Actemra (Tocilizumab) Injection for Intravenous Infusion — Medical Benefit Drug Policy - OpenPayer

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Actemra (Tocilizumab) Injection for Intravenous Infusion — Medical Benefit Drug Policy - OpenPayer

Coverage Summary & Rationale

Polyarticular Juvenile Idiopathic Arthritis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA).
Actemra is dosed according to U.S. Food and Drug Administration (FDA) labeled dosing for polyarticular juvenile idiopathic arthritis.
Patient is not receiving Actemra in combination with a targeted immunomodulator (e.g., Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib)).
Prescribed by or in consultation with a rheumatologist.
Initial-therapy requirement
Initial authorization is for no more than 12 months.
Initial Therapy Authorization Duration

ALL of the following

Patient has previously received Actemra injection for intravenous infusion.
Documentation of positive clinical response to Actemra.
Actemra is dosed according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis.
Patient is not receiving Actemra in combination with a targeted immunomodulator (e.g., Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib)).
Authorization is for no more than 12 months.
Continuation Therapy Authorization Duration

Rheumatoid Arthritis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active rheumatoid arthritis (RA).
History of failure, contraindication, or intolerance to at least one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, minocycline, etc.).
Actemra is dosed according to FDA labeled dosing for rheumatoid arthritis.
Patient is not receiving Actemra in combination with a targeted immunomodulator (e.g., Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib)).
Initial authorization is for no more than 12 months.

Systemic Juvenile Idiopathic Arthritis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of systemic juvenile idiopathic arthritis (SJIA).
Actemra is dosed according to FDA labeled dosing for systemic juvenile idiopathic arthritis.
Patient is not receiving Actemra in combination with a targeted immunomodulator (e.g., Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib)).
Initial authorization is for no more than 12 months.
Initial Therapy Authorization Duration

ALL of the following

Giant Cell Arteritis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of giant cell arteritis (GCA).
Actemra is dosed according to FDA labeled dosing for giant cell arteritis.
Patient is not receiving Actemra in combination with a targeted immunomodulator (e.g., Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib)).
Initial authorization is for no more than 12 months.
Initial Therapy Authorization Duration

ALL of the following

Cytokine Release Syndrome

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cytokine release syndrome (CRS) associated with chimeric antigen receptor (CAR) T-cell therapy.
Actemra is dosed according to FDA labeled dosing for CRS.
Administered in an appropriate inpatient or outpatient infusion setting by qualified personnel experienced in managing CRS-related complications.
Initial authorization is for no more than 12 months.
Authorization Duration

ALL of the following

Acute Graft-Versus-Host Disease

Covered when ALL of the following are met:

ALL of the following

Diagnosis of acute graft-versus-host disease (GVHD) with features for which IL-6 blockade is being considered per treating clinician (note: evidence is evolving).
Actemra is dosed according to available dosing guidance or clinical trial protocol; clinical rationale and supporting documentation must be provided.
Patient is not receiving Actemra in combination with another targeted immunomodulator.
Initial authorization is for no more than 12 months.
Authorization Duration

ALL of the following

Immune Checkpoint Inhibitor-Related Toxicities (severe inflammatory arthritis)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of severe inflammatory arthritis temporally related to immune checkpoint inhibitor (ICI) therapy, for which IL-6 blockade is being considered.
Patient has failed, is intolerant to, or has a contraindication to conventional therapies appropriate for ICI-related inflammatory arthritis (e.g., NSAIDs, corticosteroids, conventional DMARDs) as determined by the treating oncologist or rheumatologist.
Actemra is dosed consistent with the clinical indication and available guidance; dosing rationale must be documented.
Patient is not receiving Actemra in combination with another targeted immunomodulator.

Coverage Rationale — Cytokine Release Syndrome (from Policy History)

Policy history-derived coverage rationale for CRS — preserved for reference:

ALL of the following

Actemra is covered for treatment of cytokine release syndrome (CRS) associated with CAR T-cell therapy when dosed per FDA labeling and when prescribed and administered in an appropriate clinical setting.
Use should follow established institutional CRS management algorithms and involve clinicians experienced in CAR T-cell therapy and CRS management.
Documentation of CRS diagnosis and clinical course, including prior supportive measures and rationale for tocilizumab use, should be provided at time of prior authorization request.
Authorization duration is generally up to 12 months as clinically appropriate.

Continuation Therapy Criteria

Continuation branches — Consolidated

Consolidated continuation requirements (documentation of prior Actemra use, positive clinical response, dosing and authorization limits) for indications with continuation branches.

RA continuation

Patient has previously received Actemra injection for intravenous infusion
Documentation of positive clinical response
Actemra is dosed according to FDA labeled dosing for rheumatoid arthritis
Patient is not receiving Actemra in combination with a targeted immunomodulator (examples listed above)

Use Limitations & Combination Therapy Exclusions

Policy‑wide exclusion: Actemra IV should not be used in combination with targeted immunomodulators for many indications; examples of targeted immunomodulators listed in the policy include Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib).

