Tocilizumab (Actemra®, Tofidence™, & Tyenne®) Injection for Intravenous Infusion – Commercial Medical Benefit Drug Policy
Customize your policy alerts
Sign up for sierra health and life Policy 2026D0043Y alerts
Get alerted when Policy 2026D0043Y changes without checking for updates manually.
Monitor payer policy activity
Medical benefit drug policy governing use, prior authorization criteria, and coding for intravenous tocilizumab products (Actemra, Tofidence, Tyenne) across multiple indications including PJIA, SJIA, RA, GCA, CRS, acute GVHD, and immune checkpoint inhibitor-related toxicities. This part (1 of 2) contains preferred-product rules, indication-specific medical necessity criteria, and applicable procedure/diagnosis codes.
Added language to indicate any U.S. Food and Drug Administration approved tocilizumab product is considered preferred; products not listed will be considered non-preferred until reviewed by UnitedHealthcare.
Replaced 'Targeted immunomodulator' with 'systemic targeted immunomodulator' and replaced 'Biologic or targeted synthetic DMARD' with 'systemic targeted immunomodulator' across diagnosis-specific criteria.
Updated examples of systemic targeted immunomodulators for rheumatoid arthritis (added Cimzia, Enbrel, Orencia; nomenclature updates for adalimumab and Xeljanz/XR).
Updated list of systemic targeted immunomodulators that must not be received in combination with tocilizumab for specific indications; for Giant Cell Arteritis added Kevzara (sarilumab) and removed several agents including adalimumab and certolizumab.
Updated CMS and References sections to reflect the most current information.
Coverage Summary
This medical-benefit policy (Part 1 of 2) governs intravenous (IV) formulations of tocilizumab — specifically Actemra (tocilizumab), Tofidence (tocilizumab‑bavi), and Tyenne (tocilizumab‑aazg) — and defines prior authorization, coding, and indication‑specific medical necessity criteria across multiple indications. Covered indications addressed in this part include polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), moderately to severely active rheumatoid arthritis (RA), giant cell arteritis (GCA), chimeric antigen receptor (CAR) T cell–related cytokine release syndrome (CRS), steroid‑refractory acute graft‑versus‑host disease (GVHD), and severe immune checkpoint inhibitor–related toxicities. The policy includes preferred‑product rules (Actemra and Tyenne preferred), criteria for use of non‑preferred IV biosimilars (e.g., Tofidence), and the diagnosis‑specific medical necessity criteria and applicable procedure/diagnosis codes for IV tocilizumab.
Preferred Product Exception Criteria
Preferred Product Criteria
Treatment with Tofidence or other non-preferred tocilizumab biosimilar is medically necessary for the indications specified in this policy when the following conditions are met:
ALL of the following
One of the following must be met:
14-week trial + physician attestation
- Documentation of a trial of at least 14 weeks of Actemra or Tyenne resulting in minimal clinical response to therapy and residual disease activity.
- Physician attests that in their clinical opinion, the clinical response would be expected to be superior with Tofidence or other tocilizumab biosimilar product than experienced with Actemra or Tyenne.
Intolerance/contraindication + attestation
- Documentation of intolerance, contraindication, or adverse event to Actemra or Tyenne.
- Physician attests that in their clinical opinion, the same intolerance, contraindication, or adverse event would not be expected to occur with Tofidence or other tocilizumab biosimilar product.
- Patient has not had a loss of a favorable response after established maintenance therapy with Actemra or Tyenne or other tocilizumab biosimilar product.
Required in addition to one of the branches above.
General Coverage Rationale / Preferred Product: Actemra (tocilizumab) and Tyenne (tocilizumab-aazg) are the preferred tocilizumab products. Coverage for Tofidence (tocilizumab-bavi) or any U.S. Food and Drug Administration–approved tocilizumab product not listed by name in this policy will be considered non-preferred until reviewed and will be provided only when the Preferred Product Criteria above and the applicable Diagnosis-Specific Coverage Criteria are met. Members already receiving a non-preferred tocilizumab product will be required to change therapy to Actemra or Tyenne unless they meet the Preferred Product Criteria for continuation of the non-preferred product.
Policy note: Diagnosis-Specific Coverage Criteria (summary of revisions): The Diagnosis-Specific Criteria clarify initial and continuation requirements across labeled indications (e.g., rheumatoid arthritis, systemic and polyarticular juvenile idiopathic arthritis). Revisions emphasize: documentation of FDA‑labeled dosing, prescriber attestations when self-administration is not feasible, prior failure/intolerance to non-biologic DMARD(s) or other specified therapies where noted, and authorization durations (initial and continuation) generally limited to no more than 12 months. These criteria must be met in addition to the Preferred Product requirements for coverage of non-preferred tocilizumab products.
