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PHARMACY POLICY – 5.01.520 : Pharmacy Medical Necessity Criteria for Brands

Effective Date: Sept. 1, 2021 RELATED MEDICAL POLICIES: Last Revised: Aug. 3, 2021 5.01.521 Pharmacologic Treatment of Neuropathy, Fibromyalgia, and Seizure Replaces: N/A Disorders 5.01.605 Medical Necessity Criteria for Pharmacy Edits

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POLICY CRITERIA | CODING | RELATED INFORMATION EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Drugs are grouped into classes. can be in the same class because they work in the same way, have a similar chemical structure, or are used for the same purpose. There are a number of classes for drugs. These include monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin- norepinephrine reuptake inhibitors (SNRIs). MAOIs and TCAs were the first drugs developed in the 1950s and are considered first-generation antidepressants. Because antidepressants like SSRIs and SNRIs were developed later they are considered second-generation antidepressants. Like most drugs, second-generation antidepressants come in both brand and generic form. The active ingredients in generic drugs are chemically identical to the active ingredients in brand name drugs. Because generic drugs have the same active ingredients as brand name drugs, they are usually tried first. This policy describes when brand-name second-generation antidepressants may be considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria

Condition Medical Necessity Depression Brand selective serotonin reuptake inhibitor (SSRI), serotonin/norepinephrine reuptake inhibitor (SNRI), and any second-generation antidepressant, when used to treat depression, may be considered medically necessary when there has been a trial and failure of two generic second-generation antidepressants. • Examples of generic second-generation antidepressants include but are not limited to: , , venlafaxine, , mirtazapine

Note: For diagnosis of diabetic peripheral neuropathy, chronic musculoskeletal pain or fibromyalgia, see Related Policies.

Anxiety Brand selective serotonin reuptake inhibitor (SSRI), serotonin/norepinephrine reuptake inhibitor (SNRI), and any second-generation antidepressant, when used to treat anxiety, may be considered medically necessary when there has been a trial and failure of two generic SSRIs, two generic SNRIs, or one generic SSRI and one generic SNRI. • Examples of generic SSRIs include but are not limited to: , , fluoxetine, , sertraline • Examples of generic SNRIs include but are not limited to: desvenlafaxine, , venlafaxine

Note: For diagnosis of diabetic peripheral neuropathy, chronic musculoskeletal pain or fibromyalgia, see Related Policies.

Drug Not Medically Necessary Brand SSRI, SNRI, and any All other uses of brand SSRI, SNRI, and any second-generation second- generation antidepressant for this policy are considered not medically antidepressant necessary.

Page | 2 of 14 ∞ Length of Approval Approval Criteria Initial authorization All brand SSRI, SNRI, and any second-generation antidepressant may be approved up to 3 years. Re-authorization criteria Future re-authorization of brand SSRI, SNRI, and any second- generation antidepressant may be approved up to 3 years as long as the medical necessity criteria are met and chart notes demonstrate that the patient continues to show a positive clinical response to therapy.

Documentation Requirements The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following: • Office visit notes that contain the diagnosis, relevant history, physical evaluation and history

Coding

N/A

Related Information

Benefit Application

This policy applies to all pharmacy benefit contracts that include Pharmacy Prior Authorization Edits.

This policy is managed through the Pharmacy benefit.

Evidence Review

Page | 3 of 14 ∞ Description

Pathophysiology of Depression

While the pathology of depression is far from completely understood, it is apparent that both heredity and environmental factors play a part. Genetic microarray techniques are being used to identify candidate genes, with the hope of developing a pharmacogenomic approach to predicting which drugs will be most effective in each patient. However, this knowledge is still in its infancy, and its practical application will be some time in the future. For now, practitioners must continue using empiric approaches to treatment, both pharmacologic and otherwise.

Disease Burden

More than 18 million Americans suffer from depression. Over 15% will experience at least one major depressive episode during their lifetimes. Exact prevalence rates are difficult to determine because of the extent to which depression goes unreported. It occurs twice as frequently in women as in men. A meta-analysis showed that depressed persons have a 1.5-2 fold increased risk of mortality.

In 2000, the economic burden of depression in the U.S. was estimated to be $83.1 billion. Indirect costs include related mortality and morbidity, as well as significant amounts of absenteeism and presenteeism that can impact workplace productivity. Quality of life of patients and those around them also suffer.

Pharmacotherapy

An overview of the various treatment modalities used in depression was provided in Lancet by Ebmeier et al. Treatments include a variety of cognitive behavioral approaches, psychotherapy, treatment with antidepressant and in severely resistant cases, electroconvulsive therapy. Of the nonpharmacologic treatment modalities, cognitive behavioral approaches have the best supporting evidence. Drugs used to treat depression include selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOI) and several agents with combinations of , noradrenergic and activity.

