Subject: Orencia SGM 2127-A P2024_R

Drug

ORENCIA  (abatacept)

Policy:

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

• Moderately to severely active rheumatoid arthritis (RA) in adults
• Moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
• Active psoriatic arthritis (PsA) in patients 2 years of age and older
• Prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor

Compendial Uses

• Oligoarticular juvenile idiopathic arthritis
• Chronic graft versus host disease
• Immune checkpoint inhibitor-related toxicity

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

Documentation

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

Rheumatoid Arthritis (RA)

• 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.
  • 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).
• Continuation Requests: Chart notes or medical record documentation supporting positive clinical response.

Articular Juvenile Idiopathic Arthritis (JIA)

• Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy.
• Continuation requests: Chart notes or medical record documentation supporting positive clinical response.

Psoriatic Arthritis (PsA)

• 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.
• Continuation requests: Chart notes or medical record documentation supporting positive clinical response.

Chronic Graft Versus Host Disease

• For 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.
• Continuation requests: Chart notes or medical record documentation supporting positive clinical response.

Immune Checkpoint Inhibitor-Related Toxicity

For 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.

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

• Rheumatoid arthritis and articular juvenile idiopathic arthritis: rheumatologist
• Psoriatic arthritis: rheumatologist or dermatologist
• Prophylaxis of acute graft versus host disease (aGVHD), chronic GVHD, and immune checkpoint inhibitor-related toxicity: oncologist or hematologist

Coverage Criteria

Rheumatoid Arthritis (RA)

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.

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active RA when both of the following criteria are met:

• Member meets either of the following criteria:
  • Member has been tested for either of the following biomarkers and the test was positive:
    • Rheumatoid factor (RF)
    • Anti-cyclic citrullinated peptide (anti-CCP)
  • Member has been tested for ALL of the following biomarkers:
    • RF
    • Anti-CCP
    • C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
  • Member meets either of the following criteria:
    • 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).
    • Member has an intolerance or contraindication to methotrexate (see Appendix A).

Articular Juvenile Idiopathic Arthritis (JIA)

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

Authorization of 12 months may be granted for members 2 years of age or older for treatment of moderately to severely active articular juvenile idiopathic arthritis when any of the following criteria is met:

• 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.
• Member has had an inadequate response to a trial of scheduled non-steroidal anti-inflammatory drugs (NSAIDs) and/or intra-articular glucocorticoids (e.g., triamcinolone hexacetonide) and one of the following risk factors for poor outcome:
  • Involvement of ankle, wrist, hip, sacroiliac joint, and/or temporomandibular joint (TMJ)
  • Presence of erosive disease or enthesitis
  • Delay in diagnosis
  • Elevated levels of inflammation markers
  • Symmetric disease
• Member has risk factors for disease severity and potentially a more refractory disease course (see Appendix B) and member also meets one of the following:
  • High-risk joints are involved (e.g., cervical spine, wrist, or hip)
  • Has high disease activity
  • Is judged to be at high risk for disabling joint disease

Psoriatic Arthritis (PsA)

Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active psoriatic arthritis.

Authorization of 12 months may be granted for members 2 years of age or older for treatment of active psoriatic arthritis when either of the following criteria is met:

• Member has mild to moderate disease and meets one of the following criteria:
  • Member has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) administered at an adequate dose and duration.
  • Member has an intolerance or contraindication to methotrexate or leflunomide (see Appendix A), or another conventional synthetic drug (e.g., sulfasalazine).
  • Member has enthesitis.
• Member has severe disease.

Prophylaxis of Acute Graft Versus Host Disease

Authorization of 1 month may be granted for prophylaxis of acute graft versus host disease in members 2 years of age or older when both of the following criteria are met:

• Member is undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.
• The requested medication will be used in combination with a calcineurin inhibitor (e.g., cyclosporine, tacrolimus) and methotrexate.

Chronic Graft Versus Host Disease

Authorization of 12 months may be granted for treatment of chronic graft versus host disease when either of the following criteria is met:

• Member has had an inadequate response to systemic corticosteroids.
• Member has an intolerance or contraindication to corticosteroids.

Immune Checkpoint Inhibitor-Related Toxicity

Authorization of 6 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the member has myocarditis and meets any of the following:

• Member has had an inadequate response to systemic corticosteroids.
• Member has an intolerance or contraindication to corticosteroids.
• Member has concomitant myositis and the requested medication will be used in combination with ruxolitinib.

Continuation of Therapy

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 RA 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.

Articular Juvenile Idiopathic Arthritis (JIA)

Authorization of 12 months may be granted for all members 2 years of age or older (including new members) who are using the requested medication for moderately to severely 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:

• Number of joints with active arthritis (e.g., swelling, pain, limitation of motion)
• Number of joints with limitation of movement
• Functional ability

Psoriatic Arthritis (PsA)

Authorization of 12 months may be granted for all members 2 years of age or 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:

• Number of swollen joints
• Number of tender joints
• Dactylitis
• Enthesitis
• Skin and/or nail involvement
• Functional status
• C-reactive protein (CRP)

Chronic Graft Versus Host Disease

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for chronic graft versus host 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.

Prophylaxis of Acute Graft Versus Host Disease and Immune Checkpoint Inhibitor-Related Toxicity

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

Other

For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) 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 (e.g., chest x-ray). 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 for the same indication.

Dosage and Administration

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

Appendix

Appendix A: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate or Leflunomide

• Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
• Drug interaction
• Risk of treatment-related toxicity
• Pregnancy or currently planning pregnancy
• Breastfeeding
• Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)
• Hypersensitivity
• History of intolerance or adverse event

Appendix B: Risk Factors for Articular Juvenile Idiopathic Arthritis

• Positive rheumatoid factor
• Positive anti-cyclic citrullinated peptide antibodies
• Pre-existing joint damage

Place of Service:

Outpatient

The above policy is based on the following references:

1. Orencia [package insert]. Princeton, NJ: Bristol-Myers Squibb; May 2024.
2. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685-699.
3. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 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. 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.
6. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2018;71:5-32.
7. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on June 11, 2024 from: https://www.cdc.gov/tb/testing/.
8. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 14, 2024.
9. 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.
10. 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.
11. 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.
12. 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.
13. Gossec L, Kerschbaumer A, Ferreira RJO, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024;83(6):706-719. Published 2024 May 15. doi:10.1136/ard-2024-225531.
14. 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.
15. 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.

 

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.

January 01, 2025