Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ibrance. 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.The drug is requested to treat breast cancer in combination with Aromasin after failure of previous endocrine therapy, which is an off-label (non-FDA approved) use. The enrollee is a 65 year old woman with metastatic breast cancer involving bones. Her cancer is hormone receptor positive and HER2 negative. She was treated with Ibrance and Letrozole in 2018. PET scanning showed loss of abnormal uptake at T8 while on the combination. She stopped the Ibrance due to poor tolerance and continued on Letrozole followed by Aromasin. She now has progression of the cancer on PET scan with multiple new hypermetabolic lesions in the axial and proximal appendicular skeleton. The prescriber requests Ibrance to be given with Aromasin. While the documentation supports that the enrollee did not have progression on Ibrance, the requested use as second line treatment in combination with the aromatase inhibitor, Aromasin, does not meet medically accepted use. The drug is indicated to be given with Fulvestrant after failure of first line endocrine therapy.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Ibrance for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Ibrance. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.