Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Bipolar II Disorder. 
Treatment: Formulary exception for Pristiq 100MG (milligrams) OR (oral) TB24 (24-hour tablet). 

The insurer denied: Formulary exception for Pristiq 100MG (milligrams) OR (oral) TB24 (24-hour tablet). 
The denial is overturned. 

The case involves an adult female who is requesting authorization for coverage of Pristiq (desvenlafaxine succinate extended release 24 hours) for treatment of bipolar depression with a diagnosis of bipolar II disorder with depression as the main problem according to her prescribing physician. There is no report of other co-morbid psychiatric conditions, co-occurring substance use disorder or, general medical conditions that are a focus of treatment in this case. For the past year, the patient has been prescribed brand Pristiq (desvenlafaxine succinate extended release 24 hours) with a dosage of 100 milligrams daily. She has failed treatment with the generic formulation of Pristiq, as well as duloxetine and venlafaxine. Additionally, the use of brand Pristiq together with Depakote and Wellbutrin has produced a sustained positive clinical response such that the patient is able to function with regard to social, educational, occupational and daily activities. 

Under the health plan, prior authorization criteria limits coverage when at least three formulary alternative agents have not been prescribed, including duloxetine, venlafaxine, sertraline, paroxetine, citalopram, escitalopram, mirtazapine and vilazodone as well as Pristiq available in generic formulation (desvenlafaxine). Coverage limits apply when step therapy has not been achieved that would allow for prior authorization and coverage of the requested medication. The health plan denial determination indicated that criteria were not met and that the request for brand Pristiq is not a covered under the plan. 

The prescribing clinician is requesting coverage for brand Pristiq in view of the effective use for one year to address the patient's depression, and indicates that plan criteria are met in view of past treatment with venlafaxine, duloxetine and generic formulation of Pristiq (desvenlafaxine). The issue under review is brand Pristiq (desvenlafaxine succinate extended release 24 hours). 

The health plan should cover the proposed treatment in this case. 

As indicated in the appeal, the prescribing clinician is requesting continued coverage for brand Pristiq in view of the effective use for one year to address the patient's depression. Incidentally, the appeal indicates that plan criteria are met in view of past treatment with venlafaxine, duloxetine and generic formulation of Pristiq (desvenlafaxine), i.e., three formulary alternatives including adverse effects with the generic formulation of Pristiq. 

In this case scenario, three formulary drugs have been ineffective for this patient, and there is no evidence that other formulary alternatives would be as effective as the requested non-formulary drug which has been effective and tolerated for one year or more. The formulary alternatives noted in the denial determination would pose adverse effects for this patient as opposed to the non-formulary drug that is well tolerated and effective. Moreover, it would be detrimental to the patient to change from a medication that is effective and well tolerated whereas there is no evidence that the patient would tolerate or respond to another formulary alternative. Additionally, as noted in the appeal, the plan criteria with step therapy are also met in this case. Thus, the requested benefit of Pristiq is considered a covered benefit under the plan in keeping with the plan definition that supports the medical necessity and clinical appropriateness for the requested benefit of brand Pristiq (desvenlafaxine succinate extended release 24 hours).
This answer is in keeping with the scientific literature and published guidelines, referenced below, as well as prevailing standards of medical practice.