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Atypical Antipsychotics Step Therapy with Quantity Limit Program Summary

Policy Number: PH-91029

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies. 

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

01-01-2025            

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Abilify Mycite®

(aripiprazole)

Tablet with sensor, strips, and pod (Starter kit)

Tablet with sensor and strips (Maintenance kit)

Treatment of:

  • Schizophrenia
  • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
  • Adjunctive Treatment of Major Depressive Disorder
  • Irritability Associated with Autistic Disorder
  • Tourette’s Disorder

34

Abilify®

(aripiprazole)*

Tablet

Oral solution

Orally disintegrating tablet

Treatment of:

  • Schizophrenia
  • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
  • Adjunctive Treatment of Major Depressive Disorder
  • Irritability Associated with Autistic Disorder
  • Tourette’s Disorder

*generic available

6

Caplyta®

(lumateperone)

Capsule

-Schizophrenia in adults

-Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

36

Clozapine ODT, Clozaril®

(clozapine)

Tablet*

Orally disintegrating tablet*^

- Treatment-resistant schizophrenia

- Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder

*generic available

^12.5mg ODT brand name only

1; 15

Cobenfy™

(xanomeline and trospium chloride)

Capsule

Treatment of schizophrenia in adults

34

Fanapt®

(iloperidone)

Tablet

Treatment of schizophrenia

10

Geodon®

(ziprasidone)

Capsule*

- Treatment of schizophrenia

- Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder

- Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate

*generic available

5

Invega ER®

(paliperidone ER)

Tablet*

- Treatment of schizophrenia

- Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants

*generic available

7

Latuda®

(lurasidone)

Tablet*

Treatment of:

  • Schizophrenia
  • Depressive Episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate

11

Lybalvi®

(olanzapine-samidorphan)

Tablet

- Schizophrenia in adults

- Bipolar I disorder in adults

  • Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
  • Maintenance monotherapy treatment

37

Rexulti®

(brexpiprazole)

Tablet

- Treatment of schizophrenia in adults and pediatric patients ages 13 years and older

- Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)

- Treatment of agitation associated with dementia due to Alzheimer’s disease

Limitation of Use: Rexulti is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease

14

Risperdal®, Risperidone ODT

(risperidone)

Tablet*

Orally disintegrating tablet*^

Oral solution*

- Treatment of schizophrenia

- As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder

- Treatment of irritability associated with autistic disorder

*generic available

^0.25mg tablet brand name only

2

Saphris®

(asenapine)

Sublingual tablet*

- Treatment of schizophrenia

- Bipolar I disorder

- Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age

- Adjunctive treatment to lithium or valproate in adults

- Maintenance monotherapy treatment in adults

*generic available

9

Secuado®

(asenapine)

Transdermal system

- Treatment of schizophrenia

 

35

Seroquel®

(quetiapine)

Tablet*

- Treatment of schizophrenia

- Bipolar I disorder manic episodes

- Bipolar disorder, depressive episodes

*generic available

4

Seroquel XR®

(quetiapine)

Tablet*

- Treatment of schizophrenia

- Bipolar I disorder, manic, or mixed episodes

- Bipolar disorder, depressive episodes

- Major depressive disorder, adjunctive therapy with antidepressants

*generic available

8

Versacloz®

(clozapine)

Oral suspension

- Treatment-resistant schizophrenia.

- Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder

13

Vraylar®

(cariprazine)

Capsule

- Treatment of schizophrenia in adults

- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults

- Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults

- Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults

15

Zyprexa®, Zyprexa® Zydis®

(olanzapine)*

Tablet

Orally disintegrating tablet

- Treatment of schizophrenia

- Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder

- Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder.

 

As ZYPREXA and fluoxetine in combination for the:

  • Treatment of depressive episodes associated with bipolar I disorder.
  • Treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode

*generic available

3

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Schizophrenia

Schizophrenia is a psychiatric disorder that involves chronic or recurrent psychosis. Antipsychotic medications are first-line treatment for schizophrenia. Antipsychotics have been shown to reduce positive symptoms of schizophrenia, such as hallucinations, delusions, and suspiciousness.  Negative symptoms of schizophrenia, such as diminished emotional expression and lack of motivation, have proven particularly difficult to treat. Clozapine is generally considered the most effective antipsychotic drug for the treatment of schizophrenia. Due to adverse effects such as agranulocytosis and seizures, it’s use is reserved for patients with  treatment-resistant disease, suicide risk, or risk of aggressive behavior despite other treatments.  Antipsychotic medications are commonly grouped into two categories, with “second-generation” or “atypical” applied to clozapine and all antipsychotics first marketed after clozapine was approved in 1989, and “first-generation” applied to all antipsychotics marketed previously. Atypical antipsychotics tend to cause fewer extrapyramidal side effects than first generation antipsychotics. Elderly patients, in particular, are at increased risk of chronic confusion and disorientation during treatment with first generation antipsychotic drugs.(16,17)

