Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bipolar Disorder.
Treatment: Paliperidone ER 6MG OR TB24.
The insurer denied the Paliperidone ER 6MG OR TB24.
The denial is overturned. 

The patient is a female with diagnoses of Bipolar I Disorder, Posttraumatic Stress Disorder (PTSD), attention deficit hyperactivity disorder (ADHD), and co-occurring opioid and stimulant use disorders. The patient is prescribed paliperidone extended-release formulation at a daily dose of 6 mg (milligrams) which has resulted in stabilization of mood. Other psychotropic medications include buspirone, fluvoxamine, guanfacine, and prazosin, as well as prn (as needed) use of trazodone. She receives medication assisted treatment with Suboxone. General medical co-morbidities include COPD (chronic obstructive pulmonary disease) with asthma, GERD (gastroesophageal reflux disease), restless leg syndrome and chronic knee pain with associated treatments. The patient is an every day smoker at two packs per day.

The patient's mental status examination reveals relative stability with residual problems with anxiety and attention/focus, as well as reports of insomnia. Mood is stable and there are not severe symptoms such as psychosis, mania, severe cognitive impairment, perceptual disturbance, dissociation, or suicidal ideation or aggressive impulses. Insight and judgment are noted to be good.

The patient receives monitoring, medications targeting the symptoms of mental disorders, and participation in regularly scheduled group therapies. The patient had a difficult clinical course prior to stabilization on the current regimen. She is abstinent from illicit substances of abuse with negative drug screens.

The patient is single and lives with others and is unemployed. She has past legal issues and history of incarceration. Family history is positive for mental disorder.

The health plan has denied authorization for coverage of paliperidone ER (extended release) indicating that the patient has not failed a trial of risperidone which is required under the plan guidelines in order to allow a coverage exception for paliperidone. The prescribing physician argues that the patient is known to destabilize if taken off paliperidone, and that discontinuation of paliperidone would be detrimental to the patient with risk for re-hospitalization or incarceration.

Yes, the treatment with Paliperidone ER is medically necessary for this patient.

In this case scenario, the patient has demonstrated a clinical response to Paliperidone ER/Invega ER at a daily dose of 6 mg, as noted in the clinical summary. The patient has a history of bipolar disorder complicated by trauma history, ADHD and co-occurring substance use disorder with ongoing treatments, as noted in the clinical summary. Thus, the requested benefit of Paliperidone ER at the current dosage of 6 mg is reasonable and in the patient's best interest in keeping with prevailing standards of medical practice, as the patient has achieved mood stabilization with this medication together with other ongoing treatments, as noted in the clinical summary.

The paliperidone ER is indicated in this case scenario, and the use of the Paliperidone at a daily dose of 6 mg has been effective for this patient and is clinically appropriate and medically necessary.

Formulary alternatives such as risperidone 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 and the tolerability noted with the current medication, paliperidone ER.

Thus, the health plan's alternative formulation(s) of an atypical antipsychotic medication is not prudent or reasonable in this clinical scenario due to the patient's clinical response to Paliperidone ER. The proposed treatment of Invega/Paliperidone ER at the effective dosage of 6 mg is medically necessary, and provision of the treatment can reasonably be expected to be health beneficial for the patient and withholding the treatment can reasonably be expected to affect the patient's health adversely, as the prescribing physician asserts.

This answer is consistent with prevailing standards of professional practice and the scientific literature and published guidelines, referenced below, as well as instruction for New York State medical necessity reviews that is applicable in this case review.