Monoclonal Antibodies to Interleukin-6
Customize your policy alerts
Sign up for Anthem Policy CC-0066 alerts
Get alerted when Policy CC-0066 changes without checking for updates manually.
Monitor payer policy activity
Clinical coverage criteria, quantity limits, and prior authorization requirements for IL-6 receptor monoclonal antibodies (tocilizumab products and sarilumab) across multiple indications including RA, GCA, JIA, CRS, SSc-ILD, transplant rejection, and others for Anthem members.
Removed Tyenne from certain HCPCS (M0235, M0236 and Q0235) and later added HCPCS Q0238, M0233, and M0234 for Tyenne effective 4/1/26.
Updated tocilizumab criteria to include additional NCCN recommendations and expanded pediatric COVID-19 approvals; updated biosimilar step therapy and convenience notes.
Added HCPCS codes M0233-M0250 and Q0235-Q0249 for IV and injection administration of tocilizumab products for hospitalized COVID-19 patients meeting steroid and oxygenation requirements.
Coverage Criteria for IL-6 Inhibitors
Initial Therapy - Tocilizumab products
Covered when ALL of the following per listed indication are met (grouped by indication below).
Initial and continuation therapy - Kevzara
Covered when ALL of the following are met for rheumatoid arthritis or other specified indications.
Continuation Therapy - Tocilizumab products
Continuation requests may be approved when ALL of the following are met.
Coverage conditions and quantity limits
Covered when product-specific and indication-specific clinical criteria and member benefit provisions are met; COVID-19 HCPCS codes require hospitalized patients receiving systemic corticosteroids and requiring supplemental oxygen or higher-level respiratory support.
See HCPCS code descriptions for product-specific assignment
Specific to 162 mg/0.9 mL presentations
150 mg and 200 mg presentations
Requests for IL-6 receptor monoclonal antibodies used in combination with certain other immunomodulatory therapies are not approved. Specifically, use of IL-6 inhibitors in combination with topical or oral JAK inhibitors, ozanimod, etrasimod, deucravacitinib, nintedanib, or the listed biologic immunomodulators (including but not limited to TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, abatacept, IL-1 inhibitors, other IL-6 inhibitors, rituximab, or natalizumab) is not approved and will not meet coverage criteria.
Recent policy revisions updated the exclusion and combination lists. The 02/20/2026 document history notes removal of pirfenidone from the prohibited combination list and removal of selected exclusions (for example, tuberculosis and other select exclusions). The history also documents coding updates to HCPCS assignments for tocilizumab biosimilars and Tyenne effective on the dates indicated.
Requests that do not satisfy the indication-specific medical necessity criteria described elsewhere in this policy, or requests that propose combining IL-6 inhibitors with the prohibited agents listed above, will not be approved and are considered not medically necessary.
The lists of procedure, diagnosis, and device codes included in this policy are provided for informational purposes only. Inclusion or exclusion of a code does not by itself guarantee coverage; determination of coverage and reimbursement depends on the member's contract benefits and applicable prior authorization decisions at the time of service.