Bipolar Disorder

Bipolar disorder is a mood disorder that is characterized by episodes of mania, hypomania, and major depression. Initiation of maintenance therapy is recommended to prevent relapse, minimize suicide attempts, and maybe associated with reduced rates of violent behavior. First line maintenance therapy is recommended, if possible, to consist of the same regimen that successfully treated the acute bipolar mood episode. Lithium, quetiapine, divalproex, and lamotrigine monotherapy are considered first-line treatments.  Second line therapy is reserved for those who do not tolerate first-line maintenance pharmacotherapy. Olanzapine, risperidone, carbamazepine, paliperidone, ziprasidone, and lurasidone are all considered second-line therapies.(18,19)

Major Depressive Disorder

Major depressive disorder (MDD), also known as unipolar major depression, is diagnosed when a patient has suffered at least one major depressive episode and have no history of mania or hypomania. Goal of initial treatment for depression is symptom remission and restoring baseline functioning.  Selective serotonin reuptake inhibitors (SSRIs) along with serotonin norepinephrine reuptake inhibitors (SNRIs), bupropion, and mirtazapine are considered first line treatment options for adults with major depressive disorder (MDD). Guidelines do not consider antipsychotics as a first line treatment of major depressive disorder without psychosis. However, they suggest that psychotic depression typically responds better to the combination of an antipsychotic and an antidepressant medication rather than either component alone, although some research has shown comparable responses for anti-depressive treatment or antipsychotic treatment alone.(20,21)

Autism

Practice Parameters-American Academy of Child and Adolescent Psychiatry (AACAP, 2014) suggest pharmacotherapy may be offered when there is a specific target symptom or comorbid condition, potentially increasing patient ability to profit from educational and other interventions, and allow less restrictive environments through management of severe and challenging behaviors. Frequent targets for pharmacologic intervention include associated comorbid conditions (e.g., anxiety, depression) and other features (e.g., aggression, self-injurious behavior, hyperactivity, inattention, compulsive-like behaviors, repetitive or stereotypic behaviors, and sleep disturbances). Various considerations (e.g., adverse effects) should inform pharmacologic treatment. Risperidone and aripiprazole have been FDA approved for the treatment of irritability (e.g., physical aggression, severe tantrum behavior) associated with autism. There is a growing body of controlled evidence for pharmacologic intervention. The guideline provides a summary chart of medications supported by RCTs for use in children with autism spectrum disorder (ASD), including target symptoms, ages, dosing, potential adverse effects, and outcomes.

  • Antipsychotics supported by RCTs showing positive effects on various target symptoms in ASD include aripiprazole, haloperidol, olanzapine, and risperidone.
  • Combining medication with parent training is moderately more efficacious than medication alone for decreasing serious behavioral disturbance and modestly more efficacious for adaptive functioning. Individuals with ASD may be nonverbal, so treatment response is often judged by caregiver report and observation of specific behaviors. Although this may help document the effectiveness of the selected medication, an overall goal of treatment is to facilitate the child’s adjustment and engagement with educational intervention.

Despite many randomized trials, confidence in reported improvements remains low for most interventions.  Risperidone and aripiprazole improved challenging behavior in the short term (less than 6 months) but also significant harms including weight gain, appetite changes, and EPS.(22,23)

Dementia-Related Psychosis (off-label use)

The American Psychiatric Association (APA) recommends that nonpharmacologic interventions be attempted before a trial of antipsychotic drug therapy and that the interventions attempted be guided by the patient’s level of distress and the risk to the patients and caregiver. In addition, the FDA states that physicians who prescribe antipsychotics to elderly patients with dementia-related psychosis should discuss the risk of increased mortality with their patients, patients’ families, and caregivers. Evidence indicates that antipsychotics provide weak benefits for the treatment of psychosis and agitation in patients with dementia. Adverse effects of antipsychotics include sedation, metabolic effects, and cognitive impairment. For many patients with Alzheimer’s disease, antipsychotics can be tapered and discontinued without significant signs of withdrawal or return of behavioral symptoms.

