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ph-1156

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

Policy Number: PH-1156

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
07-01-2024

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Aplenzin® (bupropion extended release) Tablet	Treatment of: - Major Depressive Disorder (MDD) - Seasonal Affective Disorder (SAFD)		22
Auvelity® (dextromethorphan hbr-bupropion hcl tab er) Tablet	Treatment of Major Depressive Disorder (MDD) in adults		29
Celexa® (citalopram)* Tablet Oral solution	Treatment of depression	*generic available	1, 2
Citalopram Capsule	Treatment of Major Depressive Disorder (MDD) in adults		4
Cymbalta® (duloxetine delayed release) Capsule*	Treatment of: - Major Depressive Disorder (MDD) - Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7 years of age and older - Diabetic Peripheral Neuropathic Pain (DPNP) in adults - Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older - Chronic Musculoskeletal Pain (CMP) in adults	*generic available	13
Desvenlafaxine ER Tablet	Treatment of Major Depressive Disorder (MDD)		18
Effexor XR® (venlafaxine extended release) Capsule*	Treatment of: - Major Depressive Disorder (MDD) - Panic Disorder (MDD) - Generalized Anxiety Disorder (GAD) - Social Anxiety Disorder (SAD)	*generic available	16
Fetzima® (levomilnacipran ER) Capsule	Treatment of Major Depressive Disorder (MDD) in adults Limitation of Use: Fetzima is not approved for the management of fibromyalgia. The efficacy and safety of Fetzima for the management of fibromyalgia have not been established.		17
Fluoxetine 60 mg Tablet*	Treatment of: - Major Depressive Disorder (MDD) - Obsessive Compulsive Disorder (OCD) - Bulimia Nervosa - Panic Disorder (PD), with or without agoraphobia	*generic available	3
Fluoxetine Delayed Release Capsule	Acute and maintenance treatment of Major Depressive Disorder (MDD)		10
Prozac® (fluoxetine)* Tablet Capsule Oral solution	Treatment of: - Acute and maintenance treatment of Major Depressive Disorder (MDD) - Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) - Acute and maintenance treatment of Bulimia Nervosa - Acute treatment of Panic Disorder (PD), with or without agoraphobia	*generic available	11
Forfivo XL® (bupropion extended release) Tablet	Treatment of Major Depressive Disorder (MDD)		23
Lexapro® (escitalopram)* Tablet Oral suspension	Treatment of: - Major Depressive Disorder (MDD) in adults and pediatric patients 12 years of age and older - Generalized Anxiety Disorder (GAD) in adults and pediatric patients 12 years of age and older	*generic available	6
Paxil® (paroxetine)* Tablet Oral suspension	Treatment of: - Major Depressive Disorder (MDD) - Obsessive Compulsive Disorder (OCD) - Panic Disorder (PD) - Generalized Anxiety Disorder (GAD) - Social Anxiety Disorder (SAD) - Post-Traumatic Stress Disorder (PTSD)	*generic available	7
Paxil CR® (paroxetine extended release) Tablet*	Treatment of: - Major Depressive Disorder (MDD) - Panic Disorder (PD) - Social Anxiety Disorder (SAD) - Premenstrual Dysphoric Disorder (PMDD)	*generic available	8
Pexeva® (paroxetine mesylate) Tablet	Treatment of: - Major Depressive Disorder (MDD) - Obsessive Compulsive Disorder (OCD) - Panic Disorder (PD) - Generalized Anxiety Disorder (GAD)		9
Pristiq® (desvenlafaxine succinate extended release) Tablet*	Treatment of Major Depressive Disorder (MDD)	*generic available	20
Remeron SolTab® (mirtazapine ODT) Orally disintegrating tablet*	Treatment of Major Depressive Disorder (MDD)	*generic available	25
Remeron® (mirtazapine) Tablet*	Treatment of Major Depressive Disorder (MDD)	*generic available	25
Sertraline Capsule	Treatment of: - Major depressive disorder (MDD) in adults - Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older		24
Trintellex® (vortioxetine) Tablet	Treatment of Major Depressive Disorder (MDD)		27
Venlafaxine besylate ER Tablet	Treatment of: - Major Depressive Disorder (MDD) - Social Anxiety Disorder (SAD)		21
Viibryd® (vilazodone) Tablet*	Treatment of Major Depressive Disorder (MDD)	*generic available	28
Wellbutrin SR® (bupropion sustained release) Tablet*	Treatment of Major Depressive Disorder (MDD)	*generic available	30
Wellbutrin XL® (bupropion extended release) Tablet*	Treatment of: - Major Depressive Disorder (MDD) - Seasonal Affective Disorder (SAFD)	*generic available	31
Zoloft® (sertraline)* Tablet Oral concentrate	Treatment of: - Major Depressive Disorder (MDD) - Obsessive Compulsive Disorder (OCD - Panic disorder (PD) - Post-traumatic stress disorder (PTSD) - Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD)	*generic available	12
Zurzuvae™ (zuranolone) Capsules	Treatment of postpartum depression (PPD) in adults		42

