ModifiedCentenePolicy CP.PHAR.649

Talquetamab-tgvs (Talvey)

Defines Centene medical necessity criteria, dosing limits, and authorization durations for Talvey in adults with relapsed or refractory multiple myeloma; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyTalquetamab-tgvs (Talvey) - Clinical Policy

Policy CodePolicy CP.PHAR.649

Change TypeMaterial updates to coverage criteria, coding (J3055), and approval durations

Effective DateDec 1, 2023

Next Review Date

Key ActionSubmit prior authorization using HCPCS code J3055 and include documentation of diagnosis, prior lines of therapy, and recent disease measurements or IMWG-defined progression.

SourceLink

POLICY UPDATE CHANGES

Added option to be prescribed in combination with Tecvayli with ≥ 3 prior lines of therapy per NCCN; initial approval duration changed from 6 to 12 months for Medicaid/HIM.

Removed miscellaneous HCPCS codes and added J3055 (Injection, talquetamab-tgvs, 0.25 mg).

Added IMWG criterion defining progressive multiple myeloma disease as MM class alignment.

Added HCPCS code J3055 for injection, talquetamab-tgvs, 0.25 mg.

Added IMWG criterion defining progressive multiple myeloma disease as MM class alignment.

≥4Required prior lines (single agent)

≥3Required prior lines (combination)

0.4 mg/kg wkly or 0.8 mg/kg q2wMaintenance dosing options

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C9399, J3590Removed HCPCS codes

12 monthsMedicaid/HIM initial approval

Coverage Criteria

Initial Therapy

Policy/Criteria It is the policy of health plans affiliated with Centene Corporation® that Talvey is medically necessary when the following criteria are met:

ALL of the following

Diagnosis of multiple myeloma (MM).
Prescribed by or in consultation with an oncologist or hematologist.
Age ≥ 18 years.
Disease is relapsed or refractory.
One of the following:
- Member has measurable disease as evidenced by one of the following assessed within the last 30 days: (i) Serum M-protein ≥ 0.5 g/dL; (ii) Urine M-protein ≥ 200 mg/24 h; (iii) Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) with abnormal serum FLC ratio.
- Member has progressive disease, as defined by the IMWG response criteria (see Appendix D), assessed within 60 days following the last dose of the last antimyeloma drug regimen received.
Prescribed in one of the following ways:
- In combination with Tecvayli®: member has received ≥ 3 prior lines of therapy.
- As a single agent: member has received or has documented intolerance to ≥ 4 prior lines of therapies (see Appendix B) that include all of the following: (i) one proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib); (ii) one immunomodulatory drug (e.g., thalidomide, lenalidomide, pomalidomide); (iii) one anti‑CD38 monoclonal antibody (e.g., daratumumab, isatuximab).
Dose limits (one of):
- Dose does not exceed 0.4 mg/kg once weekly.
- Dose does not exceed 0.8 mg/kg every 2 weeks.
- Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA‑approved or recommended by NCCN. Prior authorization may be required.
Approval duration: Medicaid/HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.

Continuation Therapy

II. Continuation Therapy — Covered for continuation when ALL of the following are met for Multiple Myeloma:

ALL of the following

Member is currently receiving Talvey via the Centene benefit, or documentation supports that the member is currently receiving Talvey for a covered indication and has received this medication for at least 30 days.
Member is responding positively to therapy.
If request is for a dose increase, one of the following must be met:
- Dose does not exceed 0.4 mg/kg once weekly.
- Dose does not exceed 0.8 mg/kg every 2 weeks.

Policy-level coverage updates

Policy-level coverage updates — updates relevant to coverage and approval duration (operational changes):

ALL of the following

HCPCS code J3055 (Injection, talquetamab‑tgvs, 0.25 mg) added; previous placeholder codes C9399 and J3590 removed.
Policy created 08.29.23; P&T Approval 11.23.
02.20.24: Removed HCPCS codes [C9399, J3590] and added J3055 (operational coding update).
07.15.24 (4Q 2024 annual review): Added IMWG criterion defining progressive MM disease as MM class alignment; references reviewed and updated. P&T Approval 11.24.
07.09.25 (4Q 2025 annual review): Added option to be prescribed in combination with Tecvayli with ≥ 3 prior lines of therapy per NCCN; initial approval duration changed from 6 to 12 months for Medicaid/HIM; references reviewed and updated. P&T Approval 11.25.

