Subject: Simponi 2014-A SGM P2022a

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
                    adults, in combination with methotrexate.
               2.  Active psoriatic arthritis (PsA) in adults, alone or in
                    combination with methotrexate.
               3.  Active ankylosing spondylitis (AS) in adults.
               4.  Moderately to severely active ulcerative colitis (UC) in
                    adults 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.

          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.  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.  Ankylosing spondylitis (AS), axial spondyloarthritis (axSpA),
                and psoriatic arthritis (PsA)
                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.

           C.  Ulcerative colitis (UC)
                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 of
                             hospitalization due to acute, severe ulcerative
                             colitis (if applicable).
                 2.  Continuation requests: Chart notes or medical record
                      documentation supporting positive clinical response to
                      therapy or remission.

 
   III.  PRESCRIBER SPECIALTIES

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

 
    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 adult
                     members 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 adult
                     members 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.  Ulcerative colitis (UC)
                1.  Authorization of 12 months may be granted for adult
                     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 adult
                     members 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).

                3.  Authorization of 12 months may be granted for adult
                     members who have ever been hospitalized for acute
                     severe UC (e.g., continuous bleeding, severe toxic
                     symptoms, including fever and anorexia).

 
      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 adult
                 members (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.  Ulcerative colitis (UC)
                1.  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                         ulcerative colitis and who achieve or maintain remission.

                2.  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
                     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)

 
    VI.  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: 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. 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. 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.
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. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on August 18, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.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 28, 2023