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

CLINICAL RATIONALE

Depression	Selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), bupropion, mirtazapine, and several newer agents are typically used as first-line medications because their safety and tolerability may be preferable to patients and clinicians compared to those of tricyclic antidepressants (TCAs) and monoamine oxidase (MAO) inhibitors(32). Many clinical features and medication characteristics influence the choice of a first-line antidepressant. There are no absolutes, and relative differences between medications are small, hence, selecting an antidepressant involves an individualized needs assessment for each patient(33). No antidepressant has been clearly shown to be superior to another. All FDA-approved antidepressant medications should be considered potentially appropriate for first-line treatment(32).
Anxiety Disorders	Guidelines for treatment of anxiety include several anxiety-related conditions: generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and social anxiety disorder (SAD). SSRIs are generally considered first-line therapy for GAD and PD. In the treatment of PD, TCAs are as effective as SSRIs, but adverse effects may limit the use of TCAs in some patients. Extended-release venlafaxine is effective and well tolerated for GAD and PD, whereas duloxetine has been adequately evaluated only for GAD. Due to the typical delay in onset of action, medications should not be considered ineffective until they are titrated to the high end of the dose range and continued for at least four weeks. Once symptoms have improved, medications should be used for 12 months before tapering to limit relapse. Some patients will require longer treatment(34). OCD has a highly selective response to serotonergic medications. SSRIs are preferred for initial therapy. There is insufficient evidence to show that one SSRI is superior, and the choice should be individualized, taking into account potential drug interactions and tolerability. Dosage should be increased over four to six weeks until maximum dose is achieved. Trial of therapy should continue for eight to 12 weeks, with at least four to six weeks at the maximum tolerable dosage. It usually takes at least four to six weeks for patients to note any significant improvement in symptoms; it may take 10 weeks or longer for some. If successful, medication should be continued for at least one to two years, if not indefinitely(35). Among adult patients with PTSD, fluoxetine, paroxetine, sertraline, and venlafaxine are appropriate choices, with none showing improved efficacy over the others(36). For SAD, SSRIs and SNRIs venlafaxine are the clear first-line pharmacotherapy treatment based on demonstrated efficacy in randomized controlled trials and meta-analyses. Medications in these classes that have been FDA-approved in the U.S. are paroxetine (immediate-release and controlled release), sertraline, fluvoxamine controlled release, and venlafaxine extended release. Other medications in these classes with evidence of efficacy from randomized controlled trials include citalopram, escitalopram, and vilazodone. Fluoxetine has had mixed results in randomized controlled trials. SNRIs should be used with caution in patients at risk for suicide due to greater toxicity in overdose. No individual medication within this class has been consistently shown to be superior to another in this class(37).
Neuropathic Pain	First-line treatment for neuropathic pain include TCAs, gabapentin, pregabalin, and SNRI antidepressants (duloxetine [most studied], venlafaxine) as first-line therapies(38). For patients with diabetic neuropathy, only two medications, pregabalin and duloxetine, have been approved by the FDA. However, in addition to those two medications, gabapentin and amitriptyline are considered first-line therapy. SNRIs such as venlafaxine and desvenlafaxine are considered second-line therapy. SSRIs such as citalopram, paroxetine, and escitalopram are considered third-line therapy(39).
Fibromyalgia	Pharmaceutical therapy recommendations depend on the source of the guideline. Guidelines are available from the European League Against Rheumatism (EULAR-2016), the Canadian Pain Society (2012) and the Association of the Scientific Medical Societies in Germany (AWMF-2012). Recommendations from these guidelines include amitriptyline, pregabalin, gabapentin, SNRIs (including duloxetine and milnacipran), and SSRIs. Amitriptyline, pregabalin, and duloxetine are used most commonly(40).
Chronic Musculoskeletal Pain	Antidepressants are options for the treatment of chronic pain. Meta-analyses of randomized controlled trials indicate that TCAs and SNRIs provide effective pain relief for a variety of chronic pain etiologies(41). Duloxetine is FDA approved for chronic musculoskeletal pain(13).
Safety	All of the above listed agents have had a black box warning issued by the FDA. The warning concerns suicidal thoughts and behaviors. Since there are small differences between the warnings, they are not listed here. Please see the respective agent’s prescribing information for the warning(1-14,16-18,20-31).

