Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Paranoid Schizophrenia. 
Treatment: Formulary exception for Invega Sustenna 156mg/ml. 

The insurer denied the Formulary exception for Invega Sustenna 156mg/ml. 
The denial is overturned. 

The patient is a adult female diagnosed with schizophrenia, paranoid type. 

The patient was started on Invega Sustenna long-acting injections, with an initial dose of 234 mg (milligrams) IM (intramuscular) resulting in tolerability with plans for maintenance therapy with monthly injections of Invega Sustenna at a dosage of 156 mg (milligrams). The patient has no co-occurring substance use disorders or acute medical issues reported. 

The patient's current health plan has denied coverage for continued treatment with Invega Sustenna on the basis of the Prescription Drug Plan indicating that Invega Sustenna is non-formulary. The health plan formulary requires treatment failure with at least three alternative formulary agents and step therapy before a formulary exception is allowed. These include risperidone, olanzapine, ziprasidone, aripiprazole including Aristada, paliperidone ER (extended release) and Rexulti. 

The patient receives monthly monitoring for the Invega Sustenna targeting symptoms of schizophrenia due to her past history of non-adherence and adverse drug effects or treatment failure with other psychotropic medications, and due to the patient's evaluation of a response to Invega Sustenna and need for monthly injections; the patient's clinician is requesting continued coverage the long-acting injectable formulation of the antipsychotic medication, paliperidone palmitate/Invega Sustenna at a once monthly dosage of 156 mg (milligrams). 

The appeal indicates that Invega Sustenna was started with an acute inpatient stay with plans for maintenance treatment. The reason for denial was due to the requested drug being non-formulary with reference to prior authorization criteria and step therapy and alternative formulary meds. 

Yes, the health plan should cover the Formulary exception for Invega Sustenna.
The formulary alternatives would not be as effective for this patient, as a long-acting injectable is necessary and clinically appropriate in this case. Additionally, the formulary alternatives would not be as effective as the requested non-formulary drug due to issues related to adherence and need for once monthly contact for evaluation and management, including injections of Invega Sustenna. Because the Invega Sustenna is well-tolerated, the non-formulary drug is more likely to be effective, as formulary drugs pose risk for adverse effects for this patient, and to switch from a drug that is well-tolerated to one that is not known to be tolerated or effective would be detrimental and inappropriate in this case scenario with a reasonable degree of medical certainty. Thus, the favorable coverage determination is in the best interest of the patient and is reasonable, reflecting sound medical judgment. In this case scenario, the patient has demonstrated a clinical response to Invega Sustenna, as noted in the clinical summary. 

The formulary alternatives are not reasonable in this clinical scenario because there is no evidence that the patient would respond to formulary alternatives with the same level of response noted with Invega Sustenna. Oral formulations that are provided on the formulary of antipsychotic medication are not reasonable alternatives, as the health plan asserts in the reason for denial, and in this clinical scenario due to the patient's well risk of non-adherence to medication and severity of illness that required inpatient level care with the start of Invega Sustenna with plans for monthly injections. 

The requested health service with Invega Sustenna at the effective dosage of 156 mg (milligrams) dosed at appropriate monthly intervals is therefore medically necessary, and provision of the treatment with Invega Sustenna can reasonably be expected to be health beneficial for the patient. Withholding the treatment with Invega Sustenna can reasonably be expected to affect the patient's health adversely. Thus, a formulary exception should be made for the requested benefit of Invega Sustenna 156mg (milligrams)/ml (milliliter) syringe. The health plan should cover the formulary exception for the continued use of Invega Sustenna 156 mg (milligrams)/0.5 ml (milliliter) syringe. 

This answer is consistent with prevailing standards of professional practice and the scientific literature, referenced below, and with the appeal indicating that Invega Sustenna was started with an acute inpatient stay with plans for maintenance treatment with dosing at 156 mg (milligrams) per month.