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ph-91156

Atypical Antipsychotics – Extended Maintenance Agents Step Therapy and Quantity Limit Program Summary

Policy Number: PH-91156

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
04-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Abilify Asimtufii® (aripiprazole) IM injection	Treatment of schizophrenia in adults As maintenance monotherapy treatment of bipolar I disorder in adult		13
Abilify Maintena® (aripiprazole) IM injection	Treatment of schizophrenia in adults Main monotherapy treatment of bipolar I disorder in adults		1
Aristada Initio® (aripiprazole) IM injection	In combination with oral aripiprazole, is indicated for the initiation of Aristada when used for the treatment of schizophrenia in adults		3
Aristada® (aripiprazole) IM injection	Treatment of schizophrenia in adults		2
Erzofri® (paliperidone palmitate er) Prefilled syringe	Treatment of schizophrenia in adults. Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.		16
Invega Hafyera™ (paliperidone) IM injection	Treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Sustenna) for at least four months OR An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Trinza) for at least one three-month cycle		12
Invega Sustenna® (paliperidone) IM injection	Treatment of schizophrenia in adults Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants		4
Invega Trinza® (paliperidone) IM injection	Treatment of schizophrenia in patients after they have been adequately treated with Invega Sustenna (1-month paliperidone palmitate extended-release injectable suspension) for at least four months		5
Perseris® (risperidone) SC injection	Treatment of schizophrenia in adults		6
Risperdal Consta® (risperidone) IM injection	Treatment of schizophrenia As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder		7
Rykindo® (risperidone ER) IM injection	Treatment of schizophrenia in adults As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.		15
Uzedy® (risperidone ER) SC injection	Treatment of schizophrenia in adults		14
Zyprexa® Relprevv™ (olanzapine) IM injection	Treatment of schizophrenia		8

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

CLINICAL RATIONALE

Safety

The Atypical Antipsychotics – Extended Maintenance Agents carry a black box 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 not approved for the treatment of patients with dementia-related psychosis. In addition to the FDA black box warning, Zyprexa Relprevv carries a black box warning concerning post-injection delirium/sedation syndrome. The warning states that patients are at risk for severe sedation (including coma) and/or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. Because of this risk, Zyprexa Relprevv is available only through a restricted distribution program called Zyprexa Relprevv Patient Care Program and requires, prescriber, healthcare facility, patient, and pharmacy enrollment.(1-15)

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.(1-8,12-15)

REFERENCES

Number	Reference
1	Abilify Maintena prescribing information. Otsuka America Pharmaceutical, Inc. February 2020.
2	Aristada prescribing information. Alkermes, Inc. December 2023.
3	Aristada Initio prescribing information. Alkermes, Inc. December 2023.
4	Invega Sustenna prescribing information. Janssen Pharmaceuticals, Inc. July 2022.
5	Invega Trinza prescribing information. Janssen Pharmaceuticals, Inc. August 2021.
6	Perseris prescribing information. Indivior, Inc. August 2022.
7	Risperdal Consta prescribing information. Janssen Pharmaceuticals, Inc. Februaary 2021.
8	Zyprexa Relprevv prescribing information. Eli Lilly and Company. October 2023.
9	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.
10	Rabins PV, Rovner BW et. al. Guideline Watch (2014) Practice Guideline for the Treatment of Patients with Alzheimer’s Disease and Other Dementias. American Psychiatric Association. Available: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/alzheimerwatch.pdf.
11	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.
12	Invega Hafyera prescribing information. Janssen Pharmaceuticals, Inc. August 2021.
13	Abilify Asimtufii prescribing information. Otsuka Pharmaceutical Co., Ltd. August 2023.
14	Uzedy prescribing information. Teva Neuroscience, Inc. May 2023.
15	Rykindo prescribing informaiton. Shandong Luye Pharmaceutical Co, Ltd. January 2023.
16	Erzofri prescribing information. Shandong Luye Pharmaceutical Co., Ltd. July 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

