CurrentUnitedHealthcarePolicy IEXD0043.13

Tocilizumab (Actemra®, Tofidence®, & Tyenne®) Injection for Intravenous Infusion – Individual Exchange Medical Benefit Drug Policy

UnitedHealthcare Individual Exchange medical-benefit drug policy governing coverage, preferred-product rules, diagnosis-specific medical necessity criteria, and applicable billing codes for intravenous tocilizumab products (Actemra, Tofidence, Tyenne) for Individual Exchange plans in all states except MA, NV, and NY. This part (1 of 2) includes preferred product criteria, diagnosis-specific clinical criteria for multiple indications, and lists applicable HCPCS and ICD-10 codes.

Policy Summary

PayerUnitedHealthcare

PolicyTocilizumab (Actemra®, Tofidence®, & Tyenne®) Injection for Intravenous Infusion – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0043.13

Change TypeProduct preference & diagnosis-specific criteria edits

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionPrescribers must obtain authorization and submit prescriber attestation (and explanation) that patient or caregiver cannot be trained or are physically unable to self-administer when seeking continuation; initial and continuation approvals have defined duration limits per indication.

SourceLink

POLICY UPDATE CHANGES

Language indicating any U.S. FDA approved tocilizumab product not listed by name will be considered non-preferred until reviewed by UnitedHealthcare.

Non-Medical Necessity Plans: added language indicating any tocilizumab product is to be approved contingent on the coverage criteria in the Diagnosis-Specific Criteria section.

Replaced terminology 'targeted immunomodulator' with 'systemic targeted immunomodulator' and 'Biologic or targeted synthetic DMARD' with 'systemic targeted immunomodulator'.

Updated lists of examples of systemic targeted immunomodulators for rheumatoid arthritis, polyarticular JIA, systemic JIA, and giant cell arteritis (added and removed specific agents).

Continuation criterion added requiring prescriber attestation regarding inability to self-administer self-administered tocilizumab formulations.

Archived previous policy version IEXD0043.12.

Updated References section to reflect current information (package inserts and guidelines through 2024/2025/2026).

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

8Indications with specific criteria in Part 1

3Tocilizumab product HCPCS codes listed

>=4Dose-limit indications (doses)

3Major Indications Discussed

1Policy Version Revised (03/01/2026)

~70ICD-10 Codes Listed

Coverage Summary

This policy part governs UnitedHealthcare Individual Exchange medical-benefit coverage for intravenous tocilizumab products (IV formulations of Actemra, Tofidence, and Tyenne) for Individual Exchange plans in all states except Massachusetts, Nevada, and New York. The coverage stance is covered_with_criteria; IV tocilizumab is managed under medical benefit with diagnosis-specific medical necessity criteria and product-preference rules. Self-administered subcutaneous tocilizumab formulations (pharmacy benefit) are explicitly out of scope for this part.

Preferred Product Criteria

Treatment with Tofidence or other non-preferred tocilizumab biosimilar is medically necessary when the following conditions are met. Preserve the nested logic: a ONE-of branch (either trial + attestation OR intolerance/contraindication + attestation) AND the maintenance/no-loss-of-response requirement.

ALL of the following

ONE of
- ALL of the following
  - 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.
    Prescriber attestation should include clinical rationale and relevant clinical measures (e.g., DAS28, tender/swollen joint counts, inflammatory markers).
- ALL of the following
  - 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.
    Attestation should specify the nature of the intolerance/contraindication and why an alternative tocilizumab product is expected to be tolerated.
Patient has not had a loss of a favorable response after established maintenance therapy with Actemra or Tyenne or other tocilizumab biosimilar product.
Maintenance therapy requirement: members already on a non-preferred tocilizumab will be required to change to preferred product (Actemra or Tyenne) unless documentation meets the ONE-of branch above and prescriber attests. If the member had established maintenance on a preferred or non-preferred product without loss of response, switching is not required.

Step Therapy

Preferred product requirement

Prior authorization is required. For requests to use a non-preferred tocilizumab (e.g., Tofidence), include documentation of the 14-week trial with clinical response measures or documentation of intolerance/contraindication, plus the prescriber attestation described above. For continuation requests, include evidence of prior positive response and the prescriber attestation confirming inability to self-administer when applicable.

Attach clinical notes documenting trials, adverse events, labs, and outcome measures (e.g., DAS28, CRP/ESR).
If claiming inability to self-administer for pediatric/juvenile indications, include caregiver or patient training attempts and reason for inability.
For members switching from a non-preferred to preferred product: document reason for change and whether loss of response occurred.