Antipsychotic drug therapy generally is reserved for patients who have severe symptoms or when associated agitation, combativeness, or violent behavior puts the patient or others in danger. Current evidence indicates that the atypical antipsychotics can provide modest improvement in behavioral manifestations; some evidence suggests that efficacy may be better for psychosis than for other manifestations. Antipsychotic efficacy appears to be similar among available agents and therefore the choice of agent should be based on adverse effect profile and other patient considerations; to minimize adverse effects, the lowest possible effective dose should be used.(24,25)

Tourette's Disorder

Tourette's disorder is a neuropsychiatric disorder characterized by involuntary motor and vocal tics. Although the etiology of Tourette's disorder is unknown, evidence suggests that pathophysiology of  this disorder involves an abnormality in the central dopaminergic system. Currently, the medications that are FDA approved for the treatment of Tourette’s disorder are aripiprazole, haloperidol, and pimozide although most clinicians use atypical antipsychotics prior to the two approved agents.  Clonidine and guanfacine are considered first line agents due to their low side effect profile. However, the level of evidence for their effectiveness is less than antipsychotics and they lack an FDA approval. Atypical neuroleptics (aripiprazole or risperidone) are typically used if the alpha-2 agonists are ineffective or intolerable.

According to the American Academy of Neurology guidelines, there was moderate confidence that haloperidol, risperidone, aripiprazole, tiapride, clonidine, onabotulinumtoxin A injections were probably more likely than placebo to reduce tics. There was low confidence that pimozide, ziprasidone, metoclopramide, guanfacine, topiramate, and tetrahydrocannabinol were possibly more likely than placebo to reduce tics. There is high confidence that the patients need to be counseled and monitored for adverse events such as weight gain, drug-induced movement disorders, elevated prolactin levels, sedation, and effects on the heart rate, blood pressure, and ECGs. The class of medicine is selected based on the severity of the tics and the side effect profile of the medicine based on other comorbidities such as depression, anxiety, and sleep disturbance. The American Academy of Child & Adolescent Psychiatry states that atypical antipsychotics are effective in Tourette’s Disorder (TD). At the time the guidelines were published, no atypical antipsychotics were FDA approved, and only haloperidol and pimozide had been approved for TD. The guidelines found that risperidone is the most well studied non-FDA labeled atypical antipsychotic for the treatment of TD. Risperidone was found to be at least as effective as clonidine, haloperidol, and pimozide; with less frequent and severe side effects. The most common adverse reaction with risperidone therapy was mild to moderate sedation. No clinically significant extrapyramidal symptoms were observed.(26-29)

Safety

The atypical antipsychotic agents carry a boxed warning for increased mortality in elderly patients with dementia-related psychosis. The warning states that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. These agents are not approved for the treatment of patients with dementia-related psychosis.(1-15,30-33) 

Abilify, Caplyta, Latuda, Rexulti, Risperdal, and Seroquel/Seroquel XR have an additional boxed warning for an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for worsening and emergence of suicidal thoughts and behaviors.(2,4,6,8,11,14,30,32)

All clozapine agents including Versacloz, have the following boxed warnings:(1,12,13)

  • Severe Neutropenia: Clozaril can cause severe neutropenia, which can lead to serious and fatal infections. Patients initiating and continuing treatment with Clozaril must have a baseline blood absolute neutrophil count (ANC) measured before treatment initiation and regular ANC monitoring during treatment.
  • Clozaril is available only through a restricted program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS).
  • Orthostatic Hypotension, Bradycardia, and Syncope: Risk is dose related. Starting dose is 12.5 mg. Titrate gradually and use divided dosages.
  • Seizure: Risk is dose related. Titrate gradually and use divided doses. Use with caution in patients with history of seizure or risk factors for seizure.
  • Myocarditis, Cardiomyopathy and Mitral Valve Incompetence: Can be fatal. Discontinue and obtain cardiac evaluation if findings suggest these cardiac reactions.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Clozaril is not approved for this condition. 

REFERENCES                                                                                                                                                                           

Number

Reference

1

Clozaril tablets prescribing information. Novartis Pharmaceuticals Co. May 2023.

2

Risperdal prescribing information. Janssen Pharmaceuticals, Inc. December 2022.

3

Zyprexa and Zyprexa Zydis prescribing information. Eli Lilly and Company. April 2021.

4

Seroquel prescribing information. AstraZeneca Pharmaceuticals LP. January 2022.

5

Geodon prescribing information. Roerig – Pfizer Inc. February 2022.

6

Abilify prescribing information. Otsuka America Pharmaceutical, Inc. November 2022.

7

Invega prescribing information. Janssen, Pharmaceuticals, Inc. March 2022.