Coding, Dosing and Quantity Limits
| Actemra (tocilizumab) IV vials 80 mg, 200 mg, 400 mg | Limit = 8 mg/kg as frequently as every 4 weeks |
| Avtozma (tocilizumab-anoh) IV vials 80 mg, 200 mg, 400 mg | Limit = 8 mg/kg as frequently as every 4 weeks |
| Tofidence (tocilizumab-bavi) IV vials 80 mg, 200 mg, 400 mg | Limit = 8 mg/kg as frequently as every 4 weeks |
| Tyenne (tocilizumab-aazg) IV vials 80 mg, 200 mg, 400 mg | Limit = 8 mg/kg as frequently as every 4 weeks |
| Actemra 162 mg/0.9 mL autoinjector or prefilled syringe | Limit = 4 autoinjectors or syringes per 28 days |
| Avtozma 162 mg/0.9 mL autoinjector or prefilled syringe | Limit = 4 autoinjectors or syringes per 28 days |
| Tyenne 162 mg/0.9 mL autoinjector or prefilled syringe | Limit = 4 autoinjectors or syringes per 28 days |
| Kevzara (sarilumab) 150 mg, 200 mg prefilled pen/syringe | Limit = 2 pens/syringes per 28 days |
| J3262 | Injection, tocilizumab, 1 mg [Actemra subcutaneous (tocilizumab)] |
| J3590 | Unclassified biologics [when specified as Actemra subcutaneous (tocilizumab)] |
| Q5133 | Injection, tocilizumab-bavi (Tofidence), biosimilar, 1 mg |
| Q5135 | Injection, tocilizumab-aazg (Tyenne), biosimilar, 1 mg |
| Q5156 | Injection, tocilizumab-anoh (Avtozma), biosimilar, 1 mg |
| M0233 | Intravenous infusion, tocilizumab-aazg, for hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO, includes |
| M0234 | Intravenous infusion, tocilizumab-aazg, for hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO, includes |
| M0235 | Intravenous infusion, monoclonal antibody products with an indication for post-exposure prophylaxis or treatment of COVID-19 ... first dose [when specified as Tofidence (tocilizumab-bavi)] |
| M0236 | Intravenous infusion, monoclonal antibody products ... second dose |
| M0237 | Intravenous infusion, tocilizumab-anoh, for hospitalized adult patients with COVID-19 ... includes |
| M0238 | Intravenous infusion, tocilizumab-anoh, for hospitalized adult patients with COVID-19 ... includes |
| M0249 | Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years and older) with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO only, includes infusion and post administration monitoring |
| M0250 | Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years and older) with COVID-19 ... second dose [Actemra IV 2nd dose administration] |
| Q0235 | Injection, monoclonal antibody products with an indication of post-exposure prophylaxis or treatment of COVID-19 ... 1 mg [when specified as Tofidence (tocilizumab-bavi)] |
| Q0237 | Injection, tocilizumab-anoh, for hospitalized adult patients with COVID-19 ... 1 mg [Avtozma] |
| J12.82 | Pneumonia due to coronavirus disease 2019 |
| U07.1 | COVID-19 |
| M05.00-M05.A | Rheumatoid arthritis with rheumatoid factor |
| M06.00-M06.09 | Rheumatoid arthritis without rheumatoid factor |
| M06.4 | Inflammatory polyarthropathy |
| M06.80-M06.89 | Other specified rheumatoid arthritis |
| M06.9 | Rheumatoid arthritis, unspecified |
| M08.00-M08.9A | Juvenile arthritis |
| M31.5 | Giant cell arteritis with polymyalgia rheumatica |
| M31.6 | Other giant cell arteritis |
| © CPT Only | American Medical Association copyright statement for CPT |
Prior Authorization, Documentation and Provider Responsibilities
Prior Authorization Required
Prior authorization required per indication — Prior authorization is required for initial and continuation requests. Approvals are granted only when indication‑specific clinical criteria (including age, diagnosis, prior therapies, and objective testing where applicable) are met. Coverage is contingent on the member's contract and benefit limitations; inclusion of a code in this policy does not guarantee member coverage.
- Prior authorization required for all indications listed unless otherwise specified in the member’s benefit plan.
- Approvals granted when indication‑specific criteria in the policy are documented and met.
- Inclusion of a procedure, diagnosis or device code in this document is informational and does not determine member coverage — verify member benefits prior to authorization.
Guideline‑Directed Step Therapy and Prior Therapy Documentation
Guideline‑directed step therapy and prior therapy documentation — Therapy decisions should follow guideline recommendations (for example, ACR guidance for rheumatoid arthritis: DMARD monotherapy with methotrexate titrated to maximally tolerated dose prior to biologic or JAK inhibitor use). Providers must document prior therapies, intolerance, contraindications, or inadequate response as required for the specific indication.
