Subject: Orencia 2127-A SGM P2021a
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 in adults
2. Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age or older
3. Active psoriatic arthritis in adults
B. Compendial Uses
1. Oligoarticular juvenile idiopathic arthritis
2. Chronic graft versus host disease
3. Immune checkpoint inhibitor-related toxicity
4. 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
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. 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.
2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response.
C. Psoriatic arthritis (PsA): For continuation requests: Chart notes or medical record documentation supporting positive clinical
response.
D. 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.
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.
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 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. Moderately to severely 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 moderately to severely active articular juvenile idiopathic arthritis.
2. Authorization of 12 months may be granted for treatment of moderately to severely active articular juvenile idiopathic
arthritis when any of the following criteria are met:
i. The member 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 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. Are judged to be at high risk for disabling joint disease.
C. Active psoriatic arthritis (PsA)
Authorization of 12 months may be granted for treatment of active psoriatic arthritis (PsA).
D. Prophylaxis of acute graft versus host disease
Authorization of 1 month may be granted for prophylaxis of acute graft versus host disease when both
of the following criteria are met:
1. Member is undergoing hematopoietic stem cell transplantation (HSCT) from a matched or
1 allele-mismatched unrelated-donor
2. The requested medication will be used in combination with a calcineurin inhibitor (e.g., cyclosporine,
tacrolimus) and methotrexate
E. 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:
1. Member has experienced an inadequate response to systemic corticosteroids.
2. Member has an intolerance or contraindication to corticosteroids.
F. Immune checkpoint inhibitor-related toxicity
Authorization of 1 month may be granted for treatment of immune checkpoint inhibitor-related toxicity when the member has
cardiac toxicity.
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 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.
B. Moderately to severely 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 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:
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
C. 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
D. Prophylaxis of acute graft versus host disease, chronic graft versus host disease, and immune
checkpoint inhibitor-related toxicity
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization
criteria.
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.
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: 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:
- Orencia [package insert]. Princeton, NJ: Bristol-Myers Squibb; December 2021.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 9, 2021.
- 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.
- 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.
- 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