REFERENCES

Number	Reference
1	Celexa prescribing information. Allergan USA, Inc. August 2023.
2	Citalopram solution prescribing information. Aurobindo Pharma Limited. August 2023.
3	Fluoxetine 60 mg tablet prescribing information. Nivagen Pharmaceuticals, Inc. June 2021.
4	Citalopram capsule prescribing information. Almatica Pharma, LLC. August 2023.
5	Reference No Longer Used
6	Lexapro prescribing information. AbbVie, Inc. August 2023.
7	Paxil prescribing information. GlaxoSmithKline. August 2023.
8	Paxil CR prescribing information. Apotex Corp. August 2023.
9	Pexeva prescribing information. Sebela Pharmaceuticals, Inc. August 2023.
10	Fluoxetine delayed release capsule prescribing information. Dr. Reddy’s Laboratories Limited. July 2023.
11	Prozac prescribing information. Eli Lilly and Company. August 2023.
12	Zoloft prescribing information. Pfizer, Inc. August 2023.
13	Cymbalta prescribing information. Eli Lilly and Company. August 2023.
14	Reference No Longer Used
15	Reference No Longer Used
16	Effexor XR prescribing information. Pfizer, Inc. August 2023.
17	Fetzima prescribing information. Allergan USA, Inc. August 2023.
18	Desvenlafaxine ER prescribing information. Alembic Pharms LTC. September 2021.
19	Reference No Longer Used
20	Pristiq prescribing information. Pfizer, Inc. August 2023.
21	Venlafaxine besylate ER tablets prescribing information. Almatica Pharma LLC. March 2022.
22	Aplenzin prescribing information. Valeant Pharmaceuticals North America, LLC. March 2022.
23	Forfivo prescribing information. Almatica Pharma, Inc. December 2019.
24	Sertraline prescribing information. Almatica Pharma LLC. October 2021.
25	Remeron prescribing information. Merck & Co, Inc. November 2021.
26	Remeron SolTab prescribing information. Merck & Co, Inc. November 2021.
27	Trintellix prescribing information. Takeda Pharmaceuticals America, Inc. August 2023.
28	Viibryd prescribing information. Allergan, Inc. August 2023.
29	Auvelity prescribing information. Axsome Therapeutics, Inc. December 2022.
30	Wellbutrin SR prescribing information. GlaxoSmithKline, LLC. December 2022.
31	Wellbutrin XL prescribing information. Bausch Health Companies, Inc. March 2022.
32	Halverson J, Beevers C, Kamholz B. Clinical Practice Review for Major Depressive Disorder. Anxiety and Depression Association of America, November 2020. https://adaa.org/resources-professionals/practice-guidelines-mdd.
33	Kennedy SH, Lam RW, McIntyre RS, et. al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder. Canadian Journal Psychiatry. 2016, Vol. 61(9)540-560. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4994790/pdf/10.1177_0706743716659417.pdf
34	Locke AB, Kirst N, Shuultz CG. Diagnosis and Management of Generalized Anxiety Disorder and Panic Disorder in Adults. Am Fam Physician. 2022;106(2):157-164. https://www.aafp.org/pubs/afp/issues/2022/0800/generalized-anxiety-disorder-panic-disorder.pdf.
35	Fenske JN, Petersen K. Obsessive-Compulsive Disorder: Diagnosis and Management. Am Fam Physician. 2015 Nov 15;92(10):896-903. Available at: https://www.aafp.org/afp/2015/1115/p896.html
36	Courtois CA, Sonis J, Brown LS, et. al. Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder (PTSD) in Adults(2017). American Psychological Association. Available at: https://www.apa.org/ptsd-guideline/ptsd.pdf
37	van Amerigen M, Heimberg RG, Schneier F, et. al. Clinical Practice Review for Social Anxiety Disorder. Anxiety and Depression Association of America. September 15, 2015. Available at: https://adaa.org/resources-professionals/clinical-practice-review-social-anxiety
38	Gilron I, Baron R, Jensen T. Neuropathic Pain: Principles of Diagnosis and Treatment. Mayo Clinic Proceedings, April 2015. Available at: https://www.mayoclinicproceedings.org/article/S0025-6196(15)00105-6/fulltext#sec6
39	Castelli, G., Desai, K., Cantone, R., Peripheral Neuropathy: Evaluation and Differential Diagnosis Treating Painful Diabetic Peripheral Neuropathy: An Update. American Family Physician. 2020;102(12):732-739. https://www.aafp.org/pubs/afp/issues/2020/1215/p732.html.
40	Kia S, Choy E. Update on Treatment Guideline in Fibromyalgia Syndrome with Focus on Pharmacology. Biomedicines. 2017 Jun; 5(2): 20. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489806/
41	American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management. Anesthesiology. 2010;112:810-833. Available at: https://anesthesiology.pubs.asahq.org/article.aspx?articleid=1932775.
42	Zurzuvae prescribing information. Sage Therapeutics, Inc. August 2023.

