Mass General Brigham Health Plan Actemra IV Prior Auth | OpenPayer

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Mass General Brigham Health Plan Actemra IV Prior Auth | OpenPayer

Coverage Criteria for Actemra (tocilizumab) IV

Rheumatoid Arthritis (RA) — Initial Therapy

Authorization may be granted if the member meets ALL of the following:

RA initial criteria: Member has a diagnosis of moderate to severe rheumatoid arthritis; AND one of the following: inadequate response or adverse reaction to at least ONE traditional DMARD or contraindication to traditional DMARDs (see Appendix C); OR inadequate response or adverse reaction to ONE biologic DMARD that is FDA‑approved for the requested indication; AND appropriate dosing is provided.

See Appendix C for traditional DMARD examples.

Systemic Juvenile Idiopathic Arthritis (SJIA) — Initial Therapy

Authorization may be granted if ALL of the following are met:

SJIA initial criteria: Diagnosis of systemic juvenile idiopathic arthritis; AND one of the following: inadequate response or adverse reaction to ONE traditional DMARD or contraindication to ALL traditional DMARDs (see Appendix C); OR inadequate response or adverse reaction to ONE biologic DMARD that is FDA‑approved for the requested indication; AND appropriate dosing is provided.

Polyarticular Juvenile Idiopathic Arthritis (PJIA) — Initial Therapy

Authorization may be granted if ALL of the following are met:

PJIA initial criteria: Diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis; AND inadequate response or adverse reaction to ONE traditional DMARD or contraindication to traditional DMARDs (see Appendix C); AND appropriate dosing is provided.

Giant Cell Arteritis (GCA) — Initial Therapy

Authorization may be granted if ALL of the following are met:

GCA initial criteria: Diagnosis of giant cell arteritis; AND inadequate response or adverse reaction to ONE or contraindication to ALL systemic glucocorticoids; AND appropriate dosing is provided (both subcutaneous and intravenous dosing may be used).

Polymyalgia Rheumatica (PMR) — Initial Therapy (Off-label)

Authorization may be granted if ALL of the following are met:

PMR initial criteria: Diagnosis of polymyalgia rheumatica (PMR); AND inadequate response or adverse reaction to ONE systemic corticosteroid or contraindication to ALL systemic corticosteroids; AND inadequate response, adverse reaction, or contraindication to methotrexate.

Off‑label — initial approvals limited to 3 months.

Scleritis — Initial Therapy (Off-label)

Authorization may be granted if ALL of the following are met:

Scleritis initial criteria: Diagnosis of scleritis; AND inadequate response, adverse reaction, or contraindication to ophthalmic (topical), oral or injectable glucocorticoids; AND inadequate response, adverse reaction, or contraindication to BOTH oral or injectable immunosuppressive therapies (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, cyclophosphamide).

Off‑label — initial approvals limited to 3 months.

Uveitis — Initial Therapy (Off-label)

Authorization may be granted if ALL of the following are met:

Uveitis initial criteria: Diagnosis of uveitis; AND inadequate response, adverse reaction, or contraindication to ophthalmic (topical), oral or injectable glucocorticoids; AND inadequate response, adverse reaction, or contraindication to BOTH oral or injectable immunosuppressive therapy (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, cyclophosphamide).

Off‑label — initial approvals limited to 3 months.

Cytokine Release Syndrome (CRS) — Initial Therapy

Authorization may be granted if ALL of the following are met:

CRS initial criteria: Diagnosis of cytokine release syndrome; AND concurrent therapy with CAR T‑cell therapies (request must include anticipated date of CAR T‑cell administration); AND appropriate dosing is provided.

CRS initial approvals limited to 1 month past the anticipated CAR T‑cell administration date; reauthorization reviewed case‑by‑case.

Requests for More Frequent or Higher Doses — Conditions that may allow approval

May be approved if ALL of the following are provided:

Higher dose/frequency criteria: Documentation of severe disease; AND inadequate response or adverse reaction to ONE other injectable biologic which is FDA‑approved for the requested indication OR contraindication to ALL other injectable biologics which are FDA‑approved for the requested indication; AND documented partial response to FDA‑approved dosing of the current biologic therapy; AND documentation of a specialist consult for the requested indication.

Continuation of Therapy / Reauthorization — Reauthorization conditions and required evidence of benefit

Resubmission by the prescriber implies a positive response; reauthorization conditions apply.