8

Seroquel XR prescribing information. AstraZeneca Pharmaceuticals LP. January 2022.

9

Saphris prescribing information. Allergan USA, Inc. February 2017.

10

Fanapt prescribing information. Vanda Pharmaceuticals Inc. February 2017.

11

Latuda prescribing information. Sunovion Pharmaceuticals Inc. December 2019.

12

Clozapine ODT prescribing information. Teva Pharmaceuticals USA, Inc. April 2023.

13

Versacloz prescribing information. TruPharma, LLC. March 2023.

14

Rexulti prescribing information. Otsuka Pharmaceutical Co., Ltd. May 2023.

15

Vraylar prescribing information. Allergan USA, Inc. December 2022.

16

Patel KR, Cherian J, Gohil K, Atkinson D. Schizophrenia: overview and treatment options. P T. 2014;39(9):638-645.

17

Keepers, George A. MD., et al. Treatment of Patients with Schizophrenia. American Psychiatric Association. Third edition. September 2020. Accessed at: https://psychiatryonline.org/doi/pdf/10.1176/appi.books.9780890424841.

18

Hirschfield, Robert M. Guideline Watch: Practice Guideline for the Treatment of Patients with Bipolar Disorder. American Psychiatric Association. Second edition. November 2005. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bipolar-watch.pdf. 

19

Yatham, LN, Kennedy SH et. Al.  Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.  Bipolar Disorders.  2018; 20:97-170.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947163/pdf/BDI-20-97.pdf.

20

Simon, Gregory, MD, MPH, et al. Unipolar Major Depression in Adults: Choosing Initial Treatment. UpToDate. Last updated November 2017.

21

Glenberg, Alan MD., et al. Practice guideline for the treatment of patients with Major Depressive Disorder. American Psychiatric Association. Third edition. October 2010. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf.

22

Volkmar F, Siegel M, Woodbury-Smith M, et al. Practice parameter for the assessment and treatment of children and adolescents with autism spectrum disorder. J Am Acad Child Adolesc Psych. 2014;53(2):237–257.

23

AHRQ Draft Report: Therapies for Children with Autism Spectrum Disorder. May 2020. Available at: https://effectivehealthcare.ahrq.gov/products/autism-update/consumer.

24

Rabins, Peter, MD, MPH, et al. Practice Guideline for the Treatment of Patients with Alzheimer’s Disease and Other Dementias. Second Edition. American Psychiatric Association. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/alzheimers.pdf.

25

Reus, Victor, MD, et al. Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients with Dementia. First Edition. May 2016. American Psychiatric Association. Available at: https://psychiatryonline.org/doi/book/10.1176/appi.books.9780890426807. 

26

Serajee F, Huq A. Advances in Tourette syndrome: diagnoses and treatment. Pediatr Clin N Am 2015;62:687–701. 

27

Murphy T. K., et. al. Practice parameters for the assessment and treatment of children and adolescents with tic disorders.  Journal of the American Academy of Child & Adolescent Psychiatry. Dec 2013; Vol 52, #12: 1341-1359.  

28

Pringsheim, Tamara, MD., et al. Practice Guideline Recommendations Summary: Treatment of Tics in People with Tourettes Syndrome and Chronic Tic Disorders. May 2019. Available at:https://n.neurology.org/content/92/19/896. 

29

Padala, P.R., Oadri, S.F., & Madaan, V. (2005). Aripiprazole for the Treatment of Tourette’s Disorder. Primary Care Companion to the Journal of Clinical Psychiatry, 7(6), 296–299. https://doi.org/10.4088/pcc.v07n0605.  

30

Abilify Mycite prescribing information. Otsuka America Pharmaceutical, Inc. November 2022.

31

Secuado prescribing information. Hisamitsu Pharmaceutical Co, Inc. December 2023.

32

Caplyta prescribing information. Intra-Cellular Therapies, Inc. June 2023.

33

Lybalvi prescribing information. Alkermes, Inc. September 2023.

34

Cobenfy prescribing information. Bristol-Myers Squibb. September 2024.

