ModifiedmarylandphysicianscarempcPolicy RX.PA.048.MPC

Actemra (tocilizumab) IV prior authorization

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Defines Maryland Physicians Care prior authorization requirements, renewal rules, and coverage limitations for intravenous tocilizumab (Actemra IV) across listed rheumatologic and related indications for prescribers and payers.

Policy Summary

Payermarylandphysicianscarempc

PolicyActemra (tocilizumab) IV prior authorization

Policy CodePolicy RX.PA.048.MPC

Change TypeCoverage criteria clarified and step-therapy requirements added

Effective Date

Last ReviewFeb 1, 2026

Next Review DateFeb 1, 2026

Key ActionPrior authorization is required; initial approvals are generally for up to 3 months when initial criteria per indication are met.

SourceLink

POLICY UPDATE CHANGES

Cytokine Release Syndrome coverage was clarified to specify it must be associated with Chimeric Antigen Receptor (CAR) T-Cell Therapy.

For several indications, allowance for prescriber determination was broadened for patients currently receiving Actemra who have responded.

A trial and failure requirement with the preferred JAK inhibitor Xeljanz (tofacitinib) for at least 3 months was added for specified indications.

All indications now require trial and failure with one conventional DMARD for 3 months or intolerance to at least two conventional DMARDs.

3 monthsTypical initial approval duration

1 yearTypical reauthorization duration

J3262Applicable HCPCS code

InvestigationalNon-covered uses

02/2026Next review cycle

Coverage Criteria for Actemra (tocilizumab) IV

Initial Therapy (by indication)

Approve when ALL of the following are met for the specified indication

Giant Cell Arteritis - Initial Therapy: Approve for 3 months if: patient has tried ≥1 systemic corticosteroid for at least 3 months or has documented intolerance, or has relapsing GCA; Actemra IV is prescribed by or in consultation with a rheumatologist; dose does not exceed FDA approved label dosing for the indication; patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

Polyarticular Juvenile Idiopathic Arthritis - Initial Therapy: Approve for 3 months if: patient has tried ≥1 systemic therapy for ≥3 months or has documented intolerance to ≥2 other agents; patient has aggressive disease as determined by the prescriber; patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred TNF inhibitors (etanercept, adalimumab); patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred JAK inhibitor Xeljanz (tofacitinib); dose does not exceed FDA approved label dosing for the indication; medication is prescribed by or in consultation with a rheumatologist; patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

Rheumatoid Arthritis - Initial Therapy: Approve for 3 months if: patient has tried ONE conventional synthetic DMARD for ≥3 months or has a documented intolerance to ≥2 DMARD agents; OR patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred TNF inhibitors (etanercept, adalimumab); patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred JAK inhibitor Xeljanz (tofacitinib); dose does not exceed FDA approved label dosing for the indication; medication is prescribed by or in consultation with a rheumatologist; patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

Systemic Juvenile Idiopathic Arthritis - Initial Therapy: Approve for 3 months if: patient has tried at least TWO other systemic therapies for ≥3 months or has documented intolerance to ≥2 systemic agents; patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred TNF inhibitors (etanercept, adalimumab); patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred JAK inhibitor Xeljanz (tofacitinib); dose does not exceed FDA approved label dosing for the indication; medication is prescribed by or in consultation with a rheumatologist; patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

Castleman's Disease - Initial Therapy: Approve for 3 months if: agent is prescribed by or in consultation with an oncologist or hematologist; patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

Still's Disease - Initial Therapy: Approve for 3 months if: patient has tried one corticosteroid for ≥3 months; patient has tried ≥1 conventional synthetic DMARD for ≥3 months or was intolerant to ≥2 conventional synthetic DMARDs; patient has documented intolerance, contraindication to, or failed treatment for ≥3 months with preferred TNF inhibitors (etanercept, adalimumab); dose does not exceed FDA approved labeling for the indication; medication is prescribed by or in consultation with a rheumatologist; patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

Reauthorization (all indications)

Reauthorization — Approve for 1 year if one of the following is met

Reauthorization Pathways: A) MPC Renewal: patient has received an MPC prior authorization, has been established on therapy for at least 3 months, and has had a documented clinically significant response as determined by the provider; and patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs. OR B) Renewal from Previous Insurer: patient had prior approval from another insurer or received medication samples, has been established on therapy for at least 3 months, and has had a documented clinically significant response as determined by the provider; and patient is not concurrently using Actemra with other biologics or targeted synthetic DMARDs.

