Subject: Simponi Aria 2015-A SGM P2022

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
                1.  Axial spondyloarthritis
                2.  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.  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.  Continuation requests: Chart notes or medical record
                      documentation supporting positive clinical response.

            B.  Psoriatic arthritis (PsA), ankylosing spondylitis (AS), axial
                 spondyloarthritis (axSpA), and articular juvenile idiopathic
                 arthritis (JIA)
                 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.  PRESCRIBER SPECIALTIES

           This medication must be prescribed by or in consultation with
           one of the following:
           A.  Rheumatoid arthritis, ankylosing spondylitis, axial
                spondyloarthritis, and articular juvenile idiopathic arthritis:
                rheumatologist
           B.  Psoriatic arthritis: rheumatologist or dermatologist

 
    IV.  CRITERIA FOR INITIAL APPROVAL

           A.  Rheumatoid arthritis (RA)
                1.  Authorization of 12 months may be granted for adult
                     members who have previously received a biologic or
                     targeted synthetic drug (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 or
                     leflunomide (see Appendix A).

                2.  Authorization of 12 months may be granted for adult
                     members 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 or leflunomide (see Appendix A).
                          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.  Psoriatic arthritis (PsA)
                1.  Authorization of 12 months may be granted for members
                     2 years of age and older who have previously received a
                     biologic or targeted synthetic drug (e.g., Rinvoq, Otezla)
                     indicated for active psoriatic arthritis.

                2.  Authorization of 12 months may be granted for members
                     2 years of age and older for treatment of active psoriatic
                     arthritis when either of the following criteria is met:
                     i.      Member has mild to moderate disease and meets
                             one of the following criteria:
                             a.  Member has had an inadequate response to
                                  methotrexate, leflunomide, or another
                                  conventional synthetic drug (e.g., sulfasalazine)
                                  administered at an adequate dose and duration.
                             b.  Member has an intolerance or contraindication
                                  to methotrexate or leflunomide (see Appendix
                                  A), or another conventional synthetic drug
                                  (e.g., sulfasalazine).
                             c.  Member has enthesitis or predominantly axial
                                  disease.
                     ii.     Member has severe disease.

           C.  Ankylosing spondylitis (AS) and axial
                spondyloarthritis (axSpA)
                1.  Authorization of 12 months may be granted for adult
                     members who have previously received a biologic or
                     targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated
                     for active ankylosing spondylitis or active axial
                     spondyloarthritis.

                2.  Authorization of 12 months may be granted for adult
                     members for treatment of active ankylosing spondylitis
                     or active axial spondyloarthritis 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.

           D.  Articular juvenile idiopathic arthritis (JIA)
                1.  Authorization of 12 months may be granted for members
                     2 years of age and older who have previously received a
                     biologic or targeted synthetic drug (e.g., Xeljanz)
                     indicated for active articular juvenile idiopathic arthritis.

                2.  Authorization of 12 months may be granted for members
                     2 years of age and older for treatment of active articular
                     juvenile idiopathic arthritis when any of the following
                     criteria is met:
                     i.      Member has had an inadequate response to
                             methotrexate or another conventional synthetic
                             drug (e.g., leflunomide, sulfasalazine,
                             hydroxychloroquine) administered at an adequate
                             dose and duration.
                     ii.     Member has had an inadequate response to a trial
                             of scheduled non-steroidal anti-inflammatory drug
                             (NSAID) and/or intra-articular glucocorticoids (e.g.,
                             triamcinolone hexacetonide) and one of the
                             following risk factors for poor outcome:
                             a.  Involvement of ankle, wrist, hip, sacroiliac joint,
                                  and/or temporomandibular joint (TMJ)
                             b.  Presence of erosive disease or enthesitis
                             c.  Delay in diagnosis
                             d.  Elevated levels of inflammation markers
                             e.  Symmetric disease
                     iii.    Member has risk factors for disease severity and
                             potentially a more refractory disease course (see
                             Appendix B) 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.  Is judged to be at high risk for disabling joint
                                  disease.

 
      V.  CONTINUATION OF THERAPY

           A.  Rheumatoid arthritis (RA)
                Authorization of 12 months may be granted for all adult
                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.  Psoriatic arthritis (PsA)
                Authorization of 12 months may be granted for all members
                2 years of age and older (including new members) who are
                using the requested medication for 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.  Axial disease
                6.  Skin and/or nail involvement

           C.  Ankylosing spondylitis (AS) and axial
                 spondyloarthritis (axSpA)
                Authorization of 12 months may be granted for all adult
                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.  Articular juvenile idiopathic arthritis (JIA)
                Authorization of 12 months may be granted for all members
                2 years of age and older (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
           tuberculosis (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 drugs or targeted synthetic drugs 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.

 
  VII.  DOSAGE AND ADMINISTRATION

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

 
 VIII.  APPENDICES

           Appendix A: Examples of Contraindications to
           Methotrexate or Leflunomide  
           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: 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. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on June 6, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.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.
14. 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.
15. Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.
16. Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.

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 28, 2023