Subject: Simponi Aria 2015-A SGM P2021a

Drug

SIMPONI ARIA  (golimumab injection for intravenous use)

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.   Adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
      2.   Active psoriatic arthritis (PsA) in patients 2 years of age and older
      3.   Adult patients with active ankylosing spondylitis (AS)
      4.   Active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older 

B.   Compendial Uses
      Oligoarticular juvenile idiopathic arthritis 

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 articular juvenile idiopathic arthritis
      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.

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)
      1.   Authorization of 12 months may be granted for members who have previously received a biologic
            indicated for active ankylosing spondylitis. 

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

D.   Active articular juvenile idiopathic arthritis
      1.   Authorization of 12 months may be granted for members who have previously received a biologic or targeted
            synthetic DMARD indicated for active articular juvenile idiopathic arthritis. 

            2.   Authorization of 12 months may be granted for treatment of active articular juvenile idiopathic arthritis
                  when any of the following criteria is met:
                  i.   The member has had an inadequate response to methotrexate or another non-biologic DMARD
                       administered at an adequate dose and duration.
                  ii.  The member has risk factors (see Appendix C) and the member also meets one of the following:
                       a.   High-risk joints are involved (e.g., cervical spine, wrist, or hip).
                       b.   High disease activity.
                       c.   Are judged to be at high risk for disabling joint disease. 

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)
      Authorization of 12 months may be granted for all members (including new members) who are using the
      requested medication for active ankylosing spondylitis 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.   Active articular juvenile idiopathic arthritis
      Authorization of 12 months may be granted for all members (including new members) who are using the
      requested medication for active articular juvenile idiopathic 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 joints with active arthritis (e.g., swelling, pain, limitation of motion)
      2.   Number of joints with limitation of movement
      3.   Functional ability

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 DMARD or targeted synthetic DMARD.

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 Contraindications to the Use of NSAIDs
1.   Allergic-type reaction following aspirin or other NSAID administration
2.   Asthma
3.   Gastrointestinal bleeding
4.   History of intolerance or adverse event
5.   Significant drug interaction
6.   Urticaria 

Appendix C: Risk factors for Articular Juvenile Idiopathic Arthritis
1.   Positive rheumatoid factor
2.   Positive anti-cyclic citrullinated peptide antibodies
3.   Pre-existing joint damage

Place of Service:

Outpatient

The above policy is based on the following references:

1. Simponi Aria [package insert]. Horsham, PA: Janssen Biotech, Inc.; February 2021.
2. 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.
3. 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.      
4. 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.
5. 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. 
6. 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.  
7. 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.
8. 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.
9. 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.
10. Ringold S, Angeles-Han S, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. American College of Rheumatology. 2019;1-18.
11. 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..
12. 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.
13. 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