ModifiedUnitedHealthcarePolicy 2026 P 2194-14

Tocilizumab - Actemra® (tocilizumab), Avtozma® (tocilizumab-anoh), and Tyenne® (tocilizumab-aazg) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Prior authorization and medical necessity criteria for subcutaneous tocilizumab formulations (Actemra, Avtozma, Tyenne) across multiple indications (giant cell arteritis, rheumatoid arthritis, polyarticular JIA, systemic JIA, systemic sclerosis-associated interstitial lung disease) for UnitedHealthcare Commercial Plans. Includes initial and reauthorization requirements, prescriber specialty, combination therapy exclusions, and authorization durations.

Policy Summary

PayerUnitedHealthcare

PolicyTocilizumab - Actemra® (tocilizumab), Avtozma® (tocilizumab-anoh), and Tyenne® (tocilizumab-aazg) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 2194-14

Change TypeModified (nomenclature, added product, criteria/examples updated)

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization demonstrating required diagnosis, specialist prescriber/consultation, and documented prior DMARD or targeted immunomodulator trials per criteria; authorizations typically issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Renamed program to Tocilizumab and added Avtozma to the program; updated Actemra and Tyenne to Tocilizumab throughout the program.

Added Tyenne to coverage criteria with Actemra (12/2024).

Added coverage criteria for systemic sclerosis-associated interstitial lung disease (4/2021).

Updated RA step therapy requirements over time (various dates), including preferred adalimumab products and changes to examples; removal/addition of specific preferred products.

Updated not receiving in combination language to 'targeted immunomodulator' and updated examples (7/2023).

12 monthsTypical authorization duration

>=10%HRCT fibrosis threshold (SSc-ILD)

>=3 monthsNon-biologic DMARD trial

Coverage Summary

This policy governs prior authorization and medical necessity criteria for the subcutaneous formulations of tocilizumab (Actemra, Avtozma, and Tyenne) for UnitedHealthcare Commercial Plans; the intravenous formulation is typically covered under the medical benefit and is referenced separately. Covered indications for the subcutaneous formulations include giant cell arteritis, moderately to severely active rheumatoid arthritis after inadequate response to DMARDs, polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA) (age ≥2 years), and slowing decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Quick facts and thresholds

Covered Indications5

Typical authorization duration12 months

HRCT fibrosis threshold for SSc-ILD>= 10% of the lungs

Non-biologic DMARD trial duration>= 3 months

Policy number2026 P 2194-14

Effective/last reviewEffective 2026-05-01; Last review 2026-03

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Unproven Uses / Exclusions

Claims may be denied if tocilizumab is used in combination with another systemic targeted immunomodulator for treatment of the same indication. The policy lists examples of such targeted agents (e.g., adalimumab, certolizumab, etanercept, baricitinib/Olumiant, abatacept/Orencia, upadacitinib/Rinvoq, golimumab/Simponi, tofacitinib/Xeljanz), and notes these examples are illustrative and have been updated over time.

Applicable Codes

Combination therapy examples (contraindicated for same indication)mixedNot Covered

	adalimumab (example: Humira and preferred adalimumab products)
	certolizumab (Cimzia)
	etanercept (Enbrel)
	baricitinib (Olumiant) - removed previously as preferred product
	abatacept (Orencia)
	upadacitinib (Rinvoq)
	golimumab (Simponi)
	tofacitinib (Xeljanz/XR)

Indication/diagnosis codes referencedICD-10

ICD-10 diagnosis codes may be used for automated approvals; specific ICD-10 codes not listed in policy text

Provider Actions

Prior Authorization

Prior authorization required

Initial and reauthorization requests require prior authorization and must meet the listed clinical criteria. Authorizations are typically issued for 12 months; state mandates (e.g., CT/KY/MS) may require a 30-day trial instead.

Documentation Required

Document trials and therapy history

Document prior therapy including the drug name, dates, and duration of prior non-biologic DMARDs or systemic targeted immunomodulators to demonstrate prior failure or prior therapy. Claims history may be used in lieu of submitted records when available.

Clinical Evidence & References

Evidence and program history include P&T approval and review dates: initial P&T approval 5/2020 with multiple subsequent reviews through 3/2026 (effective date 5/1/2026). Referenced package inserts include Actemra (June 2022), Tyenne (March 2024), and Avtozma (July 2025).

Background

Tocilizumab is an interleukin-6 (IL-6) receptor antagonist available in both intravenous and subcutaneous formulations. Subcutaneous formulations are labeled for moderately to severely active rheumatoid arthritis (after inadequate response to one or more DMARDs), giant cell arteritis, active polyarticular juvenile idiopathic arthritis, active systemic juvenile idiopathic arthritis (age ≥2 years), and for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The intravenous formulation is typically covered under the medical benefit and is referenced to the separate UnitedHealthcare Tocilizumab drug policy. The policy defines 'systemic targeted immunomodulator' to include biologic and targeted synthetic agents such as adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, and tofacitinib (examples listed in the policy).

Revision History

2026-05-01revisedLatest

Change effective 5/1/2026; renamed program to Tocilizumab, added Avtozma to the program, and updated Actemra and Tyenne to Tocilizumab throughout the program; updated combination examples/language with no change to clinical intent.

2024-12added

Added Tyenne to coverage criteria alongside Actemra and updated background and references.

2021-04added

Added coverage criteria for systemic sclerosis-associated interstitial lung disease (SSc-ILD), including HRCT fibrosis threshold of at least 10% and classification-based skin findings.

Policy Summary

PayerUnitedHealthcare

PolicyTocilizumab - Actemra® (tocilizumab), Avtozma® (tocilizumab-anoh), and Tyenne® (tocilizumab-aazg) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 2194-14

Change TypeModified (nomenclature, added product, criteria/examples updated)

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

Documentation Required

Specialist prescriber requirement

For most indications the prescriber must be or consult with a rheumatologist. For systemic sclerosis-associated interstitial lung disease (SSc-ILD) the prescriber must be or consult with a pulmonologist.

Billing Rule

Route/formulation scope

This program applies to subcutaneous formulations of tocilizumab. The intravenous formulation is typically covered under the medical benefit and is referenced to the separate UnitedHealthcare Drug Policy for Tocilizumab.

Denial Risk

Combination therapy exclusion

Claims may be denied if tocilizumab is used in combination with another systemic targeted immunomodulator for treatment of the same indication; multiple examples of targeted immunomodulators are listed in the policy.

Billing Rule

Authorization duration

Authorizations for both initial and reauthorization are issued for 12 months unless state mandates specify otherwise.

2023-07clarified

Clarified combination therapy exclusion language to 'targeted immunomodulator' and updated examples.

2020-05revised

Program established (P&T initial approval 5/2020) with subsequent multiple updates through 2025 modifying RA step therapy examples and preferred product lists without change to clinical intent.