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

Aplenzin ; Forfivo xl ; Wellbutrin sr ; Wellbutrin xl	Bupropion HCl Tab ER ; bupropion hbr tab er ; bupropion hcl tab ; bupropion hcl tab er	100 ; 100 MG ; 150 MG ; 174 MG ; 200 MG ; 300 MG ; 348 MG ; 450 MG ; 522 MG ; 75 MG	M ; N ; O	M ; N ; O ; Y
Auvelity	dextromethorphan hbr-bupropion hcl tab er	45-105 MG	M ; N ; O	N
Celexa	citalopram hydrobromide cap ; citalopram hydrobromide oral soln ; citalopram hydrobromide tab	10 MG ; 10 MG/5ML ; 20 MG ; 30 MG ; 40 MG	M ; N ; O	N ; O ; Y
Cymbalta	duloxetine hcl enteric coated pellets cap	20 MG ; 30 MG ; 40 MG ; 60 MG	M ; N ; O	O ; Y
Effexor xr	venlafaxine besylate tab er ; venlafaxine hcl cap er ; venlafaxine hcl tab ; venlafaxine hcl tab er	100 MG ; 112.5 MG ; 150 MG ; 225 MG ; 25 MG ; 37.5 MG ; 50 MG ; 75 MG	M ; N ; O	N ; O ; Y
Fetzima ; Fetzima titration pack	levomilnacipran hcl cap er	120 MG ; 20 & 40 MG ; 20 MG ; 40 MG ; 80 MG	M ; N ; O	N
Lexapro	escitalopram oxalate soln ; escitalopram oxalate tab	10 ; 10 MG ; 20 MG ; 5 MG ; 5 MG/5ML	M ; N ; O	O ; Y
Paxil ; Paxil cr ; Pexeva	paroxetine hcl oral susp ; paroxetine hcl tab ; paroxetine hcl tab er ; paroxetine mesylate tab	10 MG ; 10 MG/5ML ; 12.5 MG ; 20 MG ; 25 MG ; 30 MG ; 37.5 MG ; 40 MG	M ; N ; O	N ; O ; Y
Pristiq	desvenlafaxine succinate tab er ; desvenlafaxine tab er	100 MG ; 25 MG ; 50 ; 50 MG	M ; N ; O	N ; O ; Y
Prozac	fluoxetine hcl cap ; fluoxetine hcl cap delayed release ; fluoxetine hcl solution ; fluoxetine hcl tab	10 MG ; 20 MG ; 20 MG/5ML ; 40 MG ; 60 MG ; 90 MG	M ; N ; O	N ; O ; Y
Remeron ; Remeron soltab	mirtazapine orally disintegrating tab ; mirtazapine tab	15 MG ; 30 ; 30 MG ; 45 MG ; 7.5 MG	M ; N ; O	O ; Y
Trintellix	vortioxetine hbr tab	10 MG ; 20 MG ; 5 MG	M ; N ; O	N
Viibryd ; Viibryd starter pack	vilazodone hcl tab ; vilazodone hcl tab starter kit	10 & 20 MG ; 10 MG ; 20 MG ; 40 MG	M ; N ; O	N ; O ; Y
Zoloft	sertraline hcl cap ; sertraline hcl oral concentrate for solution ; sertraline hcl tab	100 MG ; 150 MG ; 20 MG/ML ; 200 MG ; 25 MG ; 50 MG	M ; N ; O	N ; 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

