BlueCross BlueShield of Tennessee Medical Policy Manual
Tocilizumab (Actemra®); Tocilizumab-anoh (Avtozma®); Tocilizumab-bavi (Tofidence™); Tocilizumag-aazg (Tyenne®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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
Compendial Uses
Note: The criteria outlined in this policy is only applicable to coverage in the outpatient setting. Hospitalized members receiving treatment for COVID-19 will be managed according to the member’s inpatient benefit.
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
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Articular juvenile idiopathic arthritis
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.
Systemic juvenile idiopathic arthritis (sJIA)
Initial requests
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable).
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Immune checkpoint inhibitor-related toxicity, and acute graft versus host disease:
(initial requests only)
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.
Giant cell arteritis (GCA)
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
For Initial requests
Result of a chest high-resolution computed tomography (HRCT) study.
Polymyalgia rheumatica and immune checkpoint inhibitor-related inflammatory arthritis
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.
PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with one of the following:
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 either of the following criteria is met:
Articular juvenile idiopathic arthritis
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 active articular juvenile idiopathic arthritis.
Authorization of 12 months may be granted for members 2 years of age or older for treatment of active articular juvenile idiopathic arthritis when any of the following criteria is met:
Systemic juvenile idiopathic arthritis (sJIA)
Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic indicated for active sJIA.
Authorization of 12 months may be granted for members 2 years of age or older for treatment of active sJIA when the member has active systemic features (e.g., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, serositis).
Giant cell arteritis (GCA)
Authorization of 12 months may be granted for adult members for treatment of giant cell arteritis when the member’s diagnosis was confirmed by either of the following:
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Authorization of 12 months may be granted for adult members for treatment of sclerosis-associated interstitial lung disease when the diagnosis was confirmed by a high-resolution computed tomography (HRCT) study of the chest.
Cytokine release syndrome
Authorization of 1 month may be granted for the prophylaxis or treatment of cytokine release syndrome (CRS).
Unicentric Castleman disease
Authorization of 12 months may be granted for treatment of unicentric Castleman disease when all of the following criteria are met:
Multicentric Castleman disease
Authorization of 12 months may be granted for treatment of multicentric Castleman disease when either of the following criteria is met:
Immune checkpoint inhibitor-related toxicity
Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the member has moderate or severe immunotherapy-related inflammatory arthritis and either of the following criteria is met:
(e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).
Authorization of 6 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when either of the following criteria is met:
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:
Polymyalgia rheumatica (PMR)
Authorization of 12 months may be granted for treatment of polymyalgia rheumatica (PMR) when any of the following criteria is met:
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
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 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:
Systemic juvenile idiopathic arthritis (sJIA)
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 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:
Giant cell arteritis (GCA)
Authorization of 12 months may be granted for all adult 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:
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for SSc-ILD when the member is currently receiving treatment with Actemra or Tyenne.
Immune checkpoint inhibitor related inflammatory arthritis
Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for immunotherapy-related inflammatory arthritis 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.
Cytokine release syndrome, 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 initial authorization criteria.
Unicentric Castleman disease and Multicentric Castleman disease
Authorization of 12 months may be granted for continued treatment in members (including new members) who are using the requested medication for Unicentric Castleman disease or Multicentric Castleman disease when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Polymyalgia rheumatica (PMR)
Authorization of 12 months may be granted for continued treatment in members who are using the requested medication for PMR 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:
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 12 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.
DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
APPENDICES
Appendix A: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate
Appendix B: Risk Factors for Articular Juvenile Idiopathic Arthritis
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg) |
Acute Graft Versus Host Disease |
Route of Administration: Intravenous 8mg/kg every 2 weeks |
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg) |
Castleman Disease (Unicentric or Multicentric) |
Route of Administration: Intravenous 8mg/kg every 2 weeks |
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg) |
Cytokine Release Syndrome |
Route of Administration: Intravenous ≥2 Year(s) <30kg 12mg/kg (up to a maximum of 800 mg); no more than 4 total doses given at least 8 hours apart
≥2 Year(s) ≥30kg 8mg/kg (up to a maximum of 800 mg); no more than 4 total doses given at least 8 hours apart
|
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg) |
Giant Cell Arteritis |
Route of Administration: Intravenous ≥18 Years 6mg/kg (up to maximum of 600 mg) every 4 weeks |
Actemra (Tocilizumab), Tyenne (Tocilizumab-aazg) |
Giant Cell Arteritis |
Route of Administration: Subcutaneous ≥18 Years 162mg every week |
Actemra (Tocilizumab) Tofidence (Tocilizumab-bavi), Tyenne (Tocilizumab-aazg) |
Immune Checkpoint Inhibitor-Related Toxicities: Inflammatory Arthritis |
Route of Administration: Intravenous 8 mg/kg every 4 week |
Actemra (Tocilizumab) , Tyenne (Tocilizumab-aazg) |
Immune Checkpoint Inhibitor-Related Toxicities: Inflammatory Arthritis |
Route of Administration: Subcutaneous 162mg every week |
Actemra (Tocilizumab), Tyenne (Tocilizumab-aazg) |
Polyarticular Juvenile Idiopathic Arthritis or Oligoarticular Juvenile Idiopathic Arthritis |
Route of Administration: Subcutaneous ≥2 Years <30kg 162mg every 3 weeks
≥2 Years ≥30kg 162mg every 2 weeks
|
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg)
|
Polymyalgia Rheumatica |
Route of Administration: Intravenous 8mg/kg every 4 weeks |
Actemra (Tocilizumab), Tyenne (Tocilizumab-aazg) |
Polymyalgia Rheumatica |
Route of Administration: Subcutaneous 162mg every week |
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg) |
Rheumatoid Arthritis |
Route of Administration: Intravenous ≥18 Year(s) 8mg/kg (up to maximum of 800 mg) every 4 weeks |
Actemra (Tocilizumab)
|
Rheumatoid Arthritis |
Route of Administration: Subcutaneous ≥18 year(s) 162mg every week |
Rheumatoid Arthritis |
Route of Administration: Subcutaneous ≥18 Year(s) <100kg 162mg every week
≥18 Year(s) ≥100kg 162mg every week |
|
Actemra (Tocilizumab), Tofidence (Tocilizumab–bavi), Tyenne (Tocilizumab-aazg) |
Systemic Juvenile Idiopathic Arthritis |
Route of Administration: Intravenous ≥2 Year(s) <30 kg 12mg/kg every 2 weeks
≥2 Year(s) ≥30kg 8mg/kg every 2 weeks
|
Actemra (Tocilizumab), Tyenne (Tocilizumab-aazg) |
Systemic Juvenile Idiopathic Arthritis |
Route of Administration: Subcutaneous ≥2 Year(s) <30 kg 162mg every 2 weeks
≥2 Year(s) ≥30kg 162mg every week
|
Actemra (Tocilizumab), Tyenne (Tocilizumab-aazg) |
Systemic Sclerosis-Associated Interstitial Lung Disease |
Route of Administration: Subcutaneous ≥18 year(s) 162mg every week |
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
ORIGINAL EFFECTIVE DATE: 7/10/2010
MOST RECENT REVIEW DATE: 9/30/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.