CurrentBlue Cross Blue Shield - IowaPolicy 05.01.31

Tocilizumab (Actemra, biosimilars, Tyenne) drug policy

Outlines coverage, preferred product steering, prior authorization requirements, and documentation for tocilizumab products (intravenous and subcutaneous) for Wellmark Blue Cross and Blue Shield members; applies to outpatient coverage and identifies indications, preferred vs non-preferred products, and required clinical criteria.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTocilizumab (Actemra, biosimilars, Tyenne) drug policy

Policy CodePolicy 05.01.31

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review DateOct 1, 2025

Key ActionSubmit prior authorization with documentation of prior preferred-product trials or clinical rationale to avoid preferred products and required safety testing (including TB screening).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7FDA and listed covered indications

12Typical continuation authorization (months)

TyennePreferred product mandate

800 mgIV quantity limit per 28 days

Coverage Criteria for Tocilizumab Products

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Initial approval — Rheumatoid Arthritis (subcutaneous/intravenous as applicable)

Covered when BOTH of the following are met:

RA initial

Prior therapy or exception: (i) Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Enbrel, adalimumab-aacf, Simponi, Rinvoq, and Xeljanz/XR) OR (ii) Member has a clinical reason to avoid TNF inhibitors (Enbrel, adalimumab-aacf, and Simponi) AND has had an inadequate response to treatment or intolerable adverse event with the preferred products, Rinvoq AND Xeljanz or Xeljanz XR OR (iii) Member is currently receiving treatment with the requested product through insurance (excludes obtainment as samples or via manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome
Actemra-specific: If the request is for Actemra (tocilizumab), member must have had a documented intolerable adverse event with Tyenne (tocilizumab-aazg) and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information.

Initial approval — Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Covered when BOTH of the following are met:

pJIA initial

Prior therapy or exception: (i) Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (adalimumab-aacf, Enbrel, and Xeljanz/Xeljanz Oral Solution) OR (ii) Member has a clinical reason to avoid Enbrel and adalimumab-aacf AND has had an inadequate response to treatment or intolerable adverse event with the preferred product Xeljanz or Xeljanz Oral Solution OR (iii) Member is currently receiving treatment with the requested product through insurance (excludes obtainment as samples or via manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome
Actemra-specific: If the request is for Actemra (tocilizumab), documented intolerable adverse event with Tyenne (tocilizumab-aazg) required and not attributable to the active ingredient per prescribing information.

Initial approval — Giant Cell Arteritis (GCA)

Covered when BOTH of the following are met:

GCA initial: Member must meet any of the following: (i) inadequate response to treatment or intolerable adverse effects with Rinvoq (Upadacitinib) OR (ii) clinical reason to avoid Rinvoq (e.g., history of venous thromboembolism, recent cardiovascular event, malignancy risk, or other contraindication to JAK inhibitor therapy) OR (iii) Member is currently receiving treatment with the requested product through insurance (excludes obtainment as samples or via manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome. Additionally, if the request is for Actemra (tocilizumab), member must have had a documented intolerable adverse event with Tyenne (tocilizumab-aazg) not attributable to the active ingredient as described in the prescribing information.

Initial approval — Other indications (excluding SSc-ILD)

Covered when the following is met:

Other indications: Member has had a documented intolerable adverse event with Tyenne (tocilizumab-aazg) and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information.

Applies to all non-SSc-ILD indications not otherwise specified.

Preferred Drug Plan Design — Intravenous tocilizumab (Initial approval)

Must meet BOTH the Preferred Drug Plan Design for the indication and for IV tocilizumab products when applicable. For RA and pJIA, at least ONE of the following:

IV RA initial options: (a) Member has a documented inadequate response or intolerable adverse event with each of the following: Avsola; Inflectra; and Simponi Aria OR (b) Member has a documented clinical reason to avoid TNF inhibitors OR (c) Member is currently receiving treatment with the requested product through insurance (excludes obtainment as samples or via manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome.

IV pJIA initial options: (a) Member has a documented inadequate response or intolerable adverse event to Simponi Aria OR (b) Member has a documented clinical reason to avoid TNF inhibitors OR (c) Member is currently receiving treatment with the requested product through insurance (excludes obtainment as samples or via manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) - Continuation

Covered when ALL of the following are met for SSc-ILD continuation

SSc-ILD continuation: Member currently receiving tocilizumab (excluding when obtained as samples or via manufacturer's patient assistance programs)12 months authorization may be granted

Includes new members if currently on tocilizumab

Cytokine release syndrome, ICI-related inflammatory arthritis, and GVHD - Continuation

Covered when ALL of the following are met for listed immune conditions

CRS/ICI-related arthritis/GVHD continuation: Members requesting continuation must meet all initial authorization criteria12 months authorization may be granted

