with comorbidities and with chronic ITP. He has been treated with Prednisone without adequate response. He has been treated with Promacta since 6/8/2017. His platelet count is over 100,000. The prescriber requests Promacta to continue to treat him.Per DrugDex, Promacta is indicated for idiopathic thrombocytopenic purpura, chronic, Relapsed or refractory. The enrollee has ITP refractory to the steroid Prednisone. Therefore the requested use is a medically accepted use.The Plan's prior authorization criteria require failure or inadequate response to corticosteroid or IVIG or to splenectomy. The enrollee meets that criterion.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 Promacta, 25 mg tablet for the diagnosed condition. As a result, Promacta, 25 mg tablet 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 Promacta, 25 mg tablet.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Promacta is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Promacta.