Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Stivarga. Our Physician Reviewer determined that criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the requested drug is not being prescribed to treat a medically accepted indication. We reopened this case to address the Plan's argument.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Stivarga (Regorafenib) 40 mg tablet. Stivarga is requested to treat dedifferentiated chondrosarcoma. Upon the reopening of this case, the Plan submitted additional information. The enrollee is a 66-year-old man with metastatic dedifferentiated chondrosarcoma involving spine and chest wall. He has been treated with surgery, Cisplatin, Doxorubicin, Dacarbazine and Pembrolizumab. He was on Stivarga from December 2019 with a lapse due to inability to get the drug and resumed in February 2020. Imaging by MRI on April 23, 2020, 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. Per the Medicare Benefit Policy Manual (page 63), a use is identified by a compendium as medically accepted if the: 1. indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex; or, 2. narrative text in AHFS-DI or Clinical Pharmacology is supportive. A use is not medically accepted by a compendium if: 1. indication is a Category 3 in NCCN or a Class III in DrugDex; or, 2. narrative text in AHFS or Clinical Pharmacology is not supportive. The complete absence of narrative text on a use is considered neither supportive nor non-supportive. 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.This decision affirms our previous favorable decision.