General prior therapy and authorization criteria

Coverage requires specified prior therapy and meets indication-specific criteria (details in other policy parts).

Prior DMARD requirement: All indications require trial and failure with one conventional DMARD for 3 months OR intolerance to at least two conventional DMARDs.3 months

Expanded upon required initial DMARD therapy and reauthorization requirements.

JAK inhibitor requirement for selected indications: For specified indications (e.g., polyarticular JIA and SJIA per revisions), trial and failure with preferred JAK inhibitor Xeljanz (tofacitinib) for at least 3 months is required.3 months

Added 11/2022 and updated 05/2023.

Authorization duration: Initial authorization up to 3 months; reauthorization periods match initial authorization (typical reauthorization is 1 year when criteria are met).

Limitation stated in policy.

Requests for intravenous tocilizumab (Actemra IV) for indications or uses not specifically listed in this policy are classified as investigational/experimental and will not be covered.

Actemra IV administered for any purpose other than the policy-specified indications is considered investigational or experimental and is not a covered benefit under this policy.

Any use of Actemra IV outside the indications enumerated in this document is designated investigational/experimental and therefore excluded from coverage.

Coding and Dosing Information

Applicable HCPCS CodesHCPCSCovered

J3262

Injection, tocilizumab, 1mg

Applicable HCPCS CodesHCPCSCovered

J3262

Injection, tocilizumab, 1mg

Dosing (inv-09)

Manufacturer dosing requirementMust be prescribed at a dose within the manufacturer's dosing guidelines (based on diagnosis, weight, etc) listed in the FDA approved labeling.

Weight-based dosing noteDosing must follow FDA‑approved labeling which includes weight- and indication-specific IV dosing regimens.

Diagnosis-specific dosing noteDose must be appropriate for the specific approved indication (e.g., GCA, RA, SJIA, PJIA) per label instructions.

Concurrent therapy restrictionDosing must be consistent with requirements that Actemra IV not be used concurrently with other biologic or targeted synthetic DMARDs (per indication criteria).

Documentation expectationPrescriber must document that the prescribed dose is within FDA labeling as part of prior authorization and reauthorization requests.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — initial approvals up to 3 months

Prior authorization is required for Actemra IV; when the initial coverage criteria for the requested indication are met, initial approvals are generally granted for up to 3 months.

Billing Rule

Prior authorization and applicable code — J3262; initial approvals up to 3 months

Prior authorization must be requested for Actemra IV using HCPCS code J3262 (Injection, tocilizumab, 1 mg). Initial approvals are up to 3 months and reauthorization intervals follow the same limits.

Applicable HCPCS code: J3262 (Injection, tocilizumab, 1 mg).

Step Therapy

Required prior therapy trials (corticosteroids, csDMARDs, TNF inhibitors, JAK inhibitor where specified)

Prior to approval for several indications, patients must have trialed specified prior therapies (systemic corticosteroids, conventional synthetic DMARDs, preferred TNF inhibitors, and where specified the preferred JAK inhibitor) for the durations noted or have documented intolerance/contraindication.

GCA: trial of ≥1 systemic corticosteroid for ≥3 months or documented intolerance, or relapsing GCA (chunk 3).
Rheumatoid arthritis and Still's: trial of one conventional synthetic DMARD for ≥3 months or intolerance to ≥2 DMARDs (chunks 3, 15).
SJIA: trial of ≥2 other systemic therapies for ≥3 months or documented intolerance to ≥2 agents; intolerance/failed TNF inhibitors and preferred JAK inhibitor Xeljanz for ≥3 months (chunk 9).

Step Therapy

DMARD and JAK inhibitor step requirements

All indications require trial and failure with one conventional synthetic DMARD for at least 3 months or documented intolerance to at least two conventional DMARDs; selected indications (polyarticular JIA, SJIA per revisions) also require trial and failure with the preferred JAK inhibitor Xeljanz (tofacitinib) for at least 3 months.

Conventional DMARD examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine (chunk 3).
JAK inhibitor (Xeljanz) trial requirement added for polyarticular JIA and SJIA in revision history (chunks 26, 25).

