Subject: Simponi 2014-A SGM P2021a

Drug

SIMPONI  (golimumab for subcutaneous injection)

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. 

A.   FDA-Approved Indications
      1.   Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
      2.   Active psoriatic arthritis (PsA), alone or in combination with methotrexate
      3.   Active ankylosing spondylitis (AS)
      4.   Moderately to severely active ulcerative colitis (UC) who have demonstrated corticosteroid dependance
            or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids,
            azathioprine, or 6-mercaptopurine for inducing and maintaining clinical response, improving endoscopic
            appearance of the mucosa during induction, inducing clinical remission, and achieving and sustaining clinical
            remission in induction responders. 

B.   Compendial Use
      Axial spondyloarthritis

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.   Rheumatoid arthritis (RA)
      1.   For 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.   Laboratory results, chart notes, or medical record documentation of biomarker testing (i.e., rheumatoid
                 factor [RF], anti-cyclic citrullinated peptide [anti-CCP], and C-reactive protein [CRP] and/or 
                 erythrocyte sedimentation rate [ESR]) (if applicable).

      2.   For continuation requests: Chart notes or medical record documentation supporting positive clinical response. 

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

C.   Ankylosing spondylitis (AS) and axial spondyloarthritis
      1.   Initial requests: Chart notes, medical record documentation, or claims history supporting previous
            medications tried (if applicable). 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. 

D.   Ulcerative colitis (UC)
      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.   Moderately to severely active rheumatoid arthritis (RA)
      1.   Authorization of 12 months may be granted for members who have previously received a biologic or
            targeted synthetic DMARD (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active rheumatoid
            arthritis. The requested medication must be prescribed in combination with methotrexate or leflunomide
            unless the member has a clinical reason not to use methotrexate (see Appendix A) or leflunomide.
      2.   Authorization of 12 months may be granted for treatment of moderately to severely active RA when all
            of the following criteria are met:
            i.   Member meets either of the following criteria:
                 a.   Member has been tested for either of the following biomarkers and the test was positive:
                       1.   Rheumatoid factor (RF)
                       2.   Anti-cyclic citrullinated peptide (anti-CCP)
                 b.   Member has been tested for ALL of the following biomarkers:
                       1.   RF
                       2.   Anti-CCP
                       3.   C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
           ii.   Member is prescribed the requested medication in combination with methotrexate or leflunomide or
                has a clinical reason not to use methotrexate (see Appendix A) or leflunomide.
           iii.  Member meets either of the following criteria:
                a.   Member has experienced an inadequate response to at least a 3-month trial of methotrexate
                      despite adequate dosing (i.e., titrated to at least 15 mg/week).
                b.   Member has an intolerance or contraindication to methotrexate (see Appendix A). 

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

C.   Active ankylosing spondylitis (AS) and active axial spondyloarthritis
      1.   Authorization of 12 months may be granted for members who have previously received a biologic
            indicated for active ankylosing spondylitis or active axial spondyloarthritis. 

      2.   Authorization of 12 months may be granted for treatment of active ankylosing spondylitis and active
            axial spondyloarthritis when any of the following criteria is met:
            a.   Member has experienced an inadequate response to at least two non-steroidal anti-inflammatory
                  drugs (NSAIDs).
            b.   Member has an intolerance or contraindication to two or more NSAIDs. 

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 B). 

IV. CONTINUATION OF THERAPY 

      A.   Moderately to severely active rheumatoid arthritis (RA)
            Authorization of 12 months may be granted for all members (including new members) who are using
            the requested medication for moderately to severely active rheumatoid arthritis and who achieve or
            maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from
            baseline in tender joint count, swollen joint count, pain, or disability. 

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 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:
      1.   Number of swollen joints
      2.   Number of tender joints
      3.   Dactylitis
      4.   Enthesitis
      5.   Skin and/or nail involvement 

C.   Active ankylosing spondylitis (AS) and active axial spondyloarthritis
      Authorization of 12 months may be granted for all members (including new members) who are
      using the requested medication for active ankylosing spondylitis or active axial spondyloarthritis and
      who achieve or maintain a positive clinical response with the requested medication 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.   Functional status
      2.   Total spinal pain
      3.   Inflammation (e.g., morning stiffness) 

D.   Moderately to severely active ulcerative colitis (UC)
      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. 

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 Contraindications to Methotrexate
1.   Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease
2.   Breastfeeding
3.   Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia)
4.   Elevated liver transaminases
5.   History of intolerance or adverse event
6.   Hypersensitivity
7.   Interstitial pneumonitis or clinically significant pulmonary fibrosis
8.   Myelodysplasia
9.   Pregnancy or currently planning pregnancy
10. Renal impairment
11. Significant drug interaction

Appendix B: 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.  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. Simponi [package insert]. Horsham, PA: Janssen Biotech, Inc.; September 2019.
2. Van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the international ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978-991.
3. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-699. doi:10.1136/annrheumdis-2019-216655.
4. Singh JA,Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis  2016;68(1)1-26.    
5. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784.
6. 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.
7. 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. 
8. 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.
9. Peluso R, Lervolino S, Vitiello M, et al. Extra-articular manifestations in psoriatic arthritis patients. 2015;34(4):745-53.
10. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70:896–904.
11. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. doi:10.1002/art.41042.
12. 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.
13. Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on November 15, 2021 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
14. 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.
15. 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.
16. Aletaha D, Neogi T, Silman, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
17. Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
18. Smolen JS, Aletaha D. Assessment of rheumatoid arthritis activity in clinical trials and clinical practice. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available with subscription. URL: www.uptodate.com. Accessed March 19, 2021.
19. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.

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.

March 16, 2022