Prior Authorization

Product preference determination and review

Requests for non-preferred tocilizumab will be reviewed and adjudicated through prior authorization. Include the prescriber attestation for continuation (see criteria) when applicable. Missing attestation or insufficient clinical documentation may result in denial or request for additional information.

Prescriber attestation must state whether the patient or caregiver are unable to be trained or are physically unable to self-administer tocilizumab (when relevant) and provide an explanation.
For continuation: include documentation of prior positive clinical response and duration of maintenance therapy.
Submit relevant prior biologic/DMARD history, dosing records, and any adverse event documentation.

Initial Therapy Criteria (Diagnosis-specific)

Polyarticular Juvenile Idiopathic Arthritis (PJIA) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA)
Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer tocilizumab FDA labeled for self-administration; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for treatment of the same indication

Continuation Therapy Criteria (Diagnosis-specific)

Polyarticular Juvenile Idiopathic Arthritis (PJIA) - Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Patient has previously received tocilizumab injection for intravenous infusion
Documentation of positive clinical response to tocilizumab
Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer tocilizumab FDA labeled for self-administration; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis

Unproven / Exclusions

There are no blanket 'not medically necessary' statements listed in this part; coverage is controlled by specified criteria and product-preference rules. Concomitant use of tocilizumab with specified systemic targeted immunomodulators for the same indication is prohibited across multiple indications (examples listed in the diagnosis-specific criteria). Self-administered subcutaneous tocilizumab products are covered under the pharmacy benefit and are not addressed by this medical-benefit policy part.

Applicable Codes

Billing Rule

Use applicable HCPCS J/Q codes

Use applicable HCPCS J/Q codes when billing tocilizumab products for intravenous infusion.

J3262 - Tocilizumab, 1 mg
Q5133 - Tocilizumab, 1 mg (biosimilar)
Q5135 - Tocilizumab, 1 mg (biosimilar)

Provider Actions

Prior Authorization

Authorization required and duration limits

Authorization is required for both initial and continuation intravenous tocilizumab therapy. Initial authorizations for rheumatoid arthritis, polyarticular JIA, systemic JIA, and giant cell arteritis are limited to no more than 12 months. Initial and continuation authorizations for cytokine release syndrome (CRS), steroid‑refractory acute GVHD, and immune checkpoint inhibitor–related toxicities are limited to no more than 4 doses. Submit claims with the applicable HCPCS J/Q codes for the product administered.

Initial authorization limit (RA, PJIA, SJIA, GCA): up to 12 months
Initial/continuation authorization limit (CRS, acute GVHD, ICI-related toxicities): up to 4 doses
Applicable HCPCS codes: J3262, Q5133, Q5135

Documentation Required

Prescriber attestation for inability to self-administer

For multiple pediatric and adult indications, the prescriber must attest that the patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab formulations labeled for self-administration and must submit an explanation. This attestation is required for initial and continuation therapy where specified in the diagnosis-specific criteria.

Clinical Evidence

ACT-RAYACT-RAY: 2–3 year results showed TCZ strategies achieved drug‑free remission in some patients; safety similar across strategies

Guideline supportNCCN and society guidelines (ACR/ACR‑VF) support tocilizumab for CRS, GVHD, GCA and rheumatologic indications

ACT-RAY randomized trial (Huizinga et al.): 2-year and 3-year analyses of the ACT-RAY study showed that treat-to-target strategies with tocilizumab can lead to sustained drug-free remission in some patients, with similar safety between add-on and switch strategies; secondary endpoints included rates and durability of TCZ-free and drug-free remission and minimal radiographic progression at week 104.

NCCN recommendations: the NCCN Drugs & Biologics Compendium supports tocilizumab for multiple oncology/supportive care indications, including management of CAR T-cell-related cytokine release syndrome (CRS) and other indications cited in supportive care guidance. The policy cites package inserts and guidelines updated through 2024–2026 as supporting references.

Background

Background: This policy part covers intravenous tocilizumab products (Actemra, Tofidence, Tyenne) under the medical benefit for UnitedHealthcare Individual Exchange plans. Self-administered subcutaneous formulations of Actemra and Tyenne are obtained under the pharmacy benefit and are not included in this medical-benefit policy part. The policy applies to Individual Exchange plans in all states except Massachusetts, Nevada, and New York and is designated as part 1 of 2 for tocilizumab policy content.

Definitions

TocilizumabUsed in this policy to refer to all tocilizumab products including Actemra, Tofidence (tocilizumab-bavi), and Tyenne (tocilizumab-aazg).

Systemic targeted immunomodulatorPolicy-preferred terminology replacing 'targeted immunomodulator' or 'biologic/targeted synthetic DMARD' to denote systemic biologic or targeted synthetic agents used for autoimmune/inflammatory conditions.

