Pharmacy Medical Necessity Guidelines: Antipsychotic Medications Effective: July. 1, 2016 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit RX Department to Review RXUM This Pharmacy Medical Necessity Guideline applies to the following: INTotal Health Medicaid Plan INTotal Health Medicaid Plan INTotal Health FAMIS Plan INTotal Health FAMIS Plan Fax Numbers: RXUM: 855-762-5205 OVERVIEW Only 40 percent of patients in primary care respond to the first choice of antidepressant medication. Approximately 20 percent stop the medication due to side effects, and 30 percent have no response. Initial severity of depression and chronicity of a depressive episode are associated with a higher risk of treatment resistance. Patients with higher initial severity and chronicity are also more likely to meet criteria for psychiatric comorbidities such as panic disorder, posttraumatic stress disorder, and dysthymia. In patients who appear to be treatment resistant, adherence to antidepressant medication should be carefully evaluated with nonjudgmental questions such as: "Many of my patients forget to take their medication on a regular basis. How often does that happen to you?" Patients with comorbid anxiety disorders such as panic disorder or post-traumatic stress disorder (PTSD) may be especially prone to side effects of medications, leading to non-adherence. Other important factors that can limit antidepressant response are chronic social stressors such as marital discord, patients with severe childhood adversity, alcohol and/or substance abuse, chronic physical pain, and Bipolar Disorder. Patients with bipolar disorder often experience substantial side effects with typical antidepressant medication regimens, and have more rapid cycles of mood swings with SSRIs. Therapy for bipolar II should include mood stabilizers such as lamotrigine or lithium. It is important that the patient is diagnosed accurately using the appropriate criteria and tools. The patient should also be evaluated to identify general medical conditions that may contribute to the disease process (i.e. hypothyroidism) or complicate its treatment. 1
Generic Name Brand Name Limitations ANTIPSYCHOTICS Atypicals Quantity Limits aripiprazole soln AL* PA aripiprazole 2 mg, 20 mg, 30 mg ABILIFY AL* PA aripiprazole 5 mg, 10 mg, 15 mg ABILIFY AL* PA QL Requires tablet splitting, tablet splitter will be covered aripiprazole ext-rel inj ABILIFY MAINTENA PA clozapine CLOZARIL AL* olanzapine ZYPREXA AL* paliperidone palmitate ext-rel inj INVEGA SUSTENNA PA quetiapine SEROQUEL AL* risperidone RISPERDAL AL* risperidone long-acting inj RISPERDAL CONSTA PA ziprasidone GEODON AL* Miscellaneous chlorpromazine fluphenazine fluphenazine inj fluphenazine decanoate inj haloperidol perphenazine thiothixene trifluoperazine COVERAGE GUIDELINES In addition to medication-specific prior authorization criteria, the Plan may authorize coverage of a preferred antipsychotic medication for Members when the following criteria are met: For members less than 18 years of age: 1. The member has had a recent psychiatric hospitalization (within the last three months) 2. The member has a history of severe harm to self or others. 3. The requested drug is being used for an FDA-approved indication with age an indication supported in the compendia of current literature (e.g., AHFS, Micromedex, current accepted guidelines). 4. The prescriber is a Psychiatrist, Neurologist, or Developmental/Behavior Pediatrician. 2
5. The prescriber has consulted with a Psychiatrist, Neurologist, or Developmental/Behavioral Pediatrician prior to prescribing the requested medication. 6. The member has received a developmentally-appropriate, comprehensive psychiatric assessment with diagnoses, impairments, treatment target and treatment plans clearly identified and documented. 7. The member may receive a onetime approval for a 3-month supply while a developmentally appropriate, comprehensive psychiatric assessment with diagnoses, impairments, treatment target and treatment plans are identified and clearly documented. 8. The member is currently established and stabilized on the requested formulary medication. The plan may authorize coverage for a non-preferred antipsychotic medication for members less than 18 years of age when all of the above and the following criteria are met or for members 18 years of age and older when the following criteria are met: 1. The member has tried and failed at least 3 formulary atypical antipsychotics 2. The member is currently established and stabilized on the requested non-formulary medication. Abilify (aripiprazole tablets) 1. The medication request is being requested for a FDA-Approved indication indication supported in the compendia of current literature (e.g., AFHS, Micromedex, current accepted guidelines) 2. Documentation is provided which supports that member is unable to take generic risperidone olanzapine due to inadequate treatment response, intolerance, or contraindication. 