Subject: Stelara 2010-A SGM P2022

Drug

STELARA  (ustekinumab)

Policy:

I.    INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. 

FDA-Approved Indications
1.   Moderate to severe plaque psoriasis (PsO) in patients 6 years or older who are candidates for
      phototherapy or systemic therapy
2.   Active psoriatic arthritis (PsA) alone or in combination with methotrexate (MTX).
3.   Moderately to severely active Crohn’s disease (CD)
4.   Moderately to severely active ulcerative colitis (UC)

All other indications are considered experimental/investigational and not medically necessary. 

II.  DOCUMENTATION 

Submission of the following information is necessary to initiate the prior authorization review: 

A.   Plaque psoriasis
      1.   Initial requests:
            i.   Chart notes or medical record documentation of affected area(s) and body surface
                 area (BSA) affected.
            ii.  Chart notes, medical record documentation, or claims history supporting previous
                 medications tried (if applicable), including response to therapy. If therapy is not advisable,
                 documentation of clinical reason to avoid therapy.
      2.   Continuation requests: Chart notes or medical record documentation of decreased body surface
            area (BSA) affected and/or improvement in signs and symptoms.

B.   Psoriatic arthritis: For continuation requests: Chart notes or medical record documentation
      supporting positive clinical response. 

C.   Crohn’s disease
      1.   Initial requests:
            i.   Chart notes, medical record documentation, or claims history supporting previous medications
                 tried (if applicable), including response to therapy. If therapy is not advisable, documentation of
                 clinical reason to avoid therapy.
            ii.  Chart notes or medical record documentation supporting diagnosis of fistulizing Crohn’s
                disease (if applicable)
      2.   Continuation requests: Chart notes or medical record documentation supporting positive clinical
            response to therapy or remission.

D.   Ulcerative colitis
      1.   Initial requests: Chart notes, medical record documentation, or claims history supporting previous
            medications tried (if applicable), including response to therapy. If therapy is not advisable,
            documentation of clinical reason to avoid therapy.
      2.   Continuation requests: Chart notes or medical record documentation supporting positive clinical
            response to therapy or remission. 

III. CRITERIA FOR INITIAL APPROVAL 

A.   Moderate to severe plaque psoriasis (PsO)
      1.   Authorization of 12 months may be granted for members who previously received Otezla or a
            biologic indicated for the treatment of moderate to severe plaque psoriasis. 

      2.   Authorization of 12 months may be granted for treatment of moderate to severe plaque psoriasis
            in members when any of the following criteria is met:
            i.   Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)
                 are affected.
            ii.  At least 10% of the body surface area (BSA) is affected
            iii. At least 3% of body surface area (BSA) is affected and the member meets any of the following criteria:
                a.   Member has had an inadequate response or intolerance to either phototherapy
                      (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin.
                b.   Member has a clinical reason to avoid pharmacologic treatment with methotrexate,
                      cyclosporine and acitretin (see Appendix A). 

B.   Active psoriatic arthritis (PsA)
      Authorization of 12 months may be granted for treatment of active psoriatic arthritis (PsA).

C.   Moderately to severely active Crohn’s disease (CD)
      1.   Authorization of 12 months may be granted for members who have previously received a
            biologic indicated for the treatment of Crohn’s disease. 

      2.   Authorization of 12 months may be granted for the treatment of moderately to severely
            active CD when the member has had an inadequate response, intolerance, or contraindication
            to at least one conventional therapy option (see Appendix B). 

      3.   Authorization of 12 months may be granted for the treatment of fistulizing CD.

D.   Moderately to severely active ulcerative colitis (UC)
      1.   Authorization of 12 months may be granted for members who have previously received a
            biologic or targeted synthetic drug (e.g., Xeljanz) indicated for moderately to severely active
            ulcerative colitis. 

      2.   Authorization of 12 months may be granted for the treatment of moderately to severely active UC
            when the member has had an inadequate response, intolerance, or contraindication to at least
            one conventional therapy option (see Appendix C).

IV.  CONTINUATION OF THERAPY 

A.   Moderate to severe plaque psoriasis (PsO)
      Authorization of 12 months may be granted for all members (including new members) who are
      using the requested medication for moderate to severe plaque psoriasis and who achieve or
      maintain positive clinical response as evidenced by low disease activity or improvement in signs
      and symptoms of the condition when any of the following is met:
      1.   Reduction in body surface area (BSA) affected from baseline
      2.   Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning,
            cracking, pain)

B.   Active psoriatic arthritis (PsA)
       Authorization of 12 months may be granted for all members (including new members) who are using the
       requested medication for active psoriatic arthritis and who achieve or maintain positive clinical response
       as evidenced by low disease activity or improvement in signs and symptoms of the condition when there
       is improvement in any of the following from baseline:
       1.   Number of swollen joints
       2.   Number of tender joints
       3.   Dactylitis
       4.   Enthesitis
       5.   Skin and/or nail involvement

      C.   Moderately to severely active Crohn’s Disease (CD)
            1.   Authorization of 12 months may be granted for all members (including new members) who are
                  using the requested medication for moderately to severely active Crohn’s disease and who achieve or
                  maintain remission. 

