Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lonsurf. 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 Lonsurf 20-8/19; 40/28. The drug is requested to treat metastatic colorectal cancer not previously treated with Irinotecan, Oxaliplatin or an anti-VEGF agent. , which is an off-label (non-FDA approved) use. The enrollee is an 88 year old man who has comorbidities and metastatic rectal cancer involving liver and pleural effusion. His tumor is KRAS wild type. He has been treated with surgery, radiation with 5FU, Capecitabine, and Panitumumab. His CEA is rising and imaging shows slight increase in pleural effusion and liver lesion with new hydronephrosis. The enrollee's blood pressures were normal at each submitted office visit. He is taking anti-hypertensive medications. The office note indicates options include Oxaliplatin and Irinotecan. He was approved for Stivarga but did not take it as it was too expensive. The prescriber requests Lonsurf to treat him. The prescriber states the enrollee does not want further IV chemotherapy. He states the enrollee will not tolerate Irinotecan due to severe diarrhea side effect and that enrollee has severe hypertension and cannot receive Avastin.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 Lonsurf 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 Lonsurf. 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.