Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Bipolar Affective Disorder, Major Depression. 
Treatment: Formulary exception for Invega Sustenna 117MG/0.75mL(Milliliter) IM Susy. 
The insurer denied the Formulary exception for Invega Sustenna 117MG/0.75mL IM Susy. 
The denial is overturned. 

The patient is a male. He is in treatment for a severe and persistent mental disorder best characterized as bipolar disorder in the context of a history of severe episodes of depression with suicidal behavior and co-occurring substance use disorder with multiple substances of abuse including cannabis and cocaine. The patient was previously hospitalized twice with one inpatient treatment episode following a suicide attempt with stabbing self in the chest requiring treatment for a pneumothorax. When depressed, the patient exhibits depressed mood, sad affect, auditory hallucinations with derogatory commentary, low self-worth, tearfulness, pessimism and decreased appetite with hypersomnia and low energy and motivation. 

Previously, the patient was stabilized with the use of risperidone with subsequent use of olanzapine only to be discontinued due to noncompliance with oral antipsychotic drugs prescribed together with Depakote. Haldol decanoate was not well tolerated due to adverse effects, and subsequently a few years ago, a long-acting injectable formulation, Invega Sustenna at a dose of 117 mg (milligrams) was prescribed with a positive clinical response. The patient participates in outpatient care with continued use of Invega Sustenna the effective dose of 117 mg (milligrams) once monthly administered with injection. 

The patient has a history and a clinical course with substance use with cannabis and cocaine, and with medication non-adherence and limited insight (anosognosia) in the context of severe and recurrent episodes of depression associated with bipolar mood disorder. There are no comorbid psychiatric disorders. However, the patient has co-occurring substance use disorders, as noted, but no general medical issues that are a focus of treatment. 

The health plan denied coverage on the basis of plan criteria and policy with requirement for at least 3 trials and failure with formulary alternatives including paliperidone ER (extended release), olanzapine, risperidone, ziprasidone, quetiapine and Saphris. 

The patient's prescriber has planned to continue the patient on the long-acting injectable antipsychotic medication, Invega Sustenna, at the currently effective dose of 117 mg (milligrams) every 4 weeks or monthly. The prescribing psychiatric clinician is requesting continued coverage of this medication with a history of stopping oral medications that resulted in a recrudescence of the patient's mood disorder with symptoms of psychosis and depression, and another hospitalization with worse outcome and risk for suicide. 

Yes, the health plan should cover the Formulary exception for Invega Sustenna.
In this case scenario, the requested service should be covered despite plan criteria and policy concerning a formulary exception, indicating that a formulary alternative should be used in this case. However, the suggested formulary alternatives would not be as effective as Invega Sustenna which is a long-acting injectable medication that is warranted in this case; the clinical features of non-adherence to oral medication and risk for suicide or hospitalization or recurrence of major depressive disorder also warrants the continued use of a medication that has been effective with tolerability. 

The formulary exception is warranted, in keeping with the plan guidelines and instruction for this review, because a switch to an alternative formulary medication is contraindicated in view of the risks associated with switching to another medication that may or may not be effective or tolerated and is likely to be discontinued by the patient, as was the case with two formulary alternatives, risperidone and olanzapine. In this regard, a switch from a medication that is effective and well-tolerated to another medication is contraindicated in keeping with prevailing standards of care in this case scenario, and clearly does pose risk to the patient that contraindicates the switch to any of the suggested formulary alternatives. New York State instruction allows for a formulary exception in cases where a contraindication to the use of a formulary alternative is applicable, as in this case. 

In summary, in this case scenario, the patient has demonstrated a clinical response to Invega Sustenna with sustained benefit and on an ongoing basis for several years, as noted in the clinical summary. The patient has a history of medication non-adherence and non-compliance with treatment for the bipolar disorder resulting in acute episodes of depression that have included multiple hospitalizations and a serious suicide attempt in the context of psychosis. Thus, the requested benefit of Invega Sustenna at the current dosage of 117 mg (milligrams) administered by injection every 4 weeks or monthly is reasonable and in the patient's best interest in keeping with prevailing standards of medical practice, as well as consistent with New York State instruction for this review. 

The long-acting injectable antipsychotic medication is indicated in this case scenario, and the use of the Invega Sustenna that has been effective for this patient is clinically appropriate and medically necessary. Formulary alternatives are not reasonable and are contraindicated in this clinical scenario because there is no evidence that the patient would respond to any other formulary alternatives with the same level of response noted with Invega Sustenna. Oral formulations of an antipsychotic medication are not a reasonable alternative in this clinical scenario due to the patient's well-established pattern of non-adherence to medication and lack of insight reflecting anosognosia.