Initial Therapy Criteria (Diagnosis-specific)
Diagnosis-Specific Criteria: Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Tocilizumab is proven and medically necessary when ALL of the following criteria are met.
- Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA)
- Dosing: Tocilizumab is dosed according to FDA labeled dosing for polyarticular juvenile idiopathic arthritisper FDA
- No combination therapy: Patient is not receiving Tocilizumab in combination with a systemic targeted immunomodulator for treatment of the same indication (examples: adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), tofacitinib (Xeljanz/XR))
Examples listed in policy
- Prescriber attestation (IV route): Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer FDA-labeled self-administered Tocilizumab; prescriber must submit explanation; prescriber must be or consult a rheumatologist
Applies when IV route is used due to inability to self-administer
- Initial authorization: For initial therapy: initial authorization is for no more than 12 months<= 12 months
- Continuation of therapy: For continuation therapy: patient has previously received IV Tocilizumab; documentation of positive clinical response; Tocilizumab dosed per FDA; patient not receiving Tocilizumab in combination with a systemic targeted immunomodulator; authorization for no more than 12 months<= 12 months
Appears in both initial and continuation criteria variants
Diagnosis-Specific Criteria: Rheumatoid Arthritis (RA)
Tocilizumab is proven and medically necessary when ALL of the following criteria are met.
- Diagnosis of moderately to severely active rheumatoid arthritis (RA)
One of the following
- Prior non-biologic DMARD failure: History of failure, contraindication, or intolerance to at least one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, minocycline)
- Prior systemic targeted immunomodulator: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for RA (examples: adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), tofacitinib (Xeljanz/XR))
- Currently on Tocilizumab: Patient is currently on Tocilizumab
- Prescriber attestation (IV route): Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer FDA-labeled self-administered Tocilizumab; prescriber must submit explanation
- Dosing: Tocilizumab is dosed according to FDA labeled dosing for rheumatoid arthritisper FDA
- No combination therapy: Patient is not receiving Tocilizumab in combination with a systemic targeted immunomodulator for the same indication (examples listed in policy)
- Rheumatology involvement: Prescribed by or in consultation with a rheumatologist
- Initial authorization is for no more than 12 months<= 12 months
- Continuation criteria: For continuation of therapy: patient has previously received IV Tocilizumab; documentation of positive clinical response; prescriber attestation re: inability to self-administer; dosing per FDA; no concomitant systemic targeted immunomodulator; authorization for no more than 12 months<= 12 months
Diagnosis-Specific Criteria: Systemic Juvenile Idiopathic Arthritis (SJIA)
Tocilizumab is proven and medically necessary when ALL of the following criteria are met.
- Diagnosis of systemic juvenile idiopathic arthritis (SJIA)
- Dosing: Tocilizumab is dosed according to FDA labeled dosing for systemic juvenile idiopathic arthritisper FDA
- No combination therapy: Patient is not receiving Tocilizumab in combination with a systemic targeted immunomodulator for the same indication (examples listed in policy)
- Initial authorization is for no more than 12 months<= 12 months
- Continuation criteria: For continuation of therapy: patient has previously received IV Tocilizumab; documentation of positive clinical response; Tocilizumab dosed per FDA; patient not receiving concomitant systemic targeted immunomodulator; authorization for no more than 12 months<= 12 months
- Prescriber attestation (IV route): When IV route is used due to inability to self-administer: prescriber attestation required; prescriber must be or consult rheumatologist
Diagnosis-Specific Criteria: Giant Cell Arteritis (GCA)
Tocilizumab is proven and medically necessary when ALL of the following criteria are met.
- Diagnosis of giant cell arteritis (GCA)
- Dosing: Tocilizumab is dosed according to FDA labeled dosing for giant cell arteritisper FDA
- No combination therapy: Patient is not receiving Tocilizumab in combination with a systemic targeted immunomodulator for the same indication (examples: Kevzara (sarilumab), Orencia (abatacept), Rinvoq (upadacitinib))
Examples listed in policy
- Initial authorization is for no more than 12 months<= 12 months
- Continuation criteria: For continuation of therapy: patient has previously received IV Tocilizumab; documentation of positive clinical response; Tocilizumab dosed per FDA; patient not receiving concomitant systemic targeted immunomodulator; authorization for no more than 12 months<= 12 months
- Prescriber attestation (IV route): When IV route is used due to inability to self-administer: prescriber attestation required; prescriber must be or consult rheumatologist
Continuation Therapy Criteria
Continuation Therapy Elements
Continuation Therapy Requirements (applies across PJIA, RA, SJIA, GCA)
- Prior IV use: Patient has previously received Tocilizumab injection for intravenous infusion
- Positive response: Documentation of positive clinical response to Tocilizumab
- Dosing: Tocilizumab is dosed according to FDA labeled dosing for the specific indicationper FDA
- No concomitant systemic targeted immunomodulator: Patient is not receiving Tocilizumab in combination with a systemic targeted immunomodulator for treatment of the same indication (examples listed in each diagnosis-specific section)
- Authorization time limit: Authorization for continuation is for no more than 12 months for chronic indications<= 12 months
Dose-Limited Indications (Short-course/Acute)
Diagnosis-Specific Criteria: Cytokine Release Syndrome (CRS)
Tocilizumab is proven and medically necessary when ALL of the following criteria are met.
