UnitedHealthcare subcutaneous tocilizumab Prior Auth

Coverage Criteria — Tocilizumab (subcutaneous)

Initial Authorization — Giant Cell Arteritis

Covered when ALL of the following are met

GCA initial: (1) Diagnosis of giant cell arteritis

GCA concurrent therapy: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Authorization will be issued for 12 months.

Reauthorization — Giant Cell Arteritis

Covered when ALL of the following are met

GCA reauth response: (1) Documentation of positive clinical response to tocilizumab therapy

GCA reauth concurrent: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Authorization will be issued for 12 months.

Initial Authorization — Rheumatoid Arthritis

Covered when ALL of the following are met

RA initial diagnosis: (1) Diagnosis of moderately to severely active rheumatoid arthritis

RA DMARD failure: (2) Patient has had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs) (e.g., methotrexate, leflunomide, sulfasalazine)

RA concurrent therapy: (3) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib] for treatment of the same indication

Authorization will be issued for 12 months.

Reauthorization — Rheumatoid Arthritis

Covered when ALL of the following are met

RA reauth response: (1) Documentation of positive clinical response to tocilizumab therapy

RA reauth concurrent: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib] for treatment of the same indication

Authorization will be issued for 12 months.

Initial Authorization — PJIA

Covered when ALL of the following are met

PJIA initial diagnosis: (1) Diagnosis of active polyarticular juvenile idiopathic arthritis

PJIA concurrent therapy: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib] for treatment of the same indication

Authorization will be issued for 12 months.

Reauthorization — PJIA

Covered when ALL of the following are met

PJIA reauth response: (1) Documentation of positive clinical response to tocilizumab therapy

PJIA reauth concurrent: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib] for treatment of the same indication

Authorization will be issued for 12 months.

Initial Authorization — SJIA

Covered when ALL of the following are met

SJIA initial diagnosis: (1) Diagnosis of active systemic juvenile idiopathic arthritis

SJIA concurrent therapy: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib] for treatment of the same indication

Authorization will be issued for 12 months.

Reauthorization — SJIA

Covered when ALL of the following are met

SJIA reauth response: (1) Documentation of positive clinical response to tocilizumab therapy

SJIA reauth concurrent: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib] for treatment of the same indication

Authorization will be issued for 12 months.

Initial Authorization — SSc-ILD

Covered when ALL of the following are met

SSc-ILD initial diagnosis: (1) Diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD)

SSc-ILD concurrent therapy: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Authorization will be issued for 12 months.

Reauthorization — SSc-ILD

Covered when ALL of the following are met

SSc-ILD reauth response: (1) Documentation of positive clinical response to tocilizumab therapy

SSc-ILD reauth concurrent: (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Authorization will be issued for 12 months.

Claims-based approval rule

Additional clinical rules that can form the basis for approval

Automated or claims-based approval: UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval/reauthorization varies by program or therapeutic class.

Supports approvals without full manual criteria if claims data sufficient.

The intravenous (IV) formulation of tocilizumab is typically billed and covered under the medical benefit. For operational or coverage details about IV administration, refer to the separate UnitedHealthcare drug policy for tocilizumab; automated approvals, step therapy, or supply limits may still apply per program rules.

No additional coverage notes are specified in the source for this placeholder entry. UnitedHealthcare may use prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic to approve initial or reauthorization requests as program rules allow.

No additional coverage notes are specified in the source for this placeholder entry. Supply limits and/or Step Therapy may be in place depending on program or therapeutic class; providers should supply relevant prior medication/claim history and diagnosis codes when requesting authorization.

Initial Therapy Requirements

Initial Therapy — indication-specific initial authorization criteria

Initial authorization criteria differ by indication but generally require diagnosis and no concomitant use of another systemic targeted immunomodulator for the same indication

general initial: Diagnosis of the specific covered indication AND patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Authorization will be issued for 12 months.

RA-specific: For rheumatoid arthritis: prior inadequate response to one or more DMARDs is required

Initial therapy approval (top-level node)

Initial approval pathways: Initial approval may be granted based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic without additional documentation depending on program/therapeutic class.

Reauthorization / Continuation Criteria

Reauthorization / Continuation Therapy — requires clinical response and absence of concomitant systemic targeted immunomodulator use

Reauthorization requires clinical response and absence of concomitant systemic targeted immunomodulator use for same indication

continuation nodes: (1) Documentation of positive clinical response to tocilizumab therapy AND (2) Patient is not receiving tocilizumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Authorization will be issued for 12 months.

