Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Stivarga 40 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 Stivarga. The drug is requested to treat dedifferentiated chondrosarcoma. The patient is 66 years old with metastatic dedifferentiated chondrosarcoma involving spine and chest wall. The patient has been treated with surgery, Cisplatin, Doxorubicin, Dacarbazine and Pembrolizumab. The patient was on Stivarga  with a lapse due to inability to get the drug. Imaging by MRI showed: stable to mild interval progression of amount of neoplasm involving the T7 vertebral body. Alternatively, some of the procedures change could be due to interval treatment. No substantial change in rib involvement which is partially imaged. There is some degradation of image quality due to the extensive hardware. Degenerative findings in the cervical and thoracic spine detailed on a level by level basis above. The prescriber states there are limited active therapy options and without Stivarga the enrollee will be at direct threat to life. The prescriber requests continuation of Stivarga to treat him. Per the NCCN Guidelines, Version 1.2020 Bone Cancer page BONE-B 1 of 5, dedifferentiated chondrosarcoma should be treated per the osteosarcoma regimens. The NCCN Compendium lists Stivarga for use for dedifferentiated chondrosarcoma as second-line therapy for relapsed/refractory or metastatic disease as a single agent (preferred). The enrollee is already using the drug, therefore this is not a new start and the request 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 Stivarga for the diagnosed condition. As a result, Stivarga 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 Stivarga.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.