- Diagnosis of cytokine release syndrome (CRS)
- Therapy received: Patient has received treatment with CAR T-cell therapy (e.g., tisagenlecleucel, axicabtagene ciloleucel) or CD3-directed therapy (e.g., blinatumomab, teclistamab)
- Dosing: Tocilizumab is dosed according to FDA labeled dosing for CRSper FDA
- Initial authorization is for no more than 4 doses<= 4 doses
- Continuation criteria: For continuation of therapy: documentation of positive clinical response; patient continues to experience signs and symptoms of CRS; dosing per FDA; authorization for no more than 4 doses<= 4 doses
Diagnosis-Specific Criteria: Acute Graft-Versus-Host Disease (GVHD)
Tocilizumab is proven and medically necessary for steroid-refractory acute GVHD when ALL of the following criteria are met.
- Diagnosis of steroid-refractory acute graft-versus-host disease (GVHD)
One of the following
- Combination with steroids: Patient is receiving Tocilizumab in combination with systemic corticosteroids
- Steroid intolerance: Patient is intolerant to systemic corticosteroid therapy
- Initial authorization is for no more than 4 doses<= 4 doses
- Continuation criteria: For continuation of therapy: documentation of positive clinical response; patient continues to experience acute GVHD; one of the above corticosteroid combination/intolerance conditions must apply; authorization for no more than 4 doses<= 4 doses
Diagnosis-Specific Criteria: Immune Checkpoint Inhibitor-Related Toxicities
Tocilizumab is proven and medically necessary when ALL of the following criteria are met.
- Checkpoint therapy: Patient has recently received checkpoint inhibitor therapy (examples: pembrolizumab, nivolumab)
- Diagnosis of severe immunotherapy-related inflammatory arthritis
- Steroid trial: No symptom improvement after 7 days of starting high-dose corticosteroids>= 7 days
- Infliximab failure: History of failure, contraindication, or intolerance to infliximab
One of the following
- Combination with steroids: Patient is receiving Tocilizumab in combination with systemic corticosteroids
- Steroid intolerance: Patient is intolerant to systemic corticosteroid therapy
- Authorization is for no more than 4 doses<= 4 doses
Concurrent Therapy & Exclusions
Policy rule: Patients must not receive tocilizumab in combination with certain systemic targeted immunomodulators for the same indication. The policy replaces prior terminology ('Targeted immunomodulator' and 'Biologic or targeted synthetic DMARD') with the updated term 'systemic targeted immunomodulator' across diagnosis‑specific criteria, and the examples of agents that must not be used concomitantly are specified within each indication section.
Diagnosis‑specific note on prohibited combinations: the policy provides updated lists of systemic targeted immunomodulators that must not be co‑administered with tocilizumab for the same indication. For Giant Cell Arteritis, the policy specifically adds Kevzara (sarilumab) to the list of agents not to be combined and removes several agents (including adalimumab, certolizumab [Cimzia], etanercept [Enbrel], baricitinib [Olumiant], golimumab [Simponi], and tofacitinib [Xeljanz]) from that GCA exclusion list. Similar updated example lists are provided for PJIA, RA, and SJIA.
Provider Actions & Requirements
Prior Authorization Required
Prior authorization is required for intravenous tocilizumab. Initial authorizations are limited to no more than 12 months for chronic rheumatologic indications (PJIA, SJIA, RA, GCA) and no more than 4 doses for CRS, steroid-refractory acute GVHD, and checkpoint inhibitor–related toxicities.
Documentation Required
Submit documentation to support requests including prior treatment trials or reasons for non-preferred substitution (for example, documentation of a trial of at least 14 weeks of Actemra or Tyenne when requesting a non-preferred tocilizumab), documentation of intolerance/contraindication/adverse event to preferred products, and physician/prescriber attestations (e.g., that clinical response would be expected to be superior with the requested non-preferred product or that the same adverse event would not be expected to recur). Also include prescriber attestation and explanation when IV route is used because the patient or caregiver cannot be trained or is physically unable to self-administer.
