CurrentUCarePolicy Utilization Review Policy 133A

Inflammatory Conditions - Tocilizumab Intravenous Products Utilization Management Medical Policy

Prior authorization and utilization management criteria for medical-benefit tocilizumab intravenous products for UCare Medical Assistance and Exchange plans (PMAP, Connect, MSC+, MnCare, Individual and Family Plans). Includes FDA-approved indications, other supported uses, dosing thresholds, step therapy (preferred product) and conditions not recommended for approval.

Policy Summary

PayerUCare

PolicyActemra - Medical Assistance, Exchange

Policy CodePolicy Utilization Review Policy 133A

Change TypePreferred biosimilar step; multiple indication and dosing revisions

Effective DateJan 1, 2020

Next Review Date

Key ActionSubmit chart notes documenting indication, prior therapies, and objective response or intolerance as required by indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Tyenne (biosimilar to Actemra IV) was added to the policy and designated preferred biosimilar effective 01/01/2025 for new-to-therapy patients.

Giant Cell Arteritis criterion changed to require patient has tried or is currently taking a systemic corticosteroid unless contraindicated.

Systemic Juvenile Idiopathic Arthritis and Adult-Onset Still's Disease alignment and indication-specific referrals clarified; dosing interval for SJIA changed from at least 1 week to at least 2 weeks between doses.

Cytokine Release Syndrome associated with Bispecific CD3 T-Cell Engager therapy and Graft-Versus-Host Disease were added as conditions of approval.

VEXAS syndrome was added as a condition of approval.

Polymyalgia Rheumatica dosing changed from 6 mg/kg (max 600 mg) to 8 mg/kg (max 800 mg) per dose.

Castleman disease initial-therapy HIV/HHV-8 negativity and relapsed/refractory requirements were modified for unicentric vs multicentric disease and later removed for unicentric disease.

Requirement added that toxicity developed while receiving a checkpoint inhibitor; removed prior requirement for NSAID trial.

Throughout the policy, wording updated; biosimilar additions included.

Selected revision dates listed up to 05/13/2026; document indicates last revised 04/23/2025 with selected revisions through 05/13/2026.

12Covered Indications & Supported Uses Listed

1Preferred Product (Tyenne)

3Not Recommended Conditions Listed

2023-2026Revision history range (years)

Coverage Summary

Coverage stance: covered with criteria for tocilizumab intravenous products under Utilization Review Policy 133A, applying to UCare Medical Assistance and Exchange plans (PMAP, Connect, MSC+, MnCare, Individual and Family Plans). The policy notes a preferred biosimilar: Tyenne, which is required for patients new to therapy effective 2025-01-01, ahead of non-preferred products (e.g., Actemra, Tofidence). Prior authorization is required and initial prescriptions must be by or in consultation with a relevant specialist; approval durations and dosing thresholds are specified in the policy. (Policy number: Utilization Review Policy 133A; Effective date: 1/1/2020; Last revised: 04/23/2025, selected revisions through 05/13/2026.)

Key thresholds & quick facts

Preferred product (new-to-therapy effective 01/01/2025)Tyenne (preferred biosimilar)

Max dose (general)800 mg per dose

Giant Cell Arteritis max doseUp to 6 mg/kg, maximum 600 mg per dose

sJIA max dose (pediatric <30 kg)Up to 12 mg/kg per dose

RA dosing guidelineUp to 8 mg/kg per dose; interval ≥ 4 weeks

Number of covered indications & supported uses12

Not recommended conditions listed3

Last policy review date2026-05-13

General Authorization & Step Therapy Requirements

General Authorization Policy Statement

Covered when ALL of the following general authorization requirements are met:

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{"text":"Prior authorization is required before initiation of tocilizumab intravenous products for Medical Assistance and Exchange plans (UCare).","note":"Operational: Authorization must be on file prior to administration where applicable."},

{"text":"Prescription or treatment plan must be initiated or reviewed by an appropriate specialist (e.g., rheumatologist, oncologist, hematologist, or other specialist relevant to the indication).","note":"Operational: Specialist documentation (consult note, treatment plan, or progress notes) should be included in the request."},

Initial Therapy Criteria (FDA-Approved Indications)

Continuation Therapy Criteria

Currently Receiving Tocilizumab — Continuation Criteria (Selected Indications)

