Read PA-ABH_Invega Non Formulary Guideline_100517 text version

Last Review: 04/2010

AETNA BETTER HEALTH IN PENNSYLVANIA

NON-FORMULARY Clinical Guideline Invega® (paliperidone) Invega SustennaTM (paliperidone palmitate) FDA Indications

Invega · Acute and maintenance treatment of schizophrenia · Acute treatment of schizoaffective disorder as monotherapy · Acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants Invega Sustenna Acute and maintenance treatment of schizophrenia

Dosage Forms

Invega: 3 mg, 6 mg, 9 mg extended-release tablets Invega Sustenna: 39 mg, 78 mg, 117 mg, 156 mg, or 234 mg prefilled syringes

Dosage

Invega Schizophrenia: 6 mg once daily, administered in the morning. When dose increases are indicated, small increments of 3 mg/day are recommended. Maximum dosage is 12 mg/day. Schizoaffective disorder: 6 mg administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended dose range of 3 mg to 12 mg once daily. If clinical assessment warrants, increase the dose at increments of 3 mg/day at intervals of more than 4 days. Maximum recommended dosage is 12 mg/day. Invega Sustenna: administered by a healthcare professional Schizophrenia: for patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment. Initiate Invega Sustenna with a dose of 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle. The recommended monthly maintenance dose is 117 mg; some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on individual patient tolerability and/or efficacy. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.

Authorization Guidelines

Prior authorization personnel will review the request for prior authorization and apply the clinical guidelines to assess the medical necessity of the request for a prescription for Invega or Invega Sustenna. If the guidelines are met, the reviewer will prior

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authorize the prescription. If the guidelines are not met, the prior authorization request will be referred to a physician reviewer for a medical necessity determination. Such a request for prior authorization will be approved when, in the professional judgment of the physician reviewer, the services are medically necessary to meet the medical needs of the recipient. For patients who meet all of the following: · Is 18 years of age and older · No hypersensitivity to paliperidone or risperidone · Not being used for control of behavioral disorders in elderly patients with dementia Black box warning for dementia in elderly patients: Atypical antipsychotics are not approved for control of behavioral disorders in elderly patients with dementia. In April 2005 the FDA mandated that all manufacturers include a black box warning noting that increased death rates have been noted in these patients receiving atypical antipsychotics. Death typically occurred due to heart failure, sudden death, or infections (primarily pneumonia). · Medical records documenting diagnosis of schizophrenia and trial of formulary antipsychotics or contraindication to formulary antipsychotics per product information

Prior Authorization Requirements

Initial Approval Indefinitely Renewal N/A

Additional Information

· Invega may increase QT interval and should be used with caution in combination with drugs that increase QT interval and in patients with risk factors for prolonged QT interval. Drugs that prolong the QT interval: [Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., quinolones, macrolides)]No dosage adjustment is required in patients with mild to moderate hepatic impairment. Invega has not been studied in patients with severe hepatic impairment. Table 1. Relative Incidence of Atypical Antipsychotic Drug Adverse Effects

References

1. Gold Standard, Inc. Invega. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed February 6, 2010. 2. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Second Edition. February 2004. Available at: http://www.psych.org/psych_pract/treatg/pg/Schizophrenia2ePG_05-15-06.pdf. Accessed June 25, 2007. 3. Invega [package insert]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc; July 2009. 4. Invega Sustenna [package insert]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc; July 2009.

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Primary Reference Policy

7600.12 Non-Formulary Management Table 1. Adverse Event Profile of Atypical Antipsychotics

Adverse Drug Reaction EPS/tardive dyskinesia Prolactin elevation Weight gain Glucose abnormalities Lipid abnormalities QTc prolongation Sedation Hypotension Anticholinergic side effects Aripiprazole 0 0 0 0 0 0 + 0 0 Olanzapine 0 0 +++ +++ +++ 0 + + ++ Risperidone + +++ ++ ++ ++ + + + 0 Quetiapine 0 0 ++ ++ ++ 0 ++ ++ 0 Ziprasidone 0§ + 0 0 0 ++ 0 0 0

0 = no risk or rarely causes side effects at therapeutic dose; + = mild or occasionally causes side effects at therapeutic dose; ++ = sometimes causes side effects at the therapeutic dose; +++ = frequently causes side effects at therapeutic dose Also causes nausea and headache Also carries warning about potential development of cataracts §Possible exception of akathisia

All novel psychotropics have a warning in their prescribing information regarding the risk of hyperglycemia and/or diabetes mellitus. According to the American Psychiatric Association's practice guideline for the treatment of patients with schizophrenia, olanzapine has a stronger association with weight gain, diabetes, and dyslipidemia, risperidone and quetiapine have intermediate-effects, and aripiprazole and ziprasidone appear to have the least concern. According to Invega product information, the effects of paliperidone are likely similar to risperidone.

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