Applies to cytokine release syndrome, immune checkpoint inhibitor-related inflammatory arthritis, and graft versus host disease

Polymyalgia rheumatica (PMR) - Continuation

Covered when ALL of the following are met for polymyalgia rheumatica (PMR) continuation

PMR continuation: Member is using medication for PMR and achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs/symptoms12 months authorization may be granted

Improvement required in any of: morning stiffness; hip or shoulder pain; hip or shoulder ROM; CRP and/or ESR

Other Diagnoses - Continuation

Covered when ALL of the following are met for other diagnoses

Other indications continuation: Member is using tocilizumab for an indication outlined in Criteria for Initial Approval and there is no evidence of unacceptable toxicity or disease progression on current regimen12 months authorization may be granted

Applies to indications beyond those specifically listed above

Baseline Safety Requirements

Required baseline safety conditions for initiation

TB screening: Documented negative TB test (TST or IGRA) within 12 months prior to initiating therapy for persons naïve to biologic or targeted synthetic drugs; if screening is positive, further testing must confirm no active disease; do not administer to members with active TB; treat latent TB before initiation.negative TB within 12 months

Applies to all indications

Concomitant biologic restriction: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.no concomitant biologic/targeted synthetic for same indication

Applies to all indications

The outpatient coverage criteria in this policy apply to ambulatory (outpatient) use of tocilizumab products. They do not apply to hospitalized members receiving Actemra (or a biosimilar) for COVID-19

Prior to initiating tocilizumab, document a negative tuberculosis (TB) screen (TST or IGRA) within the prior 12 months for persons naïve to biologic or targeted synthetic therapies. If TB screening is positive, complete further evaluation (for example, chest x-ray) to exclude active disease. Do not administer the requested medication to members with active TB infection.

Use of non-preferred tocilizumab products (for example, Actemra or other targeted/non‑preferred formulations) requires that the member first meet the policy's preferred‑product step requirements or document an approved clinical exception. For intravenous requests, the request must also meet the Preferred Drug Plan Design for IV tocilizumab when applicable. Requests lacking required prior trials of preferred products or appropriate exception documentation may be denied.

Tocilizumab (including Actemra and biosimilars) is considered not medically necessary when the member does not meet the criteria outlined in this policy. Examples include failure to document required negative TB screening within 12 months, concomitant use with another biologic or targeted synthetic agent for the same indication, or absence of required prior‑therapy trial(s) or documented clinical rationale to avoid preferred products. Members receiving samples or manufacturer patient assistance must still meet initial approval criteria to continue coverage.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization
Prior Authorization Required
Prior authorization is required for initiation and continuation of tocilizumab therapy. Initial approvals are granted only when the member meets the applicable Preferred Drug Plan Design (including step-therapy requirements) AND the Criteria for Initial Approval. Continuation requests must document ongoing clinical benefit; authorization may be granted for the durations specified under the Preferred Drug Plan Design and continuation criteria (for many indications this may be up to 12 months). Requests that do not meet the stated criteria will be considered not medically necessary and may be denied.
Prior authorization required for both initiation and continuation.
Continuation authorizations may be granted for specified durations (e.g., up to 12 months for SSc-ILD, PMR, and other eligible indications).

Prior Authorization
IV Prior Authorization Specifics
Intravenous (IV) tocilizumab requests must meet the Preferred Drug Plan Design specific to IV products in addition to the indication-specific criteria. For IV rheumatoid arthritis and polyarticular JIA indications, approval requires documented inadequate response or intolerable adverse events to the listed preferred IV biologics (e.g., Avsola, Inflectra, Simponi Aria) or a documented clinical reason to avoid TNF inhibitors, or current benefit on the requested IV product.
Must meet BOTH the indication-specific Preferred Drug Plan Design and the IV tocilizumab Preferred Drug Plan Design.
Examples of preferred IV comparators include Avsola, Inflectra, and Simponi Aria (RA criteria list).
Requests for IV tocilizumab for indications other than SSc-ILD, CRS, and COVID-19: Tyenne is the preferred product unless criteria for an alternate are met.

Step Therapy
Failure to Meet Step Criteria
Failure to meet step-therapy (preferred product) requirements or lack of adequate supporting documentation may lead to denial. The policy requires trial and inadequate response or intolerance to the specified number of preferred products before approving non-preferred tocilizumab, unless an accepted exception applies.
Step therapy generally requires failure of two preferred products for subcutaneous indications (specified per indication).
Requests may be denied if the member has not tried the required preferred products or if documentation of trials/responses is absent.

