Prior Authorization Approval Criteria - Denver Health Medical Plan

230 Pages·2014·2.02 MB·English

by  Raines, Joshua

Prior Authorization Approval Criteria

Effective Date: 01/01/2015

This document contains Prior Authorization Approval Criteria for the following medications:

1. Abilify (aripiprazole)
2. Abilify Maintena (aripiprazole long-acting injectable)
3. Adcirca (tadalafil)
4. Amitiza (lubiprostone)
5. Ampyra (dalfampridine)
6. Anzemet (dolasetron)
7. Aranesp (darbepoetin alfa)
8. Aubagio (teriflunomide)
9. Azilect (rasagiline)
10. Celebrex (celecoxib)
11. Cimzia (certolizumab)
12. Coartem (artemether/lumefantrine)
13. Copaxone 40 mg (glatiramer)
Page 1 of 4
14. Cuprimine/Depen (penicillamine)
15. D.H.E. 45 (dihydroergotamine injection)
16. Daytrana (methylphenidate extended release transdermal system)
17. Dovonex (calcipotriene)
18. EMSAM (selegiline transdermal system)
19. Entocort EC (budesonide)
20. Ergomar (ergotamine)
21. Exjade (deferasirox)
22. Fanapt (iloperidone)
23. Focalin (dexmethylphenidate)
24. Focalin XR (dexmethylphenidate extended release)
25. Gilenya (fingolimod)
26. Gleevec (imatinib)
27. Hycamtin (oral topotecan)
28. Hydergine (ergoloid mesylates)
29. Incivek (telaprevir)
30. Intuniv (guanfacine extended release)
31. Invega (paliperidone)
32. Invega Sustenna (paliperidone palmitate)
33. IVIG (intravenous immunoglobulin)
34. Kapvay (clonidine extended release)
35. Kineret (anakinra)
36. Latuda (lurasidone)
37. Letairis (ambrisentan)
38. Leukine (sargramostim)
39. Levitra (vardenafil)
40. Lunesta (eszopiclone)
41. Lysteda (tranexamic acid)
42. Neupogen (filgrastim)
43. Nexavar (sorafenib)
44. Novarel (chorionic gonadotropin)
45. Nuedexta (dextromethorphan/quinidine)
46. Orap (pimozide)
Page 2 of 4
47. Paxil CR (paroxetine extended release)
48. Pristiq (desvenlafaxine)
49. Qualaquin (quinine sulfate)
50. Remicade (infliximab)
51. Revatio (sildenafil)
52. Revlimid (lenalidomide)
53. Risperdal Consta (risperidone long-acting injection)
54. Rozerem (ramelteon)
55. Sandostatin (octreotide acetate)
56. Saphris (asenapine)
57. Sensipar (cinalcalcet)
58. Seroquel XR (quetiapine XR)
59. Silenor (doxepin)
60. Somatropin
61. Somatuline Depot (lanreotide acetate)
62. Somavert (pegvisomant)
63. Sonata (zaleplon)
64. Soriatane (acitretin)
65. Sovaldi (sofosbuvir)
66. Sporanox (itraconazole)
67. Sprycel (dasatinib)
68. Strattera (atomoxetine)
69. Sutent (sunitinib)
70. Tarceva (erlotinib)
71. Tecfidera (dimethyl fumarate)
72. Thalomid (thalidomide)
73. Tracleer (bosentan)
74. Ventavis (iloprost)
75. Vfend (voriconazole)
76. Viibryd (vilazodone)
77. Vyvanse (lisdexamfetamine dimesylate)
78. Xeloda (capecitabine)
79. Zavesca (miglustat)
Page 3 of 4
80. Zyprexa Relprevv (olanzapine pamoate extended release injection)
81. Zytiga (abiraterone)

Page 4 of 4
Prior Authorization Approval Criteria
Abilify (aripiprazole)

Generic name: aripiprazole
Brand name: Abilify
Medication class: Antipsychotic

FDA-approved uses:
• Treatment of schizophrenia in adults and adolescents (ages 13-17)
• Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
and pediatric patients (ages 10-17)
• Maintenance treatment of bipolar I disorder in adults
• Adjunctive treatment of major depressive disorder in adults
• Treatment for irritability with autistic disorder in pediatric patients (ages 6-17 years)