	Bupropion HCl Tab 100 MG	100 MG	120	Tablets	30	DAYS
	Bupropion HCl Tab 75 MG	75 MG	60	Tablets	30	DAYS
	citalopram hydrobromide cap	30 MG	30	Capsules	30	DAYS
	citalopram hydrobromide oral soln	10 MG/5ML	600	mLs	30	DAYS
	desvenlafaxine tab er	100 MG ; 50 MG	30	Tablets	30	DAYS
	Duloxetine HCl Enteric Coated Pellets Cap 40 MG (Base Eq)	40 MG	90	Capsules	30	DAYS
	escitalopram oxalate soln	5 MG/5ML	600	mLs	30	DAYS
	fluoxetine hcl cap delayed release	90 MG	4	Capsules	28	DAYS
	fluoxetine hcl solution	20 MG/5ML	600	mLs	30	DAYS
	Fluoxetine HCl Tab 10 MG	10 MG	30	Tablets	30	DAYS
	Fluoxetine HCl Tab 20 MG	20 MG	120	Tablets	30	DAYS
	Fluoxetine HCl Tab 60 MG	60 MG	30	Tablets	30	DAYS
	fluvoxamine maleate cap er	100 MG ; 150 MG	60	Capsules	30	DAYS
	Fluvoxamine Maleate Tab 100 MG	100 MG	90	Tablets	30	DAYS
	Fluvoxamine Maleate Tab 25 MG	25 MG	30	Tablets	30	DAYS
	Fluvoxamine Maleate Tab 50 MG	50 MG	30	Tablets	30	DAYS
	sertraline hcl cap	150 MG ; 200 MG	30	Capsules	30	DAYS
	venlafaxine besylate tab er	112.5 MG	30	Tablets	30	DAYS
	venlafaxine hcl tab	100 MG ; 25 MG ; 37.5 MG ; 50 MG ; 75 MG	90	Tablets	30	DAYS
	Venlafaxine HCl Tab ER 24HR 150 MG (Base Equivalent)	150 MG	30	Tablets	30	DAYS
	Venlafaxine HCl Tab ER 24HR 225 MG (Base Equivalent)	225 MG	30	Tablets	30	DAYS
	Venlafaxine HCl Tab ER 24HR 37.5 MG (Base Equivalent)	37.5 MG	30	Tablets	30	DAYS
	Venlafaxine HCl Tab ER 24HR 75 MG (Base Equivalent)	75 MG	90	Tablets	30	DAYS
Aplenzin	bupropion hbr tab er	174 MG ; 348 MG ; 522 MG	30	Tablets	30	DAYS
Auvelity	dextromethorphan hbr-bupropion hcl tab er	45-105 MG	60	Tablets	30	DAYS
Celexa	citalopram hydrobromide tab	10 MG ; 20 MG ; 40 MG	30	Tablets	30	DAYS
Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 20 MG (Base Eq)	20 MG	60	Capsules	30	DAYS
Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 30 MG (Base Eq)	30 MG	60	Capsules	30	DAYS	Smart QL: 2 capsules daily for 60 days 3 capsules daily thereafter
Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 60 MG (Base Eq)	60 MG	60	Capsules	30	DAYS
Effexor xr	Venlafaxine HCl Cap ER 24HR 150 MG (Base Equivalent)	150 MG	30	Capsules	30	DAYS	Smart QL: 1 capsule daily for 60 days 2 capsules daily thereafter
Effexor xr	Venlafaxine HCl Cap ER 24HR 37.5 MG (Base Equivalent)	37.5 MG	30	Capsules	30	DAYS
Effexor xr	Venlafaxine HCl Cap ER 24HR 75 MG (Base Equivalent)	75 MG	90	Capsules	30	DAYS
Fetzima	levomilnacipran hcl cap er	120 MG ; 20 MG ; 40 MG ; 80 MG	30	Capsules	30	DAYS
Fetzima titration pack	levomilnacipran hcl cap er	20 & 40 MG	28	Capsules	180	DAYS
Forfivo xl ; Wellbutrin xl	bupropion hcl tab er	150 MG ; 300 MG ; 450 MG	30	Tablets	30	DAYS
Lexapro	Escitalopram Oxalate Tab 10 MG (Base Equiv)	10 ; 10 MG	30	Tablets	30	DAYS
Lexapro	Escitalopram Oxalate Tab 20 MG (Base Equiv)	20 MG	30	Tablets	30	DAYS	Smart QL: 1 tablet daily for 60 days 2 tablets daily thereafter
Lexapro	Escitalopram Oxalate Tab 5 MG (Base Equiv)	5 MG	30	Tablets	30	DAYS
Paxil	Paroxetine HCl Oral Susp 10 MG/5ML (Base Equiv)	10 MG/5ML	900	mLs	30	DAYS
Paxil	Paroxetine HCl Tab 10 MG	10 MG	30	Tablets	30	DAYS
Paxil	Paroxetine HCl Tab 20 MG	20 MG	30	Tablets	30	DAYS
Paxil	Paroxetine HCl Tab 30 MG	30 MG	60	Tablets	30	DAYS
Paxil	Paroxetine HCl Tab 40 MG	40 MG	30	Tablets	30	DAYS
Paxil cr	Paroxetine HCl Tab ER 24HR 12.5 MG	12.5 MG	30	Tablets	30	DAYS
Paxil cr	Paroxetine HCl Tab ER 24HR 25 MG	25 MG	60	Tablets	30	DAYS
Paxil cr	Paroxetine HCl Tab ER 24HR 37.5 MG	37.5 MG	60	Tablets	30	DAYS
Pexeva	Paroxetine Mesylate Tab 10 MG (Base Equiv)	10 MG	30	Tablets	30	DAYS
Pexeva	Paroxetine Mesylate Tab 20 MG (Base Equiv)	20 MG	30	Tablets	30	DAYS
Pexeva	Paroxetine Mesylate Tab 30 MG (Base Equiv)	30 MG	60	Tablets	30	DAYS
Pexeva	Paroxetine Mesylate Tab 40 MG (Base Equiv)	40 MG	30	Tablets	30	DAYS
Pristiq	desvenlafaxine succinate tab er	100 MG ; 25 MG ; 50 ; 50 MG	30	Tablets	30	DAYS
Prozac	Fluoxetine HCl Cap 10 MG	10 MG	30	Capsules	30	DAYS
Prozac	Fluoxetine HCl Cap 20 MG	20 MG	120	Capsules	30	DAYS
Prozac	Fluoxetine HCl Cap 40 MG	40 MG	60	Capsules	30	DAYS
Remeron	mirtazapine tab	15 MG ; 30 ; 30 MG ; 45 MG ; 7.5 MG	30	Tablets	30	DAYS
Remeron soltab	mirtazapine orally disintegrating tab	15 MG ; 30 MG ; 45 MG	30	Tablets	30	DAYS
Trintellix	vortioxetine hbr tab	10 MG ; 20 MG ; 5 MG	30	Tablets	30	DAYS
Viibryd	vilazodone hcl tab	10 MG ; 20 MG ; 40 MG	30	Tablets	30	DAYS
Viibryd starter pack	vilazodone hcl tab starter kit	10 & 20 MG	1	Tablets	180	DAYS
Wellbutrin sr	Bupropion HCl Tab ER ; bupropion hcl tab er	100 ; 100 MG ; 150 MG ; 200 MG	60	Tablets	30	DAYS
Zoloft	Sertraline HCl Oral Concentrate for Solution 20 MG/ML	20 MG/ML	300	mLs	30	DAYS
Zoloft	Sertraline HCl Tab 100 MG	100 MG	60	Tablets	30	DAYS
Zoloft	Sertraline HCl Tab 25 MG	25 MG	30	Tablets	30	DAYS
Zoloft	Sertraline HCl Tab 50 MG	50 MG	30	Tablets	30	DAYS
Zurzuvae	zuranolone cap	20 MG	28	Capsules	365	DAYS	*Quantity limit is cumulative for the 20mg and 25 mg strengths.
Zurzuvae	zuranolone cap	25 MG	28	Capsules	365	DAYS	*Quantity limit is cumulative for the 20mg and 25 mg strengths.
Zurzuvae	zuranolone cap	30 MG	14	Capsules	365	DAYS