POLICY AGENT SUMMARY STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

risperidone orally disintegrating tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

M ; N ; O

N ; Y

Abilify

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

M ; N ; O

O ; Y

Abilify mycite maintenanc ; Abilify mycite starter ki

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

M ; N ; O

N

Caplyta

lumateperone tosylate cap

10.5 MG ; 21 MG ; 42 MG

M ; N ; O

N

Clozaril ; Versacloz

clozapine orally disintegrating tab  ; clozapine susp  ; clozapine tab

100 MG ; 12.5 MG ; 150 MG ; 200 MG ; 25 MG ; 50 MG ; 50 MG/ML

M ; N ; O

N ; O ; Y

Cobenfy ; Cobenfy starter pack

xanomeline tartrate-trospium chloride cap  ; xanomeline-trospium chloride cap pack

100-20 MG ; 125-30 MG ; 50-20 & 100-20 MG ; 50-20 MG

M ; N ; O

N

Fanapt ; Fanapt titration pack

iloperidone tab

1 & 2 & 4 & 6 MG ; 1 MG ; 10 MG ; 12 MG ; 2 MG ; 4 MG ; 6 MG ; 8 MG

M ; N ; O

N

Geodon

ziprasidone hcl cap

20 MG ; 40 MG ; 60 MG ; 80 MG

M ; N ; O

O ; Y

Invega

paliperidone tab er

1.5 MG ; 3 MG ; 6 MG ; 9 MG

M ; N ; O

O ; Y

Latuda

lurasidone hcl tab

120 MG ; 20 MG ; 40 MG ; 60 MG ; 80 MG

M ; N ; O

O ; Y

Lybalvi

olanzapine-samidorphan l-malate tab

10-10 MG ; 15-10 MG ; 20-10 MG ; 5-10 MG

M ; N ; O

N

Risperdal

risperidone soln

1 MG/ML

M ; N ; O

O ; Y

Risperdal

risperidone tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

M ; N ; O

O ; Y

Saphris ; Secuado

asenapine maleate sl tab  ; asenapine td patch

10 MG ; 2.5 MG ; 3.8 MG/24HR ; 5 MG ; 5.7 MG/24HR ; 7.6 MG/24HR

M ; N ; O

N ; O ; Y

Seroquel

quetiapine fumarate tab

100 MG ; 150 MG ; 200 MG ; 25 MG ; 300 MG ; 400 MG ; 50 MG

M ; N ; O

N ; O ; Y

Seroquel ; Seroquel xr

quetiapine fumarate tab  ; quetiapine fumarate tab er

100 MG ; 150  ; 150 MG ; 200 MG ; 25 MG ; 300 MG ; 400 MG ; 50 MG

M ; N ; O

N ; O ; Y

Seroquel xr

quetiapine fumarate tab er

150  ; 150 MG ; 200 MG ; 300 MG ; 400 MG ; 50 MG

M ; N ; O

O ; Y

Zyprexa

olanzapine tab

10 MG ; 15 MG ; 2.5 MG ; 20 MG ; 5 MG ; 7.5 MG

M ; N ; O

O ; Y

Zyprexa zydis

olanzapine orally disintegrating tab

10 MG ; 15 MG ; 20 MG ; 5 MG

M ; N ; O

O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Aripiprazole Oral Solution 1 MG/ML

1 MG/ML

900

mLs

30

DAYS

aripiprazole orally disintegrating tab

10 MG ; 15 MG

60

Tablets

30

DAYS

Clozapine Orally Disintegrating Tab 150 MG

150 MG

180

Tablets

30

DAYS

Clozapine Orally Disintegrating Tab 200 MG

200 MG

120

Tablets

30

DAYS

Clozapine Orally Disintegrating Tab 25 MG

25 MG

270

Tablets

30

DAYS

Quetiapine Fumarate Tab

150 MG

30

Tablets

30

DAYS

risperidone orally disintegrating tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