Usual dose range:
• Schizophrenia – adults 10 mg-30mg/day
• Schizophrenia – adolescents 2 mg-30 mg/day
• Bipolar mania – adults 15 mg-30 mg/day
• Bipolar mania – pediatric patients 2 mg-30 mg/day
• Irritability associated with autistic disorder 2mg-15 mg/day
• As an adjunct to antidepressants for the 2 mg-15 mg/day
treatment of major depressive disorder - adults

Criteria for use: (bullet points are all inclusive unless otherwise noted)
Initiation criteria
Schizophrenia:
Adults
• FDA indicated diagnosis
• 18 years of age or older
• Failure to respond (or intolerance) to an adequate trial (4-6 weeks) of
three formulary antipsychotic agents

Adolescents (13-17yrs)
• FDA indicated diagnosis
• Age 13 to 17 years of age
• Failure to respond (or intolerance) to an adequate trial (30 days) of one
formulary atypical antipsychotic

Page 1 of 5
Bipolar I Disorder:
Adults
• FDA indicated diagnosis
• 18 years of age or older
• Failure to respond (or intolerance) to an adequate trial (at least 30 days
with adequate blood levels) of each of the following:
Lithium,
o
Valproic acid,
o
Two formulary antipsychotic agents
o

Adolescents (10-17yrs)
• FDA indicated diagnosis
• Age 10 to 17 years of age
• Failure to respond (or intolerance) to an adequate trial (30 days) of one
formulary atypical antipsychotic

Major depressive disorder:
Adults
• FDA indicated diagnosis
• 18 years of age or older
• Failure to respond (or intolerance) to an adequate trial (4-6 weeks of an
adequate dose) of each of the following:
A Selective Serotonin Reuptake Inhibitor (SSRI),
o
A Serotonin and Norepinephrine Reuptake Inhibitor (SNRI),
o
Combination trial of an SSRI or SNRI with bupropion
o
Combination trial of an SSRI or SNRI with lithium
o
A combination trial of a SSRI or SNRI and quetiapine (unless BMI>35
o
or BMI>30 with multiple risk factors (HTN/DM/etc))
• Must be used as adjunctive or add-on treatment to antidepressant
therapy and not as monotherapy

Irritability associated with autistic disorder:
Children (6-17yrs)
• FDA indicated diagnosis
• Age 6 to 17 years of age
• Failure to respond (or intolerance) to an adequate trial (30 days) of one
formulary atypical antipsychotic

Page 2 of 5
Renewal criteria
All FDA indicated diagnoses:
• Must have documentation of adherence to therapy (>75% adherence)
• Documentation of effectiveness of therapy

Contraindications:
• Known hypersensitivity to aripiprazole

Not approved if:
• Past history of neuroleptic malignant syndrome, seizures, or dementia-related psychosis
• Current history of orthostatic hypotension
• Used for treatment of Bipolar Depression
• Combining with another antipsychotic unless patient has tried maximum tolerated
doses of all of the following as monotherapy:
Clozapine
o
Two other antipsychotics
o

Black box warning:
• Children, adolescents, and young adults taking antidepressants for major depressive
disorder and other psychiatric disorders are at increased risk of suicidal thinking and
behavior.
• Elderly patients with dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.

Additional considerations:
• Maximum daily dose is 30 mg/day

Approval time frames:
• Initial – 6 months with MDL of 1/day
• Renewal – 1 year with MDL of 1/day

