Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Ibrance 125 mg. 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 Ibrance 125 mg. The drug is requested to treat metastatic breast cancer.The enrollee is a 73 year old woman with a history of bilateral breast cancers. She now has metastases in her bones and liver. Her first breast cancer was on the left and was treated with chemotherapy and Tamoxifen. She then had right breast cancer that was hormone receptor negative and HER2 positive. She was treated with surgery, chemotherapy and Herceptin. The left axillary recurrence with hormone receptor positive, HER2 negative breast cancer that was treated with surgery, Letrozole and radiation. PET imaging showed bone and liver metastases. The office note indicates a plan to treat with Kisqali and Fulvestrant. A hand signed addendum indicates that was an error and the plan is for Ibrance and Fulvestrant. You request Ibrance to be given with Fulvestrant to treat her. A note in the appeal states she had a 14 day trial of an inhibitor. The Plan denied due to prior CDK 4/6 inhibitor. The documentation does not indicate that the enrollee has had progression of the cancer on a prior CDK 4/6 inhibitor. The time course of a trial at the beginning of July to the request at the end of July is not adequate to determine whether there is progression of the cancer. In the opinion of this reviewer the request is for first line treatment of metastatic hormone receptor positive, HER2 negative breast cancer that progressed on prior hormonal therapy, Letrozole.Per the FDA website, Ibrance is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: - an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or - Fulvestrant in patients with disease progression following endocrine therapy.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 Ibrance 125 mg for the diagnosed condition. As a result, Ibrance 125 mg 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 Ibrance 125 mg.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.