60

Tablets

30

DAYS

Risperidone Orally Disintegrating Tab 4 MG

4 MG

120

Tablets

30

DAYS

Abilify

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

30

Tablets

30

DAYS

Abilify mycite maintenanc ; Abilify mycite starter ki

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

30

Tablets

30

DAYS

Caplyta

lumateperone tosylate cap

10.5 MG ; 21 MG ; 42 MG

30

Capsules

30

DAYS

Clozaril

Clozapine Tab 100 MG

100 MG

270

Tablets

30

DAYS

Clozaril

Clozapine Tab 200 MG

200 MG

120

Tablets

30

DAYS

Clozaril ; Versacloz

clozapine orally disintegrating tab  ; clozapine susp  ; clozapine tab

100 MG ; 12.5 MG ; 150 MG ; 200 MG ; 25 MG ; 50 MG ; 50 MG/ML

90

Tablets

30

DAYS

Cobenfy

xanomeline tartrate-trospium chloride cap

50-20 MG

60

Capsules

30

DAYS

Cobenfy

xanomeline tartrate-trospium chloride cap

100-20 MG

60

Capsules

30

DAYS

Cobenfy

xanomeline tartrate-trospium chloride cap

125-30 MG

60

Capsules

30

DAYS

Cobenfy starter pack

xanomeline-trospium chloride cap pack

50-20 & 100-20 MG

56

Capsules

180

DAYS

Fanapt

iloperidone tab

1 MG ; 10 MG ; 12 MG ; 2 MG ; 4 MG ; 6 MG ; 8 MG

60

Tablets

30

DAYS

Fanapt titration pack

Iloperidone Tab 1 MG & 2 MG & 4 MG & 6 MG Titration Pak

1 & 2 & 4 & 6 MG

1

Pack

180

DAYS

Geodon

ziprasidone hcl cap

20 MG ; 40 MG ; 60 MG ; 80 MG

60

Capsules

30

DAYS

Invega

Paliperidone Tab ER 24HR 6 MG

6 MG

60

Tablets

30

DAYS

Invega ; Invega hafyera ; Invega sustenna ; Invega trinza

paliperidone palmitate er susp pref syr  ; paliperidone tab er

1.5 MG ; 1092 MG/3.5ML ; 117 MG/0.75ML ; 156 MG/ML ; 1560 MG/5ML ; 234 MG/1.5ML ; 273 MG/0.88ML ; 3 MG ; 39 MG/0.25ML ; 410 MG/1.32ML ; 546 MG/1.75ML ; 6 MG ; 78 MG/0.5ML ; 819 MG/2.63ML ; 9 MG

30

Tablets

30

DAYS

Latuda

lurasidone hcl tab

120 MG ; 20 MG ; 40 MG ; 60 MG ; 80 MG

30

Tablets

30

DAYS

Latuda

Lurasidone HCl Tab 80 MG

80 MG

60

Tablets

30

DAYS

Lybalvi

olanzapine-samidorphan l-malate tab

10-10 MG ; 15-10 MG ; 20-10 MG ; 5-10 MG

30

Tablets

30

DAYS

Rexulti

brexpiprazole tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

30

Tablets

30

DAYS

Rexulti

brexpiprazole tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

30

Tablets

30

DAYS

Risperdal

Risperidone Soln 1 MG/ML

1 MG/ML

480

mLs

30

DAYS

Risperdal

Risperidone Tab 4 MG

4 MG

120

Tablets

30

DAYS

Saphris ; Secuado

asenapine maleate sl tab  ; asenapine td patch

10 MG ; 2.5 MG ; 3.8 MG/24HR ; 5 MG ; 5.7 MG/24HR ; 7.6 MG/24HR

60

Tablets

30

DAYS

Secuado

asenapine td patch

3.8 MG/24HR ; 5.7 MG/24HR ; 7.6 MG/24HR

30

Patches

3

DAYS

Seroquel

quetiapine fumarate tab

100 MG ; 150 MG ; 200 MG ; 25 MG ; 300 MG ; 400 MG ; 50 MG

90

Tablets

30

DAYS

Seroquel

Quetiapine Fumarate Tab 300 MG

300 MG

60

Tablets

30

DAYS

Seroquel

Quetiapine Fumarate Tab 400 MG

400 MG

60

Tablets

30

DAYS

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 150 MG

150  ; 150 MG

30

Tablets

30

DAYS

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 200 MG

200 MG

30

Tablets

30

DAYS

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 300 MG

300 MG

60

Tablets

30

DAYS

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 400 MG

400 MG

60

Tablets

30

DAYS

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 50 MG

50 MG

60

Tablets

30

DAYS

Versacloz

Clozapine Susp 50 MG/ML

50 MG/ML

540

mLs

30

DAYS

Vraylar

cariprazine hcl cap  ; cariprazine hcl cap therapy pack

1.5 & 3 MG ; 1.5 MG ; 3 MG ; 4.5 MG ; 6 MG

30

Capsules

30

DAYS

Vraylar

Cariprazine HCl Cap Therapy Pack 1.5 MG (1) & 3 MG (6)

1.5 & 3 MG

7

Capsules

180

DAYS

Zyprexa

olanzapine tab

10 MG ; 15 MG ; 2.5 MG ; 20 MG ; 5 MG ; 7.5 MG

30

Tablets

30

DAYS

Zyprexa zydis

olanzapine orally disintegrating tab

10 MG ; 15 MG ; 20 MG ; 5 MG

30

Tablets

30

DAYS

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

risperidone orally disintegrating tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Abilify

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Abilify mycite maintenanc ; Abilify mycite starter ki