ADDITIONAL QUANTITY LIMIT INFORMATION

Wildcard	Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Additional QL Information	Targeted NDCs When Exclusions Exist	Effective Date	Term Date

58180025106730	Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 30 MG (Base Eq)	30 MG	Smart QL: 2 capsules daily for 60 days 3 capsules daily thereafter
58180090107050	Effexor xr	Venlafaxine HCl Cap ER 24HR 150 MG (Base Equivalent)	150 MG	Smart QL: 1 capsule daily for 60 days 2 capsules daily thereafter
58160034100330	Lexapro	Escitalopram Oxalate Tab 20 MG (Base Equiv)	20 MG	Smart QL: 1 tablet daily for 60 days 2 tablets daily thereafter
58060090000120	Zurzuvae	zuranolone cap	20 MG	*Quantity limit is cumulative for the 20mg and 25 mg strengths.
58060090000125	Zurzuvae	zuranolone cap	25 MG	*Quantity limit is cumulative for the 20mg and 25 mg strengths.

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Aplenzin ; Forfivo xl ; Wellbutrin sr ; Wellbutrin xl	Bupropion HCl Tab ER ; bupropion hbr tab er ; bupropion hcl tab ; bupropion hcl tab er	100 ; 100 MG ; 150 MG ; 174 MG ; 200 MG ; 300 MG ; 348 MG ; 450 MG ; 522 MG ; 75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Auvelity	dextromethorphan hbr-bupropion hcl tab er	45-105 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Celexa	citalopram hydrobromide cap ; citalopram hydrobromide oral soln ; citalopram hydrobromide tab	10 MG ; 10 MG/5ML ; 20 MG ; 30 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Cymbalta	duloxetine hcl enteric coated pellets cap	20 MG ; 30 MG ; 40 MG ; 60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Effexor xr	venlafaxine besylate tab er ; venlafaxine hcl cap er ; venlafaxine hcl tab ; venlafaxine hcl tab er	100 MG ; 112.5 MG ; 150 MG ; 225 MG ; 25 MG ; 37.5 MG ; 50 MG ; 75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Fetzima ; Fetzima titration pack	levomilnacipran hcl cap er	120 MG ; 20 & 40 MG ; 20 MG ; 40 MG ; 80 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lexapro	escitalopram oxalate soln ; escitalopram oxalate tab	10 ; 10 MG ; 20 MG ; 5 MG ; 5 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil ; Paxil cr ; Pexeva	paroxetine hcl oral susp ; paroxetine hcl tab ; paroxetine hcl tab er ; paroxetine mesylate tab	10 MG ; 10 MG/5ML ; 12.5 MG ; 20 MG ; 25 MG ; 30 MG ; 37.5 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pristiq	desvenlafaxine succinate tab er ; desvenlafaxine tab er	100 MG ; 25 MG ; 50 ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prozac	fluoxetine hcl cap ; fluoxetine hcl cap delayed release ; fluoxetine hcl solution ; fluoxetine hcl tab	10 MG ; 20 MG ; 20 MG/5ML ; 40 MG ; 60 MG ; 90 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Remeron ; Remeron soltab	mirtazapine orally disintegrating tab ; mirtazapine tab	15 MG ; 30 ; 30 MG ; 45 MG ; 7.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trintellix	vortioxetine hbr tab	10 MG ; 20 MG ; 5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Viibryd ; Viibryd starter pack	vilazodone hcl tab ; vilazodone hcl tab starter kit	10 & 20 MG ; 10 MG ; 20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zoloft	sertraline hcl cap ; sertraline hcl oral concentrate for solution ; sertraline hcl tab	100 MG ; 150 MG ; 20 MG/ML ; 200 MG ; 25 MG ; 50 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
	Bupropion HCl Tab 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Bupropion HCl Tab 75 MG	75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	citalopram hydrobromide cap	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	citalopram hydrobromide oral soln	10 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	desvenlafaxine tab er	100 MG ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Duloxetine HCl Enteric Coated Pellets Cap 40 MG (Base Eq)	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	escitalopram oxalate soln	5 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	fluoxetine hcl cap delayed release	90 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	fluoxetine hcl solution	20 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Fluoxetine HCl Tab 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Fluoxetine HCl Tab 20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Fluoxetine HCl Tab 60 MG	60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	fluvoxamine maleate cap er	100 MG ; 150 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Fluvoxamine Maleate Tab 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Fluvoxamine Maleate Tab 25 MG	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Fluvoxamine Maleate Tab 50 MG	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	sertraline hcl cap	150 MG ; 200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	venlafaxine besylate tab er	112.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	venlafaxine hcl tab	100 MG ; 25 MG ; 37.5 MG ; 50 MG ; 75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Venlafaxine HCl Tab ER 24HR 150 MG (Base Equivalent)	150 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Venlafaxine HCl Tab ER 24HR 225 MG (Base Equivalent)	225 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Venlafaxine HCl Tab ER 24HR 37.5 MG (Base Equivalent)	37.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Venlafaxine HCl Tab ER 24HR 75 MG (Base Equivalent)	75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aplenzin	bupropion hbr tab er	174 MG ; 348 MG ; 522 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Auvelity	dextromethorphan hbr-bupropion hcl tab er	45-105 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Celexa	citalopram hydrobromide tab	10 MG ; 20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 20 MG (Base Eq)	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 30 MG (Base Eq)	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Cymbalta	Duloxetine HCl Enteric Coated Pellets Cap 60 MG (Base Eq)	60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Effexor xr	Venlafaxine HCl Cap ER 24HR 150 MG (Base Equivalent)	150 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Effexor xr	Venlafaxine HCl Cap ER 24HR 37.5 MG (Base Equivalent)	37.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Effexor xr	Venlafaxine HCl Cap ER 24HR 75 MG (Base Equivalent)	75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Fetzima	levomilnacipran hcl cap er	120 MG ; 20 MG ; 40 MG ; 80 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Fetzima titration pack	levomilnacipran hcl cap er	20 & 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Forfivo xl ; Wellbutrin xl	bupropion hcl tab er	150 MG ; 300 MG ; 450 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lexapro	Escitalopram Oxalate Tab 10 MG (Base Equiv)	10 ; 10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lexapro	Escitalopram Oxalate Tab 20 MG (Base Equiv)	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lexapro	Escitalopram Oxalate Tab 5 MG (Base Equiv)	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil	Paroxetine HCl Oral Susp 10 MG/5ML (Base Equiv)	10 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil	Paroxetine HCl Tab 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil	Paroxetine HCl Tab 20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil	Paroxetine HCl Tab 30 MG	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil	Paroxetine HCl Tab 40 MG	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil cr	Paroxetine HCl Tab ER 24HR 12.5 MG	12.