Benefit distinction: this medical benefit policy applies specifically to Actemra for intravenous infusion; self‑administered subcutaneous Actemra products are obtained under the pharmacy benefit and therefore are not covered under this IV medical benefit.

Applicable Codes

HCPCS - Actemra billingHCPCSCovered

J3262

Injection, tocilizumab, 1 mg

ICD-10 Diagnosis Codes referencedICD-10

D89.810	Acute graft-versus-host disease
D89.831	Cytokine release syndrome, grade 1
D89.832	Cytokine release syndrome, grade 2
D89.833	Cytokine release syndrome, grade 3
D89.834	Cytokine release syndrome, grade 4
D89.835	Cytokine release syndrome, grade 5
D89.839	Cytokine release syndrome, grade unspecified
M05.00	Felty's syndrome, unspecified site
M05.011	Felty's syndrome, right shoulder
M05.012	Felty's syndrome, left shoulder

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Applicable ICD-10 Diagnosis Codes (listed in document)ICD-10

M08.049	Unspecified juvenile rheumatoid arthritis, unspecified hand
M08.051	Unspecified juvenile rheumatoid arthritis, right hip
M08.052	Unspecified juvenile rheumatoid arthritis, left hip
M08.059	Unspecified juvenile rheumatoid arthritis, unspecified hip
M08.061	Unspecified juvenile rheumatoid arthritis, right knee
M08.062	Unspecified juvenile rheumatoid arthritis, left knee
M08.069	Unspecified juvenile rheumatoid arthritis, unspecified knee
M08.071	Unspecified juvenile rheumatoid arthritis, right ankle and foot
M08.072	Unspecified juvenile rheumatoid arthritis, left ankle and foot
M08.079	Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot

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Authorization, Documentation & Billing Actions

Prior Authorization

Authorization required with duration limits

Initial authorization is required. Maximum durations are specified: chronic rheumatologic indications (e.g., PJIA, RA, SJIA, GCA) are generally limited to no more than 12 months; cytokine release syndrome (CRS), steroid-refractory acute GVHD, and immune checkpoint inhibitor–related toxicities are limited to no more than 4 doses.

Documentation Required

Requirement to document prior therapy or response

Document prior therapies or treatment response as specified by indication. For RA initial therapy, document failure, contraindication, or intolerance to at least one non‑biologic DMARD or prior treatment with a biologic/targeted synthetic DMARD (or current Actemra use). For continuations, document prior Actemra IV use and a positive clinical response. For CRS, acute GVHD, and checkpoint inhibitor–related toxicities, document recent receipt of CAR‑T, CD3‑directed therapy, or checkpoint inhibitor therapy and response to corticosteroids or infliximab as applicable.

Clinical Evidence & Guidance

ACT-RAYRandomized ACT-RAY trial: treat-to-target with tocilizumab showed TCZ-free remissions in a subset, minimal radiographic progression at 2 years, similar safety

NCCNNCCN Compendium: tocilizumab listed with 2A recommendations for CAR-T/CRS, GVHD, checkpoint toxicities, Castleman’s disease

ACT‑RAY trial: a randomized strategy trial (TCZ add‑on vs switch) demonstrated that treat‑to‑target strategies with tocilizumab could achieve sustained drug‑free remission in a subset of patients, with minimal radiographic progression at 2 years and similar safety between strategies.

NCCN compendium: the NCCN Drugs & Biologics Compendium lists tocilizumab with (2A) recommendations across multiple uses including CAR‑T related toxicities, Castleman’s disease, acute GVHD, and immunotherapy‑related toxicities; NCCN guidance also specifies dosing and limits for repeat dosing in CAR‑T/CRS scenarios.

Guideline support: professional society guidance cited in the policy includes ACR and ACR/VF (for RA, JIA, and GCA), reflecting guideline‑supported use of tocilizumab in appropriate clinical contexts.

Background & Definitions

Scope: this medical benefit drug policy addresses Actemra (tocilizumab) injection for intravenous infusion across multiple labeled and related indications (rheumatologic and immune‑mediated conditions, cytokine release syndrome, acute GVHD, checkpoint inhibitor‑related toxicities), and specifies coverage criteria, authorization durations, and applicable codes.

Background: Actemra is an anti‑IL‑6 receptor monoclonal antibody; the policy references FDA‑labeled dosing for individual indications and notes that subcutaneous formulations are covered under the pharmacy benefit rather than this IV medical benefit.

Combination use: the policy consistently requires that patients not receive Actemra in combination with a targeted immunomodulator for many indications and provides examples of those targeted immunomodulators. Effective and last review dates: Effective Date: July 1, 2024; Last review: July 1, 2024.

Policy Revision History

07/01/2024revisedLatest

Revised coverage criteria for initial therapy for Cytokine Release Syndrome: replaced criterion specifying receipt of Blincyto (blinatumomab) alone with language requiring receipt of CD3-directed therapy (e.g., Blincyto (blinatumomab), Tecvayli (teclistamab)).

07/01/2024archived

Archived previous policy version 2024D0043U as supporting information.