CurrentBlue Cross Blue Shield - IowaPolicy 05.05.19

Talvey (talquetamab-tgvs) coverage and prior authorization criteria

This policy defines coverage, prior authorization requirements, dosing limits, and continuation criteria for Talvey (talquetamab-tgvs) for members of Wellmark/Blue Cross and Blue Shield of Iowa, including FDA-approved and selected compendial uses.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTalvey (talquetamab-tgvs) coverage and prior authorization criteria

Policy CodePolicy 05.05.19

Change TypeCode update and policy revision

Effective DateJan 1, 2024

Next Review Date

Key ActionObtain prior authorization; authorization of 12 months may be granted when initial criteria for labeled or compendial uses are met.

SourceLink

POLICY UPDATE CHANGES

J3055 HCPCS code for talquetamab-tgvs, 0.25 mg, effective 4/1/24 is listed for billing.

Policy reviewed and revised in April 2026 with current effective date April 19, 2026.

≥4Required prior lines of therapy

12 moAuthorization period

0.4 mg/kg wklyMaintenance dosing options

73% ORROverall response rate

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Initial Therapy

Authorization of 12 months may be granted when one of the following criteria groups is met:

FDA‑approved multiple myeloma indication: Member is an adult 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 (FDA label).>=4 prior lines

Supports FDA‑approved indication

Bridge to BCMA‑directed CAR‑T therapy: Requested agent may be used as a bridge to BCMA‑directed CAR T‑cell therapy and member has received at least one prior line of therapy that includes at least one immunomodulatory agent and at least one proteasome inhibitor.>=1 prior line with specified agents

Allows use as bridge to BCMA CAR‑T

Combination with teclistamab‑cqyv: Requested medication will be used in combination with teclistamab‑cqyv and member has received at least 3 prior therapies.>=3 prior therapies

Combination use criteria

Compendial uses: Authorization may be granted for POEMS syndrome, monoclonal immunoglobulin deposition disease (MIDD), and plasma cell‑related monoclonal gammopathy of renal significance (MGRS) as a single agent or in combination with teclistamab‑cqyv.compendial indication

Compendial indications listed

Continuation Therapy

Covered when ALL of the following are met:

Continuation of therapy: Member is receiving Talvey for an indication listed in Criteria for Initial Approval and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.no progression; no unacceptable toxicity

Reauthorization may be granted for 12 months

Talvey (talquetamab-tgvs) is considered not medically necessary for members who do not meet the criteria set forth for initial approval.

Use of Talvey when the specified approval criteria are not met is considered not medically necessary.

Dosing Regimens and Maintenance Schedules

Regimen	Step-up dosing (Days 1, 4, 7)	Maintenance dosing	Coverage status
{"text":"Weekly maintenance after step-up","status":""},{"text":"Day 1: 0.01 mg/kg; Day 4: 0.06 mg/kg; Day 7 (first treatment dose): 0.4 mg/kg","status":""},{"text":"0.4 mg/kg once weekly (beginning one week after first treatment dose)","status":"covered"},{"text":"Covered with criteria","status":""}
{"text":"Every-2-weeks (biweekly) maintenance after step-up","status":""},{"text":"Day 1: 0.01 mg/kg; Day 4: 0.06 mg/kg; Day 7 (step-up dose 3 / first treatment dose): 0.4 mg/kg","status":""},{"text":"0.8 mg/kg every 2 weeks (beginning two weeks after first treatment dose)","status":"covered"},{"text":"Covered with criteria","status":""}

Billing Codes and Dosing Schedule Summary

Billing HCPCS CodesHCPCS

J3055	Injection, talquetamab-tgvs, 0.25 mg (effective 4/1/24)
C9163	Injection, talquetamab-tgvs, 0.25 mg (cancelled 3/31/24)

Dosing schedules — step-up and maintenance

Step-up dose — Day 10.01 mg/kg (first step-up dose)

Step-up dose — Day 40.06 mg/kg (second step-up dose)

Step-up dose — Day 70.4 mg/kg (first treatment/third step-up dose)

Maintenance — weekly option0.4 mg/kg once weekly after step-up

Maintenance — biweekly option0.8 mg/kg every 2 weeks after step-up (biweekly regimen)

Provider Actions, Prior Authorization, and Documentation

Documentation Required

Required documentation

Submission of the following information is necessary to initiate the prior authorization review: chart notes or medical record documentation demonstrating failure of previous lines of therapy.