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil cr	Paroxetine HCl Tab ER 24HR 25 MG	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxil cr	Paroxetine HCl Tab ER 24HR 37.5 MG	37.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pexeva	Paroxetine Mesylate Tab 10 MG (Base Equiv)	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pexeva	Paroxetine Mesylate Tab 20 MG (Base Equiv)	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pexeva	Paroxetine Mesylate Tab 30 MG (Base Equiv)	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pexeva	Paroxetine Mesylate Tab 40 MG (Base Equiv)	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pristiq	desvenlafaxine succinate tab er	100 MG ; 25 MG ; 50 ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prozac	Fluoxetine HCl Cap 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prozac	Fluoxetine HCl Cap 20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prozac	Fluoxetine HCl Cap 40 MG	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Remeron	mirtazapine tab	15 MG ; 30 ; 30 MG ; 45 MG ; 7.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Remeron soltab	mirtazapine orally disintegrating tab	15 MG ; 30 MG ; 45 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trintellix	vortioxetine hbr tab	10 MG ; 20 MG ; 5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Viibryd	vilazodone hcl tab	10 MG ; 20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Viibryd starter pack	vilazodone hcl tab starter kit	10 & 20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Wellbutrin sr	Bupropion HCl Tab ER ; bupropion hcl tab er	100 ; 100 MG ; 150 MG ; 200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zoloft	Sertraline HCl Oral Concentrate for Solution 20 MG/ML	20 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zoloft	Sertraline HCl Tab 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zoloft	Sertraline HCl Tab 25 MG	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zoloft	Sertraline HCl Tab 50 MG	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zurzuvae	zuranolone cap	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zurzuvae	zuranolone cap	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zurzuvae	zuranolone cap	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
Brand Agents other than Cymbalta	TARGET AGENT(S) Aplenzin (bupropion) Auvelity (dextromethorphan hbr-bupropion hcl tab er) Celexa (citalopram)* Citalopram (capsules)^{^} Desvenlafaxine ER (tablets)^{^} Effexor (venlafaxine)* Effexor XR (venlafaxine extended release)* Fetzima (levomilnacipran extended release) Fluoxetine 60 mg (tablets)^{^} Fluoxetine delayed release* (capsules)^{^} Forfivo XL (bupropion extended release) Lexapro (escitalopram)* Paxil (paroxetine hydrochloride)* Paxil CR (paroxetine extended release)* Pexeva (paroxetine mesylate) Pristiq (desvenlafaxine succinate)* Prozac (fluoxetine)* Remeron (mirtazapine)* Remeron SolTab (mirtazapine)* Sertraline (capsules)^{^} Trintellix (vortioxetine) Viibryd (vilazodone)* Wellbutrin (bupropion)* Wellbutrin SR (bupropion extended release)* Wellbutrin XL (bupropion extended release)* Zoloft (sertraline)* * - available as a generic; generic included as a prerequisite in step therapy program ^ – branded generic product(s) available; targeted in the step therapy program Brand Antidepressant Agent(s) (except Cymbalta) will be approved when ONE of the following are met: The patient has been treated with the requested agent within the past 180 days OR The prescriber states that the patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed OR The request is for Auvelity AND ONE of the following: The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to TWO generic antidepressant agents (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR The patient has an FDA labeled contraindication to ALL generic antidepressants (i.e., SSRI, SNRI, bupropion, mirtazapine or vilazodone) OR The request is for a medication other than Auvelity AND ONE of the following: The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to a generic antidepressant agent (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR The patient has an FDA labeled contraindication to ALL generic antidepressants (i.e., SSRI, SNRI, bupropion, mirtazapine or vilazodone) Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Cymbalta	TARGET AGENT(S) Cymbalta (duloxetine)* * - available as a generic; generic included as a prerequisite in step therapy program Cymbalta will be approved when ONE of the following are 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 in the past 365 days that includes use of a generic antidepressant agent (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR The patient has a diagnosis of neuropathic pain and ONE of the following: The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prerequisite agent (i.e., amitriptyline, nortriptyline, desipramine, imipramine, or gabapentin) OR The patient has an FDA labeled contraindication to ALL prerequisite agents (i.e., amitriptyline, nortriptyline, desipramine, imipramine, or gabapentin) OR The patient has a diagnosis of fibromyalgia and ONE of the following: The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prerequisite agent (i.e., amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, gabapentin, or tramadol) OR The patient has an FDA labeled contraindication to ALL prerequisite agents (i.e., amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, gabapentin, or tramadol) OR The patient has a diagnosis of chronic musculoskeletal pain and ONE of the following: The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prerequisite agent (i.e., acetaminophen, oral NSAID, topical NSAID, tramadol, amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, or gabapentin)OR The patient has an FDA labeled contraindication to ALL prerequisite agents (i.e., acetaminophen, oral NSAID, topical NSAID, tramadol, amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, or gabapentin OR If using for a diagnosis other than neuropathic pain, fibromyalgia, or musculoskeletal pain, ONE of the following: The patient has an intolerance or hypersensitivity to a generic antidepressant (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR The patient has an FDA labeled contraindication to ALL generic antidepressants (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Brand Agents other than Cymbalta

