Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Paranoid Schizophrenia

Treatment: Invega Sustenna 234 mg/1.5mL injection

The insurer denied coverage for Invega Sustenna 234 mg/1.5mL injection

The denial is overturned

 
This adult had a history of psychotic symptoms including auditory hallucinations, responding to internal stimuli, erratic behavior, dangerous and aggressive behavior including destroying everything in the house and talking to self. He had a history of alcohol use and Paranoid Schizophrenia. He was single, unemployed, and living with his family. He was reported to have poor adherence and compliance with oral antipsychotic medications. He was taking Invega Sustenna intramuscular (IM) with efficacy and tolerability with only sleepiness as a side effect. He also had taken Prolixin Decanoate IM in the past and was also taking Risperidone and Cogentin. It was reported that he had received a loading dose of Invega Sustenna 234 milligrams (mg)/1.5 milliliter (ml) injection and another loading dose of Invega Sustenna 156 mg/1.5 ml injection with the plan for maintenance treatment of Invega Sustenna 156 mg/1.5 ml injection.
The insurer denied coverage for Invega Sustenna 234 mg/1.5 ml injection stating that there were other medications on formulary that he could have been treated with for his diagnosis of Schizophrenia including Aristada, Aripiprazole, Asenapine Maleate, Clozapine, Latuda, Olanzapine, Paliperidone ER, Quetiapine and Quetiapine ER, Risperidone, and Ziprasidone.
Paliperidone is the generic for Invega. According to Current Psychiatry Volume 17 No. 8 pages 45-55, "Paliperidone Palmitate: Adjusting Dosing Intervals and Measuring Serum Concentrations," by decreasing injection intervals, the paliperidone serum concentration will increase to new steady states. the use of long term injectable antipsychotics is complicated by length time needed to reach steady state. Decreasing the time interval can increase therapeutic concentrations before the therapeutic effects are gone. It also avoids the need for oral supplementation of antipsychotic medication.
The Invega Sustenna given was reportedly effective and tolerable. There would be a risk of worsened symptoms or intolerability if taking Arista IM which was on formulary as he had lack of efficacy and tolerability issues with other antipsychotic medications. If he were to stop this Invega Sustenna medication, he likely would decompensate and have worsened psychotic symptoms, behaviors, and functioning. Therefore, Invega Sustenna is considered to be more effective for him currently than formulary medications. As a result, the recommendation is to reverse the previous decision and approve coverage for Invega Sustenna 234 mg/1.5 ml injection and also 156 mg/1.5 ml if given after the 234 mg/1.5 ml. 
While the formulary drugs themselves are not expected to cause adverse effects, switching the patient from the currently effective treatment would place the patient at high risk for decompensating due to the history of oral noncompliance, and unknown effect of a different IM medication. 

While not all of the formulary drugs were tried or the patient did not have an adverse reaction or contraindication, again, the patient has a history of oral medication noncompliance, and it is unknown if the other IM medication will be effective; switching the patient from the currently effective treatment would place the patient at high risk for decompensating.  

The formulary drugs are expected to be ineffective due to history of noncompliance with oral antipsychotic medications.

The not formulary drug is expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Invega Sustenna 234 mg/1.5mL injection for use in the treatment of paranoid schizophrenia is overturned.