This policy applies to the following medications:

Page | 4 of 14 ∞ • Single Source Brand (SSB) selective serotonin reuptake inhibitor (SSRI), serotonin/norepinephrine reuptake inhibitor (SNRI) and any other SSB second-generation antidepressants (antidepressants other than tricyclic and MAOI agents).

Summary of Evidence

Current evidence from head-to-head comparative trials of second-generation antidepressants, systematic reviews, and meta-analyses indicates these agents are of comparable efficacy and effectiveness as measured by HAM-D or MADRS response (>50% improvement), though one study reported a statistically superior but modest improvement in MADRS score with escitalopram compared to citalopram. Overall, the data support for a meaningful difference is not compelling.

Evidence from four small comparative effectiveness trials failed to provide compelling evidence of the superiority of escitalopram. In the one study that showed a statistically significant difference in the primary endpoint (change from baseline in MADRS score), the effect size was modest, and p value was barely significant.

Two longer-term (≥6 month) efficacy and safety studies of duloxetine (Cymbalta) duloxetine have been published, and the manufacturer supplied data on two unpublished trials. Although not compelling, evidence now supports the relative safety of longer-term (6 month to 1 year) use of duloxetine for the treatment of major depressive disorder. Other evidence also shows comparable efficacy with venlafaxine and comparable onset of effect with escitalopram.

A meta-analysis of 117 small randomized controlled trials including 25,928 patients compared 12 “new generation” antidepressants for efficacy and tolerability. The authors concluded that escitalopram and sertraline offered the best combination of efficacy and patient acceptability. Of the two, they felt that sertraline might be the best choice when starting treatment, because it has the best balance between efficacy, safety and cost. Although well-designed, this study is limited by the size and heterogeneity of the individual trials that were included. In particular, the evidence supporting superiority of escitalopram over citalopram is based on 5 small trials, all of which were manufacturer-sponsored. There is no clinical reason to expect a meaningful difference between these two agents, assuming that the doses of the S-isomer are equal.

A similar meta-analysis of 203 studies yielded no substantial differences among agents. The authors concluded that the body of existing evidence does not favor selection of one particular antidepressant over the others based on efficacy or effectiveness.

Page | 5 of 14 ∞ U.S. guidelines for the treatment of adults with depression from the American Psychiatric Association recommend use of antidepressants as preferred initial treatment or as a part of a preferred initial treatment regimen for most patients with any level of severity of MDD. Initial choice of medication should consider anticipated side effects, safety or tolerability of side effects for individual patients, patient preference, quantity and quality of clinical trial data, and cost. Based on these factors, the APA indicates SSRIs, desipramine, , bupropion, venlafaxine, and mirtazapine are likely to be effective for most patients.

2009 Update

A literature search was performed for March 2009 through December 2009. No published randomized studies were found that would change the policy statements.

2011 Update

Updated to incorporate reference to newly U.S. Food and Drug Administration (FDA-approved indication for Cymbalta in chronic musculoskeletal pain). No other significant updates to the literature were found.

2012 Update

Updated to allow for recent availability of generic escitalopram; thus, trial of generic citalopram is no longer a specific requirement for access to Lexapro. No other significant updates to the literature were found.

2014 Update

Updated to include newly available generic duloxetine and Khedezla, a new venlafaxine extended release product. No other significant changes to the literature were found at this time.

Page | 6 of 14 ∞ 2015 Update

Expanded the indication of Major Depressive Disorder to Depressive Disorders; Expanded the indication of Generalized Anxiety Disorder to Anxiety Disorders. Updated these new expanded indications with separate criteria: For patients with Depressive Disorders, trial and failure of at least two generically available second generation antidepressants; or patients with Anxiety Disorders, trial and failure of at least two generically available SSRIs, or at least one generically available SSRI and one generically available SNRI.

2016 Update

A literature search was performed for April 1, 2015 through December 6, 2016. No published randomized studies were found that would change existing policy statements.

2017 Update

A literature search was performed for July 1, 2016 through November 2, 2017. No published studies were found that would change existing policy statements.

2019 Update

A literature search was performed for December 1, 2018 through November 30, 2019. No published studies were found that would change existing policy statements.

2020 Update

No changes to policy statement. Combined depression and anxiety criteria into one table. Added a table documenting that all other uses of brand SSRI, SNRI, and any second- generation antidepressant for this policy are considered not medically necessary. Added a Length of Approval and Documentation Requirements table to policy.

Page | 7 of 14 ∞ 2021 Update

A literature search was performed for July 1, 2020 through June 30, 2021. No published studies were found that would change existing policy statements.

References

1. Rush, AJ, Pincus HA, First MB et al. Handbook of Psychiatric Measures, First Edition, pp100-102. 2000; Washington, DC, American Psychiatric Association Press. Rush AJ, op. cit., pp526-540.

2. Gartlehner G, Hansen RA, Kahwati L. Drug Class Review on Second Generation Antidepressants. 2011. Available at http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0009808/ Accessed July 29, 2021.

3. Lepola UM, Loft H, Reines EH. Escitalopram (10-20 mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol. 2003;18(4):211-217.

