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Clinical Pharmacy Program Guidelines for - ARIZONA

Program Prior Authorization Medication Antipsychotics Markets in Scope Arizona

1. Background:

Preferred Typical Antipsychotics/ Non-Preferred Typical Antipsychotics Antimanic Agents Haldol® () concentrate/tablets* Triavil® (-) tablet* Haldol decanoate® ( Moban () tablet solution)* Loxitane® () capsules* Trilafon (perphenazine) tablets* Mellaril® () tablets* Navane® (thiothixene) capsules* Orap® () tablets* Prolixin® ( hydrochloride) concentrate/elixir/tablets* Prolixin® (fluphenazine decanoate) solution Stelazine® () tablets* Thorazine® () tablets /solution* carbonate capsules/tablets Lithium carbonate CR tablet (Lithobid)* Lithium solution

Preferred Atypical Antipsychotics Non-Preferred Atypical Antipsychotics Abilify® () tablets* Abilify Discmelt® (aripiprazole) orally Clozaril® () tablets/orally disintegrating tablet dispersible tablet * Abilify MyCite (aripiprazole tablet with Geodon® () capsules* sensor) Fazaclo (clozapine orally disintergrating Abilify Oral Solution® (aripiprazole) tablet) Caplyta () capsule Latuda () tablets Invega® () tablet Risperdal® () oral solution/tablets* Fanapt® () tablets Risperdal M-Tab® (risperidone) orally Seroquel XR® ( extended release) disintegrating tablet* tablet Seroquel® (quetiapine) tablets* Perseris (risperidone) SubQ injection ® Zyprexa () tablets* Rexulti () tablet ® Zyprexa Zydis (olanzapine) orally Saphris () sublingual tablet dispersible tablet* Secuado (asenapine) Symbyax (/ olanzapine) capsule Abilify Maintena ® (aripiprazole) IM Versacloz (clozapine) suspension injection Vraylar () capsule Aristada () IM injection Zyprexa Relprevv (olanzapine) IM injection Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc.

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Aristada (aripirazole lauroxil) Initio IM Injection Invega Sustenna ® (paliperidone) IM injection Invega Trinza ® (paliperidone) IM injection Risperdal Consta ® (risperidone) IM injection

*Only generic versions are covered

UHC C&S Plan Minimum Age Edits: Prior authorization is required for atypical claims for members less than the following ages:

Generic Name Brand Name Age Edit PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral ARIPIPRAZOLE TABLETS ABILIFY health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral ASENAPINE MALEATE SUBLINGUAL SAPHRIS health provider PA Required for Ages < 18 years and patients ≥ 18 years when prescribed by a non-behavioral CLOZAPINE ORALLY DISPERSABLE TABLET FAZACLO health provider PA Required for Ages < 18 years and patients ≥ 18 years when prescribed by a non-behavioral CLOZAPINE TABLETS CLOZARIL health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral LURASIDONE HCL TABS LATUDA health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral OLANZAPINE ORALLY DISPERSABLE TABLET ZYPREXA ZYDIS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral OLANZAPINE TABLETS ZYPREXA health provider PA Required for Ages < 6 years and patients ≥ 6 years when QUETIAPINE FUMARATE TABLETS SEROQUEL prescribed by a non-behavioral

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health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral RISPERIDONE ORALLY DISPERSABLE TABLET RISPERIDONE ODT health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral RISPERIDONE ORAL SOLUTION RISPERDAL health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral RISPERIDONE TABLETS RISPERDAL health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral ZIPRASIDONE HCL CAPSULES GEODON health provider PA Required for Ages < 18 years and patients 18 years and older when prescribed by a non- ARIPIPRAZOLE LAUROXIL ARISTADA and Aristada Initio Behavioral Health provider PA Required for Ages < 18 years and patients 18 years and older when prescribed by a non- ARIPIPRAZOLE SUSPENSION ABILIFY MAINTENA Behavioral Health provider PA Required for Ages < 18 years and patients 18 years and older when prescribed by a non- PALIPERIDONE PALMITATE SUSPENSION INVEGA SUSTENNA Behavioral Health provider PA Required for Ages < 18 years and patients 18 years and older when prescribed by a non- PALIPERIDONE PALMITATE SUSPENSION INVEGA TRINZA Behavioral Health provider PA Required for Ages < 18 years and patients 18 years and older when prescribed by a non- RISPERIDONE MICROSPHERES SUSPENSION RISPERDAL CONSTA Behavioral Health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral CHLORPROMAZINE HCL SOLUTION VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral CHLORPROMAZINE HCL TABLETS VARIOUS health provider

