CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tecvayli (teclistamab-cqyv) coverage criteria for multiple myeloma

Defines accepted indications, exclusions, coding, and prior authorization requirements for Tecvayli (teclistamab-cqyv) use in adults with relapsed or refractory multiple myeloma for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTecvayli (teclistamab-cqyv) coverage criteria for multiple myeloma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document supporting evidence (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature) and confirm member meets criteria including ≥4 prior lines of therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4prior lines of therapy required for coverage

J9380HCPCS code

1.5 mg/kgsingle dose limit

REMSREMS required

Coverage Criteria for Tecvayli (teclistamab-cqyv)

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Initial therapy coverage criteria

Covered when ALL of the following are met

Eligibility for Tecvayli in multiple myeloma: Adult member with relapsed or refractory multiple myeloma who has received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Examples of classes provided in policy: proteasome inhibitors (bortezomib, carfilzomib, ixazomib); immunomodulatory agents (lenalidomide, thalidomide, pomalidomide); anti-CD38 antibodies (daratumumab, isatuximab)

Requests will be excluded or denied when any of the following conditions are present: disease progression while taking Tecvayli (teclistamab-cqyv); concurrent use with other anti-cancer therapies; or dosing that exceeds the single dose limit of 1.5 mg/kg. These exclusion criteria reflect safety and policy limits intended to prevent ineffective or unsafe combinations and to enforce the specified per‑dose maximum.

Off‑label uses of Tecvayli (teclistamab-cqyv) that are considered investigational and not eligible for coverage include indications that lack sufficient supportive evidence or are not generally accepted by the medical community. The policy defines sufficient evidence as literature that adequately represents the patient and disease characteristics, the therapy regimen, and clinically meaningful outcomes (for example, ASCO‑recommended thresholds such as hazard ratio < 0.80 or survival benefit ≥ 3 months). Case reports and abstracts without full peer‑reviewed articles are explicitly noted as inadequate evidence for establishing accepted off‑label use; coverage for off‑label indications requires support from CMS‑recognized compendia or acceptable peer‑reviewed literature.

Covered Regimens and Dosing

Regimen	Indication / Eligibility	Dosing Requirements	Coverage Status
Tecvayli (teclistamab-cqyv) monotherapy with step-up dosing per REMS	Relapsed or refractory multiple myeloma in adult members who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody	Initiate treatment using the teclistamab-cqyv step-up dosing schedule as required by the product labeling and REMS to reduce risk of cytokine release syndrome (CRS); withhold or discontinue per severity of CRS or neurologic toxicity	Covered with criteria

Provider Actions, Authorization, and Exclusions

Prior Authorization

Prior Authorization Required

Prior authorization is required for teclistamab-cqyv (Tecvayli) per payer policy. Continuation requests may be eligible only if the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

Continuation allowed if no disease progression on Tecvayli
Prior use within last 12 months without >30-day lapse
No additions of other medications on continuation request

Documentation Required

Supporting Evidence Requirement

Use must be supported by one of the following sources: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets CMS evidentiary standards (per Medicare Benefit Policy Manual, Chapter 15). Requests lacking support from these sources may be denied.

Acceptable evidence: FDA labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; peer-reviewed literature meeting CMS standards

Step Therapy

Step-up Dosing Requirement

Initiate teclistamab-cqyv using the manufacturer-recommended step-up dosing schedule to reduce the risk of cytokine release syndrome (CRS). Monitor patients for CRS and neurologic toxicity per REMS and withholding/discontinuation guidance in the prescribing information.

Follow teclistamab-cqyv step-up dosing schedule prior to maintenance dosing
Monitor and manage CRS and neurologic toxicity per REMS and PI guidance

Line of Therapy Requirements

salvage

Line of therapy requirement: Used as monotherapy in adult members with relapsed or refractory multiple myeloma who have received at least four prior lines of therapyat least 4 prior lines

Includes requirement that prior lines include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Key Definitions

REMS

REMS requirementTecvayli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)

Reason for REMSDue to risk of cytokine release syndrome (CRS) and neurologic toxicity including ICANS

Mitigation action notedInitiate treatment with step-up dosing schedule and monitor for CRS and neurologic toxicity; withhold or discontinue based on severity

Background

Tecvayli (teclistamab-cqyv) is a B‑cell maturation antigen (BCMA)‑targeting bispecific antibody indicated as monotherapy 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. Serious adverse events associated with teclistamab include cytokine release syndrome (CRS) and neurologic toxicity (including ICANS); because of these risks, treatment must follow the REMS‑specified step‑up dosing and monitoring requirements to mitigate life‑threatening reactions.