3. Documentation is provided which supports that the member is unable to take at least two generic atypical antipsychotics due to inadequate treatment response, intolerance, or contraindication. 4. The member has a clinical condition for which there is no generic alternative or the listed generic alternatives are not recommended based on published guidelines or clinical literature. Abilify (aripiprazole) 5mg, 10mg, and 15mg tablets 1. Unless the member has a chart-documented physical limitation which prevents them from using a pill splitter to split the pills, the member will be required to obtain tablets containing twice the prescribed dose and split the tablet per dose. Abilify Maintena (aripiprazole extended-release injectable suspension) 1. The member does NOT have a dementia-related psychosis 2. The member has established tolerability with oral aripiprazole 3. The requested drug is being prescribed for the treatment of schizophrenia 4. The member is unwilling or unable to take the tablets or capsules orally or is at high risk for noncompliance 3
Invega Sustenna (paliperidone) injection 1. The member does NOT have dementia-related psychosis 2. The member has established tolerability with oral paliperidone or oral risperidone 3. Invega Sustenna is being prescribed for the treatment of one of the following: 3.1. Schizophrenia 3.2. Schizoaffective disorder as monotherapy or as adjunct to mood stabilizers or antidepressants 4. The member has a history of noncompliance and/or refuses to utilize oral medications Risperdal Consta (risperidone) long-acting injection 1. The member does NOT have dementia-related psychosis 2. The member has established tolerability with oral risperidone 3. Risperdal Consta is being prescribed for the treatment of one of the following: 3.1. Schizophrenia 3.2. Monotherapy or as adjunctive therapy therapy to lithium or valproate for the maintenance treatment of bipolar I disorder 5. The member is unwilling or unable to take the tablets or capsules orally or is at high risk for noncompliance Seroquel XR (quetiapine extended-release) 1. The medication request is being requested for a FDA-Approved indication indication supported in the compendia of current literature (e.g., AFHS, Micromedex, current accepted guidelines) 2. Documentation is provided which supports that member is unable to take generic risperidone olanzapine due to inadequate treatment response, intolerance, or contraindication. 3. Documentation is provided which supports that the member is unable to take at least two generic atypical antipsychotics due to inadequate treatment response, intolerance, or contraindication. 4. The member has a clinical condition for which there is no generic alternative or the listed generic alternatives are not recommended based on published guidelines or clinical literature. LIMITATIONS 1. Approval duration: 1.1. A onetime 3 month approval may be granted when a developmentally-appropriate, comprehensive psychiatric assessment is completed 1.2. When all criteria have been met, lifetime approval may be granted for continuity of care. 4
2. Quantity limits as follows: aripiprazole 5 mg, 10 mg, 15 mg ABILIFY AL* PA QL Requires tablet splitting, tablet splitter will be covered CODES None. REFERENCES 1. DRUGDEX System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/ (cited: April 2016). 2. Abilify (aripiprazole) [prescribing information]. Tokyo, Japan: Otsuka Pharmaceuticals; January 2016 3. Abilify Maintena (aripiprazole) [prescribing information]. Tokyo, Japan: Otsuka Pharmaceuticals; January 2016 4. Invega Sustenna (paliperidone) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals Inc.; March 2016. 5. Seroquel XR (quetiapine extended-release) [prescribing information]. Wilmington, DE: Astra Zeneca Pharmaceuticals LP; October 2013. 6. Risperdal Consta (risperidone) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals Inc.; March 2016. APPROVAL HISTY April 13, 2016: Summary of P&T review Subsequent endorsement date(s) and changes made: January 18, 2017: Content review and formatting updates approved per P&T Committee. ADDITIONAL INFMATION 5