CurrentEmblemHealthPolicy MG.MM.PH.395

Talvey (talquetamab-tgvs) subcutaneous injection

Defines EmblemHealth medical necessity and authorization criteria for Talvey (talquetamab-tgvs) for adult patients with relapsed or refractory multiple myeloma, and lists coding and authorization details affecting providers requesting coverage.

Policy Summary

PayerEmblemHealth

PolicyTalvey (talquetamab-tgvs) subcutaneous injection

Policy CodePolicy MG.MM.PH.395

Change TypeMaterial revisions to authorization length and coding

Effective Date

Next Review DateFeb 12, 2025

Key ActionObtain prior authorization and submit clinical evidence demonstrating the member meets age and prior-therapy criteria for a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

Length of Authorization was changed to provide coverage for 12 months (may be renewed) replacing prior split initial/continuation durations.

Updated applicable procedure codes: J3055 added; J9999 and C9399 removed.

Updated/added ICD-10 diagnosis codes related to multiple myeloma and plasma cell leukemia.

12 monthsLength of authorization

>=4Required prior lines of therapy

J3055Applicable HCPCS code

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Coverage Criteria

inv-01: Initial Therapy — covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Therapy Criteria: Patient is 18 years of age or older; AND patient has tried and failed at least four prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.age >= 18; prior lines >= 4

From Initial Criteria section

inv-02: Renewal Therapy — covered when ALL of the following are met

Renewal covered when ALL of the following are met:

Renewal Criteria: Member has responded positively to the treatment as determined by the prescribing physician; AND member has not experienced unacceptable toxicity from the drug.clinical response documented; no unacceptable toxicity

Renewal Criteria; authorization length: 12 months

There are no explicit exclusions listed in the policy for uses of talquetamab-tgvs (Talvey) beyond the labeled indication; the document specifically defines the covered indication as adult patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy. Any request for treatment outside that defined indication would therefore fall outside the policy’s stated covered population.

The policy requires that the member meet the stated eligibility criteria for coverage. Specifically, the patient must be an adult (≥18 years) and must have failed at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Use in patients who do not meet the age or prior therapy requirements will not satisfy the medical necessity criteria and is not covered under this policy.

Initial Therapy

inv-14: Initial Therapy — initial authorization criteria (nested medical necessity logic)

Initial authorization criteria

Initial: Patient age >= 18; AND prior therapy requirement: patient has tried and failed at least four prior therapies, which must include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.age >= 18; prior lines >= 4

From Initial Criteria section

Continuation / Renewal Criteria

inv-15: Continuation Therapy — continuation/renewal conditions for ongoing therapy

Continuation/renewal conditions for ongoing therapy

Continuation: Member demonstrates clinical response to therapy as judged by the prescribing clinician; AND member has not experienced unacceptable toxicity attributable to the drug; authorization may be renewed for 12‑month periods.clinical response; acceptable toxicity profile

Continuation/renewal criteria and authorization length

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests for therapy must be submitted to EmblemHealth with complete clinical documentation to allow review.

Authorization granted for 12 months (may be renewed).

Documentation Required

Required Clinical Evidence Submission

The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria. Without this documentation EmblemHealth cannot properly review the request and may deny authorization.

Treating physician must document that patient meets all applicable clinical criteria (see Initial Criteria).
Include prior therapy history documenting failure of required agents/classes.

Coding and Billing

Applicable Procedure CodesHCPCSCovered

J3055

Injection, talquetamab-tgvs, 0.25 mg

Applicable NDCsNDCCovered

57894-0470-01	Talvey 40mg/mL Solution
57894-0469-01	Talvey 3mg/1.5mL Solution

ICD-10 DiagnosesICD-10

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.11	Plasma cell leukemia in remission
C90.12	Plasma cell leukemia in relapse

Step Therapy / Prior Treatment Requirements

Required prior therapies before Talvey
Patient must have tried and failed at least four prior therapies including: a proteasome inhibitor; an immunomodulatory drug; and an anti-CD38 antibody.

Background

Talquetamab-tgvs (Talvey) is a bispecific T‑cell engaging antibody that binds CD3 on T cells and GPRC5D on multiple myeloma cells (and some normal keratinized tissues). Binding engages and activates T cells, inducing release of proinflammatory cytokines and lysis of multiple myeloma cells. Talvey is indicated for treatment of 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.

Definitions

talquetamab-tgvs (Talvey) — definition

Generic and brand nametalquetamab-tgvs (Talvey)

Drug classBispecific T-cell engaging antibody (bispecific T-cell engager)

Mechanism of actionBinds CD3 on T‑cells and GPRC5D on multiple myeloma cells to activate T‑cells, induce release of proinflammatory cytokines, and mediate lysis of myeloma cells.

Indication summaryTreatment of 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.

Expression of targetGPRC5D is expressed on multiple myeloma cells, non‑malignant plasma cells, and some healthy keratinized epithelial tissues (e.g., skin and tongue).