Abilify asimtufii ; Abilify maintena	aripiprazole im er susp prefilled syringe ; aripiprazole im for er susp prefilled syringe	300 MG ; 400 MG ; 720 MG/2.4ML ; 960 MG/3.2ML	M ; N ; O ; Y	N
Abilify maintena	aripiprazole im for extended release susp	300 MG ; 400 MG	M ; N ; O ; Y	N
Aristada ; Aristada initio	aripiprazole lauroxil im er susp prefilled syr	1064 MG/3.9ML ; 441 MG/1.6ML ; 662 MG/2.4ML ; 675 MG/2.4ML ; 882 MG/3.2ML	M ; N ; O ; Y	N
Erzofri	paliperidone palmitate er susp pref syr	351 MG/2.25ML	M ; N ; O ; Y	N
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 117 MG/0.75ML	117 MG/0.75ML	M ; N ; O ; Y	N
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 156 MG/ML	156 MG/ML	M ; N ; O ; Y	N
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 234 MG/1.5ML	234 MG/1.5ML	M ; N ; O ; Y	N
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 39 MG/0.25ML	39 MG/0.25ML	M ; N ; O ; Y	N
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 78 MG/0.5ML	78 MG/0.5ML	M ; N ; O ; Y	N
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1092 MG/3.5ML	M ; N ; O ; Y	N
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1560 MG/5ML	M ; N ; O ; Y	N
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 273 MG/0.875ML	273 MG/0.88ML	M ; N ; O ; Y	N
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 410 MG/1.315ML	410 MG/1.32ML	M ; N ; O ; Y	N
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 546 MG/1.75ML	546 MG/1.75ML	M ; N ; O ; Y	N
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 819 MG/2.625ML	819 MG/2.63ML	M ; N ; O ; Y	N
Perseris	risperidone subcutaneous for er susp prefilled syr	120 MG ; 90 MG	M ; N ; O ; Y	N
Risperdal consta ; Risperidone er	risperidone microspheres for im extended rel susp	12.5 MG ; 25 MG ; 37.5 MG ; 50 MG	M ; N ; O ; Y	O ; Y
Rykindo	risperidone for im extended release suspension	25 MG ; 37.5 MG ; 50 MG	M ; N ; O ; Y	N
Uzedy	risperidone subcutaneous er susp pref syr	100 MG/0.28ML ; 125 MG/0.35ML ; 150 MG/0.42ML ; 200 MG/0.56ML ; 250 MG/0.7ML ; 50 MG/0.14ML ; 75 MG/0.21ML	M ; N ; O ; Y	N
Zyprexa relprevv	olanzapine pamoate for extended rel im susp	210 MG ; 300 MG ; 405 MG	M ; N ; O ; Y	N