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Caplyta

lumateperone tosylate cap

10.5 MG ; 21 MG ; 42 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Clozaril ; Versacloz

clozapine orally disintegrating tab  ; clozapine susp  ; clozapine tab

100 MG ; 12.5 MG ; 150 MG ; 200 MG ; 25 MG ; 50 MG ; 50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cobenfy ; Cobenfy starter pack

xanomeline tartrate-trospium chloride cap  ; xanomeline-trospium chloride cap pack

100-20 MG ; 125-30 MG ; 50-20 & 100-20 MG ; 50-20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Fanapt ; Fanapt titration pack

iloperidone tab

1 & 2 & 4 & 6 MG ; 1 MG ; 10 MG ; 12 MG ; 2 MG ; 4 MG ; 6 MG ; 8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Geodon

ziprasidone hcl cap

20 MG ; 40 MG ; 60 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Invega

paliperidone tab er

1.5 MG ; 3 MG ; 6 MG ; 9 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Latuda

lurasidone hcl tab

120 MG ; 20 MG ; 40 MG ; 60 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lybalvi

olanzapine-samidorphan l-malate tab

10-10 MG ; 15-10 MG ; 20-10 MG ; 5-10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Risperdal

risperidone soln

1 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Risperdal

risperidone tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Saphris ; Secuado

asenapine maleate sl tab  ; asenapine td patch

10 MG ; 2.5 MG ; 3.8 MG/24HR ; 5 MG ; 5.7 MG/24HR ; 7.6 MG/24HR

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel

quetiapine fumarate tab

100 MG ; 150 MG ; 200 MG ; 25 MG ; 300 MG ; 400 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel ; Seroquel xr

quetiapine fumarate tab  ; quetiapine fumarate tab er

100 MG ; 150  ; 150 MG ; 200 MG ; 25 MG ; 300 MG ; 400 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel xr

quetiapine fumarate tab er

150  ; 150 MG ; 200 MG ; 300 MG ; 400 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Zyprexa

olanzapine tab

10 MG ; 15 MG ; 2.5 MG ; 20 MG ; 5 MG ; 7.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Zyprexa zydis

olanzapine orally disintegrating tab

10 MG ; 15 MG ; 20 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Aripiprazole Oral Solution 1 MG/ML

1 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

aripiprazole orally disintegrating tab

10 MG ; 15 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Clozapine Orally Disintegrating Tab 150 MG

150 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Clozapine Orally Disintegrating Tab 200 MG

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Clozapine Orally Disintegrating Tab 25 MG

25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Quetiapine Fumarate Tab

150 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

risperidone orally disintegrating tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Risperidone Orally Disintegrating Tab 4 MG

4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Abilify

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Abilify mycite maintenanc ; Abilify mycite starter ki

aripiprazole tab

10 MG ; 15 MG ; 2 MG ; 20 MG ; 30 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Caplyta

lumateperone tosylate cap

10.5 MG ; 21 MG ; 42 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Clozaril

Clozapine Tab 100 MG

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Clozaril

Clozapine Tab 200 MG

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Clozaril ; Versacloz

clozapine orally disintegrating tab  ; clozapine susp  ; clozapine tab

100 MG ; 12.5 MG ; 150 MG ; 200 MG ; 25 MG ; 50 MG ; 50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cobenfy

xanomeline tartrate-trospium chloride cap

125-30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cobenfy

xanomeline tartrate-trospium chloride cap

100-20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cobenfy

xanomeline tartrate-trospium chloride cap

50-20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cobenfy starter pack

xanomeline-trospium chloride cap pack

50-20 & 100-20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Fanapt

iloperidone tab

1 MG ; 10 MG ; 12 MG ; 2 MG ; 4 MG ; 6 MG ; 8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Fanapt titration pack

Iloperidone Tab 1 MG & 2 MG & 4 MG & 6 MG Titration Pak

1 & 2 & 4 & 6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Geodon

ziprasidone hcl cap

20 MG ; 40 MG ; 60 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Invega

Paliperidone Tab ER 24HR 6 MG

6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Invega ; Invega hafyera ; Invega sustenna ; Invega trinza

paliperidone palmitate er susp pref syr  ; paliperidone tab er

1.5 MG ; 1092 MG/3.5ML ; 117 MG/0.75ML ; 156 MG/ML ; 1560 MG/5ML ; 234 MG/1.5ML ; 273 MG/0.88ML ; 3 MG ; 39 MG/0.25ML ; 410 MG/1.32ML ; 546 MG/1.75ML ; 6 MG ; 78 MG/0.5ML ; 819 MG/2.63ML ; 9 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Latuda