Chart notes or medical records demonstrating failure of previous lines of therapy

Step Therapy

Step-up dosing and monitoring required

Initial step-up dosing and monitoring are required prior to maintenance dosing. Follow the step-up schedule below and monitor per manufacturer guidance and institutional protocols for infusion reactions and other adverse events before administering maintenance doses.

Weekly dosing schedule (maintenance): 0.4 mg/kg once weekly — first maintenance dose = Day 7 step-up dose then weekly thereafter
Biweekly dosing schedule (maintenance): 0.8 mg/kg every 2 weeks — first maintenance dose = Day 7 step-up dose then every 2 weeks thereafter
Step-up dosing (both schedules): Day 1 = 0.01 mg/kg; Day 4 = 0.06 mg/kg; Day 7 = first treatment dose (0.4 mg/kg)

Prior Authorization

Prior authorization required

Authorization of 12 months may be granted when initial criteria for labeled or compendial uses are met. Talvey is considered not medically necessary for members who do not meet the specified criteria for initial approval.

Prior authorization may be approved for up to 12 months for indicated uses (e.g., relapsed/refractory multiple myeloma, POEMS, MIDD, MGRS) when criteria are met
Talvey is not medically necessary if the member does not meet the policy's initial approval criteria

Line of Therapy / Salvage Use

salvage

FDA label relapsed/refractory multiple myeloma (salvage): Patients must have relapsed or refractory disease and received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody.>=4 prior lines

Salvage (line of therapy)

salvage

Bridge to BCMA CAR‑T (salvage): Use as a bridge to BCMA‑directed CAR T‑cell therapy allowed after at least one prior line of therapy that includes at least one immunomodulatory agent and at least one proteasome inhibitor.>=1 prior line

Salvage (pre‑CAR‑T bridging)

Key Definitions

GPRC5D — definition and clinical relevance

Gene/proteinG protein-coupled receptor, family C, group 5, member D (GPRC5D)

Cell surface statusCell-surface protein targeted by talquetamab

Clinical relevanceEnhanced expression on malignant plasma cells and used as a therapeutic target in multiple myeloma

Normal tissue expressionPresent on normal plasma cells and keratinized epithelial tissues (skin, tongue), which contributes to on-target toxicities

CRS — Cytokine releasing syndrome (definition and precautions)

TermCytokine releasing syndrome (CRS)

Clinical riskCommon severe adverse event with talquetamab; necessitates monitoring and is a principal reason for REMS and boxed warning

Monitoring requirementPatients must be monitored inpatient for 48 hours after each step-up dosing due to CRS risk

Associated toxicitiesMay be accompanied by neurologic toxicity and ICANS; CRS was a primary safety concern in trials

Background and Clinical Context

Multiple myeloma is a malignancy of plasma cells in the bone marrow that leads to end-organ damage including bone lesions, cytopenias, renal impairment, and increased risk of infections; it primarily affects older adults. Talquetamab is a bispecific antibody that redirects T-cell cytotoxicity by binding GPRC5D on malignant plasma cells and CD3 on T cells, and received accelerated approval based on the MonumenTAL-1 trial.

Therapy with Talvey requires careful monitoring because immune-mediated toxicities such as cytokine release syndrome (CRS) and other adverse events are associated with treatment; prior authorization with documentation of prior therapies and adherence to recommended step-up dosing and monitoring is required for initiation and continuation.

Authorization for treatment or reauthorization is granted for up to 12 months when coverage criteria are met and there is no evidence of unacceptable toxicity or disease progression while on therapy.