CurrentColorado Rocky Mountain Health PlansPolicy N/A

Tocilizumab step therapy (subcutaneous formulations) coverage criteria

Defines step therapy requirements for coverage of subcutaneous tocilizumab formulations (Actemra, Avtozma, Tyenne) for rheumatoid arthritis and other diagnoses; applies to members requiring pharmacy benefit coverage and new-to-therapy members. Infused (IV) tocilizumab is addressed under a separate medical benefit policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTocilizumab step therapy (subcutaneous formulations) coverage criteria

Policy CodePolicy N/A

Change TypeAdded Avtozmanaming and medication list updates

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document failure, contraindication, or intolerance to two preferred products (drug, date, and duration) for new-to-therapy members.

SourceLink

POLICY UPDATE CHANGES

Program renamed to Tocilizumab and Avtozma (tocilizumab-anoh) was added to the program; Actemra and Tyenne were updated to be referenced as tocilizumab throughout the program.

Avtozma (tocilizumab-anoh) was added and Tyenne was included in coverage criteria alongside Actemra.

2preferred product trials required before tocilizumab coverage

12 monthsauthorization duration

subcutaneousformulations in scope

05/01/2026

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Coverage Criteria for Subcutaneous Tocilizumab

inv-01: Rheumatoid arthritis — initial therapy

Covered when ALL of the following are met

RA initial approval

Step requirement: History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): preferred adalimumab product(s); Cimzia (certolizumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Xeljanz/Xeljanz XR (tofacitinib)2 failed preferred products
Authorization issued for 12 months; alternatively, members currently on documented tocilizumab therapy may be continued per claims history

inv-02: Current therapy / manufacturer sample provision — 1 top-level node

Current user or sample rule: Either: (1) Patient is currently on tocilizumab therapy as documented in claims history; OR (2) Patient meets initial authorization requirements. Patients established solely via manufacturer-supplied samples or manufacturer assistance programs are NOT considered current users and must meet initial authorization criteria.

If current use is documented in claims, approval may be granted without meeting the two-preferred-product trials

Infused (intravenous) formulations of tocilizumab are not included in this pharmacy-managed subcutaneous step therapy program. Intravenous tocilizumab for rheumatoid arthritis is typically billed and covered under the medical benefit; refer to the UnitedHealthcare Drug Policy for specific coverage and administration guidance.

Patients who were established on tocilizumab therapy solely by receipt of manufacturer‑supplied samples in the prescriber’s office or through manufacturer assistance programs (for example, sample cards redeemable at a pharmacy) are not considered current users for continuation purposes. Such patients must meet the initial authorization/step therapy requirements (including documentation of failure, contraindication, or intolerance to two preferred products) as if they were new to therapy.

Initial Therapy

inv-11: Initial therapy — 1 top-level node

Initial tocilizumab approval: Diagnosis of moderately to severely active rheumatoid arthritis AND failure/contraindication/intolerance to two preferred products (document drug, date, and duration of trial) OR documented current tocilizumab use (not established by manufacturer sample)

Authorization issued for 12 months

Continuation Therapy

inv-12: Continuation therapy — continuation for existing users

Continuation for existing users

Continuation: Members currently on tocilizumab therapy as documented in claims history will be allowed to continue their current therapy.

Claims history documentation is required for continuation approval; receipt of manufacturer samples does not qualify as documented current use

Step Therapy Requirements

Required prior trials	Notes / documentation
Two preferred products (must have history of failure, contraindication, or intolerance)
Document drug name, date, and duration of trial for each preferred product; alternatively, approval may be granted if patient is a current tocilizumab user documented in claims (patients established only via manufacturer samples do not qualify)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tocilizumab. Approvals will be issued for 12 months.

Authorization duration: 12 months

Step Therapy

Step Therapy Requirement

New-to-therapy members must try and fail two preferred products before tocilizumab will be approved. Preferred products include adalimumab (preferred adalimumab products), Cimzia (certolizumab), Enbrel (etanercept), Rinvoq (upadacitinib), Simponi (golimumab), and Xeljanz/Xeljanz XR (tofacitinib). Infused RA medications are not part of this step requirement.

Step requirement: trial/failure of 2 preferred products prior to tocilizumab for members new to therapy

Site of Care and Benefit Routing

Billing Rule

IV infusions = medical benefit; SC = pharmacy benefit

Intravenous (infusion) tocilizumab administrations are typically billed and covered under the medical benefit, while subcutaneous tocilizumab formulations are managed under the pharmacy step therapy program.

Products in Scope

Note

Actemra, Avtozma, Tyenne included as 'tocilizumab'

Subcutaneous formulations of Actemra, Avtozma (tocilizumab-anoh), and Tyenne (tocilizumab-aazg) are included in this step therapy program and are referred to collectively as tocilizumab.

Definitions

Step therapy — definition of step therapy program

DefinitionStep therapy is a utilization management program that requires a member to try specified lower-cost preferred alternatives before coverage is provided for the requested drug (subcutaneous tocilizumab).

Program requirementNew-to-therapy members must try and fail two preferred products prior to coverage of subcutaneous tocilizumab (Actemra, Avtozma, Tyenne).

Preferred product examplesPreferred options include adalimumab products, Cimzia (certolizumab), Enbrel (etanercept), Rinvoq (upadacitinib), Simponi (golimumab), and Xeljanz/XR (tofacitinib).

Current usersMembers currently on tocilizumab therapy as documented in claims history may continue without meeting the step trials requirement.

ExclusionsInfused (intravenous) tocilizumab medications for rheumatoid arthritis are not part of this subcutaneous step therapy criteria.

Background

Tocilizumab is an interleukin‑6 (IL‑6) receptor antagonist indicated for the treatment of adults with moderately to severely active rheumatoid arthritis after an inadequate response to one or more disease‑modifying antirheumatic drugs (DMARDs). This program manages the subcutaneous tocilizumab products (Actemra, Avtozma, Tyenne) under step therapy and requires use of preferred alternatives prior to coverage of tocilizumab for new‑to‑therapy members.