- Documented trial and inadequate response to methotrexate titrated to maximally tolerated dose when required (or documented intolerance/contraindication to methotrexate and other conventional DMARDs when allowed).
- For indications that require prior therapies (e.g., failure of IVIG plus rituximab for chronic antibody‑mediated renal transplant rejection), provide dates, doses, duration and response.
- Biosimilar step therapy: when applicable, step therapy may require use of a biosimilar; exception allowed for interchangeable biosimilars per policy updates (see coding/step therapy section).
Diagnosis and Prior Therapy Documentation
Diagnosis and prior therapy documentation required for authorization — Providers must submit documentation that supports the requested indication and demonstrates prior therapy trials or failures where specified. Records should include relevant history, prior medication names, dosing, dates, clinical response, and reasons for discontinuation (e.g., intolerance, adverse events, lack of efficacy).
- Provide medical records, clinic notes, or summaries showing diagnosis and meeting of clinical criteria in the policy.
- Document prior medication trials (start/stop dates, doses, reason for discontinuation) when required by the indication.
- For requests citing prior biologic or immunomodulator use, include concurrent medication lists and rationale for switching or combining if applicable.
SSc‑ILD Imaging and PFT Documentation
SSc‑ILD imaging and pulmonary function testing documentation — For Systemic Sclerosis‑Associated Interstitial Lung Disease (SSc‑ILD) requests, providers must supply objective imaging and PFT data demonstrating disease characteristics and eligibility.
- Chest high‑resolution CT (HRCT) report demonstrating ground glass opacification or fibrosis consistent with SSc‑ILD.
- Pulmonary function testing showing Forced Vital Capacity (FVC) > 55% of predicted as required by the criteria (include test date and numeric values).
- Include clinical correlation and treating clinician notes describing disease course and rationale for tocilizumab use in SSc‑ILD.
Documentation for Authorization
Documentation for authorization and provider responsibilities — Supply complete supporting documentation to facilitate timely review. The Plan may perform history and coding reviews; incomplete or missing documentation may delay or result in denial.
- Submit diagnosis‑specific documentation and product‑specific information (drug, route, dose, and billing code) with the authorization request.
- Be prepared to provide operative reports, infusion records, or prior authorization determinations if requested.
- The Plan may review coding and historical revisions when processing requests; administrative or coding updates in the document history may affect authorization handling.
Override and Precedence
Override and precedence — Federal and state laws, contract language, or other Plan utilization management programs may override or take precedence over the clinical criteria in this policy. When conflicts exist, the applicable law, regulation, or contract language governs.
- If state or federal mandates require coverage different from this policy, those mandates supersede the policy criteria.
- Provider should verify applicable contractual provisions and state/federal requirements when submitting an authorization request.
Copyright / Reproduction
Copyright and reproduction — The content of this publication is protected. Reproduction, storage, or transmission in any form without permission from the health plan is prohibited.
- No part of this publication may be reproduced, stored in a retrieval system or transmitted by any means without permission from the health plan.
- © CPT Only - American Medical Association
Background and Clinical Context
Interleukin-6 receptor monoclonal antibodies act by inhibiting IL-6 signaling and are used to treat multiple inflammatory and immune-mediated conditions. These agents are approved for disorders including rheumatoid arthritis, giant cell arteritis, various juvenile idiopathic arthritis subtypes (including systemic and polyarticular forms), and cytokine release syndrome, and are also used in select refractory conditions such as systemic sclerosis–associated interstitial lung disease (SSc-ILD) and chronic antibody-mediated renal transplant rejection where standard therapies have failed. Some indications have conditional or limited supporting evidence and require documentation of prior therapies or specific diagnostic testing (for example, HRCT and PFTs for SSc-ILD).
Definitions and Disease Descriptions
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.