Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Seroquel 600 mg daily, clonazepam 1 mg twice daily, modafinil 200 mg daily and Belsomra 20 mg (frequency unknown) for treatment of the enrollees behavioral health conditions.Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medications. Although appropriate patient-centric care may ultimately arrive at rather uncommon medication regimens, there is no longitudinal evidence in the medical record of systematic progression through standard pharmacologic therapies, applied in conjunction with evidence-based non-pharmacologic interventions, to arrive at the rather atypical regimen requested by the patient.  In terms of indication, the patient has been diagnosed with unspecified anxiety disorder.  There is no history of a psychotic illness, major depressive disorder, bipolar spectrum disorder, or excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work disorder.  There is no evidence that standard therapies, such as alternative medication strategies, treatment with cognitive behavioral therapy for anxiety and insomnia, or consultation with a sleep clinic, have been exhausted.  Under these circumstances, the requested medication regimen is not an evidence-based intervention for an anxiety disorder. Seroquel is an atypical antipsychotic.  It is not indicated for insomnia.  Seroquel therapy requires monitoring for metabolic syndrome and liver functioning.  Further, Seroquel can cause prolongation of the QTc interval so periodic electrocardiograms may be indicated, particularly if the patient is treated with other medicines that may impact cardiac conduction.  Additionally, prescribed in combination with another cytochrome p450 3A4 substrate (clonazepam) in presence of a 3A4 inducer (modafinil) introduces the possibility of significant drug-drug interactions that demands clinical monitoring during treatment.  The patient was taking two other sedating medications, clonazepam and Belsomra.  The potentially synergistic effect of combining multiple central nervous system depressants can result in sedation and cognitive dulling, which may manifest in memory concerns in this case, that may prompt the well-intended ideation of additional wakefulness pharmacotherapy. Moreover, the safety of modafinil has not been established for off-label indications.  Belsomra is relatively new to the marketplace, so the long-term adverse effects may not yet be apparent.  The use of benzodiazepines, which have been commonly prescribed for decades, was recently associated with an increased risk of Alzheimers disease.  Regardless of the particular association, a safety analysis of the risks of benzodiazepine therapy often outweigh the potential benefits.  Final Result: The reviewer determined that the requested medications are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The physician reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.