MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Antidepressants: Pharmacy Medical Necessity Criteria for Brands

Number 5.01.520*

Effective Date March 10, 2014

Revision Date(s) 03/10/14; 11/11/13; 07/08/13; 07/30/12; 05/10/11; 01/12/10; 2/10/09

Replaces N/A

*This policy is managed through the Pharmacy benefit.

Policy

Branded SSRI, 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 at least two generically available second generation antidepressants.

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

Related Policies

5.01.521

Pharmacologic Treatment of Neuropathy, Fibromyalgia and Seizure Disorders

5.01.605

Medical Necessity Criteria for Pharmacy Edits

Policy Guidelines

Branded SSRI, SNRI and any second generation antidepressant may be covered under the following circumstances:

  • Patient with major depressive disorder or generalized anxiety disorder has had a trial and failure of at least two generically available second generation antidepressant (examples of, but not limited to; fluoxetine, sertraline, venlafaxine, bupropion, mirtazepine).
  • For approval of Pristiq®, Khedezla™ or Desvenlafaxine, the patient must have failed at least two generics meeting the above criteria, one of which must be venlafaxine.

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 recent 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

A recent 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 medications 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 serotonergic, noradrenergic and dopaminergic activity.

This policy applies to the following medications:

  • Branded SSRI (selective serotonin reuptake inhibitor), SNRI (serotonin/norepinephrine reuptake inhibitor) and any other second generation antidepressants (antidepressants other than tricyclic and MAOI agents).

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 services representative to determine whether there are any benefit limitations applicable to this service or supply. This medical does not apply to Medicare Advantage.

Benefit Application

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

Rationale

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.

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, nortriptyline, 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.

References

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  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/ Last accessed March 14, 2014.
  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.
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  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.
  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 fluvoxamine, 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.
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  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.
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  74. Criteria reviewed and approved by the P&T Committee September 26, 2006.
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Coding

Codes

Number

Description

 

 

This policy is managed through the Pharmacy benefit.

Type of Service

Prescription Drug

 

Place of Service

Inpatient/
Physician's Office

 

Appendix

N/A

History

Date

Reason

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 esomeprazole (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 Pregabalin 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 corticosteroids 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.

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.)


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).
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