Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Schizophrenia
Treatment: Invega Sustenna
The insurer denied the Invega Sustenna.
The determination is overturned.

The patient has a history of a chronic psychotic disorder best characterized as paranoid type schizophrenia, and a clinical course that has included paranoid thinking and persecutory delusions in the context of a thought disorder and symptoms that meet criteria for schizophrenia.

The patient was treated with aripiprazole in the past with adverse effects including akathisia, nausea and vomiting, headache and blurred vision. She was switched to Invega (paliperidone) with plans to proceed to use of the long-acting injectable formulation of this medication, Invega Sustenna (paliperidone palmitate).

The patient's current health plan and pharmacy benefits manager has denied coverage for treatment with Invega Sustenna on the basis of a formulary that requires treatment failure with the alternative agent, Aristada (aripiprazole lauroxil).

The patient has comorbid psychiatric disorders that include attention deficit hyperactivity disorder (ADHD) treated with Focalin in the past, and persistent depressive disorder (dysthymia) with intermittent episodes of major depression treated with Wellbutrin XL (extended release) 300 milligrams (mg). The patient has no substance use disorder or general medical issues.

The mental status examination with the current presentation reveals a calm and guarded female who is disheveled. Speech is monotone, but clear and normal with thought processing that is disorganized, circumstantial and tangential with illogical thought patterns and delusions. Mood and affect is blunted or flat with anxiety and tension. She denied suicidal or homicidal ideation, and had no cognitive impairment or evidence for mood disturbance. Insight and judgment were indicated as poor.

The patient's clinician is requesting coverage of the long-acting injectable formulation of the antipsychotic medication, paliperidone palmitate/Invega Sustenna at a once monthly or initial dosage of 234 milligrams (mg).

The case records/progress notes, health plan documents, appeal documents and correspondence from the health plan, as well as the health plan's rationale for the denial of certification for coverage of Invega Sustenna, were reviewed. The health plan's prior authorization and formulary exception criteria were reviewed.

At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug Invega Sustenna 234, or would have adverse effects.

In this case, the formulary drug Aristada will likely be ineffective or would not be as effective as the non-formulary drug Invega Sustenna due to the risk of adverse effects.

The patient has demonstrated a lack of tolerability with the oral formulation of aripiprazole and would therefore be expected to have tolerability problems and adverse effects with Aristada (aripiprazole lauroxil). Thus, the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

The patient has a history of medication adverse effects and inadequate response to a formulation similar to the formulary medication and medication tolerability problems with aripiprazole oral formulation. Thus, the requested benefit of Invega Sustenna at the current or starting dosage of 234 mg is reasonable and in the patient's best interest in keeping with prevailing standards of medical practice. The long-acting injectable antipsychotic medication is indicated in this case scenario, and the use of the Invega Sustenna is clinically appropriate and considered medically necessary for this patient. The formulary alternative is not reasonable in this clinical scenario due to the adverse effects experienced with oral aripiprazole. Provision of the treatment with Invega Sustenna can reasonably be expected to be health beneficial for the patient.

This answer is consistent with prevailing standards of professional practice and the scientific literature.