CurrentMass General Brigham Health PlanPolicy N/A

Targeted Immunomodulators Tyenne IV (tocilizumab-aazg vial) Effective 01/06/2025

Prior authorization policy for Tyenne IV (tocilizumab-aazg vial) administered via the medical benefit; defines covered indications, clinical criteria for authorization, dosing conformity requirements, limits for initial and reauthorization periods, and rules for dose escalation requests.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTargeted Immunomodulators Tyenne IV (tocilizumab-aazg vial) Effective 01/06/2025

Policy CodePolicy N/A

Change TypeAdded policy (created for P&T; adopted MassHealth criteria)

Effective DateJan 6, 2025

Next Review Date

Key ActionTyenne IV (vial) will be managed with prior authorization via the medical benefit; requests must meet the listed indication-specific criteria and dosing must be within FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Tyenne IV (vial) will be managed with prior authorization via Medical Benefit effective 01/06/25.

6Covered Indications listed

6 monthsInitial approval duration

1 yearReauthorization duration

Coverage Summary

Scope: Prior authorization policy for Tyenne IV (tocilizumab-aazg vial) administered via the medical benefit; defines covered indications and clinical criteria for authorization, requires dosing to be within FDA labeling, includes initial and reauthorization durations, and allows documentation-based dose escalation review. Benefit routing: vial managed under the medical benefit with prior authorization; auto-injection prefilled syringe routed to the pharmacy benefit. Coverage stance: covered with criteria. Effective date: 01/06/2025.

Overall Authorization

Authorization may be granted when ALL of the following are met (or reviewed case-by-case for members new to the plan currently receiving treatment):

Case-by-case allowance

Case-by-case allowance: Member is new to the plan currently receiving treatment with requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs)

Authorization criteria when not new-to-plan

Covered Indications (ONE of the following)
- Cytokine release syndrome
  - Cytokine release syndrome - diagnosis: Diagnosis of cytokine release syndrome
  - Cytokine release syndrome - CAR T cell: Concurrent therapy with CAR T-cell therapies (request must include anticipated date of administration)
  - Cytokine release syndrome - dosing: Dosing is appropriate within the FDA labeling
- Giant cell arteritis
  - GCA - diagnosis: Diagnosis of giant cell arteritis
  - GCA - prior steroid: Inadequate response or adverse reaction to ONE or contraindication to ALL systemic glucocorticoids
  - GCA - dosing: Dosing is appropriate within the FDA labeling
- Moderate-to-severe Polyarticular juvenile idiopathic arthritis (PJIA)
  - PJIA - diagnosis: Diagnosis of moderate-to-severe polyarticular juvenile idiopathic arthritis
  - Prior therapy requirement (ONE of)
    PJIA - traditional DMARDs: Inadequate response or adverse reaction to ONE or contraindication to ALL traditional DMARDs
    PJIA - anti-TNF: Inadequate response or adverse reaction to ONE or contraindication to ALL anti-TNF agents
  - PJIA - dosing: Dosing is appropriate within the FDA labeling
- Moderate-to-severe Rheumatoid arthritis (RA)
  - RA - diagnosis: Diagnosis of moderate-to-severe rheumatoid arthritis
  - Prior therapy requirement (ONE of)
    RA - traditional DMARDs: Inadequate response or adverse reaction to ONE or contraindication to ALL traditional DMARDs
    RA - biologic DMARD: Inadequate response or adverse reaction to ONE biologic DMARD that is FDA-approved for the requested indication
  - RA - dosing: Dosing is appropriate within the FDA labeling
- Systemic juvenile idiopathic arthritis (SJIA)
  - SJIA - diagnosis: Diagnosis of systemic juvenile idiopathic arthritis
  - Prior therapy requirement (ONE of)
    SJIA - traditional DMARDs: Inadequate response or adverse reaction to ONE or contraindication to ALL traditional DMARDs
    SJIA - biologic DMARD: Inadequate response or adverse reaction to ONE biologic DMARD that is FDA-approved for systemic juvenile idiopathic arthritis
  - SJIA - dosing: Dosing is appropriate within the FDA labeling
- Polymyalgia Rheumatica (PMR)
  - PMR - diagnosis: Diagnosis of polymyalgia rheumatica (PMR)
  - PMR - methotrexate: Inadequate response, adverse reaction, or contraindication to methotrexate
  - PMR - steroids: Inadequate response or adverse reaction to ONE or contraindication to ALL systemic corticosteroids

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Requests for More Frequent or Higher Doses

Requests for more frequent or higher doses of injectable biologics may be approved if ALL of the following is provided:

Dose escalation documentation (ALL of)

Severe disease: Documentation of a severe disease
Prior biologic therapy (ONE of)
- Prior inadequate response to other injectable biologic: Inadequate response or adverse reaction to ONE other injectable biologic which is FDA-approved for the requested indication
- Contraindication to other injectables: Contraindication to ALL other injectable biologics which are FDA-approved for the requested indication
Partial response documented: Documented partial response to FDA-approved dosing of current biologic therapy
Specialist consult: Documentation of specialist consult for the requested indication

Provider Actions & Requirements

Prior Authorization

Prior authorization required via Medical Benefit

Tyenne IV (vial) will be managed with prior authorization via the medical benefit; requests must meet the listed indication-specific criteria and dosing must be within FDA labeling. For cytokine release syndrome, requests must include anticipated date of CAR T-cell administration.

For cytokine release syndrome requests, include the anticipated date of CAR T-cell administration.

Documentation Required

Documentation for dose escalation requests

For more frequent or higher doses, submit documentation of severe disease, prior inadequate response or contraindication to other injectable biologics, documented partial response to FDA-approved dosing, and a specialist consult.

Billing Rule

Benefit routing

Tyenne IV (vial) is managed under the medical benefit; Tyenne auto-injection prefilled syringe is available on the pharmacy benefit and follows the MassHealth Drug List coverage and criteria.

Documentation Required

Continuation of therapy resubmission

Resubmission by the prescriber for reauthorization will be interpreted as evidence of positive response to therapy.

Background & Evidence

Tyenne (tocilizumab-aazg) is an interleukin‑6 antagonist indicated for: rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (SJIA), polyarticular juvenile idiopathic arthritis (PJIA), cytokine release syndrome, and polymyalgia rheumatica (PMR).

Benefit routing: the Tyenne auto-injection prefilled syringe is available on the pharmacy benefit per the MassHealth Drug List; the Tyenne IV (vial) formulation is managed under the medical benefit and requires prior authorization.

Package insert: Tyenne [package insert], Fresenius Kabi USA LLC; 2024 Mar. The package insert is referenced as the source for FDA dosing and labeling used to define dosing conformity in the authorization criteria.

OpenPayer

Targeted Immunomodulators Tyenne IV (tocilizumab-aazg vial) Effective 01/06/2025

Coverage Summary

Requests for More Frequent or Higher Doses

Continuation of Therapy

Applicable Codes

Provider Actions & Requirements

Background & Evidence

Revision History