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PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral FLUPHENAZINE HCL CONCENTRATE VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral FLUPHENAZINE HCL ELIXIR VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral FLUPHENAZINE HCL TABLETS VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral HALOPERIDOL LACTATE CONCENTRATE VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral HALOPERIDOL TABLETS VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral LOXAPINE SUCCINATE CAPSULES LOXITANE health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral PERPHENAZINE TABLETS VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral PIMOZIDE ORAP health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral THIORIDAZINE HCL TABLETS VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral THIOTHIXENE CAPSULES VARIOUS health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral TRIFLUOPERAZINE HCL TABLETS VARIOUS health provider PA Required for Ages < 18 years FLUPHENAZINE DECANOATE SOLUTION FLUPHENAZINE DECANOATE and patients ≥ 18 years when

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prescribed by a non-behavioral health provider PA Required for Ages < 18 years and patients ≥ 18 years when prescribed by a non-behavioral HALOPERIDOL DECANOATE SOLUTION HALDOL DECANOATE health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral Lithium capsules/ tablets Lithium health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral Lithium CR tablets Lithobid health provider PA Required for Ages < 6 years and patients ≥ 6 years when prescribed by a non-behavioral Lithium solution Lithium health provider

Off-labeled Use: Drug therapies must be utilized in accordance with FDA approved indications OR the uses found within the compendia of literature† AND the drug is being prescribed for a medically accepted indication that is recognized as a covered benefit by the applicable health plans’ program. Authorization for off-labeled use of medication will be evaluated on an individual basis. Review of an off-labeled request by the UnitedHealthcare Community & State Medical Staff will be predicated on the appropriateness of treatment, scientific evidence and full consideration of medical necessity. †-compendia of current literature: a. Food and Drug Administration (FDA) approved indications and limits, b. Published practice guidelines and treatment protocols, c. Comparative data evaluating the efficacy, type and frequency of side effects and potential drug interactions among alternative products as well as the risks, benefits and potential member outcomes, d. Drug Facts and Comparisons, e. American Hospital Formulary Service Drug Information, f. United States Pharmacopeia – Drug Information, g. DRUGDEX Information System, h. UpToDate, i. MicroMedex, j. Peer-reviewed medical literature, including randomized clinical trials, outcomes, research data and pharmacoeconomic studies, and k. Other drug reference resources

Indications

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The intent of the criteria is to ensure the appropriate utilization of antipsychotic agents for the appropriate FDA labeled indications and consistent with current evidence in the literature.

2. Coverage Criteria:

A. Preferred Antipsychotics: Antipsychotic Medications in Children Under 6 Years Old

All of the following:

1. The patient has been diagnosed per current DSM criteria with one of the following disorders: a. Bipolar Spectrum Disorder b. Schizophrenic Spectrum Disorder c. Tourette’s or other tic disorder d. Autism Spectrum Disorder

-AND-

2. The requesting clinician has documented that psychosocial issues have been evaluated before request for antipsychotic medications

-AND-

3. The requesting clinician has documented non-medication alternatives that have been attempted before request for antipsychotic medications

-AND-

4. The above documentation includes information on the expected outcomes and an evaluation of potential adverse events

-AND-

5. The member does not have a known hypersensitivity to the requested agent

Authorization will be issued for 12 months.

B. Preferred Antipsychotics: Antipsychotic Medications for Patients ≥ 6 years of Age prescribed by a Non-Behavioral Health Provider

i. One of the following:

a. Both of the following:

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1. The requested medication must be used for an FDA approved indication or the use of the drug is supported by information in the appropriate compendia of literature *

-AND-

2. The patient meets the FDA minimum age limit or the prescriber attests they are aware of FDA labeling regarding the use of the antipsychotic medication and feels the treatment with the requested medication is medically necessary. (Document rationale for use)

-OR-

b. The patient is currently on the requested medication

Authorization will be issued for 12 months.