Continuation Evidence
For continuation/renewal requests provide evidence of prior IV tocilizumab use and documentation of a positive clinical response. For CRS or acute GVHD continuation requests, also document that the patient continues to experience signs and symptoms of CRS or ongoing acute GVHD when requesting additional doses.
Preferred Product Step Requirement
Members receiving a non-preferred tocilizumab (for example, Tofidence) will be required to change therapy to a preferred product (Actemra or Tyenne) to continue coverage unless they meet the preferred-product exception criteria specified in the policy.
Verify Member Benefits
Verify the member-specific benefit plan document and any applicable federal or state mandates before making a coverage determination; the member-specific plan governs in the event of a conflict.
Non-Listed Products Considered Non-Preferred
Tocilizumab products not listed by name in this policy will be considered non-preferred until reviewed by UnitedHealthcare; such products require review/prior authorization per the plan prior to coverage.
Use of Objective Evidence-Based Rationale
UnitedHealthcare may rely on objective, evidence-based rationale when making determinations. In the absence of Medicare NCD/LCD guidance, Medicare Advantage Organizations may create coverage determinations using authoritative evidence. UnitedHealthcare may also use third-party tools (e.g., InterQual) to assist administration.
Applicable Codes
| M08.3 | Systemic juvenile rheumatoid arthritis |
| M08.2A | Polyarticular juvenile rheumatoid arthritis, bilateral involvement |
| M08.88 | Other juvenile rheumatoid arthritis, multiple sites |
Clinical Evidence & References
Evidence: ACT‑RAY trial (Huizinga et al.) — 2‑ and 3‑year results from the ACT‑RAY study showed that treat‑to‑target strategies with tocilizumab can achieve sustained drug‑free remission in a subset of RA patients, with similar safety profiles between add‑on and switch strategies and most patients demonstrating minimal radiographic progression at week 104.
Guidelines and compendia: the policy references key guidance supporting tocilizumab use including the 2021 American College of Rheumatology (ACR) guideline for rheumatoid arthritis, the 2019 ACR/Arthritis Foundation guideline for juvenile idiopathic arthritis, the 2021 ACR/Vasculitis Foundation guideline for giant cell arteritis, and recommendations from the NCCN Drugs & Biologics Compendium (which includes tocilizumab recommendations for CRS, acute GVHD, and certain immune‑related toxicities).
Background & Definitions
Background: This policy applies to intravenous formulations of tocilizumab (Actemra, Tofidence, Tyenne). Self‑administered subcutaneous tocilizumab formulations (Actemra and Tyenne when available for subcutaneous use) are managed under the pharmacy benefit except where the member's plan documents or specified delegated‑plan exceptions indicate medical‑benefit coverage. The policy designates Actemra and Tyenne as preferred products for IV tocilizumab; non‑preferred biosimilars (for example, Tofidence or other FDA‑approved tocilizumab products not listed by name) require documentation meeting the preferred‑product criteria (such as trial duration, intolerance/contraindication, and physician attestation) to establish medical necessity.
| Term | Definition |
|---|---|
| Tocilizumab | |
| Refers to all tocilizumab products including Actemra (tocilizumab), Tofidence (tocilizumab-bavi), and Tyenne (tocilizumab-aazg). | |
| Systemic targeted immunomodulator | |
| Revised policy term encompassing biologic DMARDs and targeted synthetic DMARDs used systemically for conditions such as rheumatoid arthritis. |
Revision History
Added language that any U.S. Food and Drug Administration–approved tocilizumab product not listed by name in the policy will be considered non-preferred until reviewed by UnitedHealthcare; clarified preferred products are Actemra and Tyenne and non-preferred biosimilars (e.g., Tofidence) require meeting preferred product criteria.
Replaced terminology across diagnosis-specific criteria: 'Targeted immunomodulator' and 'Biologic or targeted synthetic DMARD' were changed to 'systemic targeted immunomodulator'.
Updated examples of systemic targeted immunomodulators for rheumatoid arthritis: added Cimzia (certolizumab), Enbrel (etanercept), Orencia (abatacept); updated nomenclature for adalimumab and Xeljanz to 'adalimumab' and 'Xeljanz/Xeljanz XR (tofacitinib)'.
Updated list of systemic targeted immunomodulators that must not be received in combination with tocilizumab for specific indications; for Giant Cell Arteritis added Kevzara (sarilumab) and removed several agents including adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), golimumab (Simponi), and tofacitinib (Xeljanz).
Updated CMS and References sections to reflect current information.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.