III. Diagnoses/Indications for which coverage is NOT authorized: Non‑FDA approved indications not addressed in this policy are not covered unless there is sufficient documentation of efficacy and safety according to the off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid), or per the member's evidence of coverage documents.

Coverage is subject to the terms, conditions, exclusions, and limitations of the applicable benefit plan and to state and federal requirements. This clinical policy is a guide to medical necessity and does not guarantee payment. Determinations are subject to Health Plan coverage documents and administrative policies.

Important Reminder: This clinical policy was developed by licensed health care professionals based on current standards of medical practice, peer‑reviewed literature, agency approvals, evidence‑based guidelines, and expert input. The Health Plan retains the right to change, amend, or withdraw this clinical policy at any time. Providers should exercise professional judgment and are responsible for treatment decisions. This policy does not constitute medical advice or a guarantee of coverage.

Coding and Billing

Relevant HCPCS CodesHCPCS

J3055

Injection, talquetamab-tgvs, 0.25 mg

Covered HCPCS Codes (informational)HCPCS

J3055

Injection, talquetamab-tgvs, 0.25 mg

Removed HCPCS CodesHCPCSNot Covered

C9399	Unclassified drugs or biologicals (removed)
J3590	Unclassified drugs (removed)

Measurable disease criteria (serum/urine/FLC) — thresholds for M-protein and FLC

Serum M‑protein thresholdSerum Mprotein ≥ 0.5 g/dL (assessed within 30 days)

Urine M‑protein thresholdUrine Mprotein ≥ 200 mg/24 h (assessed within 30 days)

Involved free light chain (FLC) thresholdInvolved FLC ≥ 10 mg/dL (100 mg/L) with an abnormal serum FLC ratio (assessed within 30 days)

Prior lines of therapy for combination use — required count for combination with Tecvayli

Combination use with TecvayliMember has received ≥ 3 prior lines of therapy to qualify for talquetamab‑tgvs when prescribed in combination with Tecvayli

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for talquetamab-tgvs (J3055). Requests must document member eligibility (diagnosis of multiple myeloma, relapsed/refractory disease, age ≥18, prior lines of therapy or combination use per criteria, and prescriber specialty). Use J3055 when requesting authorization and submitting claims.

Prior authorization required: demonstrate diagnosis, prior treatment history, prescriber specialty, measurable or progressive disease per IMWG, and dosing consistent with policy.
Use HCPCS code J3055 — Injection, talquetamab-tgvs, 0.25 mg — for all talquetamab-tgvs authorization requests and claims.

Billing Rule

Billing Code: Use J3055

Providers must bill talquetamab-tgvs using HCPCS code J3055. Do not submit talquetamab-tgvs under miscellaneous codes such as C9399 or J3590; claims billed to those codes may be denied or delayed.

Background

Talquetamab‑tgvs (Talvey) is a bispecific GPRC5D‑directed CD3 T‑cell engager approved under an accelerated pathway for adult patients with relapsed or refractory multiple myeloma who have received multiple prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody. Continued approval depends on verification of clinical benefit from confirmatory trials; the International Myeloma Working Group (IMWG) response criteria are referenced in the policy to define progressive disease where applicable.

Definitions and Criteria

Talquetamab-tgvs (Talvey) — definition

Agent classBispecific GPRC5D‑directed CD3 T‑cell engager

Proprietary nameTalquetamab‑tgvs (Talvey)

Indication contextApproved for relapsed or refractory multiple myeloma after prior lines of therapy (see policy for full criteria)

IMWG progressive disease — definition and qualifying events

Primary IMWG progression rule≥25% increase from lowest response value in serum M‑component (with absolute increase ≥ 0.5 g/dL) or urine M‑component (with absolute increase ≥ 200 mg/24 h)

FLC‑only patientsIn patients without measurable serum/urine M‑protein: an absolute increase in the difference between involved and uninvolved FLC > 10 mg/dL qualifies

Line of Therapy Criteria

Second-line (Line of Therapy) Criteria

Line of therapy options: Combination with Tecvayli: member has received ≥ 3 prior lines of therapy; Single‑agent use: member has received or is intolerant to ≥ 4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Lines referenced must include PI, IMiD, and anti‑CD38 as specified in the policy.