Coverage Rationale / Edits Summary

Coverage Rationale / Diagnosis-Specific Criteria (summary of edits reflected in this part): Material edits effective 2026-03-01 include revisions to product-preference language to state that any U.S. FDA–approved tocilizumab product not listed by name will be considered non-preferred until reviewed by UnitedHealthcare; addition of a Non-Medical Necessity plan contingency that any tocilizumab product is to be approved contingent on meeting the Diagnosis-Specific Criteria; and standardization of terminology by replacing 'targeted immunomodulator' and 'Biologic or targeted synthetic DMARD' with 'systemic targeted immunomodulator' across criteria.

Additional material edits updated lists of example systemic targeted immunomodulators for multiple indications (RA, polyarticular JIA, systemic JIA, and GCA), including additions (e.g., Cimzia, Enbrel, Olumiant, Orencia) and removals/ replacements (e.g., adalimumab edits, Xeljanz -> Xeljanz / Xeljanz XR), and revised examples of agents the patient must not be receiving in combination with tocilizumab.

A prescriber attestation requirement was added as a continuation criterion: for continuation when self-administration is not feasible, the prescriber must submit an explanation attesting that the patient or caregiver cannot be trained or are physically unable to self-administer the FDA-labeled tocilizumab product.

Other operational edits include treatment-specific constraints (e.g., dose/authorization limits for CRS, GVHD, and immune checkpoint inhibitor–related toxicities) and the retention/archiving of previous policy versions; these changes are documented in the policy history effective 03/01/2026.

Coverage Rationale / Diagnosis-Specific Criteria (summary of edits reflected in this part)

Policy edits effective 03/01/2026 revised product preference language and multiple diagnosis-specific criteria; continuation and combination therapy constraints applied per indication.

Revision History

2026-03-01policy_edit_addedLatest

Added product preference language: any U.S. FDA approved tocilizumab product not listed by name in this policy will be considered non-preferred until reviewed by UnitedHealthcare.

2026-03-01policy_edit_addedLatest

Non-Medical Necessity Plans: clarified that any tocilizumab product is to be approved contingent on meeting the coverage criteria in the Diagnosis-Specific Criteria section.

Policy Summary

PayerUnitedHealthcare

PolicyTocilizumab (Actemra®, Tofidence®, & Tyenne®) Injection for Intravenous Infusion – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0043.13

Change TypeProduct preference & diagnosis-specific criteria edits

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

Prescribed by or in consultation with a rheumatologist

Initial authorization is for no more than 12 months

Rheumatoid Arthritis (RA) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active rheumatoid arthritis (RA)
ONE of
- History of failure or intolerance to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced
- Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for RA (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib))
- Patient is currently on tocilizumab
Prescriber attestation that patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for rheumatoid arthritis
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for the same indication
Prescribed by or in consultation with a rheumatologist
Initial authorization is for no more than 12 months

Systemic Juvenile Idiopathic Arthritis (SJIA) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of systemic juvenile idiopathic arthritis (SJIA)
Prescriber attestation that patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for SJIA
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for the same indication
Prescribed by or in consultation with a rheumatologist
Initial authorization is for no more than 12 months

Giant Cell Arteritis (GCA) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of giant cell arteritis (GCA)
Prescriber attestation that patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for GCA
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., Kevzara (sarilumab), Orencia (abatacept), Rinvoq (upadacitinib)) for the same indication
Prescribed by or in consultation with a rheumatologist
Initial authorization is for no more than 12 months

Cytokine Release Syndrome (CRS)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cytokine release syndrome (CRS)
ONE of
- Patient received chimeric antigen receptor (CAR) T cell therapy (e.g., tisagenlecleucel, axicabtagene ciloleucel)
- Patient received CD3-directed therapy (e.g., blinatumomab, teclistamab)
Tocilizumab is dosed according to FDA labeled dosing for CRS
Initial authorization is for no more than 4 doses

Acute Graft-Versus-Host Disease (GVHD)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of steroid-refractory acute GVHD
ONE of
- Patient is receiving tocilizumab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Initial authorization is for no more than 4 doses

Immune Checkpoint Inhibitor-Related Toxicities

Covered when ALL of the following are met:

ALL of the following

Patient has recently received checkpoint inhibitor therapy (e.g., pembrolizumab, nivolumab)
Diagnosis of severe immunotherapy-related inflammatory arthritis
No symptom improvement after 7 days of starting high-dose corticosteroids
History of failure, contraindication, or intolerance to infliximab
ONE of
- Patient is receiving tocilizumab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Authorization is for no more than 4 doses

Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for treatment of the same indication