Renewal/Continuation notes

Historical operational notes regarding renewal

Renewal duration: Authorization issue was updated historically to 12 months for renewal (noted in 2020).12 months

Operational history — confirms renewal length used previously.

Coding and Authorization Duration

Authorization duration (historical note)

Authorization durationAuthorization (initial and reauthorization) will be issued for 12 months.

Historical noteOperational update in 2020 confirms 12-month renewal length previously used.

ScopeApplies to prior authorizations issued for subcutaneous tocilizumab products under this program.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Subcutaneous tocilizumab products require prior authorization. Approvals are typically issued for 12 months when criteria are met.

Applies to Actemra, Avtozma, Tyenne (subcutaneous formulations)

Note

Prior Authorization May Use Claim/Medication History and Claim Logic

Approvals and reauthorizations may be based on prior claim/medication history, diagnosis codes (ICD-10), and automated claim logic. UnitedHealthcare may use automated approval and re-approval processes which vary by program or therapeutic class.

Step Therapy

Supply Limits, Step Therapy, and Medical Benefit Note

Supply limits and/or step therapy may apply. The intravenous formulation of tocilizumab is typically covered under the medical benefit — refer to the UnitedHealthcare Drug Policy for Tocilizumab for IV-specific rules.

Step Therapy and Supply Limits

Requirement	Details
Supply limits and/or step therapy may be in place
UnitedHealthcare may apply supply limits and/or Step Therapy as part of program management; automated approvals may also be granted based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Step therapy detail	Notes
Specific step therapy requirements are program- and therapeutic class–dependent
Use of automated approval/re-approval processes and supply-limit or step-therapy application varies by program or therapeutic class; details are determined by the applicable UnitedHealthcare program and referenced product listings (e.g., Actemra, Avtozma, Tyenne).

Place of Service — Infusion vs Pharmacy

Billing Rule

IV infusions billed to medical; subcutaneous to pharmacy

Intravenous tocilizumab infusions are typically billed under the medical benefit; the subcutaneous formulation covered by this program is processed under the pharmacy benefit.

Note

See UnitedHealthcare drug policy for IV tocilizumab details

Refer to the UnitedHealthcare Drug Policy for Tocilizumab for details about intravenous (infusion) coverage and site-of-care billing rules.

Definitions and Product Names

DMARD definition

DefinitionDMARD = disease-modifying antirheumatic drugs.

ExamplesExamples referenced in policy: methotrexate, leflunomide, sulfasalazine.

Clinical contextDMARDs are used as prior therapy for rheumatoid arthritis before initiating subcutaneous tocilizumab per policy criteria.

Tocilizumab products

Reference biologicActemra (tocilizumab).

Biosimilar — TyenneTyenne (tocilizumab-aazg).

Biosimilar — Avtozma

Background — Tocilizumab

Tocilizumab is an interleukin‑6 (IL‑6) receptor antagonist available in both intravenous (IV) and subcutaneous formulations. Within this program, the subcutaneous formulation is subject to pharmacy benefit prior authorization rules, while the intravenous infusion is typically covered under the medical benefit. UnitedHealthcare may approve requests based on documented clinical criteria or, in some programs, solely on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic. Supply limits and/or step therapy may apply depending on the program or therapeutic class; providers should refer to the separate UnitedHealthcare drug policy for full IV administration guidance.

Biosimilar and Reference Product Notes

Billing Rule

Actemra included and treated equivalently in program

Actemra (tocilizumab) was added to the program naming and is treated equivalently within the program alongside other tocilizumab products.

Note

Actemra inclusion and package insert cited

Actemra (tocilizumab) and other tocilizumab products (Tyenne, Avtozma) are cited in the program references and package insert listings.

OpenPayer

Tocilizumab (subcutaneous) prior authorization

Coverage Criteria — Tocilizumab (subcutaneous)

Initial Therapy Requirements

Reauthorization / Continuation Criteria

Coding and Authorization Duration

Provider Actions and Documentation Requirements

Step Therapy and Supply Limits

Place of Service — Infusion vs Pharmacy

Definitions and Product Names

Background — Tocilizumab

Biosimilar and Reference Product Notes