*Compendia of current literature: a. Food and Drug Administration (FDA) approved indications and limits, b. Published practice guidelines and treatment protocols, c. Comparative data evaluating the efficacy, type and frequency of side effects and potential drug interactions among alternative products as well as the risks, benefits and potential member outcomes, d. Drug Facts and Comparisons, e. American Hospital Formulary Service Drug Information, f. United States Pharmacopeia – Drug Information, g. DRUGDEX Information System, h. UpToDate, i. MicroMedex, j. Peer-reviewed medical literature, including randomized clinical trials, outcomes, research data and pharmacoeconomic studies, and k. Other drug reference resources

C. Preferred Antipsychotics: Fazaclo, Clozaril, Fluphenazine Decanoate, Haldol Decanoate for Patients ≥ 18 years of age prescribed by a Non-Behavioral Health Provider or patients <18 years of age

i. One of the following:

a. Both of the following:

1. The requested medication must be used for an FDA approved indication or the use of the drug is supported by information in Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc.

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the appropriate compendia of literature *

-AND-

2. The patient meets the FDA minimum age limit or the prescriber attests they are aware of FDA labeling regarding the use of the antipsychotic medication and feels the treatment with the requested medication is medically necessary. (Document rationale for use)

-OR-

b. The patient is currently on the requested medication

Authorization will be issued for 12 months.

*Compendia of current literature: a. Food and Drug Administration (FDA) approved indications and limits, b. Published practice guidelines and treatment protocols, c. Comparative data evaluating the efficacy, type and frequency of side effects and potential drug interactions among alternative products as well as the risks, benefits and potential member outcomes, d. Drug Facts and Comparisons, e. American Hospital Formulary Service Drug Information, f. United States Pharmacopeia – Drug Information, g. DRUGDEX Information System, h. UpToDate, i. MicroMedex, j. Peer-reviewed medical literature, including randomized clinical trials, outcomes, research data and pharmacoeconomic studies, and k. Other drug reference resources

D. Long- Acting Injectable Antipsychotics

a. Invega Sustenna

1. Patient has a diagnosis of or schizoaffective disorder

-AND-

2. One of the following: a. Both of the following: • Patient is non-adherent with oral Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc.

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dosage forms • Patient has established tolerability with oral paliperidone or oral risperidone

-OR-

b. Patient is unable to take oral solid alternatives

-AND-

3. If the patient is < 18 years of age, the prescriber attests they are aware of FDA labeling regarding use of long acting injectable antipsychotic products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary. (Document rationale for use) b. Risperdal Consta

1. Patient has one of the following diagnoses: • Schizophrenia or schizoaffective disorder •

-AND-

2. One of the following: a. Both of the following: • Patient is non-adherent with oral atypical antipsychotic dosage forms • Patient has established tolerability with oral risperidone

-OR-

b. Patient is unable to take oral solid alternatives

-AND-

3. If the patient is < 18 years of age, the prescriber attests they are aware of FDA labeling regarding use of long acting injectable antipsychotic products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary. (Document rationale for use) c. Abilify Maintena

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1. Patient has one of the following diagnoses: • Schizophrenia or schizoaffective disorder • Bipolar disorder

-AND-

2. One of the following: a. Both of the following: • Patient is non-adherent with oral atypical antipsychotic dosage forms • Patient has established tolerability with oral aripriprazole

-OR-

b. Patient is unable to take oral solid alternatives

-AND-

3. If the patient is < 18 years of age, the prescriber attests they are aware of FDA labeling regarding use of long acting injectable antipsychotic products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary. (Document rationale for use) d. Invega Trinza

1. Patient has a diagnosis of schizophrenia or schizoaffective disorder

-AND-

2. Patient has been treated with Invega Sustenna for at least 4 months.

-AND-

3. If the patient is < 18 years of age, the prescriber attests they are aware of FDA labeling regarding use of long acting injectable antipsychotic products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary. (Document rationale for use) e. Aristada

