Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Erlotinib HCL, 150 mg tablet, 21 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 Erlotinib, 150 mg tablet; 21/21.The drug is requested to treat pancreatic cancer. The enrollee is a 71 year old woman with metastatic unresectable pancreatic cancer involving liver and lungs. She was treated with neoadjuvant FOLFIRINOX (5FU, Leucovorin, Irinotecan and Oxaliplatin.) Surgery was aborted due to unresectability. She then received Gemzar/Abraxane. Imaging showed 1. Increase in size and number of hypermetabolic pulmonary metastases. 2. A hypermetabolic segment 8 hepatic metastasis is again seen. 3. Infiltrative pancreatic mass and abdominal lymphadenopatty are better evaluated on contrast enhanced. CT. The prescriber initially requested Erlotinib to be given with Capecitabine. Per the office note, her performance status was 1. On appeal, the plan was changed. The prescriber requests Erlotinib to be given with Gemzar (Gemcitabine).Per the NCCN compendium, Subsequent therapy in combination with gemcitabine for locally advanced or metastatic disease for patients with good performance status (ECOG PS 0-1) and disease progression previously treated with fluoropyrimidine-based therapy. The enrollee has ECOG PS 1. The drug will be used with Gemcitabine and she has had progression after 5FU, a fluoropyrimidine based treatment.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 Erlotinib HCL, 150 mg tablet, 21 per 21 days for the diagnosed condition. As a result, Erlotinib HCL, 150 mg tablet, 21 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 Erlotinib HCL, 150 mg tablet, 21 per 21 days.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.