CurrentCareSourcePolicy N/A

Talvey (talquetamab-tgvs) — Coverage Criteria and Prior Authorization

Defines prior authorization, coverage criteria, dosing, and prescribing requirements for Talvey (talquetamab-tgvs) for treatment of relapsed or refractory multiple myeloma in adults within the payer's jurisdiction.

Policy Summary

PayerCareSource

PolicyTalvey (talquetamab-tgvs) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateSep 11, 2024

Key ActionObtain prior authorization and document prior therapies showing at least four prior systemic regimens including required classes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=4lines of prior therapy required

REMSrisk management

Weekly/q2wmaintenance dosing options

NCCN Preferredguideline status

Coverage and Authorization Criteria

Initial FDA-Approved Indication Criteria

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Age: Patient is >= 18 years of age>= 18

Prior lines: Patient has received at least four prior systemic regimens>= 4

Required prior classes: Among previous regimens, patient has received at least one agent from each: proteasome inhibitor; immunomodulatory drug; anti-CD38 monoclonal antibodyat least one drug from each class

Examples in policy: bortezomib, carfilzomib, ixazomib; lenalidomide, pomalidomide, thalidomide; daratumumab, isatuximab

Prescriber: Medication prescribed by or in consultation with an oncologist

Specialist requirement due to monitoring needs (REMS)

Dosing regimen: Approve one of the following step-up followed by maintenance dosing schedules: Weekly schedule with step-up 0.01 mg/kg, 0.06 mg/kg, 0.4 mg/kg then 0.4 mg/kg weekly; OR Every-2-weeks schedule with step-up 0.01 mg/kg, 0.06 mg/kg, 0.4 mg/kg, 0.8 mg/kg then 0.8 mg/kg every 2 weeksfollow specific step-up and maintenance dosing

See policy for timing: each step-up dose given 2–7 days apart; maintenance dosing no more frequently than weekly or every 2 weeks as specified

Dosing Regimens and Schedules

Regimen	Step‑up dosing (mg/kg)	Maintenance dosing (mg/kg & interval)	Notes
Weekly schedule	Dose 1: 0.01 mg/kg; Dose 2: 0.06 mg/kg (2–7 days after Dose 1); Dose 3: 0.4 mg/kg (2–7 days after Dose 2)	0.4 mg/kg — no more frequently than once weekly	Maintenance therapy after step‑up dosing until disease progression or unacceptable toxicity
Every‑2‑weeks (q2w) schedule	Dose 1: 0.01 mg/kg; Dose 2: 0.06 mg/kg (2–7 days after Dose 1); Dose 3: 0.4 mg/kg (2–7 days after Dose 2); Dose 4: 0.8 mg/kg (2–7 days after Dose 3)	0.8 mg/kg — no more frequently than once every 2 weeks	Maintenance therapy after step‑up dosing until disease progression or unacceptable toxicity

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit coverage of Talvey. Approval is recommended when the patient meets the Recommended Authorization Criteria. All approvals are provided for the duration noted in the authorization. Requests for doses outside the dosing documented in the policy will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist).

Prior authorization required for Talvey (medical benefit)
Dose exceptions reviewed case-by-case by clinician
Approvals provided for specified duration

Step Therapy

Prior Lines / Class Therapy Requirement

Patient must have previously received at least four systemic regimens, including agents from each of the following classes: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Examples: proteasome inhibitors — bortezomib, carfilzomib (Kyprolis), ixazomib (Ninlaro); immunomodulatory agents — lenalidomide, pomalidomide (Pomalyst), thalidomide (Thalomid); anti-CD38 monoclonal antibodies — daratumumab (Darzalex, Darzalex Faspro), isatuximab (Sarclisa).

At least four prior systemic regimens required
Must include: proteasome inhibitor; immunomodulatory agent; anti‑CD38 monoclonal antibody
Examples of each class provided for documentation

Documentation Required

Prescriber and Documentation Requirements

Talvey must be prescribed by, or in consultation with, a physician who is an oncologist or a specialist in the treated condition. Documentation submitted with the prior authorization request should include: prior therapy history (including names, classes, and dates of at least four systemic regimens), evidence the patient meets age and FDA‑label requirements, and the intended dosing regimen. Maintain documentation of consultation when the prescriber is not an oncologist. Requests lacking adequate documentation of prior therapies or specialist involvement may be delayed or denied.

Prescriber: oncologist or specialist; consultation documentation required if prescribed by non‑specialist
Documentation must list prior regimens (names, classes, dates) demonstrating the required therapies
Include intended dosing regimen and rationale if dose differs from policy

Denial Risk

Denial Trigger for Non‑Specified Indications

Requests for coverage will be denied when the request does not meet the Recommended Authorization Criteria or when required documentation (prior therapies, specialist involvement, or dosing information) is not provided.

Denial if criteria not met
Denial if required documentation is missing

Eligibility by Prior Lines of Therapy

salvage

Line of therapy requirement: Patient 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

Matches FDA indication and NCCN Preferred (Category 2A) recommendation

Definitions and Background

Talvey (talquetamab-tgvs)

Generic nameTalquetamab-tgvs

Brand nameTalvey

MechanismBispecific GPRC5D-directed CD3 T-cell engager

Indication summaryTreatment of relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Risk Evaluation and Mitigation Strategy (REMS)

REMS requirementTalvey approved with a Risk Evaluation and Mitigation Strategy (REMS) program

Primary risks addressedCytokine release syndrome (CRS) and neurotoxicity, including ICANS

Monitoring implicationSpecialized monitoring and management protocols required per REMS

Talvey (talquetamab‑tgvs) is a bispecific GPRC5D‑directed CD3 T‑cell engager indicated for adults with relapsed or refractory multiple myeloma who have received prior systemic therapy. Use requires enrollment in the approved REMS program because of risks for cytokine release syndrome (CRS) and neurotoxicity (including ICANS), and dosing is weight‑based with a required step‑up schedule followed by maintenance dosing either weekly or every 2 weeks until disease progression or unacceptable toxicity. Prior authorization is required; approval is recommended when the patient meets the policy’s eligibility criteria (including prior lines and class exposure and specialist prescribing/documentation requirements).