Authorization is for no more than 12 months

Rheumatoid Arthritis (RA) - Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Patient has previously received tocilizumab injection for intravenous infusion
Documentation of positive clinical response
Prescriber attestation that patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for rheumatoid arthritis
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for the same indication
Prescribed by or in consultation with a rheumatologist (where present)

Systemic Juvenile Idiopathic Arthritis (SJIA) - Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Patient has previously received tocilizumab injection for intravenous infusion
Documentation of positive clinical response
Prescriber attestation that patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for SJIA
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for the same indication
Authorization is for no more than 12 months

Giant Cell Arteritis (GCA) - Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Patient has previously received tocilizumab injection for intravenous infusion
Documentation of positive clinical response to tocilizumab
Prescriber attestation that patient or caregiver cannot be trained or are physically unable to self-administer tocilizumab; prescriber must submit explanation
Tocilizumab is dosed according to FDA labeled dosing for GCA
Patient is not receiving tocilizumab in combination with a systemic targeted immunomodulator (e.g., Kevzara (sarilumab), Orencia (abatacept), Rinvoq (upadacitinib)) for the same indication
Authorization is for no more than 12 months

Cytokine Release Syndrome (CRS) - Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response
Patient continues to experience signs and symptoms of CRS
Tocilizumab is dosed according to FDA labeled dosing for CRS
Authorization is for no more than 4 doses

Acute GVHD - Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response
Patient continues to experience acute GVHD
ONE of
- Patient is receiving tocilizumab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Authorization is for no more than 4 doses

Prescriber must submit an explanation describing inability to self-administer (required for initial and where continuation criteria specify).

Documentation Required

Clinical response documentation for continuation

Continuation approvals require documentation of a positive clinical response to tocilizumab. For continuation of intravenous therapy across indications the prescriber must provide evidence of clinical benefit (as specified in each indication's continuation criteria).

Documentation of positive clinical response is required for continuation authorization.

Step Therapy

Preferred product requirement

Actemra and Tyenne are designated preferred products. Members currently receiving non-preferred tocilizumab products must change to a preferred product (Actemra or Tyenne) to continue coverage unless they meet the non-preferred criteria: either a documented trial of at least 14 weeks of Actemra or Tyenne with minimal clinical response plus physician attestation that the non-preferred product would likely be superior, or documentation of intolerance/contraindication/adverse event to Actemra or Tyenne plus physician attestation that the same issue would not be expected with the non-preferred product.

Preferred: Actemra (tocilizumab) and Tyenne (tocilizumab-aazg).
Non-preferred continuation allowed only if Preferred Product Criteria are met (14-week trial + attestation, or intolerance/contraindication + attestation).

Prior Authorization

Product preference determination and review

Any U.S. FDA–approved tocilizumab product not listed by name in this policy is considered non-preferred until reviewed by UnitedHealthcare. Approvals for non-preferred tocilizumab products are contingent on meeting the policy's diagnosis-specific coverage criteria and will be reviewed by UnitedHealthcare prior to approval.

Unnamed FDA‑approved tocilizumab products are non-preferred pending UnitedHealthcare review.
Approvals for non-preferred products must meet diagnosis-specific criteria in the policy.

ALL of the following

Any U.S. FDA approved tocilizumab product not listed by name in this policy will be considered non-preferred until reviewed by UnitedHealthcare
Added language; affects product preference determinations
For Non-Medical Necessity Plans: any tocilizumab product is to be approved contingent on meeting the coverage criteria in the Diagnosis-Specific Criteria section
Approval contingent on meeting diagnosis-specific criteria
Replacement of terminology: 'targeted immunomodulator' -> 'systemic targeted immunomodulator'; 'Biologic or targeted synthetic DMARD' -> 'systemic targeted immunomodulator'
Terminology updated across diagnostic criteria

2026-03-01criteria_revisionLatest

Terminology standardized across criteria: replaced 'targeted immunomodulator' with 'systemic targeted immunomodulator' and 'Biologic or targeted synthetic DMARD' with 'systemic targeted immunomodulator'.

2026-03-01criteria_revisionLatest

Updated lists of example systemic targeted immunomodulators for multiple indications (RA, polyarticular JIA, systemic JIA, and GCA) with additions, removals, and name replacements (examples include adding Cimzia, Enbrel, Olumiant, Orencia for RA lists; removing Olumiant from SJIA list; replacing Xeljanz with Xeljanz/Xeljanz XR; and adding Kevzara and removing several agents from GCA examples).

2026-03-01policy_edit_addedLatest

Added continuation criterion requiring prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to self-administer tocilizumab (prescriber must submit explanation) for continuation approvals across applicable indications.

policy_archiveLatest

Archived previous policy version IEXD0043.12.

2026-03-01references_updatedLatest

Updated References section to reflect current package inserts and guidelines (references through 2024/2025/2026).