CurrentMass General Brigham Health PlanPolicy N/A

Tecvayli (teclistamab-cqyv) — Coverage Criteria

Defines prior authorization, coverage criteria, and limitations for Tecvayli (teclistamab-cqyv) for adult members with relapsed or refractory multiple myeloma under Mass General Brigham Health Plan pharmacy/specialty benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTecvayli (teclistamab-cqyv) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and document at least 4 prior therapies including an anti‑CD38 mAb, a proteasome inhibitor, and an immunomodulatory agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=4required prior lines of therapy

12 moapproval duration

Adultspatient population

Relapsed/RR/Progressive MMcovered diagnosis

Coverage Criteria for Tecvayli (teclistamab-cqyv)

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inv-01: Initial therapy coverage criteria

Authorization may be granted for treatment when ALL of the following are met:

Main criteria: Member has received at least 4 prior therapies for multiple myeloma including at least ONE drug from each of the following categories: Anti-CD38 monoclonal antibody (e.g., daratumumab); Proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib); Immunomodulatory agent (e.g., lenalidomide, pomalidomide); Diagnosis of relapsed, refractory, or progressive multiple myeloma>=4 prior therapies with specified classes

Medication regimens being used in accordance with NCCN guidelines can be reviewed for medical necessity

inv-02: Continuation of Therapy

Reauthorization (Continuation of Therapy) may be granted when ALL of the following are met:

Reauthorization criteria: Diagnosis of relapsed, refractory, or progressive multiple myeloma; No evidence of unacceptable toxicity or disease progression while on current regimenN/A

Reauthorizations may be granted for 12 months

inv-03: New-to-plan members

Exceptions and special authorizations:

New-to-plan continuation: Members new to the plan who are currently receiving Tecvayli may be authorized, excluding when the product was obtained as samples or via manufacturer's patient assistance programsN/A

Use obtained as samples or via manufacturer's patient assistance programs is excluded from new-to-plan authorization consideration.

Use of product obtained as samples or provided through a manufacturer's patient assistance program is excluded from consideration when reviewing requests to authorize Tecvayli for members who are new to the plan. Such supply sources will not be counted as active, continuable therapy for purposes of new‑to‑plan continuation authorization.

Coding and Required Prior Therapies

Required prior lines of therapy

Required prior lines of therapyMember must have received at least 4 prior therapies for multiple myeloma, including at least one anti‑CD38 monoclonal antibody, one proteasome inhibitor, and one immunomodulatory agent.

Anti‑CD38 monoclonal antibody (example)Daratumumab is listed as an example anti‑CD38 monoclonal antibody.

Proteasome inhibitor (examples)Bortezomib, ixazomib, or carfilzomib are listed as example proteasome inhibitors.

Immunomodulatory agent (examples)Lenalidomide or pomalidomide are listed as example immunomodulatory agents.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation of Tecvayli. Exceptions: members already receiving treatment with Tecvayli when the product was not obtained via samples or manufacturer's patient assistance programs may be considered for authorization without a new prior authorization.

Applies to new initiations of Tecvayli (teclistamab-cqyv)
Exception: members already receiving Tecvayli when not obtained as samples or via manufacturer assistance

Documentation Required

Required Documentation

Documentation must support the diagnosis and prior treatment history. Submit medical record evidence confirming relapsed, refractory, or progressive multiple myeloma and details of prior therapies.

Documentation of diagnosis: relapsed, refractory, or progressive multiple myeloma
Medical records showing prior therapy history (see required therapies)
For reauthorization, documentation that there is no evidence of unacceptable toxicity or disease progression while on current regimen

Documentation Required

Prior Therapies Required

Authorization requires documentation that the member has received at least 4 prior therapies for multiple myeloma including agents from specific classes.

At least 4 prior therapies in total
Includes at least ONE anti-CD38 monoclonal antibody (e.g., daratumumab)
Includes a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib)
Includes an immunomodulatory agent (e.g., lenalidomide, pomalidomide)
Medication regimens consistent with NCCN guidelines may be reviewed for medical necessity

Step Therapy

Benefit-Level Controls

Benefit-level controls may apply — step therapy and quantity limits are noted in the benefit grid. Specific step edits and quantity limits should be confirmed in the member's benefit plan.

Step therapy and quantity limit may apply per benefit grid
Confirm specific edits in the member's plan

Background

Tecvayli (teclistamab‑cqyv) is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Prior authorization is required for initiation; reauthorization may be granted when the member continues to have relapsed, refractory, or progressive disease without unacceptable toxicity, generally for up to 12 months. Documentation should show the diagnosis and prior therapy history to support medical necessity, and benefit‑level controls such as step therapy and quantity limits are indicated in the benefit grid.

Definitions

Relapsed, refractory, or progressive multiple myeloma

DefinitionRelapsed, refractory, or progressive multiple myeloma: disease that has returned after treatment (relapsed), failed to respond to treatment (refractory), or shows disease progression; compendial use is noted for progressive disease.

FDA‑approved populationTecvayli is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Compendial useProgressive multiple myeloma is listed as a compendial indication in the policy.

Initial Authorization Criteria

inv-12: Initial authorization

Initial authorization criteria

Initial therapy: Member has relapsed, refractory, or progressive multiple myeloma; Member has received ≥ 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent>=4 prior therapies

Medication regimens consistent with NCCN guidelines can be reviewed for medical necessity

Reauthorization / Continuation Criteria

inv-13: Reauthorization

Reauthorization requirements

Continuation nodes: Diagnosis of relapsed, refractory, or progressive multiple myeloma; No evidence of unacceptable toxicity or disease progression on current regimenN/A