Page 3 of 5
References:
• Abilify Prescribing Information (2013). Bristol-Myers Squibb Company, Princeton, NJ.
• American Psychiatric Association. Five things physicians and patients should question [guideline on the
internet, cited May 1 2014]. Available from: http://www.choosingwisely.org/doctor-patient-
lists/american-psychiatric-association/
• Edwards SJ, Hamilton V, Nherera L, Trevor N. Lithium or an atypical antipsychotic drug in the management
of treatment-resistant depression: a systematic review and economic evaluation. Health Technol Assess.
2013;17(54):1-190.
• PL Detail-Document, Comparison of Atypical Antipsychotics. Pharmacist’s Letter/Prescriber’s Letter.
October 2012.
• PL Detail-Document, Off-label Use of Atypical Antipsychotics in Adults. Pharmacist’s Letter/Prescriber’s
Letter. December 2011.
• PL Detail-Document, Atypical Antipsychotics in Kids. Pharmacist’s Letter/Prescriber’s Letter. January 2012.
• American Academy of Child and Adolescent Psychiatry. Practice Parameter For The Use Of Atypical
Antipsychotic Medications In Children And Adolescents 2011
http://www.aacap.org/App_Themes/AACAP/docs/practice_parameters/Atypical_Antipsychotic_Medicati
ons_Web.pdf
• American Psychiatric Association. Guideline Watch (September 2009): Practice Guideline for the
Treatment of Patients with Schizophrenia. September 2009.
• NICE (2009) Schizophrenia: Core Interventions in the Treatment and Management of Schizophrenia in
Adults in Primary and Secondary Care. NICE clinical guideline 82. Available at www.nice.org.uk/CG82
[NICE guideline]
• American Psychiatric Association. Practice guideline for the treatment of patients with major depressive
disorder (3rd Edition). October 2010. http://www.psych.org/guidelines/mdd2010.
• Treatment-resistant depression: an update. Pharmacist's Letter/Prescriber's Letter 2009;25(5):250510.
• Sussman N. Translating science into service: lessons learned from the Sequenced Treatment Alternatives
to Relieve Depression (STAR*D) study. Prim Care Companion J Clin Psychiatry 2007;9:331-7.
• Nierenberg AA, Fava M, Trivedi MH, et al. A comparison of lithium and T3 augmentation following two
failed medication treatments for depression: a STAR*D report. Am J Psychiatry 2007;163:1519-30.
• Marcus RN, McQuade RD, Carson WH, et al. The Efficacy and Safety of Aripiprazole as Adjunctive Therapy
in Major Depressive Disorder. A Second Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study. J Clin Psychopharmacol 2008;28:156–165.
• Thase ME, Jonas A, Khan A, et al. Aripiprazole monotherapy in nonpsychotic bipolar I depression: results
of 2 randomized, placebo-controlled studies. J Clin Psychopharmacol. 2008;28(1):13-20.
• Berman RM, Marcus RN, Swanink R, et al. The Efficacy and Safety of Aripiprazole as Adjunctive Therapy in
Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. J Clin
Psychiatry 2007;68:843–853.
• Berman RM, Fava M, Thase ME, et al. Aripiprazole Augmentation in Major Depressive Disorder: A Double-
Blind, Placebo-Controlled Study in Patients with Inadequate Response to Antidepressants. CNS Spectr.
2009;14(4):197-206
• Future Research Needs for First- and Second-Generation Antipsychotics for Children and Young Adults
[Internet].Future Research Needs Papers, No. 13. Christian R, Saavedra L, Gaynes BN, et al. Rockville (MD):
Agency for Healthcare Research and Quality (US); February 2012 Feb.
http://www.ncbi.nlm.nih.gov/books/NBK84656/
• American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia,
second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56. Available from:
http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1682213.

Page 4 of 5
Formal Review as per Rx-DOP-3.0 Criteria Development and Maintenance Procedures:
Initial: 06/28/2013
Revision: 06/28/2014

Page 5 of 5
Prior Authorization Approval Criteria
Abilify Maintena
(aripiprazole long-acting injectable)

Generic name: aripiprazole long-acting injectable
Brand name: Abilify Maintena
Medication class: Antipsychotic

FDA-approved uses:
• Treatment of schizophrenia in adults

Usual dose range:
• Schizophrenia – adults 400mg monthly

Criteria for use: (bullet points are all inclusive unless otherwise noted)
Initiation criteria
Schizophrenia:
Adults
• FDA indicated diagnosis
• 18 years of age or older
• Documented response to oral aripiprazole
• Patient has a history of noncompliance and/or refuses to utilize oral
medication and documentation that patient education and other efforts
to improve adherence have been attempted
• Failure to respond (or intolerance) to an adequate trial (4-6 weeks) of
each of the following:
Risperidone extended release IM (Risperdal Consta)
o
Haldol decanoate or fluphenazine decanoate
o

Renewal criteria
Schizophrenia:
• Must have documentation of adherence to therapy (>95% compliance)
• Documentation of effectiveness of therapy
• Documentation of continued need for long-acting injection (including a review of
adherence with other oral medications)

Contraindications:
• Known hypersensitivity to aripiprazole.

Page 1 of 3