4. Burke WJ, Gergel I, Bose A. Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry. 2002;63(4):331-336.

5. Colonna L, Andersen HF, Reines EH. A randomized, double-blind, 24-week study of escitalopram (10 mg/day) versus citalopram (20 mg/day) in primary care patients with major depressive disorder. Curr Med Res Opin. 2005;21(10):1659-1668.

6. Moore N, Verdoux H, Fantino B. Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder. Int Clin Psychopharmacol. 2005;20(3):131-137.

7. Sechter D, Troy S, Paternetti S, Boyer P. A double-blind comparison of sertraline and fluoxetine in the treatment of major depressive episode in outpatients. Eur Psychiatry. 1999;14(1):41-48.

8. Fava M, Hoog SL, Judge RA, Kopp JB, Nilsson ME, Gonzales JS. Acute efficacy of fluoxetine versus sertraline and paroxetine in major depressive disorder including effects of baseline insomnia. J Clin Psychopharmacol. 2002;22(2):137-147.

9. Bennie EH, Mullin JM, Martindale JJ. A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression. J Clin Psychiatry. 1995;56(6):229-237.

10. Thompson C. Management of depression in real-life settings: knowledge gained from large scale clinical trials. Int Clin Psychopharmacol. 1994;9 Suppl 3:21-25.

11. Newhouse PA, Krishnan KR, Doraiswamy PM, Richter EM, Batzar ED, Clary CM. A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients. J Clin Psychiatry. 2000;61(8):559-568.

12. Chouinard G, Saxena B, Belanger MC, Ravindran A, Bakish D, Beauclair L et al. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder. J Affect Disord. 1999;54(1-2):39-48.

13. De Wilde J, Spiers R, Mertens C, Bartholome F, Schotte G, Leyman S. A double-blind, comparative, multicentre study comparing paroxetine with fluoxetine in depressed patients. Acta Psychiatr Scand. 1993;87(2):141-145.

14. Schone W, Ludwig M. A double-blind study of paroxetine compared with fluoxetine in geriatric patients with major depression. J Clin Psychopharmacol. 1993;13(6 Suppl 2):34S-39S.

15. Fava M, Amsterdam JD, Deltito JA, Salzman C, Schwaller M, Dunner DL. A double-blind study of paroxetine, fluoxetine, and placebo in outpatients with major depression. Ann Clin Psychiatry. 1998;10(4):145-150.

16. Fava M, Rosenbaum JF, Hoog SL, Tepner RG, Kopp JB, Nilsson ME. Fluoxetine versus sertraline and paroxetine in major depression: tolerability and efficacy in anxious depression. J Affect Disord. 2000;59(2):119-126.

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18. Gagiano CA. A double blind comparison of paroxetine and fluoxetine in patients with major depression. B J Clin Res. 1993;4:145-152.

19. Costa e Silva J. Randomized, double-blind comparison of venlafaxine and fluoxetine in outpatients with major depression. J Clin Psychiatry. 1998;59(7):352-357.

20. De Nayer A, Geerts S, Ruelens L, Schittecatte M, De Bleeker E, Van Eeckhoutte I et al. Venlafaxine compared with fluoxetine in outpatients with depression and concomitant anxiety. Int J Neuropsychopharmacol. 2002;5(2):115-120.

21. Rudolph RL, Feiger AD. A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression. J Affect Disord. 1999;56(2-3):171-181.

22. Silverstone PH, Ravindran A. Once-daily venlafaxine extended release (XR) compared with fluoxetine in outpatients with depression and anxiety. Venlafaxine XR 360 Study Group. J Clin Psychiatry. 1999;60(1):22-28.

23. Alves C, Cachola I, Brandao J. Efficacy and tolerability of venlafaxine and fluoxetine in outpatients with major depression. Primary Care Psychiatry. 1999;5(2):57-63.

24. Dierick M, Ravizza L, Realini R, Martin A. A double-blind comparison of venlafaxine and fluoxetine for treatment of major depression in outpatients. Prog Neuropsychopharmacol Biol Psychiatry. 1996;20(1):57-71.

25. Tylee A, Beaumont G, Bowden MW, Reynolds A. A double-blind, randomized, 12-week comparison study of the safety and efficacy of venlafaxine and fluoxetine in moderate to severe depression in general practice. Primary Care Psychiatry. 1997;3:51- 58.

26. Montgomery SA. Comparative efficacy and tolerability of escitalopram oxalate versus venlafaxine XR. Data on file, Forest Labs; 2004.

27. Bielski RJ, Ventura D, Chang CC. A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive disorder. J Clin Psychiatry. 2004;65(9):1190-1196.

28. Schatzberg AF, Kremer C, Rodrigues HE, Murphy GMJ. Double-blind, randomized comparison of mirtazapine and paroxetine in elderly depressed patients. Am J Geriatr Psychiatry. 2002;10(5):541-550.