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

Abilify asimtufii	aripiprazole im er susp prefilled syringe	720 MG/2.4ML	1	Syringe	56	DAYS
Abilify asimtufii	aripiprazole im er susp prefilled syringe	960 MG/3.2ML	1	Syringe	56	DAYS
Abilify maintena	Aripiprazole IM For ER Susp Prefilled Syringe 300 MG	300 MG	1	Syringe	28	DAYS
Abilify maintena	Aripiprazole IM For ER Susp Prefilled Syringe 400 MG	400 MG	1	Syringe	28	DAYS
Abilify maintena	aripiprazole im for extended release susp	300 MG ; 400 MG	1	Vial	28	DAYS
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 1064 MG/3.9ML	1064 MG/3.9ML	1	Syringe	56	DAYS
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 441 MG/1.6ML	441 MG/1.6ML	1	Syringe	28	DAYS
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 662 MG/2.4ML	662 MG/2.4ML	1	Syringe	28	DAYS
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 882 MG/3.2ML	882 MG/3.2ML	1	Syringe	28	DAYS
Aristada initio	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 675 MG/2.4ML	675 MG/2.4ML	1	Kit	180	DAYS
Erzofri	paliperidone palmitate er susp pref syr	351 MG/2.25ML	1	Syringe	180	DAYS
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 117 MG/0.75ML	117 MG/0.75ML	1	Kit	28	DAYS
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 156 MG/ML	156 MG/ML	1	Kit	28	DAYS
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 234 MG/1.5ML	234 MG/1.5ML	1	Kit	28	DAYS
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 39 MG/0.25ML	39 MG/0.25ML	1	Kit	28	DAYS
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 78 MG/0.5ML	78 MG/0.5ML	1	Kit	28	DAYS
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1092 MG/3.5ML	1	Syringe	180	DAYS
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1560 MG/5ML	1	Syringe	180	DAYS
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 273 MG/0.875ML	273 MG/0.88ML	1	Syringe	84	DAYS
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 410 MG/1.315ML	410 MG/1.32ML	1	Syringe	84	DAYS
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 546 MG/1.75ML	546 MG/1.75ML	1	Syringe	84	DAYS
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 819 MG/2.625ML	819 MG/2.63ML	1	Syringe	84	DAYS
Olanzapine ; Olanzapine odt ; Zyprexa ; Zyprexa relprevv ; Zyprexa zydis	olanzapine for im inj ; olanzapine orally disintegrating tab ; olanzapine pamoate for extended rel im susp ; olanzapine tab	10 MG ; 15 MG ; 2.5 MG ; 20 MG ; 210 MG ; 300 MG ; 405 MG ; 5 MG ; 7.5 MG	30	Unit	30	DAYS
Perseris	risperidone subcutaneous for er susp prefilled syr	120 MG ; 90 MG	1	Kit	28	DAYS
Risperdal consta ; Risperidone er	risperidone microspheres for im extended rel susp	12.5 MG ; 25 MG ; 37.5 MG ; 50 MG	2	Vials	28	DAYS
Rykindo	risperidone for im extended release suspension	25 MG	2	Vials	28	DAYS
Rykindo	risperidone for im extended release suspension	37.5 MG	2	Vials	28	DAYS
Rykindo	risperidone for im extended release suspension	50 MG	2	Vials	28	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	50 MG/0.14ML	1	Syringe	28	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	75 MG/0.21ML	1	Syringe	28	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	100 MG/0.28ML	1	Syringe	28	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	125 MG/0.35ML	1	Syringe	28	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	150 MG/0.42ML	1	Syringe	56	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	200 MG/0.56ML	1	Syringe	56	DAYS
Uzedy	risperidone subcutaneous er susp pref syr	250 MG/0.7ML	1	Syringe	56	DAYS
Zyprexa relprevv	Olanzapine Pamoate For Extended Rel IM Susp 210 MG (Base Eq)	210 MG	2	Vials	28	DAYS
Zyprexa relprevv	Olanzapine Pamoate For Extended Rel IM Susp 300 MG (Base Eq)	300 MG	2	Vials	28	DAYS
Zyprexa relprevv	Olanzapine Pamoate For Extended Rel IM Susp 405 MG (Base Eq)	405 MG	1	Vial	28	DAYS