Documentation Required

Examples of clinically significant response to document

Documented clinically significant response may include laboratory or clinical improvements; providers should record such responses when requesting renewal.

Examples include normalization of CRP, ESR, fibrinogen, albumin, and/or hemoglobin; resolution of constitutional symptoms; increased BMI; and reduction in lymphadenopathy.

Prior Authorization

Authorization duration — initial up to 3 months; reauthorization intervals

Initial authorizations are granted for up to 3 months when initial criteria are met; reauthorization intervals match the initial authorization period (reauthorization criteria allow approval for 1 year when renewal criteria are met).

Initial authorization: up to 3 months (chunk 19).
Reauthorization: policy specifies reauthorization pathways that can approve for 1 year when renewal criteria are satisfied (chunks 6, 4).

Denial Risk

Investigational uses excluded — non‑listed indications not covered

Requests for Actemra IV for any use not specifically listed in the policy are considered investigational or experimental and will not be covered.

Denial Risk

Investigational uses denied — non‑covered investigational/experimental indications

Requests for Actemra IV for uses other than the policy‑specified indications will be denied as not covered; providers should not expect coverage for investigational/experimental indications.

Any use outside the indications listed in the policy is considered investigational/experimental and not medically necessary.

Definitions and Drug Description

Actemra (tocilizumab) IV — definition & primary indications (inv-19)

Drug class and routeActemra (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor administered by intravenous infusion.

Primary FDA indications (examples)Indicated for giant cell arteritis (adults), polyarticular juvenile idiopathic arthritis (patients ≥ 2 years), rheumatoid arthritis (adults with moderate to severe disease), and systemic juvenile idiopathic arthritis (patients ≥ 2 years).

Purpose of policyThis policy defines prior authorization requirements for Actemra IV, tying coverage to prior therapy, specialist involvement, dosing within FDA label, and absence of concurrent biologic/targeted synthetic DMARD therapy.

Cytokine Release Syndrome (CRS) — policy scope (inv-20)

CRS coverage limitationCytokine Release Syndrome (CRS) is reviewed under this policy only when it is associated with Chimeric Antigen Receptor (CAR) T‑Cell Therapy.

Examples relocatedExamples of CAR T‑cell therapies previously listed in criteria were moved to a policy Note (no longer embedded in criteria).

Policy revision noteReview history documents clarification specifying CRS must be associated with CAR T‑Cell Therapy for consideration under this policy.

Background

Actemra (tocilizumab) IV is an interleukin-6 (IL-6) receptor inhibitor administered by intravenous infusion and is indicated for multiple inflammatory conditions including giant cell arteritis, rheumatoid arthritis, and systemic and polyarticular juvenile idiopathic arthritis. Coverage under this policy is limited to the specific indications and criteria described; uses not listed are considered investigational and are not covered.

Policy Summary

Payermarylandphysicianscarempc

PolicyActemra (tocilizumab) IV prior authorization

Policy CodePolicy RX.PA.048.MPC

Change TypeCoverage criteria clarified and step-therapy requirements added

Effective Date

Last ReviewFeb 1, 2026

Next Review DateFeb 1, 2026

Key ActionPrior authorization is required; initial approvals are generally for up to 3 months when initial criteria per indication are met.

SourceLink

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Actemra (tocilizumab) IV prior authorization

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Coverage Criteria for Actemra (tocilizumab) IV

Initial Therapy (by indication)

Approve when ALL of the following are met for the specified indication

Reauthorization (all indications)

Reauthorization — Approve for 1 year if one of the following is met

General prior therapy and authorization criteria

Coverage requires specified prior therapy and meets indication-specific criteria (details in other policy parts).

Prior DMARD requirement: All indications require trial and failure with one conventional DMARD for 3 months OR intolerance to at least two conventional DMARDs.3 months

Expanded upon required initial DMARD therapy and reauthorization requirements.

Added 11/2022 and updated 05/2023.

Authorization duration: Initial authorization up to 3 months; reauthorization periods match initial authorization (typical reauthorization is 1 year when criteria are met).

Limitation stated in policy.

Requests for intravenous tocilizumab (Actemra IV) for indications or uses not specifically listed in this policy are classified as investigational/experimental and will not be covered.

Actemra IV administered for any purpose other than the policy-specified indications is considered investigational or experimental and is not a covered benefit under this policy.