TARGET AGENT(S)

Aplenzin (bupropion)

Auvelity (dextromethorphan hbr-bupropion hcl tab er)

Celexa (citalopram)*

Citalopram (capsules)^{^}

Desvenlafaxine ER (tablets)^{^}

Effexor (venlafaxine)*

Effexor XR (venlafaxine extended release)*

Fetzima (levomilnacipran extended release)

Fluoxetine 60 mg (tablets)*^{^}

Fluoxetine delayed release (capsules)^{^}

Forfivo XL (bupropion extended release)

Lexapro (escitalopram)*

Paxil (paroxetine hydrochloride)*

Paxil CR (paroxetine extended release)*

Pexeva (paroxetine mesylate)

Pristiq (desvenlafaxine succinate)*

Prozac (fluoxetine)*

Remeron (mirtazapine)*

Remeron SolTab (mirtazapine)*

Sertraline (capsules)^{^}

Trintellix (vortioxetine)

Viibryd (vilazodone)*

Wellbutrin (bupropion)*

Wellbutrin SR (bupropion extended release)*

Wellbutrin XL (bupropion extended release)*

Zoloft (sertraline)*

* - available as a generic; generic included as a prerequisite in step therapy program

^ – branded generic product(s) available; targeted in the step therapy program

Brand Antidepressant Agent(s) (except Cymbalta) will be approved when ONE of the following are met:

The patient has been treated with the requested agent within the past 180 days OR
The prescriber states that the patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed OR
The request is for Auvelity AND ONE of the following:
1. The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to TWO generic antidepressant agents (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
The request is for a medication other than Auvelity AND ONE of the following:
1. The patient has a medication history of use in the past 365 days, intolerance, or hypersensitivity to a 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)

Length of Approval: 12 months

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

Cymbalta

TARGET AGENT(S)

Cymbalta (duloxetine)*

* - available as a generic; generic included as a prerequisite in step therapy program

Cymbalta will be approved when ONE of the following are 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 in the past 365 days that includes use of a generic antidepressant agent (i.e., SSRI, SNRI, bupropion, mirtazapine, or vilazodone) OR
The patient has a diagnosis of neuropathic pain and ONE of the following:
1. The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prerequisite agent (i.e., amitriptyline, nortriptyline, desipramine, imipramine, or gabapentin) OR
2. The patient has an FDA labeled contraindication to ALL prerequisite agents (i.e., amitriptyline, nortriptyline, desipramine, imipramine, or gabapentin) OR
The patient has a diagnosis of fibromyalgia and ONE of the following:
1. The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prerequisite agent (i.e., amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, gabapentin, or tramadol) OR
2. The patient has an FDA labeled contraindication to ALL prerequisite agents (i.e., amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, gabapentin, or tramadol) OR
The patient has a diagnosis of chronic musculoskeletal pain and ONE of the following:
1. The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prerequisite agent (i.e., acetaminophen, oral NSAID, topical NSAID, tramadol, amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, or gabapentin)OR
2. The patient has an FDA labeled contraindication to ALL prerequisite agents (i.e., acetaminophen, oral NSAID, topical NSAID, tramadol, amitriptyline, nortriptyline, desipramine, imipramine, cyclobenzaprine, or gabapentin OR
If using for a diagnosis other than neuropathic pain, fibromyalgia, or musculoskeletal pain, ONE of the following:
1. The patient has an intolerance or hypersensitivity to a generic antidepressant (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)

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 There is support for 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. There is support for 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.