Continuation (Currently Receiving Tocilizumab IV or SC): patient established on therapy for the indication-specific minimum duration and shows objective benefit or symptom improvement; approvals generally 1 year.

ref

title

Continuation durations & objective response examples

GCA continuation approval1 year (established on therapy ≥6 months with objective or symptomatic benefit)

RA continuation approval1 year (established on therapy ≥6 months with objective or symptomatic benefit)

sJIA continuation approval

Other Uses with Supportive Evidence

Conditions Not Recommended for Approval

Denial Risk

Not recommended uses

Not-recommended uses (likely to be denied): acute inpatient COVID-19 treatment is not addressed by this policy (COVID-19 treatment generally limited to specified hospitalized patients per indications and dosing guidance); concurrent use with another biologic or a targeted synthetic oral small molecule therapy for inflammatory conditions (combination biologic/targeted therapy) is not recommended; Crohn's disease is not recommended due to limited/insufficient evidence; coverage not recommended for other uses not listed in the Recommended Authorization Criteria.

COVID-19 acute inpatient treatment not addressed by this policy (policy notes the acute hospitalized COVID-19 indication is not targeted)
Concurrent biologic or targeted synthetic small molecule therapy — not recommended
Crohn's disease — not recommended
Other unlisted uses — not recommended

Applicable Products / Code Groups

Preferred Product(s)mixed

Tyenne

Preferred product (biosimilar)

Non-Preferred Productsmixed

Actemra	tocilizumab intravenous infusion (Genentech/Roche)
Avtozma	tocilizumab-anoh intravenous infusion (Celltrion)
Tofidence	tocilizumab-bavi intravenous infusion (Biogen)

Multiple additional tocilizumab IV products and biosimilars (examples listed in the policy such as Tofidence, Avtozma, Aucatzyl) were added in selected revisions and are covered under the same criteria as other tocilizumab IV products.

Dosing, Documentation & Prior Authorization Practicalities

Prior Authorization

Dosing and duration constraints

Approvals are limited to the specific dosing algorithms and durations outlined per indication in the policy; requests for dosing or durations outside the established ranges will be considered case-by-case by a clinician. Quick dose limits for reference: maximum 800 mg per dose for most indications; indication-specific limits include 6 mg/kg (max 600 mg) with ≥4-week intervals for giant cell arteritis, up to 8 mg/kg (max 800 mg) with ≥4-week intervals for RA and many adult indications, up to 10–12 mg/kg (to max 800 mg) with shorter intervals for pediatric or CRS indications, and up to four doses for CRS with ≥8 hours between doses.

Max 800 mg per dose (general maximum)
Giant cell arteritis: up to 6 mg/kg (max 600 mg); interval ≥ 4 weeks
RA and many adult indications: up to 8 mg/kg (max 800 mg); interval ≥ 4 weeks
sJIA/pediatric dosing: up to 12 mg/kg (<30 kg) or up to 8–10 mg/kg depending on weight; intervals per indication (e.g., ≥2 weeks for sJIA)
CRS (CAR T or bispecific): patient <30 kg up to 12 mg/kg to max 800 mg; ≥30 kg up to 8 mg/kg to max 800 mg; up to four doses with ≥8 hours between doses

Clinical Evidence & References

Key evidence and guideline sources cited in the policy include the Actemra prescribing information (Genentech, August 2025), the pivotal randomized trial of tocilizumab in giant-cell arteritis (Trial in N Engl J Med. 2017;377(4):317-328), and multiple guideline sources: NCCN (multiple 2024–2025 guideline versions cited), EULAR (2023, 2024), ACR (2021, 2025 guidance statements), and IDSA COVID-19 guidance (2024) as referenced in the policy.

800Maximum dose per infusion (mg)

8 mg/kgCommon max kg-based dose for adults (many indications)

12 mg/kgMax dose for patients <30 kg in CRS/sJIA (per-dose)

1Median number of doses in pivotal CAR T‑cell CRS trial

Background & Definitions

Background: Tocilizumab is an IL-6 receptor inhibitor with FDA-approved IV and SC indications for multiple inflammatory conditions (e.g., RA, GCA, pJIA, sJIA, CRS). Dosing modifications and lab monitoring are recommended, particularly in rheumatoid arthritis where dose interruptions and adjustments are advised for elevated liver enzymes, neutropenia, or thrombocytopenia; dosing algorithms and maximums (commonly up to 8–12 mg/kg with a max 800 mg per dose depending on indication) are specified. The policy references multiple guidelines (EULAR, ACR, NCCN, IDSA) and the Actemra prescribing information to guide dosing, monitoring, and indications.