29. Benkert O, Szegedi A, Kohnen R. Mirtazapine compared with paroxetine in major depression. J Clin Psychiatry. 2000;61(9):656- 663.

30. Behnke K, Sogaard J, Martin S, Bauml J, Ravindran AV, Agren H et al. Mirtazapine orally disintegrating tablet versus sertraline: a prospective onset of action study. J Clin Psychopharmacol. 2003;23(4):358-364.

31. Hong CJ, Hu WH, Chen CC, Hsiao CC, Tsai SJ, Ruwe FJ. A double-blind, randomized, group-comparative study of the tolerability and efficacy of 6 weeks' treatment with mirtazapine or fluoxetine in depressed Chinese patients. J Clin Psychiatry. 2003;64(8):921-926.

32. Feighner JP, Gardner EA, Johnston JA, Batey SR, Khayrallah MA, Ascher JA et al. Double-blind comparison of bupropion and fluoxetine in depressed outpatients. J Clin Psychiatry. 1991;52(8):329-335.

33. Coleman CC, King BR, Bolden-Watson C, Book MJ, Segraves RT, Richard N et al. A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine. Clin Ther. 2001;23(7):1040-1058.

34. Weihs KL, Settle ECJ, Batey SR, Houser TL, Donahue RM, Ascher JA. Bupropion sustained release versus paroxetine for the treatment of depression in the elderly. J Clin Psychiatry. 2000;61(3):196-202.

35. Kavoussi RJ, Segraves RT, Hughes AR, Ascher JA, Johnston JA. Double-blind comparison of bupropion sustained release and sertraline in depressed outpatients. J Clin Psychiatry. 1997;58(12):532-537.

36. Croft H, Settle EJ, Houser T, Batey SR, Donahue RM, Ascher JA. A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained release bupropion and sertraline. Clin Ther. 1999;21(4):643-658.

Page | 9 of 14 ∞ 37. Coleman CC, Cunningham LA, Foster VJ, Batey SR, Donahue RM, Houser TL et al. Sexual dysfunction associated with the treatment of depression: a placebo-controlled comparison of bupropion sustained release and sertraline treatment. Ann Clin Psychiatry. 1999;11(4):205-215.

38. Nieuwstraten CE, Dolovich LR. Bupropion versus selective serotonin-reuptake inhibitors for treatment of depression. Ann Pharmacother. 2001;35(12):1608-1613.

39. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363(9418):1341-1345.

40. Ekselius L, von Knorring L, Eberhard G. A double-blind multicenter trial comparing sertraline and citalopram in patients with major depression treated in general practice. Int Clin Psychopharmacol. 1997;12(6):323-331.

41. Sechter D, Troy S, Paternetti S, Boyer P. A double-blind comparison of sertraline and fluoxetine in the treatment of major depressive episode in outpatients. Eur Psychiatry. 1999;14(1):41-48.

42. Kroenke K, West SL, Swindle R, Gilsenan A, Eckert GJ, Dolor R et al. Similar effectiveness of paroxetine, fluoxetine, and sertraline in primary care: a randomized trial. JAMA. 2001;286(23):2947-2955.

43. Raskin J, Goldstein DJ, Mallinckrodt CH, Ferguson MB. Duloxetine in the long-term treatment of major depressive disorder. J Clin Psychiatry. 2003;64(10):1237-44.

44. Perahia, DG, Wang F, Mallinckrodt CH et al. Duloxetine in the treatment of major depressive disorder: a placebo- and paroxetine-controlled trial. Eur Psychiatry. May 10, 2006;[Epub ahead of print].

45. Goldstein DJ, Lu Y, Detke MJ et al. Duloxetine in the treatment of depression : a double-blind placebo-controlled comparison with paroxetine. J Clin Psychopharmacol. 2004;24(4):389-399.

46. Mackay FJ, Dunn NR, Wilton LV, Pearce GL, Freemantle SN, Mann RD. A comparison of , fluoxetine, sertraline and paroxetine examined by observational cohort studies. Pharmacoepid Drug Safety. 1997;6:235-246.

47. Segraves RT, Kavoussi R, Hughes AR, Batey SR, Johnston JA, Donahue R et al. Evaluation of sexual functioning in depressed outpatients: a double-blind comparison of sustained release bupropion and sertraline treatment. J Clin Psychopharmacol. 2000;20(2):122-128.

48. Clayton AH, Pradko JF, Croft HA, Montano CB, Leadbetter RA, Bolden-Watson C et al. Prevalence of sexual dysfunction among newer antidepressants. J Clin Psychiatry. 2002;63(4):357-366.

49. Aberg-Wistedt A, Agren H, Ekselius L, Bengtsson F, Akerblad AC. Sertraline versus paroxetine in major depression: clinical outcome after six months of continuous therapy. J Clin Psychopharmacol. 2000;20(6):645-652.

50. Nemeroff CB, Ninan PT, Ballenger J, Lydiard RB, Feighner J, Patterson WM et al. Double blind multicenter comparison of fluvoxamine versus sertraline in the treatment of depressed outpatients. 1995;3:163-169.

