Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nerlynx, 40 mg tablet as prescribed. 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 Nerlynx 40 mg tablet; 90 per 30 days.The drug is requested to treat breast cancer. The enrollee is a 77 year old woman with a history of left breast cancer in 2000 who was diagnosed with right breast cancer. The right sided cancer was hormone receptor negative and HER2 positive by FISH. She received neoadjuvant treatment with Taxotere, Carboplatin, Herceptin and Perjeta. At surgery there was a major response: the previously noted 2 cm breast mass was only 1 mm residual and there was 3 mm residual cancer in one lymph node. There had been a 1.4 cm right axillary mass prior to the chemotherapy. Pre-treatment CT chest/abdomen/pelvis had no evidence of metastatic cancer. After surgery she had radiation and continued with adjuvant Perjeta/Herceptin for one year. The office notes do not indicate the enrollee has metastatic cancer. The note indicates the use is as adjuvant therapy. The prescriber requests Nerlynx as continued adjuvant treatment for the enrollee.Per the FDA website, Nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant Trastuzumab (Herceptin) based therapy.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 Nerlynx, 40 mg tablet as prescribed for the diagnosed condition. As a result, Nerlynx, 40 mg tablet as prescribed 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 Nerlynx, 40 mg tablet as prescribed.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.