Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Erlotinib 150 mg, 30 per 30 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, 30 per 30 days. Erlotinib is requested to treat EGFR negative metastatic non-small cell lung cancer, with Veristrat Good testing. The documentation submitted indicates that the enrollee was previously treated with Cisplatin, Pemetrexed, and Keytruda. 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. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: In the randomized controlled TAILOR study (N=222) evaluating second-line treatment for patients with wild-type epidermal growth factor receptor (EGFR) metastatic non-small cell lung cancer (NSCLC) previously treated with a platinum-based regimen, overall survival was numerically higher with docetaxel (median overall survival, 8.2 months) compared with erlotinib (median overall survival. 5.4 months); however, statistical significance was not achieved. Median progression-free survival was statistically longer in the docetaxel arm compared with erlotinib (2.9 months versus 2.4 months). Therefore, the requested drug is being prescribed for a medically accepted indication. Additional medical information was requested by the Part D QIC. You were asked to address the Plan's prior authorization criteria. The enrollee does not satisfy the Plan's coverage criteria. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary.Our Physician Reviewer's opinion is that prior authorization exception 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 150 mg, 30 per 30 days for the diagnosed condition. As a result, Erlotinib 150 mg, 30 per 30 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 150 mg, 30 per 30 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.