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Abilify asimtufii ; Abilify maintena	aripiprazole im er susp prefilled syringe ; aripiprazole im for er susp prefilled syringe	300 MG ; 400 MG ; 720 MG/2.4ML ; 960 MG/3.2ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Abilify maintena	aripiprazole im for extended release susp	300 MG ; 400 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aristada ; Aristada initio	aripiprazole lauroxil im er susp prefilled syr	1064 MG/3.9ML ; 441 MG/1.6ML ; 662 MG/2.4ML ; 675 MG/2.4ML ; 882 MG/3.2ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri	paliperidone palmitate er susp pref syr	351 MG/2.25ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 117 MG/0.75ML	117 MG/0.75ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 156 MG/ML	156 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 234 MG/1.5ML	234 MG/1.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 39 MG/0.25ML	39 MG/0.25ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 78 MG/0.5ML	78 MG/0.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1560 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1092 MG/3.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 273 MG/0.875ML	273 MG/0.88ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 410 MG/1.315ML	410 MG/1.32ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 546 MG/1.75ML	546 MG/1.75ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 819 MG/2.625ML	819 MG/2.63ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Perseris	risperidone subcutaneous for er susp prefilled syr	120 MG ; 90 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Risperdal consta ; Risperidone er	risperidone microspheres for im extended rel susp	12.5 MG ; 25 MG ; 37.5 MG ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Rykindo	risperidone for im extended release suspension	25 MG ; 37.5 MG ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	100 MG/0.28ML ; 125 MG/0.35ML ; 150 MG/0.42ML ; 200 MG/0.56ML ; 250 MG/0.7ML ; 50 MG/0.14ML ; 75 MG/0.21ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zyprexa relprevv	olanzapine pamoate for extended rel im susp	210 MG ; 300 MG ; 405 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
Abilify asimtufii	aripiprazole im er susp prefilled syringe	720 MG/2.4ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Abilify asimtufii	aripiprazole im er susp prefilled syringe	960 MG/3.2ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Abilify maintena	Aripiprazole IM For ER Susp Prefilled Syringe 300 MG	300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Abilify maintena	Aripiprazole IM For ER Susp Prefilled Syringe 400 MG	400 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Abilify maintena	aripiprazole im for extended release susp	300 MG ; 400 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 1064 MG/3.9ML	1064 MG/3.9ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 441 MG/1.6ML	441 MG/1.6ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 662 MG/2.4ML	662 MG/2.4ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aristada	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 882 MG/3.2ML	882 MG/3.2ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aristada initio	Aripiprazole Lauroxil IM ER Susp Prefilled Syr 675 MG/2.4ML	675 MG/2.4ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri	paliperidone palmitate er susp pref syr	351 MG/2.25ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 117 MG/0.75ML	117 MG/0.75ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 156 MG/ML	156 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 234 MG/1.5ML	234 MG/1.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 39 MG/0.25ML	39 MG/0.25ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Erzofri ; Invega sustenna	Paliperidone Palmitate ER Susp Pref Syr 78 MG/0.5ML	78 MG/0.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1092 MG/3.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega hafyera	Paliperidone Palmitate ER Susp Pref Syr	1560 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 273 MG/0.875ML	273 MG/0.88ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 410 MG/1.315ML	410 MG/1.32ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 546 MG/1.75ML	546 MG/1.75ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Invega trinza	Paliperidone Palmitate ER Susp Pref Syr 819 MG/2.625ML	819 MG/2.63ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Olanzapine ; Olanzapine odt ; Zyprexa ; Zyprexa relprevv ; Zyprexa zydis	olanzapine for im inj ; olanzapine orally disintegrating tab ; olanzapine pamoate for extended rel im susp ; olanzapine tab	10 MG ; 15 MG ; 2.5 MG ; 20 MG ; 210 MG ; 300 MG ; 405 MG ; 5 MG ; 7.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Perseris	risperidone subcutaneous for er susp prefilled syr	120 MG ; 90 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Risperdal consta ; Risperidone er	risperidone microspheres for im extended rel susp	12.5 MG ; 25 MG ; 37.5 MG ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Rykindo	risperidone for im extended release suspension	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Rykindo	risperidone for im extended release suspension	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Rykindo	risperidone for im extended release suspension	37.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	125 MG/0.35ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	200 MG/0.56ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	100 MG/0.28ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	150 MG/0.42ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	250 MG/0.7ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	50 MG/0.14ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Uzedy	risperidone subcutaneous er susp pref syr	75 MG/0.21ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zyprexa relprevv	Olanzapine Pamoate For Extended Rel IM Susp 210 MG (Base Eq)	210 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zyprexa relprevv	Olanzapine Pamoate For Extended Rel IM Susp 300 MG (Base Eq)	300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zyprexa relprevv	Olanzapine Pamoate For Extended Rel IM Susp 405 MG (Base Eq)	405 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

TARGET AGENT(S)	PREREQUISITE AGENT(S)
Abilify Asimtufii (aripiprazole) Abilify Maintena (aripiprazole) Aristada (aripiprazole) Aristada Initio (aripiprazole)	Any oral brand or generic: Abilify Abilify Mycite aripiprazole ODT aripiprazole solution aripiprazole Opipza
Invega Hafyera (paliperidone)	Erzofri Invega Sustenna Invega Trinza
Invega Sustenna (paliperidone) Erzofri (paliperidone)	Any oral brand or generic: Invega ER paliperidone ER
Invega Trinza (paliperidone)	Erzofri Invega Sustenna
Perseris (risperidone) Risperdal Consta (risperidone) Rykindo (risperidone ER) Uzedy (risperidone ER)	Any oral brand or generic: Risperdal Risperdal solution risperidone Risperidone ODT, risperidone ODT
Zyprexa Relprevv (olanzapine)	Any oral brand or generic: olanzapine Zyprexa Zyprexa Zydis

* - generic available

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

The patient has been treated with the requested agent within the past 180 days OR
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
The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to one prerequisite agent OR
The patient has an FDA labeled contraindication to ALL prerequisite agents that are not expected to occur with the requested agent

Length of Approval: 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: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does not have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND Information has been provided to 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 BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

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

The requested quantity (dose) does NOT exceed the program quantity limit OR
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. Information has been provided to 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_Extended_Maintenance_STQL _ProgSum_ 04-01-2025