Definitions

Adequate trial (definition)Generally considered to be three months or longer to allow time for efficacy to be established

SJIA (term expansion)Systemic Juvenile Idiopathic Arthritis (SJIA) — Still's disease in children; dosing and monitoring per SJIA criteria

AOSD (term expansion)Adult-Onset Still's Disease (AOSD) — Still's disease in adults; related to SJIA; managed with IL-1 or IL-6 inhibitors

CRS (term expansion)Cytokine Release Syndrome (CRS) — inflammatory syndrome associated with CAR T-cell or bispecific T-cell engager therapies; tocilizumab dosing varies by weight and allows up to four doses

Revision History

2025-01-01added

Tyenne (preferred biosimilar to Actemra IV) added as the preferred product for new-to-therapy patients; preferred biosimilar step therapy required before Actemra and Tofidence for new patients.

04/23/2025clarified

Annual revision clarified that the acute treatment of hospitalized COVID-19 is not addressed by this policy; policy renamed and wording updated from 'Actemra' to generic 'tocilizumab' across the document.

05/08/2025revised

Giant cell arteritis criterion revised to require patient has tried or is currently taking a systemic corticosteroid (unless contraindicated) rather than a prior trial only.

Policy Summary

PayerUCare

PolicyActemra - Medical Assistance, Exchange

Policy CodePolicy Utilization Review Policy 133A

Change TypePreferred biosimilar step; multiple indication and dosing revisions

Effective DateJan 1, 2020

Next Review Date

Key ActionSubmit chart notes documenting indication, prior therapies, and objective response or intolerance as required by indication-specific criteria.

SourceLink

On This Page

Dosing consistent with FDA‑approved indications and product labeling is preferred. Doses outside established dosing regimens (including higher-than‑recommended doses or shortened intervals) will be considered on a case-by-case basis with supporting clinical rationale and documentation.

Operational: Include rationale and prior response data if requesting dose or interval outside labeling.

Preferred Product Step Therapy Requirements

Authorization for non‑preferred tocilizumab products or formulations requires documentation of trial or intolerance to preferred products. Covered when ANY of the following are met:

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"operator":"any",

"children":[

{"text":"Patient has documented inadequate response to all available preferred tocilizumab biosimilars or preferred products at adequate dose and duration appropriate to the indication (e.g., at least 12 weeks for rheumatoid arthritis unless intolerance or contraindication).","note":"Operational: Provide medication history with dates, doses, and objective measures of response (see provider actions)."},

{"text":"Patient has documented intolerance or contraindication to all available preferred tocilizumab biosimilars or preferred products (e.g., severe allergic reaction, anaphylaxis, or adverse effect necessitating discontinuation).","note":"Operational: Include description of adverse event, timing, and any rechallenge information if available."},

Clinical circumstances where switching to a non‑preferred product is clinically necessary (e.g., immunogenicity concerns, formulation-specific issues, or lack of access to preferred product), with supporting documentation.

Operational: Include clinical justification and supporting lab/imaging/consult notes.

"text":""

}

Prior Authorization

Prior authorization required

Prior authorization required. Submit sufficient documentation to support medical necessity before administration. Include relevant chart notes and objective measures of disease activity.

Submit complete chart notes and relevant specialty consultation notes.
Include the specific indication being treated (diagnosis and relevant disease severity).
Document prior therapies tried (drug names, doses, dates, reason for discontinuation).
Provide objective response measures where applicable (e.g., DAS28, CRP/ESR, imaging, oxygen requirements for COVID‑19 when applicable to other treatment pathways).

Step Therapy

Preferred product step therapy enforced

Preferred product step therapy enforced. New‑to‑therapy patients must start on the preferred biosimilar product unless a documented exception applies.

Effective 2025-01-01, Tyenne (preferred biosimilar) is required as the initial tocilizumab product for new-to-therapy patients under UCare Medical Assistance and Exchange plans.
To use a non‑preferred tocilizumab product at initiation, submit documentation of medical necessity per the Preferred Product Step Therapy Requirements (e.g., trial/failure, intolerance, or clinical justification).
Requests for formulary exceptions must include prior medication history, adverse events, and objective evidence of lack of efficacy where applicable.