Any use of Actemra IV outside the indications enumerated in this document is designated investigational/experimental and therefore excluded from coverage.

Coding and Dosing Information

Applicable HCPCS CodesHCPCSCovered

J3262

Injection, tocilizumab, 1mg

Applicable HCPCS CodesHCPCSCovered

J3262

Injection, tocilizumab, 1mg

Dosing (inv-09)

Manufacturer dosing requirementMust be prescribed at a dose within the manufacturer's dosing guidelines (based on diagnosis, weight, etc) listed in the FDA approved labeling.

Weight-based dosing noteDosing must follow FDA‑approved labeling which includes weight- and indication-specific IV dosing regimens.

Diagnosis-specific dosing noteDose must be appropriate for the specific approved indication (e.g., GCA, RA, SJIA, PJIA) per label instructions.

Concurrent therapy restrictionDosing must be consistent with requirements that Actemra IV not be used concurrently with other biologic or targeted synthetic DMARDs (per indication criteria).

Documentation expectationPrescriber must document that the prescribed dose is within FDA labeling as part of prior authorization and reauthorization requests.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — initial approvals up to 3 months

Prior authorization is required for Actemra IV; when the initial coverage criteria for the requested indication are met, initial approvals are generally granted for up to 3 months.

Billing Rule

Prior authorization and applicable code — J3262; initial approvals up to 3 months

Prior authorization must be requested for Actemra IV using HCPCS code J3262 (Injection, tocilizumab, 1 mg). Initial approvals are up to 3 months and reauthorization intervals follow the same limits.

Applicable HCPCS code: J3262 (Injection, tocilizumab, 1 mg).

Step Therapy

Required prior therapy trials (corticosteroids, csDMARDs, TNF inhibitors, JAK inhibitor where specified)

GCA: trial of ≥1 systemic corticosteroid for ≥3 months or documented intolerance, or relapsing GCA (chunk 3).
Rheumatoid arthritis and Still's: trial of one conventional synthetic DMARD for ≥3 months or intolerance to ≥2 DMARDs (chunks 3, 15).
SJIA: trial of ≥2 other systemic therapies for ≥3 months or documented intolerance to ≥2 agents; intolerance/failed TNF inhibitors and preferred JAK inhibitor Xeljanz for ≥3 months (chunk 9).

Step Therapy

DMARD and JAK inhibitor step requirements

Conventional DMARD examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine (chunk 3).
JAK inhibitor (Xeljanz) trial requirement added for polyarticular JIA and SJIA in revision history (chunks 26, 25).

Documentation Required

Examples of clinically significant response to document

Documented clinically significant response may include laboratory or clinical improvements; providers should record such responses when requesting renewal.

Examples include normalization of CRP, ESR, fibrinogen, albumin, and/or hemoglobin; resolution of constitutional symptoms; increased BMI; and reduction in lymphadenopathy.

Prior Authorization

Authorization duration — initial up to 3 months; reauthorization intervals

Initial authorization: up to 3 months (chunk 19).
Reauthorization: policy specifies reauthorization pathways that can approve for 1 year when renewal criteria are satisfied (chunks 6, 4).

Denial Risk

Investigational uses excluded — non‑listed indications not covered

Requests for Actemra IV for any use not specifically listed in the policy are considered investigational or experimental and will not be covered.

Denial Risk

Investigational uses denied — non‑covered investigational/experimental indications

Requests for Actemra IV for uses other than the policy‑specified indications will be denied as not covered; providers should not expect coverage for investigational/experimental indications.

Any use outside the indications listed in the policy is considered investigational/experimental and not medically necessary.

Definitions and Drug Description

Actemra (tocilizumab) IV — definition & primary indications (inv-19)

Drug class and routeActemra (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor administered by intravenous infusion.

Cytokine Release Syndrome (CRS) — policy scope (inv-20)

CRS coverage limitationCytokine Release Syndrome (CRS) is reviewed under this policy only when it is associated with Chimeric Antigen Receptor (CAR) T‑Cell Therapy.

Examples relocatedExamples of CAR T‑cell therapies previously listed in criteria were moved to a policy Note (no longer embedded in criteria).

Policy revision noteReview history documents clarification specifying CRS must be associated with CAR T‑Cell Therapy for consideration under this policy.

Background