Prior Authorization
IV Preferred Product Requirement
Intravenous requests may be denied if the Preferred Drug Plan Design for IV tocilizumab products is not met. For Actemra requests, an additional requirement is documented intolerance to Tyenne when relevant (i.e., adverse event not expected for the active ingredient).
IV requests must satisfy the IV Preferred Drug Plan Design criteria for the specific indication (see IV criteria).
Actemra-specific: documented intolerable adverse event with Tyenne required when applicable and not attributable to the active ingredient.

Documentation Required
Non-Formulary Exception and Step Requirements
Non-formulary exception requests require documentation that all covered formulary alternatives are ineffective, less effective, or unsafe. When an exception is based on prior positive therapeutic outcome or an adverse event to a preferred product, submit chart notes detailing the outcome, severity, and relationship to the active ingredient.
Non-formulary coverage requires the drug be used for an FDA-approved or compendia-supported indication and dosing.
Provide chart notes or other documentation showing prior treatment failure, adverse event severity, dosage and duration, or contraindication to formulary alternatives.
When relying on prior benefit or adverse event to a preferred product, submit detailed clinical notes documenting outcomes and why the preferred agent is unsuitable.

Documentation Required
Required Documentation and Denial Triggers
Clinical documentation must include chart notes, medical records, or claims history demonstrating prior medications tried and response, laboratory/diagnostic test results when applicable (e.g., RF, anti-CCP, CRP/ESR, HRCT for SSc-ILD, TB screening), and details of any adverse events or contraindications. Lack of this documentation is a common denial trigger.
Submit chart notes or claims history showing prior medication trials, duration, dosing, and clinical response.
Provide lab/diagnostic results required for the indication (e.g., biomarker testing for RA, HRCT for SSc-ILD, TB testing within 12 months for biologic-naïve patients).
If TB screening is positive, provide follow-up testing to exclude active disease; do not initiate therapy with active TB.

Definitions and Product Preference

Covered indications

FDA‑approved indications (selected)Rheumatoid arthritis (RA); Polyarticular juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA); Giant cell arteritis (GCA); Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD); CAR T cell‑induced severe or life‑threatening cytokine release syndrome (CRS)

Compendial indicationsUnicentric and multicentric Castleman disease; Oligoarticular JIA; Immune checkpoint inhibitor‑related inflammatory arthritis; Acute graft‑versus‑host disease; Non‑CAR T cytokine release syndrome; Polymyalgia rheumatica

COVID‑19 (inpatient)Hospitalized adults with COVID‑19 receiving systemic corticosteroids and requiring oxygenation/ventilation or ECMO (managed under inpatient benefit)

Preferred vs Targeted/Non-preferred products

Preferred productTyenne (tocilizumab‑aazg) — required when tocilizumab is needed unless clinical circumstances exclude its use

Non‑preferred / targeted productsActemra (tocilizumab), Avtozma (tocilizumab‑anoh), Tofidence (tocilizumab‑bavi), other listed agents

Step therapy requirementPolicy requires use of preferred products (e.g., two preferred products for many SC indications) prior to non‑preferred tocilizumab unless clinical exceptions apply

Continuation authorization

Typical continuation authorization durationAuthorization of 12 months may be granted for continuation when continuation criteria are met

Continuation requirement — SSc‑ILD12‑month authorization may be granted for members currently receiving tocilizumab for SSc‑ILD (excluding sample or patient assistance program supply)

Continuation requirement — Other indicationsContinuation authorizations (12 months) may be granted when there is positive clinical response and no unacceptable toxicity or progression

TB screening requirement

TB screening requirementDocumented negative TB test (TST or IGRA) within 12 months prior to initiating therapy for persons naïve to biologic or targeted synthetic drugs

Positive TB testIf screening is positive, further testing (e.g., chest x‑ray) is required to exclude active disease; do not administer if active TB; treat latent TB before initiation

ApplicabilityApplies to all indications; members with active TB infection must not receive tocilizumab

J3262	Injection, tocilizumab, 1 mg (Actemra)
Q5133	Injection, tocilizumab-bavi (tofidence), biosimilar, 1 mg
Q5135	Injection, tocilizumab-aazg (tyenne), biosimilar, 1 mg (effective 10/01/2024)
Q5156	Injection, tocilizumab-anoh (avtozma), biosimilar, 1 mg (effective 10/01/2025)
J3490	Unclassified drugs
J3590	Unclassified biologics
C9399	Unclassified drugs or biologics

OpenPayer

Tocilizumab (Actemra, biosimilars, Tyenne) drug policy

Coverage Criteria for Tocilizumab Products

Provider Actions, Prior Authorization, and Documentation Requirements

Billing Codes and Quantity Limits

Definitions and Product Preference

Background

Revision History