1. Patient has a diagnosis of schizophrenia or schizoaffective disorder

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2. One of the following: a. Both of the following: • Patient is non-adherent with oral atypical antipsychotic dosage forms • Patient has established tolerability with oral aripriprazole

-OR-

b. Patient is unable to take oral solid alternatives

-AND-

3. If the patient is < 18 years of age, the prescriber attests they are aware of FDA labeling regarding use of long acting injectable antipsychotic products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary. (Document rationale for use)

f. Perseris

1. Patient has a diagnosis of schizophrenia or schizoaffective disorder

-AND-

2. One of the following: a. Both of the following: • Patient is non-adherent with oral atypical antipsychotic dosage forms • Patient has established tolerability with oral risperidone

-OR-

b. Patient is unable to take oral solid alternatives -AND- 3. If the patient is < 18 years of age, the prescriber attests they are aware of FDA labeling regarding use of long acting injectable antipsychotic products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary. (Document rationale for use)

Initial Authorization will be issued for 6 months; reauthorization will be issued for 12 months.

E. Concomitant Antipsychotic Treatment Beyond 60 Day Cross Taper Window Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc.

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1. Refractory Schizophrenic Spectrum Disorder

All of the following:

a. Documentation of adequate trials of at least three (3) individual antipsychotics listed on the AHCCCS behavioral health drug lists, for 4-6 weeks at maximum tolerated doses and failure due to one of the following:

1. Inadequate response to maximum tolerated doses 2. Adverse reactions 3. Break through symptoms

-AND-

b. Submission of medical records supporting documentation that adherence to the treatment regimen has not been a contributing factor to the lack of response in the medication trials

-AND-

c. The member does not have a known hypersensitivity to the requested medication(s).

Authorization will be issued for 12 months

2. Refractory bipolar disorder with psychosis and/or severe symptoms

All of the following:

a. Documentation of at least four (4) evidence based treatment options dependent upon the episode type. Trials should be 4-6 weeks of maximum tolerated doses, with failure due to one of the following: 1. Inadequate response to maximum tolerated doses 2. Adverse reactions 3. Break through symptoms

-AND-

b. Submission of medical records supporting documentation that adherence to the treatment regimen has not been a contributing factor to the lack of response in the medication trials

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-AND-

c. The member does not have a known hypersensitivity to the requested medication(s).

Authorization will be issued for 12 months

F. Non-Preferred Criteria 1. A requested for a non-preferred medication will be approved based on one of the following criteria

a. All of the following:

1. One of the following:

(a) Patient has a history of failure, contraindication or intolerance to at least three preferred alternatives. Prior trials of formulary/PDL alternatives must sufficiently demonstrate that the formulary/PDL alternatives are either ineffective or inappropriate at the time of the request NOTE: In instances where there are fewer than three preferred alternatives, the patient must have a history of failure, contraindication, or intolerance to all of the preferred products.

-OR-

(b) There are no preferred formulary alternatives for the requested drug.

-AND- 2. If the request is for a multi-source brand medication, one of the following: • The multi-source brand is being requested because of an adverse reaction, allergy or sensitivity to a generic equivalent • The multi-source brand is being requested due to a therapeutic failure with the generic equivalent • The multi-source brand is being requested because transition to a generic equivalent could result in destabilization of the patient • Special clinical circumstances exist that preclude the use of a generic version of the multi-source brand medication for the patient

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3. One of the following:

(a) The requested drug must be used for an FDA-approved indication

-OR-

(b) The use of this drug is supported by information from the appropriate compendia of current literature.*

-AND-

4. The drug is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in the compendia of current literature.*

-AND-

5. The drug is being prescribed for a medically accepted indication that is recognized as a covered benefit by the applicable health plans’ program.

-OR-

b. The requested medication is a behavioral health medication and one of the following:

1. The patient has been receiving treatment with the requested non- preferred behavioral health medication and is new to the plan (enrollment effective date within the past 90 days)

-OR-

2. The patient is currently receiving treatment with the requested non- preferred behavioral health medication in the hospital and must continue upon discharge

Authorization will be issued for 12 months.