Third-line or Later (Line of Therapy) Criteria

Combination therapy line requirement: Use of talquetamab‑tgvs in combination with Tecvayli is per NCCN for patients who have received ≥ 3 prior lines of therapy.>=3 prior lines

Added in 4Q 2025 review

Covered Regimens and Combination Options

Regimen	Examples / Notes	Coverage status
Regimens containing proteasome inhibitors, immunomodulatory agents, and/or anti‑CD38 monoclonal antibodies	Examples: bortezomib + lenalidomide ± dexamethasone; carfilzomib + lenalidomide + dexamethasone; daratumumab‑containing regimens	Covered

Regimen	Indication / Line of therapy	Coverage status
Talquetamab‑tgvs with Tecvayli	Per NCCN: for patients with ≥ 3 prior lines of therapy (combination option added in 4Q 2025)	Covered

Policy Summary

PayerCentene

PolicyTalquetamab-tgvs (Talvey) - Clinical Policy

Policy CodePolicy CP.PHAR.649

Change TypeMaterial updates to coverage criteria, coding (J3055), and approval durations

Effective DateDec 1, 2023

Next Review Date

Key ActionSubmit prior authorization using HCPCS code J3055 and include documentation of diagnosis, prior lines of therapy, and recent disease measurements or IMWG-defined progression.

SourceLink

On This Page

Dose increase is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: Medicaid/HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up‑to‑date sources of professional coding guidance prior to claiming reimbursement.

Single‑agent pathway (context)

Single‑agent use requires ≥ 4 prior lines of therapy (includes PI, IMiD, and anti‑CD38) per initial approval criteria

Source guidanceCombination requirement added per NCCN guidance incorporated in 4Q 2025 policy update

Effective code for talquetamab-tgvs: J3055.
Removed/previous misc codes: C9399, J3590 — do not use these for talquetamab-tgvs.

Denial Risk

Non‑FDA Indications

Requests for non‑FDA indications that are not addressed in this policy will be denied unless the provider supplies sufficient clinical evidence supporting the off‑label use in accordance with the Health Plan off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Non‑FDA indications require supporting peer‑reviewed literature or guideline recommendations and adherence to the applicable off‑label use policy references before approval will be considered.

Denial Risk

Coding Mismatch May Trigger Denial

Claims submitted with talquetamab-tgvs coded under prior miscellaneous codes (e.g., C9399 or J3590) may be subject to denial or additional review because J3055 is the specific code added to this policy. Providers should update billing practices to avoid claim denials.

Coding mismatch risk: claims using C9399 or J3590 for talquetamab-tgvs may be denied or require resubmission.
Ensure claims and prior authorization requests both use J3055 to prevent processing delays.

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the prior authorization request to support medical necessity.

Document diagnosis of multiple myeloma and that disease is relapsed or refractory.
Include prescriber specialty (oncologist or hematologist) and member age (≥18).
Provide recent disease measurements: serum M‑protein, urine M‑protein, or involved serum free light chain (FLC) results (measured within timeframes specified in policy), or documentation of progressive disease per IMWG response criteria.
Supply prior treatment history showing number and types of prior lines of therapy (proteasome inhibitor, immunomodulatory agent, anti‑CD38 antibody) or intolerance as required by the criteria.
If dosing exceeds policy limits or is for an off‑label regimen, include supporting practice guidelines or peer‑reviewed literature.

Documentation Required

Documentation and Coding Guidance

Providers should reference current professional coding guidance and include all supporting documentation used to justify medical necessity when submitting prior authorization requests and claims.

Check up‑to‑date coding references before claim submission.
Attach clinical notes, lab results, prior therapy records, and relevant guideline or literature citations for off‑label uses.
Ensure prior authorization documentation matches claim coding (J3055) to avoid denials or delays.

Other qualifying eventsNew lesion(s), ≥50% increase in SPD or lesion diameter, ≥50% increase in circulating plasma cells (minimum 200 cells/µL), or ≥10% absolute increase in bone marrow plasma cells for non‑measurable disease

Injection, talquetamab‑tgvs, 0.25 mg — HCPCS J3055

HCPCS codeJ3055

DescriptionInjection, talquetamab‑tgvs, 0.25 mg

Coding action notedJ3055 was added and miscellaneous codes C9399 and J3590 were removed in policy updates