51. Feiger A, Kiev A, Shrivastava RK, Wisselink PG, Wilcox CX. Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction. J Clin Psychiatry. 1996;57(Suppl 2):53-62.

52. Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC. Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment. J Clin Psychiatry. 2000;61(11):863-867.

53. Michelson D, Amsterdam JD, Quitkin FM, Reimherr FW, Rosenbaum JF, Zajecka J et al. Changes in weight during a 1-year trial of fluoxetine. Am J Psychiatry. 1999;156(8):1170-1176.

54. Maina G, Albert U, Salvi V, Bogetto F. Weight gain during long-term treatment of obsessive-compulsive disorder: a prospective comparison between serotonin reuptake inhibitors. J Clin Psychiatry. 2004;65(10):1365-1371.

55. Croft H, Houser TL, Jamerson BD, Leadbetter R, Bolden-Watson C, Donahue R et al. Effect on body weight of bupropion sustained-release in patients with major depression treated for 52 weeks. Clin Ther. 2002;24(4):662-672.

56. Thase ME. Effects of venlafaxine on blood pressure: a meta-analysis of original data from 3744 depressed patients. J Clin Psychiatry. 1998;59(10):502-508.

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58. Buckley NA, McManus PR. Fatal toxicity of serotoninergic and other antidepressant drugs: analysis of United Kingdom mortality data. BMJ. 2002;325(7376):1332-1333.

59. Liu BA, Mittmann N, Knowles SR, Shear NH. Hyponatremia and the syndrome of nappropriate secretion of antidiuretic hormone associated with the use of selective serotonin reuptake inhibitors: a review of spontaneous reports. CMAJ. 1996;155(5):519-527.

60. Stewart DE. Hepatic adverse reactions associated with nefazodone. Can J Psychiatry. 2002;47(4):375-377.

61. Fochtmann LJ, Gelenberg AJ. Guideline watch (2005): practice guideline for the treatment of patients with major depressive disorder, 2nd edition. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bipolar-watch.pdf Accessed July 29, 2021.

62. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000;157:1-45.

63. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. http://focus.psychiatryonline.org/doi/abs/10.1176/foc.3.1.34?journalCode=foc Accessed July 29, 2021.

64. National Institute for Clinical Excellence (NICE). Depression in adults: The treatment and management of depression in adults. Last updated October, 2009. Available at: https://www.nice.org.uk/guidance/cg90 Accessed July 29, 2021.

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73. Gartlehner G, Gaynes BN, Hansen RA et al. Comparative benefits and harms of second-generation antidepressants: background paper for the American College of Physicians. Ann Intern Med. 2008 Nov 18;149(10):734-50.

74. Criteria reviewed and approved by the P&T Committee September 26, 2006.

75. Papakostas GI. Managing partial response or nonresponse: switching, augmentation and combination strategies for major depressive disorder. J Clin Psychiatry. 2009;70 Suppl 6:16-25

76. Little A. Treatment-resistant depression. Am Fam Physician. 2009 Jul 15;80(2):167-75.

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History

Date Comments 12/13/05 Add to Prescription Drug Section - New Policy—effective January 1, 2006.

08/08/06 Replace Policy - Policy reviewed with literature search by Pharmacy and Therapeutic Committee on July 25, 2006. Policy statement updated with exenatide and thiazolindinediones added as medically necessary; Policy Guidelines and Rationale sections updated; references added.

05/08/07 Replace Policy - Policy statement for exenatide updated with additional criteria; Policy Guidelines updated to reflect addition to policy statement. Reviewed by P&T on March 27, 2007.

06/12/07 Replace Policy - Policy statement on coverage criteria for exenatide (Byetta®), sitagliptin and (Nexium®) expanded; medically necessary indications for 5HT3 antagonists, Actiq® and Fentora™ added to policy statement. Policy Guidelines updated and Rationale updated; references added

12/11/07 Replace Policy - Policy reviewed with literature search by Pharmacy and Therapeutic Committee on May 15, 2007.Policy statement updated to include as either medically necessary or investigational under the criteria. Acyclovir, famciclovir and valacyclovir as medically necessary under criteria. References added.

04/08/08 Replace Policy - Policy updated with literature search by Pharmacy. Policy statement was updated to include fibromyalgia as a medically necessary indication under Pregabalin. References added.

12/16/08 Replace Policy - Policy updated with literature search by Pharmacy. Policy statement updated to include the use of leukotrience modifiers for the treatment of allergic rhinitis refractory to nasal under the medically necessary indication.

02/10/09 New PR Policy PR.5.01.520 - Policy information regarding antidepressants deleted from PR.5.01.605 and addressed in this new policy.

01/12/10 Replace Policy - Policy reviewed with literature search; no change to the policy statement. References added.