*Compendia of current literature: a. Food and Drug Administration (FDA) approved indications and limits, b. Published practice guidelines and treatment protocols, c. Comparative data evaluating the efficacy, type and frequency of side effects and potential drug interactions among alternative products as well as the risks, benefits Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc.

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and potential member outcomes, d. Drug Facts and Comparisons, e. American Hospital Formulary Service Drug Information, f. United States Pharmacopeia – Drug Information, g. DRUGDEX Information System, h. UpToDate, i. MicroMedex, j. Peer-reviewed medical literature, including randomized clinical trials, outcomes, research data and pharmacoeconomic studies, and k. Other drug reference resources

G. Abilify MyCite

1. Initial Authorization

a. Abilify MyCite will be approved based on one of the following criteria: 1. All of the following: i. Patient has one of the following: • Schizophrenia or schizoaffective disorder • Bipolar disorder • Autism • Major depressive disorder • Tourette’s

-AND-

ii. Submission of medical records documenting the patient is currently prescribed aripiprazole and tolerates the medication.

-AND-

iii. Submission of medical records documenting the patient’s adherence to aripiprazole is less than 80% within the past 6 months (medication adherence percentage is defined as the number of pills absent in a given time period divided by the number of pills prescribed during that same time, multiplied by 100).

-AND-

iv. All of the following strategies (if applicable to the patient) to improve patient adherence have been tried without success:

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• Utilization of a pill box. • Utilization of a smart phone reminder (ex. alarm, application, or text reminder). • Involving family members or friends to assist. • Coordinating timing of dose to coincide with dosing of another daily medication.

-AND-

v. Submission of medical records documenting patient has experienced life-threatening or potentially life-threatening symptoms, or has experienced a severe worsening of symptoms leading to a hospitalization which was attributed to the lack of adherence to aripiprazole.

-AND-

vi. Prescriber acknowledges that Abilify MyCite has not been shown to improve patient adherence and attests that Abilify MyCite is medically necessary for the patient to maintain compliance, avoid life-threatening worsening of symptoms, and reduce healthcare resources utilized due to lack of adherence.

-AND-

vii. Prescriber agrees to track and document adherence of Abilify MyCite through software provided by the manufacturer.

-AND- viii. The patient has a history of failure, contraindication, or intolerance or reason or special circumstance they cannot use two of the following: • Abilify Maintena • Invega Sustenna • Risperdal Consta • Aristada • Perseris -OR-

2. ONE of the following:

a. The patient has been receiving treatment with the requested non- preferred behavioral health medication and is new to the plan

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(enrollment effective date within the past 90 days)

-OR-

b. The patient is currently receiving treatment with the requested non-preferred behavioral health medication in the hospital and must continue upon discharge.

Authorization will be issued for 12 months

2. Reauthorization

a. Abilify MyCite will be approved based on all of the following criteria:

i. Documentation that patient is clinically stable on Abilify MyCite.

-AND-

ii.Submission of medical records documenting that the use of Abilify MyCite has increased adherence to 80% or more.

-AND-

iii.Prescriber attests that the patient requires the continued use of Abilify MyCite to remain adherent.

Authorization will be issued for 12 months

H. Caplyta Quantity Limit Note: Caplyta requests should be reviewed using the Non-Preferred criteria in Section F. This section is for Caplyta quantity limit requests only.

1. All of the following: a. One of the following:

i. The requested drug must be used for an FDA-approved indication

-OR-

ii. The use of this drug is supported by information from the appropriate compendia of current literature*

-AND-

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b. The drug is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in the compendia of current literature*

-AND-

c. The requested dosage cannot be achieved using the plan accepted quantity limit of a different dose or formulation.

-AND-

d. The drug is being prescribed for a medically accepted indication that is recognized as a covered benefit by the applicable health plans’ program.

-AND-

e. Physician has provided rationale for needing to exceed the quantity limit of one capsule (42mg) per day. NOTE: The treatment effect of Caplyta 84mg daily versus was NOT statistically significant in clinical trials.