Documentation Required

Specialist involvement and clinical documentation required

Specialist involvement and documentation required. Ensure specialty consultation and clear clinical documentation accompany authorization requests, especially when requesting non‑preferred products or doses outside labeling.

Specialist consultation note that supports diagnosis, planned dosing, monitoring plan, and rationale for agent selection.
For non‑preferred product requests, include detailed chart notes: prior medication trials with dates/doses, description of adverse reactions or inadequate response, laboratory and imaging results supporting disease activity or severity, and treatment goals.
If requesting dose or schedule outside FDA labeling, provide detailed clinical justification and supporting evidence (e.g., prior response history, toxicity at standard dosing, specialty recommendations).

1 year (established on therapy ≥6 months with objective or symptomatic benefit)

CRS (CAR T-cell) approval duration1 week (adequate to receive up to four doses)

Bispecific antibody–associated CRS approval1 week (up to four doses; interval ≥ 8 hours between doses)

Common objective response measuresCRP, ESR, resolution of fever, reduced corticosteroid dose

Common symptom improvement examplesDecreased headache/scalp/jaw pain, decreased fatigue, improved vision, improved function/ADLs

Documentation Required

Documentation required: indication, prior therapies, and objective response

Submit chart notes documenting the indication, prior therapies (with dates and reasons for discontinuation), and evidence of objective response or intolerance as required by the indication-specific criteria. Example required documents per indication: for Giant Cell Arteritis — CRP/ESR results, steroid use history, symptom improvement (vision/headache changes); for RA — validated disease activity scores (CDAI, DAS28-ESR/CRP) or CRP/ESR and symptom change; for SJIA/AOSD — fever/rash resolution, CRP/ESR, and corticosteroid dose reduction; for CRS/GVHD/Castleman/VEXAS — relevant labs (LFTs, CBC), objective markers noted in criteria, and specialist consultation notes.

Indication-specific objective measures: CRP, ESR, LFTs, CBC, disease activity scores (e.g., CDAI, DAS28, JADAS)
Documentation of prior therapies with durations and outcomes
Specialist consultation notes confirming diagnosis and treatment plan
Evidence of clinical benefit (symptom improvement or lab normalization)

Billing Rule

Policy does not address acute inpatient COVID-19 treatment

Policy explicitly states it does not address the acute treatment of hospitalized COVID-19 patients; billing or coverage requests for acute inpatient COVID-19 treatment should follow the specific COVID-19 indication/dosing guidance outside this policy. The policy also notes COVID-19 treatment in non-hospitalized patients is moved to a not-recommended category.

Policy does not address acute inpatient COVID-19 treatment
COVID-19 treatment guidance and dosing (8 mg/kg up to 800 mg single infusion with optional second dose ≥8 hours) are referenced separately and not governed by this policy

06/11/2025added

Cytokine release syndrome associated with bispecific antibodies and graft-versus-host disease were added as conditions of approval; bispecific antibody examples included.

08/13/2025revised

Immunotherapy-related toxicities scope expanded from inflammatory arthritis to broader immunotherapy-related toxicities associated with checkpoint inhibitors; added requirement that toxicity developed while receiving a checkpoint inhibitor, removed NSAID trial requirement, and expanded accepted specialists to include gastroenterologist, hepatologist, and pulmonologist.

09/24/2025revised

Avtozma added to policy as a tocilizumab IV product with same criteria as other tocilizumab products; Castleman disease initial-therapy HIV/HHV-8 negativity and relapsed/refractory/progressive requirements modified to apply to unicentric disease and not to multicentric disease.

10/29/2025revised

Castleman disease: requirement for relapsed/refractory or progressive disease for unicentric initial therapy was removed.

12/03/2025added

VEXAS syndrome (Vacuoles E1 Enzyme X-linked Autoinflammatory Somatic) was added as a condition of approval with genetic testing and corticosteroid-related criteria.

05/13/2026revisedLatest

Selected revisions included changing the systemic juvenile idiopathic arthritis (sJIA) dosing interval from at least 1 week to at least 2 weeks between doses; polymyalgia rheumatica dosing changed from 6 mg/kg (max 600 mg) to 8 mg/kg (max 800 mg) per dose; bispecific CD3 T-cell engager CRS examples and Blincyto added; immunotherapy-related toxicity language reworded and SJIA/AOSD alignment notes added. Marked as most recent selected revision.