Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Afinitor 10 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 Afinitor 10 mg. The drug is requested to treat breast cancer.  The enrollee is a 66 year old woman with metastatic breast cancer involving bones, skin, liver, lung and pleura. Her cancer is hormone receptor positive and HER2 negative. She has been treated with decompression surgery, Ibrance/Femara, Ibrance/Faslodex and Aromasin.  She has been on Aromasin, a hormonal treatment, from May 2019 to the present. CT scans on August 13, 2020 showed progression of the cancer in the left breast, skin, pleura, lung and liver. She does not have pain or respiratory or constitutional symptoms. You initially requested the drug to be given with Letrozole.  In response to inquiry you submitted office notes and stated you plan to give the drug with Tamoxifen. You request Afinitor to be given with Tamoxifen.  The use of Afinitor with Tamoxifen is supported by the NCCN Compendium: Second-line therapy andbeyond for recurrent or stage IV (M1) hormone receptor-positive, human epidermal growth factor receptor2 (HER2)-negative disease with no visceral crisis in postmenopausal women* or for premenopausal womentreated with ovarian ablation/suppression in combination with- exemestane (preferred regimen) if progressed within 12 months or on a non-steroidal aromataseinhibitor- fulvestrant (preferred regimen)-tamoxifen (preferred regimen)  The enrollee has metastatic, hormone receptor positive, HER2 negative disease and does not have visceral crisis.  She is post-menopausal and the drug will be used with Tamoxifen.  She has been treated with hormonal therapy within the last year. She therefore meets 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 10 mg tablet for the diagnosed condition. As a result, Afinitor 10 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 Afinitor 10 mg tablet.