Authorization will be issued for 12 months

*Compendia of Current Literature: a. Food and Drug Administration (FDA) approved indications and limits, b. Published practice guidelines and treatment protocols, c. Comparative data evaluating the efficacy, type and frequency of side effects and potential drug interactions among alternative products as well as the risks, benefits and potential member outcomes, d. Drug Facts and Comparisons, e. American Hospital Formulary Service Drug Information, f. United States Pharmacopeia – Drug Information, g. DRUGDEX Information System, h. UpToDate, i. MicroMedex, j. Peer-reviewed medical literature, including randomized clinical trials, outcomes, research data and pharmacoeconomic studies, and k. Other drug reference resources

3. Additional Clinical Rules:

• Notwithstanding Coverage Criteria, UnitedHealthcare may approve initial and re- authorization based solely on previous claim/medication history, diagnosis codes Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc.

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(ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class. • Supply limits may be in place.

4. Reference:

1. Manufacturer Product Information. 2. McClellan J, Kowatch R, Findling RL. Practice parameter for the assessment and treatment of children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2007;46:107-126. 3. Schur S, Sikich L, Findling, et al. Treatment recommendations for the use of antipsychotics for aggressive youth (TRAAY) Part I: Review. J Am Acad Child Adolesc Psychiatry. 2003;2:132-143. 4. Pappadopulos E, MacIntyre J, Crismon L, et al. Treatment recommendations for the use of antipsychotics for aggressive youth (TRAAY) Part II. J Am Acad Child Adolesc Psychiatry. 2003; 42(2): 145-161. 5. Kowatch R, DelBello M. The Use of mood stabilizers and atypical antipsychotics in children and adolescents with bipolar disorder. CNS Spectrums. 2003; 8(4): 273-280. 6. McClellan J, Werry J. Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. J Am Acad Child Adolesc Psychiatry. 2001;40(7): 4S-23S. 7. Stigler K, Posey D, MacDougle C. Drug therapy algorithms target autism’s problem behaviors. Current Psychiatry. 2003;2(4): 33-48. 8. Pliszka SR, Greenhill LL, Crismon ML et al. The Texas children's medication algorithm project: report of the Texas consensus conference panel on medication treatment of childhood attention-deficit/hyperactivity disorder. Part I. J Am Acad Child Adolesc Psychiatry. 2003;39:908-919. 9. Correll, C. Weight Gain and Metabolic Effects of Mood Stabilizers and Antipsychotics in Pediatric Bipolar Disorder: A and pooled analysis of short-term trials. J Am Acad Child Adolesc Psychiatry. 2007;466:687-700. 10. Abilify MyCite Prescribing Information. Otsuka Pharmaceutical Co. Ltd. Tokyo, Japan. November 2017. 11. Levenson, JL. (2018). Psychological factors affecting other medical conditions: Management. D. Solomon (Ed.), UpToDate. Retrieved December 15, 2018. 12. Cramer, JA et al. Medication Compliance and Persistence: Terminology and Definitions. Value in Health, January 2008; 11(1):44-47. 13. Brown, MT at al. Mediation Adherence: WHO Cares? May Clin Proc. April 2011; 86(4):304-314.

Program Prior Authorization –Atypical Antipsychotics Change Control Date Change January 2018 New Policy Specific to Arizona.

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February 2018 Replaced state mandated long acting injectable criteria with UPC criteria and added language for reviews based on medical necessity for patients <18 years of age. August 2018 Updated preferred/non-preferred products. Updated background. Updated BH provider language per state. November 2018 Added requirement about establishing oral tolerability for long- acting injectable antipsychotics where it was not already listed. December 2018 Added Abilify MyCite criteria February 2019 Clarified language for FDA min age requirement. March 2019 Added a diagnosis check to Abilify MyCite. 4/2019 Added Perseris criteria. Added Perseris as a step therapy option for Abilify Mycite. 7/2019 Updated preferred products per state mandate

1/2020 Added Secuado to policy

2/2020 Added Caplyta, including quantity limit criteria. Updated Non- preferred criteria 4/2020 Added continuation of therapy language for non-preferred products with drug specific criteria. Updated Abilify Mycite initial authorization duration.Updated compendia of current literature per state requirements.

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