CurrentEmblemHealthPolicy N/A

Tecvayli (teclistamab-cqyv) — Coverage Criteria for Multiple Myeloma

Defines indications, coverage criteria, and administrative requirements for Tecvayli (teclistamab-cqyv) for treatment of cancer (multiple myeloma) and governs prior authorization and continuation requests processed by Evolent for EmblemHealth lines of business.

Policy Summary

PayerEmblemHealth

PolicyTecvayli (teclistamab-cqyv) — Coverage Criteria for Multiple Myeloma

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Tecvayli requests and coverage is limited to adults with relapsed/refractory multiple myeloma after at least four prior lines of therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9380HCPCS code (per 0.5 mg)

>=4Prior lines required

1.5 mg/kgSingle dose max

REMSRestricted program

Commercial/Exchange/MedicaidApplicable LOBs

Coverage Criteria for Tecvayli (teclistamab-cqyv)

inv-01: Initial therapy — Relapsed/Refractory Multiple Myeloma

Covered when ALL of the following are met

Eligibility for Tecvayli monotherapy in multiple myeloma

Prior therapies: Has received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody>=4 prior lines
Examples: proteasome inhibitors (bortezomib, carfilzomib, ixazomib); immunomodulatory agents (lenalidomide, thalidomide, pomalidomide); anti-CD38 antibodies (daratumumab, isatuximab-irfc).

inv-02: Continuation Therapy

Continuation therapy allowed when ALL of the following are met

Continuation criteria:

Policy Summary

PayerEmblemHealth

PolicyTecvayli (teclistamab-cqyv) — Coverage Criteria for Multiple Myeloma

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Tecvayli requests and coverage is limited to adults with relapsed/refractory multiple myeloma after at least four prior lines of therapy.

SourceLink

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Prior Authorization, Documentation, and Continuation Requests

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tecvayli (teclistamab-cqyv) requests; coverage is limited to the indications and criteria specified in this guideline. Requests should reference supporting evidence such as FDA-approved labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meet CMS standards.

Affected code: J9380 - Injection, teclistamab-cqyv, 0.5 mg
Coverage limited to relapsed/refractory multiple myeloma meeting specified prior-line therapy requirements
Supporting evidence required: FDA labeling, CMS-compendia, NCCN/ASCO guidance, or peer-reviewed literature meeting CMS criteria

Documentation Required

Continuation Requests — Conditions

Continuation (re-authorization) requests may be approved without full re-application of the initial criteria when all continuation conditions are met. Ensure documentation demonstrates ongoing clinical benefit and that no exclusion criteria are present.

Member has not experienced disease progression while taking Tecvayli
The requested medication was used within the last year and there has been no lapse of more than 30 days since the prior active authorization
No additional medications are being added to the continuation request

Documentation Required

Supporting Evidence Required

Supporting evidence must be provided with initial and continuation requests. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

FDA labeling for Tecvayli
CMS-recognized compendia (e.g., Clinical Pharmacology, Micromedex, AHFS)
NCCN or ASCO clinical guidelines
Peer-reviewed clinical studies (e.g., Moreau et al., N Engl J Med 2022) that meet CMS evidence criteria

Denial Risk

Denial Triggers

Requests may be denied if any exclusion criteria are met or if documentation indicates the therapy is investigational or exceeds dosing limits.

Disease progression while taking Tecvayli
Concurrent use with other anti-cancer therapies
Dosing that exceeds single dose limit of 1.5 mg/kg
Investigational use or off-label indications not supported by CMS compendia or acceptable peer-reviewed literature

OpenPayer

Tecvayli (teclistamab-cqyv) — Coverage Criteria for Multiple Myeloma

Coverage Criteria for Tecvayli (teclistamab-cqyv)

Coding and Dose Limits

Prior Authorization, Documentation, and Continuation Requests

Key Definitions and Program Requirements

Line of Therapy Requirements

Covered Regimens and Indications

Background