Continuation: Resubmission by prescriber infers positive response to therapy and request can be recertified if dosing is appropriate; reauthorization periods are generally 12 months except cytokine release syndrome which is reviewed case‑by‑case.

Requests for prior authorization will not be considered when the product was obtained as samples or supplied through a manufacturer’s patient assistance program. Additionally, members who are new to the plan but are currently receiving Actemra may be reviewed on a case-by-case basis; however, the exclusion for samples and manufacturer assistance program supplies still applies.

Authorization may be denied or deemed not medically necessary if the request does not include documentation of the required diagnosis for the requested indication (for example, RA, SJIA, PJIA, GCA, PMR, scleritis, uveitis, or CRS), or if dosing is not appropriate for the indication. Many indications require evidence of prior therapy failure or intolerance (for example, inadequate response or adverse reaction to one or more traditional DMARDs, systemic corticosteroids, or other specified therapies) or documentation of contraindication to those therapies; absence of this documentation can lead to denial.

For Cytokine Release Syndrome (CRS) requests, the anticipated date of CAR T-cell administration must be included; CRS approvals are time-limited and reviewed case-by-case. Refer to the limitations for standard initial approval lengths: off-label indications: 3 months, CRS: 1 month past anticipated CAR T-cell administration, and all other indications: 6 months. Lack of supporting prior-treatment history, specialist documentation when required, or justification for higher-than-standard dosing/frequency are also common operational reasons for denial.

Coding and Approval Durations

Covered HCPCS/Codes for Actemra IV (example)HCPCSCovered

J3262

Injection, tocilizumab, 10 mg (example vial HCPCS often used for IV dosing) - code cited as affected code in medical benefit context

Approval durations

Off-label initial approvalInitial approvals for off-label indications: 3 months.

Cytokine Release Syndrome (CRS) initial approvalInitial approval limited to 1 month past the anticipated date of CAR T-cell administration (request must include anticipated CAR T date).

Standard initial approval (FDA‑approved indications)Initial approvals for all other indications: 6 months.

Reauthorization periodReauthorizations (continuation of therapy) are granted for 12 months.

New members stable on therapyNew members currently stable on Actemra may be approved without documentation of failed trials with conventional therapies (case-by-case review).

Provider Actions, Requirements, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required for Actemra (tocilizumab) IV; separate requirements apply when the product is obtained as samples or via manufacturer patient assistance programs. For pharmacy benefit formulations (auto-injection, prefilled syringe or other pharmacy agents in class), refer to the MassHealth Drug List for coverage, criteria, and whether prior authorization is handled through the pharmacy benefit.

Contact for Medical and Specialty Medications: All Plans Phone: 877-519-1908; Fax: 855-540-3693
Contact for Non‑Specialty Medications: All Plans Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step Therapy Requirements

Step therapy must be documented before initial approval for most indications. Providers must show inadequate response or intolerance to required prior therapies or document contraindications to those therapies per indication-specific criteria.

Rheumatoid arthritis (RA): inadequate response or adverse reaction to at least ONE traditional DMARD or contraindication to traditional DMARDs; OR inadequate response or adverse reaction to ONE biologic DMARD approved for RA.

Definitions and Drug Class

Traditional DMARDs — examples

MethotrexateIncluded as an example traditional DMARD in the policy appendix.

SulfasalazineListed in the appendix as an example traditional DMARD.

HydroxychloroquineListed in the appendix as an example traditional DMARD.

LeflunomideListed in the appendix as an example traditional DMARD.

AzathioprineListed in the appendix as an example traditional DMARD.

CyclosporineListed in the appendix as an example traditional DMARD.

ThalidomideListed in the appendix as an example traditional DMARD.

Background

Actemra (tocilizumab) is a monoclonal antibody that acts as an interleukin‑6 (IL‑6) receptor antagonist. By blocking IL‑6 signaling, it reduces inflammation and is used to treat a range of inflammatory conditions. Indications included in this policy cover FDA‑approved diseases such as rheumatoid arthritis (RA), giant cell arteritis (GCA), subtypes of juvenile idiopathic arthritis including polyarticular JIA (PJIA) and systemic JIA (SJIA), systemic sclerosis‑associated interstitial lung disease (SSc‑ILD), and treatment of CART‑cell therapy–induced cytokine release syndrome (CRS). Authorization criteria require documentation of diagnosis, prior treatment history where applicable, and appropriate dosing.