Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Erlotinib HCL, 150 mg tablet. 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; 28/28.The drug is requested to treat wild type non-small cell lung cancer, which is an off-label (non-FDA approved) use. The enrollee is a 77 year old woman with non-small cell lung cancer. Her cancer is wild type which means no sensitizing EGFR mutation. The prescriber states she cannot tolerate systemic intravenous chemotherapy. The prescriber states this is third line treatment. No other clinical information was submitted for review. The prescriber requests Erlotinib to treat her.DrugDex lists the use for metastatic NSCLC without reference to EGFR mutation as a non-FDA indication. However the guideline cited by the compendium lists Erlotinib only in the context of EGFR mutations.-Non-small cell lung cancer, Locally advanced or metastatic, as monotherapySee Drug Consult reference: Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: Clinical Practice Guideline)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 in Medicare 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 Erlotinib HCL, 150 mg tablet 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 Erlotinib HCL, 150 mg tablet.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.