lurasidone hcl tab

120 MG ; 20 MG ; 40 MG ; 60 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Latuda

Lurasidone HCl Tab 80 MG

80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lybalvi

olanzapine-samidorphan l-malate tab

10-10 MG ; 15-10 MG ; 20-10 MG ; 5-10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rexulti

brexpiprazole tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rexulti

brexpiprazole tab

0.25 MG ; 0.5 MG ; 1 MG ; 2 MG ; 3 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Risperdal

Risperidone Soln 1 MG/ML

1 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Risperdal

Risperidone Tab 4 MG

4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Saphris ; Secuado

asenapine maleate sl tab  ; asenapine td patch

10 MG ; 2.5 MG ; 3.8 MG/24HR ; 5 MG ; 5.7 MG/24HR ; 7.6 MG/24HR

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Secuado

asenapine td patch

3.8 MG/24HR ; 5.7 MG/24HR ; 7.6 MG/24HR

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel

quetiapine fumarate tab

100 MG ; 150 MG ; 200 MG ; 25 MG ; 300 MG ; 400 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel

Quetiapine Fumarate Tab 300 MG

300 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel

Quetiapine Fumarate Tab 400 MG

400 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 150 MG

150  ; 150 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 200 MG

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 300 MG

300 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 400 MG

400 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Seroquel xr

Quetiapine Fumarate Tab ER 24HR 50 MG

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Versacloz

Clozapine Susp 50 MG/ML

50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vraylar

cariprazine hcl cap  ; cariprazine hcl cap therapy pack

1.5 & 3 MG ; 1.5 MG ; 3 MG ; 4.5 MG ; 6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vraylar

Cariprazine HCl Cap Therapy Pack 1.5 MG (1) & 3 MG (6)

1.5 & 3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Zyprexa

olanzapine tab

10 MG ; 15 MG ; 2.5 MG ; 20 MG ; 5 MG ; 7.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Zyprexa zydis

olanzapine orally disintegrating tab

10 MG ; 15 MG ; 20 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Applicable Formulary

Target Agent(s)

Prerequisite Agents

Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace

Abilify (aripiprazole)*

Any generic atypical antipsychotic

Any generic antidepressant (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone)

haloperidol or pimozide

Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace

Abilify Mycite (aripiprazole)
Seroquel XR (quetiapine)*

Any generic atypical antipsychotic

Any generic antidepressant (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone)

Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace

Zyprexa (olanzapine)*
Zyprexa Zydis (olanzapine)*

Any generic atypical antipsychotic

generic fluoxetine

Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace

Clozapine ODT
Clozaril (clozapine)*
Cobenfy (xanomeline and trospium chloride)
Fanapt (iloperidone)
Geodon (ziprasidone)*
Invega (paliperidone)*
Latuda (lurasidone)*
Risperdal (risperidone)*
Risperidone ODT^/risperidone ODT
Saphris (asenapine)*
Secuado (asenapine)
Seroquel (quetiapine)*
Versacloz (clozapine)

Any generic atypical antipsychotic

Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace

Caplyta (lumateperone)
Lybalvi (olanzapine/samidorphan)

Any generic atypical antipsychotic

*-generic available

^-branded generic product

Target Agent(s) will be approved when ONE of the following is met:

  1. The request is for Abilify AND ONE of the following:
    1. The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to ONE generic antidepressant agent (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone), generic haloperidol or pimozide OR
    2. The patient has an FDA labeled contraindication to ALL generic antidepressant agents (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone), haloperidol and pimozide OR
  2. The request is for Abilify Mycite, Rexulti, Seroquel XR, or Vraylar AND ONE of the following:
    1. The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to ONE generic antidepressant agent (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR
    2. The patient has an FDA labeled contraindication to ALL generic antidepressants (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR
  3. The request is for Zyprexa or Zyprexa Zydis AND ONE of the following:
    1. The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to ONE generic fluoxetine OR
    2. The patient has an FDA labeled contraindication to ALL generic fluoxetine OR
  4. The patient has been treated with the requested agent within the past 180 days OR
  5. The prescriber states the patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed OR
  6. The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to ONE generic atypical antipsychotic OR
  7. The patient has an FDA labeled contraindication to ALL generic atypical antipsychotics

Length of Approval: For dementia-related psychosis: 3 months for initial approval; 6 months for renewals

                                For all other indications: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

 

 

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

 

Commercial _ PS _ Atypical_Antipsychotics_STQL _ProgSum_ 01-01-2025