05/10/11 Replace Policy - Medically necessary policy statement on branded SSRI, SSNI and second generation antidepressants updated to require trial and failure two generic antidepressants as a condition to be met, where it was previously only one; chronic musculoskeletal pain has been added as an exception to the investigational indications for use of duloxetine (Cymbalta®). Title changed to “Antidepressants: Pharmacy Medical Necessity Criteria for Brands.” Reviewed by P&T in March 2011.

Page | 12 of 14 ∞ Date Comments 09/11/12 Replace policy. Policy updated with literature review. Policy Guidelines section updated to allow for recent availability of generic escitalopram; thus, trial of generic citalopram is no longer a specific requirement for access to Lexapro.

07/08/13 Replace policy. Policy Guidelines updated with Desvenlafaxine, a recently released second-generation SSRI used for treating depression, which may be approved following the failure of two generics, one being venlafaxine. Clarification was added to the policy that it is managed through the member’s pharmacy benefit; this is now listed in the header and within the coding section.

12/04/13 Replace policy. Policy section updated with Khedezla™ added to the list of SSRIs which may be approved when criteria are met.

03/10/14 Replace policy. Cymbalta removed from the scope of policy; prior authorization is no longer required. (NOTE: This is a non-formulary medication; therefore, prior authorization would be required for closed formulary.)

10/13/14 Interim update. Clarification made that policy applies to branded SSRI (selective serotonin reuptake inhibitor) and second generation antidepressants (antidepressants other than tricyclic and MAOI agents) from a single source.

07/14/15 Annual Review. Policy updated with literature review. The following updates were performed: Expanded the indication of Major Depressive Disorder to Depressive Disorders; Expanded the indication of Generalized Anxiety Disorder to Anxiety Disorders; Updated these new expanded indications with separate criteria: For patients with Depressive Disorders, trial and failure of at least two generically available second generation antidepressants, and for patients with Anxiety Disorders, trial and failure of at least two generically available SSRIs, or at least one generically available SSRI and one generically available SNRI.

10/13/15 Interim Update. Requirements of venlafaxine trial for Pristiq, Khedezla or Desvenlafaxine were removed. All brand antidepressants will have same criteria of any 2 generics first. No change to policy statement.

01/01/17 Annual Review, approved December 13, 2016. No published randomized studies were found that would change existing policy statements. Minor correction was made to the 2015 update, ie, addition of “trial and failure of a generically available SNRI.”

12/01/17 Annual Review, approved November 21, 2017. No published randomized studies were found that would change existing policy statements.

11/01/18 Annual Review, approved October 26, 2018. No changes to policy.

01/01/20 Annual Review, approved December 10, 2019. No changes to policy statement.

12/01/20 Annual Review, approved November 3, 2020. No changes to policy statement. Combined depression and anxiety criteria into one table. Added a table documenting that all other uses of brand SSRI, SNRI, and any second- generation antidepressant for this policy are considered not medically necessary. Added a Length of Approval and Documentation Requirements table to policy.

Page | 13 of 14 ∞ Date Comments 09/01/21 Annual Review, approved August 3, 2021. No changes to policy statement.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2021 Premera All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Page | 14 of 14 ∞

Discrimination is Against the Law Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa Premera Blue Cross complies with applicable Federal civil rights laws and yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee does not discriminate on the basis of race, color, national origin, age, odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa disability, or sex. Premera does not exclude people or treat them differently ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf because of race, color, national origin, age, disability or sex. yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin Premera: odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. • Provides free aids and services to people with disabilities to communicate Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. effectively with us, such as: • Qualified sign language interpreters Français (French): • Written information in other formats (large print, audio, accessible Cet avis a d'importantes informations. Cet avis peut avoir d'importantes electronic formats, other formats) informations sur votre demande ou la couverture par l'intermédiaire de • Provides free language services to people whose primary language is not Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous English, such as: devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit • Qualified interpreters d'obtenir cette information et de l’aide dans votre langue à aucun coût. • Information written in other languages Appelez le 800-722-1471 (TTY: 800-842-5357).

If you need these services, contact the Civil Rights Coordinator. Kreyòl ayisyen (Creole):

Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen If you believe that Premera has failed to provide these services or enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti discriminated in another way on the basis of race, color, national origin, age, asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan disability, or sex, you can file a grievance with: avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka Civil Rights Coordinator - Complaints and Appeals kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. PO Box 91102, Seattle, WA 98111 Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 san ou pa gen pou peye pou sa. Rele nan 800-722-1471 Email [email protected] (TTY: 800-842-5357).

