Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Temazepam 15 mg capsule, 90 capsules 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 Temazepam 15 mg capsule, 90 capsules per 30 days. The drug is requested for the long-term treatment of insomnia, which is an off-label (non-FDA approved) use. You sent a letter clarifying the medical history. You stated the enrollee has been on Temazepam 45 mg at night for the treatment of insomnia. 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. The following citation in AHFS-DI, a Medicare approved compendium, does not support the use of the requested drug for the enrollee's condition: Temazepam shares the actions of other benzodiazepines and is used as a hypnotic agent in the short-term treatment of insomnia generally for periods not exceeding 7-10 days in duration. The failure of insomnia to remit after 7-10 days of temazepam therapy may indicate the presence of an underlying psychiatric and/or medical condition. Prolonged use of hypnotics is usually not indicated and should be undertaken only upon further evaluation of the patient. The possibility that insomnia may be a symptom of an underlying condition for which there may be a more specific treatment should be considered.The following citation in DrugDex, a Medicare approved compendium, does not support the use of the requested drug for the enrollee's condition: Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). Usual dosage: 15 mg before retiring; 7.5 mg may be sufficient for some patients, while others may require 30 mg. 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. 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 Temazepam 15 mg capsule, 90 capsules per 30 days 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 Temazepam 15 mg capsule, 90 capsules per 30 days. 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.