Subject: Actemra 1959-A SGM P2022
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 who have had an inadequate
response to one or more disease-modifying antirheumatic drugs (DMARDs).
2. Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
3. Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
4. Adult patients with giant cell arteritis (GCA).
5. Adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) for slowing
the rate of decline in pulmonary function.
6. Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR)
T cell-induced severe or life-threatening cytokine release syndrome (CRS).
B. Compendial Uses
1. Unicentric Castleman’s disease
2. Multicentric Castleman’s disease
3. Oligoarticular juvenile idiopathic arthritis
4. Refractory/severe immunotherapy-related inflammatory arthritis not responding to
corticosteroids and anti-inflammatory agents
5. Acute graft versus host disease
6. Cytokine release syndrome (other than severe or life-threatening CAR T cell-induced CRS)
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. Articular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis (sJIA):
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. Cytokine release syndrome, immunotherapy-related inflammatory arthritis, and 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.
D. Giant cell arteritis (GCA): For continuation requests: Chart notes or medical record documentation
supporting positive clinical response.
E. Systemic sclerosis-associated interstitial lung disease (SSc-ILD): For initial requests: Result of a chest
high-resolution computed tomography (HRCT) study.
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. 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 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 Systemic Juvenile Idiopathic Arthritis (sJIA)
1. Authorization of 12 months may be granted for members who have previously received a biologic
indicated for active systemic juvenile idiopathic arthritis.
2. Authorization of 12 months may be granted for treatment of active sJIA when any of the following
criteria is met:
i. Member has an inadequate response to at least a 1-month trial of nonsteroidal anti-inflammatory
drugs (NSAIDs).
ii. Member has an inadequate response to at least a 2-week trial of corticosteroids.
iii. Member has an inadequate response to at least a 3-month trial of methotrexate or leflunomide.
D. Giant Cell Arteritis
Authorization of 12 months may be granted for treatment of giant cell arteritis when the member’s
diagnosis was confirmed by the following:
1. Temporal artery biopsy or cross-sectional imaging; or
2. Acute-phase reactant elevation (i.e., high erythrocyte sedimentation rate [ESR] and/or high
serum C-reactive protein [CRP]).
E. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Authorization of 12 months may be granted for treatment of sclerosis-associated interstitial lung
disease when the diagnosis was confirmed by a high-resolution computed tomography (HRCT)
study of the chest.
F. Cytokine release syndrome
1. Authorization of 1 month may be granted for treatment of chimeric antigen receptor (CAR)
T cell-induced cytokine release syndrome (CRS).
2. Authorization of 1 month may be granted for treatment of cytokine release syndrome in members
with refractory CRS related to blinatumomab therapy.
G. Unicentric Castleman’s Disease
Authorization of 12 months may be granted for treatment of unicentric Castleman’s disease when
all of the following are met:
1. The member is HIV-negative.
2. The member is human herpesvirus-8-negative.
3. The requested drug will be used as monotherapy.
4. The requested drug is being used as second-line therapy for relapsed/refractory disease.
H. Multicentric Castleman’s Disease
Authorization of 12 months may be granted for treatment of multicentric Castleman’s disease
when both of the following are met:
1. The requested drug will be used as monotherapy.
2. The requested drug is being used as second-line therapy for relapsed/refractory or progressive disease.
I. Immunotherapy-related Inflammatory Arthritis
Authorization of 12 months may be granted for treatment of severe/refractory immunotherapy-related
inflammatory arthritis that is not responding to corticosteroids and anti-inflammatory agents.
J. Acute graft versus host disease
Authorization of 12 months may be granted for treatment of acute 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.
IV. CONTINUATION OF THERAPY
A. Moderately to severely active 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. 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
C. Active Systemic Juvenile Idiopathic Arthritis (sJIA)
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for active sJIA 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
4. Systemic symptoms (e.g., fevers, evanescent skin rashes)
D. Giant Cell Arteritis (GCA)
Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for GCA 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. Headaches
2. Scalp tenderness
3. Tenderness and/or thickening of superficial temporal arteries
4. Constitutional symptoms (e.g., weight loss, fever, fatigue, night sweats)
5. Jaw and/or tongue claudication
6. Acute visual symptoms (e.g., amaurosis fugax, acute visual loss, diplopia)
7. Symptoms of polymyalgia rheumatica (e.g., shoulder and/or hip girdle pain)
8. Limb claudication
E. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for SSc-ILD when the member is currently receiving treatment with
Actemra, excluding when Actemra is obtained as samples or via manufacturer’s patient assistance programs.
F. Cytokine release syndrome, immunotherapy-related inflammatory arthritis, and graft
versus host disease
All members (including new members) requesting authorization for continuation of therapy
must meet all initial authorization criteria.
G. All other diagnoses
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section III when there is no evidence of unacceptable
toxicity or disease progression while on the current regimen.
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 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.
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: 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:
- Actemra [package insert]. South San Francisco, CA: Genentech, Inc.; March 2021.
- The NCCN Drugs & Biologics Compendium. © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed January 18, 2022.
- 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.
- 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.
- Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. 2011;63(4):465-482.
- Ringold S, Weiss PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Recommendations for the Medical Therapy of Children With Systemic Juvenile Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications. Arthritis & Rheumatism. 2013;65:2499-2512.
- 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.
- Stone JH, Tuckwell K, Dimonaco S, et al. Efficacy and safety of tocilizumab in patients with giant cell arteritis: Primary and secondary outcomes from a phase 3, randomized, double-blind, placebo-controlled trial. 2016 ACR/ARHP Annual meeting. Abstract number 911.
- Hellmich B, Agueda A, Monti S, et al. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020;79(1):19-30.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on June 28, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.
- 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.
- Khanna D, Lin CJF, Furst DE, et al. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020;8(10):963-974.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Rheumatology Clinical Programs. March 2021.
- 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 January 19, 2022.
- 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.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed January 18, 2022.
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.
August 14, 2022