You can file a grievance in person or by mail, fax, or email. If you need help Deutsche (German): filing a grievance, the Civil Rights Coordinator is available to help you. Diese Benachrichtigung enthält wichtige Informationen. Diese

Benachrichtigung enthält unter Umständen wichtige Informationen You can also file a civil rights complaint with the U.S. Department of Health bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera and Human Services, Office for Civil Rights, electronically through the Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Office for Civil Rights Complaint Portal, available at Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten U.S. Department of Health and Human Services zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in 200 Independence Avenue SW, Room 509F, HHH Building Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) (TTY: 800-842-5357). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Hmoob (Hmong):

Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum Getting Help in Other Languages tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue This Notice has Important Information. This notice may have important Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv information about your application or coverage through Premera Blue no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub Cross. There may be key dates in this notice. You may need to take action dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj by certain deadlines to keep your health coverage or help with costs. You yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob have the right to get this information and help in your language at no cost. ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau Call 800-722-1471 (TTY: 800-842-5357). ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Iloko (Ilocano): Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion

ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ። Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti Arabic): partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti) العربية salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti يحوي ھذا اإلشعار معلومات ھامة . قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti التغطية التي تريد الحصول عليھا من خالل Premera Blue Cross. قد تكون ھناك تواريخ مھمة .(bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357 في ھذا اإلشعار . وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة في دفع التكاليف . يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة . اتصل :(Italiano (Italian بـ(TTY: 800-842-5357) 800-722-1471 Questo avviso contiene informazioni importanti. Questo avviso può contenere 中文 (Chinese): informazioni importanti sulla tua domanda o copertura attraverso Premera 本通知有重要的訊息。 本通知可能有關於您透過 Premera Blue Cross 提交的 Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe 申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期 essere necessario un tuo intervento entro una scadenza determinata per 之前採取行動，以保留您的健康保險或者費用補貼。您有權利免費以您的母 consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. 語得到本訊息和幫助。請撥電話 。 800-722-1471 (TTY: 800-842-5357) Chiama 800-722-1471 (TTY: 800-842-5357).

037338 (07-2016) 日本語 (Japanese): Română (Romanian): この通知には重要な情報が含まれています。この通知には、 Premera Blue Prezenta notificare conține informații importante. Această notificare Cross の申請または補償範囲に関する重要な情報が含まれている場合があ poate conține informații importante privind cererea sau acoperirea asigurării ります。この通知に記載されている可能性がある重要な日付をご確認くだ dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în aceast notificare. Este posibil s fie nevoie s ac iona i pân la anumite さい。健康保険や有料サポートを維持するには、特定の期日までに行動を ă ă ă ț ț ă termene limită pentru a vă menține acoperirea asigurării de sănătate sau 取らなければならない場合があります。ご希望の言語による情報とサポー asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話 informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 ください。 (TTY: 800-842-5357).

한국어 (Korean): Pусский (Russian): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 Настоящее уведомление содержит важную информацию. Это 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 уведомление может содержать важную информацию о вашем Premera Blue Cross. 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 заявлении или страховом покрытии через В настоящем уведомлении могут быть указаны ключевые даты. Вам, 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 возможно, потребуется принять меры к определенным предельным 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . срокам для сохранения страхового покрытия или помощи с расходами. 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 Вы имеете право на бесплатное получение этой информации и 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 . помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357). ລາວ (Lao): Fa’asamoa (Samoan): ້ ້ ້ ້ ແຈ້ງການນີ ມີ ຂໍ ມູ ນສໍ າຄັ ນ. ແຈ້ງການນີ ອາດຈະມີ ຂໍ ມູ ນສໍ າຄັ ນກ່ ຽວກັບຄໍ າຮ້ອງສະ Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ໝັ ກ ຫືຼ ຄວາມຄຸ້ ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala ວັນທີ ສໍ າຄັ ນໃນແຈ້ງການນີ້ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົ ດ atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua ເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ ມຄອງປະກັນສຸ ຂະພາບ ຫືຼ ຄວາມຊ່ວຍເຫືຼ ອເລື່ ອງ atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le ້ ້ ຄ່ າໃຊ້ຈ່າຍຂອງທ່ານໄວ້ . ທ່ານມີ ສິ ດໄດ້ ຮັບຂໍ ມູ ນນີ ແລະ ຄວາມຊ່ວຍເຫືຼ ອເປັ ນພາສາ aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai ຂອງທ່ານໂດຍບໍ່ ເສຍຄ່ າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357). i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i 徶羶ែខមរ (Khmer): ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). េសចកតជី ូនដណំ ឹងេនះ掶នព័ត៌掶ន架៉ ងស޶នំ។ ់ េសចកតីជូនដំណឹងេនះរបែហល ᾶ掶នព័ត៌掶ន架៉ ងសំ޶ន់អពំ ីទរមង់ ែបបបទ ឬζរ殶៉ បរង់ របសអ់ នក㾶មរយៈ Español (Spanish): Premera Blue Cross ។ របែហលᾶ掶ន ζលបរ េចិ ឆទសំ޶ន់េ俅កន ុងេសចកតជី ូន Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a ដណំ ងេនះ។ឹ អនករបែហលᾶរតវζរបេញូ ច ញសមត徶ពថ ដលក់ ណតំៃថ ់ ងᾶកច厶់ ស់ través de Premera Blue Cross. Es posible que haya fechas clave en este 侶侶 េដើមបីនងរកឹ 羶ទកζរ䮶侶ុ 殶៉ បរង់ សខ徶ពរបសុ ់អនក ឬរ厶កជ់ ំនួយេចញៃថល។ aviso. Es posible que deba tomar alguna medida antes de determinadas អនក掶នសទិ ធទទិ ួលព័ត掶នេ៌ នះ និងជំនួយេ俅កន ុង徶羶របស់អនកេ⮶យមនអសិ fechas para mantener su cobertura médica o ayuda con los costos. Usted លយេឡុ ើយ។ សូ មទូរស័ពទ 800-722-1471 (TTY: 800-842-5357)។ tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

