Diagnosis: Insomnia
Treatment: Belsomra
The insurer denied Belsomra.
The determination is upheld.

This is a female patient with chronic insomnia. The treating provider is requesting the coverage of Belsomra. The patient tried and failed or has been intolerant to Dayvigo, Trazodone, Hydroxyzine and melatonin. At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug, Belsomra, or would have adverse effects.

There is no evidence that the formulary drugs ramelteon, zolpidem, zolpidem extended release (ext rel) are less effective or have more adverse effects than the preferred formulary medications.

The patient has chronic insomnia. She tried and failed Dayvigo, Trazodone, Hydroxyzine and melatonin. The request is for the Belsomra. However, there is no convincing or objective evidence in the submitted documents that the patient has a contraindication to or a potential drug interaction with formulary alternatives (ramelteon, zolpidem, zolpidem ext rel). There is no evidence that the patient is intolerant to or has had a confirmed adverse event with formulary alternatives (ramelteon, zolpidem, zolpidem ext rel). There is no evidence that the patient has demonstrated an inadequate treatment response after a trial of formulary alternatives (ramelteon, zolpidem, zolpidem ext rel)
There are no adequate or well-conducted randomized controlled or cohort trials in the prevailing peer-reviewed published medical literature that established the long term efficacy and safety of Belsomra over preferred formulary drugs, such as ramelteon, zolpidem, zolpidem ext rel, for the treatment of this patient's medical condition.
There is no high-quality literature showing an improvement in health outcomes with the use of Belsomra over preferred formulary (ramelteon, zolpidem, zolpidem ext rel) for this patient's condition. There are no national guidelines that support the routine use of Belsomra over ramelteon, zolpidem, zolpidem ext rel for the treatment of chronic insomnia as in this patient's case.