      2.   Authorization of 12 months may be granted for all members (including new members) who are using the
            requested medication for moderately to severely active Crohn’s disease and who achieve or maintain a
            positive clinical response as evidenced by low disease activity or improvement in signs and symptoms
            of the condition when there is improvement in any of the following from baseline:
            i.   Abdominal pain or tenderness
            ii.  Diarrhea
            iii. Body weight
            iv. Abdominal mass
            v.  Hematocrit
            vi. Endoscopic appearance of the mucosa
            vi. Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score) 

D.   Moderately to severely active ulcerative colitis
      1.   Authorization of 12 months may be granted for all members (including new members) who are using
            the requested medication for moderately to severely active ulcerative colitis and who achieve or
            maintain remission. 

      2.   Authorization of 12 months may be granted for all members (including new members) who are
            using the requested medication for moderately to severely active ulcerative colitis and who achieve
            or maintain a positive clinical response as evidenced by low disease activity or improvement in signs
            and symptoms of the condition when there is improvement in any of the following from baseline:
            i.   Stool frequency
            ii.  Rectal bleeding
            iii. Urgency of defecation
            iv. C-reactive protein (CRP)
            v.  Fecal calprotectin (FC)
            vi. Endoscopic appearance of the mucosa
            vii. Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index of
                 Severity [UCEIS], Mayo score) 

V.   OTHER 

For all indications: Member has had a documented negative TB test (which can include a tuberculosis skin test [PPD], an interferon-release assay [IGRA], or a chest x-ray)* within 6 months of initiating therapy for persons who are naïve to biologic DMARDs or targeted synthetic DMARDs associated with an increased risk of TB. 

* If the screening testing for TB is positive, there must be further testing to confirm there is no active disease. Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication. 

For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug. 

Stelara for intravenous administration is FDA-approved for the treatment of Crohn’s disease and ulcerative colitis and will only be authorized for these conditions. 

VI.  DOSAGE AND ADMINISTRATION 

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

Special Notes:

VII. APPENDICES 

Appendix A: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine or Acitretin.
1.   Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease
2.   Breastfeeding
3.   Drug interaction
4.   Cannot be used due to risk of treatment-related toxicity
5.   Pregnancy or currently planning pregnancy
6.   Significant comorbidity prohibits use of systemic agents (examples include liver or kidney disease,
      blood dyscrasias, uncontrolled hypertension)

Appendix B: Examples of Conventional Therapy Options for CD
1.   Mild to moderate disease – induction of remission:
      a.   Oral budesonide
      b.   Alternatives: metronidazole, ciprofloxacin, rifaximin
2.   Mild to moderate disease – maintenance of remission:
      a.   Azathioprine, mercaptopurine
      b.   Alternatives: oral budesonide, methotrexate intramuscular (IM) or subcutaneous (SC), sulfasalazine
3.   Moderate to severe disease – induction of remission:
      a.   Prednisone, methylprednisolone intravenous (IV)
      b.   Alternatives: methotrexate IM or SC
4.   Moderate to severe disease – maintenance of remission:
      a.   Azathioprine, mercaptopurine
      b.   Alternative: methotrexate IM or SC
5.   Perianal and fistulizing disease – induction of remission:
      a.   Metronidazole ± ciprofloxacin, tacrolimus
6.   Perianal and fistulizing disease – maintenance of remission:
      a.   Azathioprine, mercaptopurine
      b.   Alternative: methotrexate IM or SC 

Appendix C: Examples of conventional therapy options for UC
1.   Mild to moderate disease – induction of remission:
      a.   Oral mesalamine (e.g., Asacol, Asacol HD, Lialda, Pentasa), balsalazide, olsalazine
      b.   Rectal mesalamine (e.g., Canasa, Rowasa)
      c.   Rectal hydrocortisone (e.g., Colocort, Cortifoam)
      d.   Alternatives: prednisone, azathioprine, mercaptopurine, sulfasalazine
2.   Mild to moderate disease – maintenance of remission:
      a.   Oral mesalamine, balsalazide, olsalazine, rectal mesalamine
      b.   Alternatives: azathioprine, mercaptopurine, sulfasalazine                                                                              
3.   Severe disease – induction of remission:
      a.   Prednisone, hydrocortisone IV, methylprednisolone IV
      b.   Alternatives: cyclosporine IV, tacrolimus, sulfasalazine                                                                       
4.   Severe disease – maintenance of remission:
      a.   Azathioprine, mercaptopurine
      b.   Alternative: sulfasalazine                                                    

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; December 2020.
2. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
3. Gossec L,Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712.  
4. Gladman DD, Antoni C, P Mease, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64(Suppl II):ii14–ii17.
5. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
6. Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
7. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
8. Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on 15 November 2021 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
9. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
10. Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
11. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology 2020; 158:1450.
12. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726.
13. Menter, A, Cordero, KM, Davis, DM, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):151-201.
14. Menter, A, Gelfand, JM, Connor, C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6): 1445-86.
15. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology 2021; 160: 2496- 2508.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 26, 2022