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 Kisqali 200 mg, one 600mg daily dose carton per 21 days. 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 Kisqali 200 mg; one 600 mg daily dose carton per 21 days. The drug is requested to treat metastatic breast cancer. The enrollee is a 63 year old woman with metastatic breast cancer involving bones. Her cancer is estrogen receptor positive and HER2 negative. She has had surgery, adjuvant chemotherapy with Adriamycin/Cytoxan and Docetaxel, followed by Aromasin. After relapse in 2017 she had surgery, radiation, Letrozole, and Aromasin. She now has a new right femur lesion on bone scan. You request Kisqali to be given with Fulvestrant to treat her.  Per DrugDex, Kisqali is indicated for: breast cancer, metastatic or advanced, HER-2 negative, hormone receptor-positive disease in postmenopausal women; in combination with fulvestrant as initial endocrine based therapy or following disease progression on endocrine therapy.   The enrollee has metastatic breast cancer that is hormone receptor positive and HER2 negative. The drug is being used after progression on endocrine therapy with Aromasin and Letrozole. She is post-menopausal. Therefore the requested use is a medically accepted indication and the enrollee meets the plan's prior approval 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 Kisqali 200 mg, one 600mg daily dose carton per 21 days for the diagnosed condition. As a result, Kisqali 200 mg, one 600mg daily dose carton per 21 days 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 Kisqali 200 mg, one 600mg daily dose carton per 21 days.