Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Afinitor. 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 Afinitor 10 mg; 28/28. The drug is requested to treat breast cancer. The enrollee is 40 year old woman with comorbidities who has metastatic hormone receptor positive, HER2 negative breast cancer. She has lung, bone and nodal metastases. She has been treated with radiation, Cytoxan, Taxotere, Gemcitabine, Carboplatin, Ibrance, Lupron and Faslodex. Scans showed new mediastinal and hilar adenopathy and a new right upper lung nodule. The prescriber requests Afinitor to be given with Exemestane and Lupron.Per the NCCN compendium Afinitor is indicated for second-line therapy and beyond for recurrent or stage IV (M1) hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative disease with no visceral crisis in postmenopausal women or for premenopausal women treated with ovarian ablation/suppression in combination with:- Exemestane (preferred regimen) if progressed within 12 months or on a non-steroidal aromatase inhibitor. The enrollee is receiving ovarian suppression with Lupron.Therefore the enrollee meets a medically accepted use and the plan's prior authorization criteria. 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 Afinitor for the diagnosed condition. As a result, Afinitor 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 Afinitor.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.