Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Northera. 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 Northera. Northera is requested for ongoing treatment of orthostatic hypotension which is indicated to be symptomatic neurogenic orthostatic hypotension. The initial diagnosis submitted was supraventricular tachycardia; most recently, the prescriber states that the enrollee has neurogenic orthostatic hypotension caused by primary autonomic failure.Medical records previously submitted to the Plan include records from patient encounters on September 6, 2018 and November 5, 2019. There is a detailed discussion about the possible etiology of the orthostatic hypotension in the note from September 6, 2018. Of note, other than orthostatic hypotension, there are no other manifestations of autonomic dysfunction. There is an appropriate rise in heart rate with a drop in blood pressure with standing, a history of right leg deep venous thrombosis which the prescriber states results in increase venous pooling, and it is noted that the enrollee has a history of diabetes mellitus. There is no evidence of Parkinson's disease, Multiple system atrophy, or other neurological conditions associated with primary autonomic failure. The enrollee's medication list at the time of the visit September 6, 2018 included Amitriptyline and Sotalol. Additionally, it is stated that the enrollee has been diagnosed with inappropriate sinus tachycardia which is being treated with Corlanor.Although it is noted that the enrollee has shown some benefit from the requested drug, there is insufficient documentation that the diagnosis being treated is neurogenic orthostatic hypotension related to primary autonomic failure. Therefore, based on the information provided, 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 based on the available documentation.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 no citations in the Medicare approved compendia that support the use of Northera 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 Northera. 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.