CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Talvey (talquetamab-tgvs) — Coverage Criteria (relapsed/refractory multiple myeloma)

Defines indication, coverage criteria, exclusions, coding, and authorization expectations for Talvey (talquetamab-tgvs) use in relapsed/refractory multiple myeloma for members under Neighborhood Health Plan of Rhode Island (processed by Evolent). Affects ordering providers requesting medication authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTalvey (talquetamab-tgvs) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization from Evolent and document prior therapies and supporting evidence per FDA labeling, CMS compendia, or clinical guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4required prior lines of therapy for covered indication

J3055HCPCS code

0.8 mg/kgsingle dose limit

requiredREMS

Coverage Criteria for Talvey (talquetamab-tgvs)

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inv-01: Initial therapy coverage criteria

Covered when ALL of the following are met

Multiple Myeloma indication

Prior therapies: Member has received at least four prior lines of therapy, including a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide), and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab).
From indication section

inv-02: Continuation therapy criteria

Continuation (maintenance) coverage conditions

Continuation therapy: Member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.

Continuation request conditions per policy

Exclusions: Use of Talvey (talquetamab-tgvs) is excluded when any of the following apply: disease progression while taking Talvey; concurrent use with other anticancer therapies; or dosing that exceeds the single dose limit of 0.8 mg/kg. Requests for investigational or off‑label indications are excluded when the indication is not supported by sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy defines sufficiency by whether the patient and regimen are represented in the evidence, whether outcomes are clinically meaningful (for example ASCO‑recommended thresholds such as hazard ratio <0.80 or ≥3 months OS/PFS benefit), whether study design appropriately addresses the question, and by downgrading case reports and abstracts without full articles as inadequate support.

Use of Talvey for investigational or off‑label indications is considered not acceptable when the requested use lacks adequate supporting evidence from CMS‑recognized compendia or acceptable peer‑reviewed literature. Adequate evidence is evaluated by whether the published studies appropriately represent the patient population and regimen, report clinically meaningful outcomes (for example ASCO thresholds), and use appropriate study designs; nonrandomized trials with substantial subject numbers may provide supportive evidence, whereas case reports and abstracts without full peer‑reviewed articles are generally insufficient.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required

Evolent requires prior authorization for Talvey (talquetamab-tgvs) and will only authorize treatment when the policy’s coverage criteria are met, including documentation of prior therapy history and continuity rules for continuation requests.

Evolent processes all medication requests from network ordering providers and may deem medications not authorized as not approvable and not reimbursable.
Authorization decisions require evidence per the policy (e.g., prior lines of therapy and continuation conditions).

Step Therapy

Step-up dosing requirement

Initiation of talquetamab-tgvs must follow the boxed warning recommendation to start treatment with step-up dosing to reduce the risk of cytokine release syndrome (CRS); withhold or discontinue per severity if CRS occurs.

US Boxed Warning: “Initiate talquetamab-tgvs treatment with step-up dosing to reduce the risk of CRS.”
Withhold talquetamab-tgvs until CRS resolves or permanently discontinue based on severity.

Documentation Required

Required supporting documentation

Support for Talvey requests must reference FDA labeling, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature and include documentation showing prior therapies, lack of progression for continuation requests, and adequacy of evidence for off‑label uses.

Policy lists acceptable evidence sources: FDA product labeling, CMS‑approved compendia, NCCN, ASCO guidelines, or peer‑reviewed literature.
Continuation requests exempt from not‑approvable status only if member has not progressed on the medication, prior authorization was active within the last year without a lapse >30 days, and no new medications are added.

Denial Risk

Common triggers for denial

Requests may be excluded or denied for specified reasons including disease progression while on Talvey, concurrent use with other anticancer therapies, dosing that exceeds the single‑dose limit (0.8 mg/kg), or investigational/off‑label uses lacking adequate supporting evidence per compendia or peer‑reviewed literature.

Exclusion: Disease progression while taking Talvey.
Exclusion: Concurrent use with other anticancer therapies.
Exclusion: Dosing exceeds single dose limit of 0.8 mg/kg.
Exclusion: Investigational or off‑label indications without sufficient evidence as defined by CMS compendia or acceptable peer‑reviewed literature.

Background — Drug and Indication

Talquetamab‑tgvs (Talvey) is a T‑cell–redirecting bispecific antibody indicated for adult patients with relapsed or refractory multiple myeloma after multiple prior therapies. The agent carries serious risks including cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS), and is available only through a Risk Evaluation and Mitigation Strategy (REMS) program; dosing is administered with a prescribed step‑up regimen per the REMS to reduce CRS risk.

Definitions and REMS

inv-12: Risk Evaluation and Mitigation Strategy program (TECVAYLI and TALVEY REMS required due to CRS and neurologic toxicity risks).

REMS requirementTalquetamab-tgvs (Talvey) is available only through the TECVAYLI and TALVEY REMS due to risks of cytokine release syndrome (CRS) and neurologic toxicity (including ICANS).

Safety measuresInitiate treatment with step-up dosing and monitor/treat promptly for CRS and neurologic toxicity; withhold or discontinue based on severity.

Program purposeREMS restricts distribution and requires risk mitigation because CRS and ICANS can be life-threatening or fatal.

Regimen	Indication / line of therapy	Key requirements / restrictions	Coverage status
Talvey (talquetamab-tgvs) with step-up dosing per REMS	Relapsed or refractory multiple myeloma after ≥4 prior lines of therapy	Initiate with step-up dosing per boxed warning and REMS; must not be given concurrently with other anticancer therapies; single dose must not exceed 0.8 mg/kg; available only through TECVAYLI and TALVEY REMS; prior authorization required and documentation of prior therapies is required	Covered