Appeal type: Prescription Drug
Decision: 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 Fluticasone-Salmeterol 500-50 mcg/dose as prescribed. 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 Fluticasone-Salmeterol 500-50 mcg/dose blister powder (generic Advair).Fluticasone-Salmeterol 500-50 mcg/dose blister powder is requested for treatment of chronic obstructive pulmonary disease (COPD) and asthma, in this enrollee with congestive heart failure. The prescriber indicated to the Plan in April 2020 that the enrollee had tried and failed multiple different alternatives including Breo Ellipta, Symbicort, Dulera, Combivent, and Atrovent, which resulted in respiratory distress, and that the enrollee was previously well controlled on the requested medication. The Plan asked why the enrollee could not take generic Airduo; the prescriber indicated that per the medical record, generic Airduo had also been failed. The prescriber indicated at the time of the initial request in April 2020 that a change in treatment would likely result in adverse effects for the enrollee; however the Plan denied the request.Of note, the Plan indicated that their alternatives were Utibron, Stiolto Respimat, Anoro Ellipta, Bevespi, and Trelegy; most of these alternatives do not include an inhaled steroid and are indicated for maintenance of COPD, and Trelegy contains the steroid/long acting beta agonist found in Breo Ellipta which the enrollee had previously failed. The prescriber states that the enrollee has severe asthma, and that the frequent change in medication has resulted in worsening of the enrollee's pulmonary status with respiratory distress. It is noted that off the requested medication, the patient required Prednisone 60 mg to start, which has been tapered to 20 mg. The prescriber states that it is medically necessary for the enrollee to resume the requested medication so that pulmonary condition continues to improve.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee.Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Fluticasone-Salmeterol 500-50 mcg/dose as prescribed.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.