ਪ ੰ ਜਾਬੀ (Punjabi): Tagalog (Tagalog): ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ƒ ਤੁਹਾਡੀ Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਕਵਰਜੇ ਅਤ ੇ ਅਰਜੀ ਬਾਰ ੇ ਮਹ ੱ ਤਵਪਰਨੂ ਜਾਣਕਾਰੀ ਹ ੋ ਸਕਦੀ ਹ ੈ . ਇਸ ਨ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ . tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue ਹੋ ਸਕਦੀਆਂ ਹਨ ਜੇਕਰ ਤਸੀੁ ਜਸਹਤ ਕਵਰਜੇ ਿਰੱ ਖਣੀ ਹਵੋ ੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring ਇਛ ੱ ੁਕ ਹ ੋ ਤ拓 ਤਹਾਨ ੁ ੰ ੂ ਅ ੰ ਤਮ ਤਾਰੀਖ਼ ਤ ƒ ਪਿਹਲ拓 ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੱ ਕਣ ੁ ਦੀ ਲੋੜ ਹ ੋ ਸਕਦੀ ਹ ੈ ,ਤੁਹਾਨੰ ੂ mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang ਮਫ਼ਤੁ ਿਵੱ ਚ ਤ ੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤ ੇ ਮਦਦ ਪਾਪਤ㘰 ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na 800-722-1471 (TTY: 800-842-5357). walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 .(Farsi): (TTY: 800-842-5357) فارسی اين اعالميه حاوی اطالعات مھم ميباشد .اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم :(ไทย (Thai تقاضا و يا پ وشش بيمه ای شما از طريق Premera Blue Cross باشد . به تاريخ ھای مھم در ั ประกาศนมข้ี ี ้อมลส ู ําคญ ั ประกาศนอาจม ้ี ีข ้อมลท ู ่ีส ําคญเก ั ่ียวกบการการสม ัครหร ั ือขอบเขตประกน اين اعالميه توجه نماييد .شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه . สขภาพของคุณผ ุาน ่ Premera Blue Cross และอาจมีก ําหนดการในประกาศนี ้ คณอาจจะต ุ ้อง ھای درمانی تان، به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد شما حق اين را داريد که اين اطالعات و ک مک را به زبان خود به طور رايگان دريافت نماييد . برای کسب ี่ ดําเน ินการภายในกาหนดระยะเวลาท ํ ่ีแนนอนเพ ่ ่ือจะร ักษาการประกนส ัขภาพของค ุณหร ุ ือการช ่วยเหล ือท اطالعات با شماره 1471-722-800 (کاربران TTY تماس باشماره 5357-842-800) تماس มคี่้่าใชจาย คณม ุีิิ่ี้ัู้สทธทจะไดรบขอมลและความชวยเหล ่ ื้ีอนในภาษาของคณโดยไม ุ่มค ี่้่าใชจาย โทร برقرار نماييد . 800-722-1471 (TTY: 800-842-5357) Polskie (Polish): To og oszenie mo e zawiera wa ne informacje. To og oszenie mo e ł ż ć ż ł ż Український (Ukrainian): zawiera wa ne informacje odno nie Pa stwa wniosku lub zakresu ć ż ś ń Це повідомлення містить важливу інформацію. Це повідомлення świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na може містити важливу інформацію про Ваше звернення щодо kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie страхувального покриття через Premera Blue Cross. Зверніть увагу на przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub ключові дати, які можуть бути вказані у цьому повідомленні. Існує pomocy zwi zanej z kosztami. Macie Pa stwo prawo do bezp atnej ą ń ł імовірність того, що Вам треба буде здійснити певні кроки у конкретні informacji we własnym języku. Zadzwońcie pod 800-722-1471 кінцеві строки для того, щоб зберегти Ваше медичне страхування або (TTY: 800-842-5357). отримати фінансову допомогу. У Вас є право на отримання цієї

інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за Português (Portuguese): номером телефону 800-722-1471 (TTY: 800-842-5357). Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio Tiếng Việt (Vietnamese): do Premera Blue Cross. Poderão existir datas importantes neste aviso. Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông Talvez seja necessário que você tome providências dentro de tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua determinados prazos para manter sua cobertura de saúde ou ajuda de chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông custos. Você tem o direito de obter esta informação e ajuda em seu idioma báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357). để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).