CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Imdelltra (tarlatamab-dlle) coverage criteria for extensive‑stage small cell lung cancer

Defines clinical indications, exclusions, coding, and prior authorization expectations for Imdelltra (tarlatamab-dlle) for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImdelltra (tarlatamab-dlle) coverage criteria for ES‑SCLC

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for Imdelltra (J9026) with documentation showing disease progression after platinum‑based chemotherapy, evidence per FDA/compendia/guidelines, and a CRS monitoring/step‑up dosing plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered FDA indication (ES‑SCLC after platinum)

J9026Billing code for Imdelltra

10 mgSingle dose max

Commercial/Exchange/MedicaidLines of business

Coverage Criteria for Imdelltra (tarlatamab-dlle)

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Initial therapy coverage criteria

Covered when ALL of the following are met

ES-SCLC diagnosis: Patient is an adult with extensive-stage small cell lung cancer (ES-SCLC)

Prior platinum chemotherapy: Disease has progressed on or after platinum-based chemotherapy

Indicates use in at least second-line setting

Supported evidence: Use is supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature

See Purpose for accepted evidence sources

Safety and monitoring: Step-up dosing and monitoring plan in place for cytokine release syndrome (CRS) and neurologic toxicity with processes to withhold or discontinue therapy based on severity

Boxed warning requires step-up dosing to reduce CRS; monitor and manage per labeling

Coverage exclusions include: disease progression while taking Imdelltra (tarlatamab-dlle), and concurrent use with other anticancer therapies. Requests will also be excluded when dosing exceeds the single dose limit of 10 mg. Additionally, investigational or off‑label uses lacking sufficient supporting evidence (per the policy’s evidence standards) are not approvable. The policy specifies that adequacy of evidence is judged by representation of the patient and regimen in published data, clinically meaningful outcomes (for example ASCO-recommended thresholds such as a hazard ratio < 0.80 or >= 3 months benefit in OS/PFS when applicable), appropriate study design, and the nature of the evidence (noting that case reports and meeting abstracts without full peer‑reviewed articles are generally insufficient).

Off‑label or investigational uses of Imdelltra (tarlatamab-dlle) are excluded when they lack adequate supporting evidence. Acceptable support must come from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. The policy defines sufficient evidence by whether the patient/cancer characteristics and the administered regimen are adequately represented in published studies, whether outcomes are clinically meaningful (using standards such as ASCO’s guidance), whether study design is appropriate for the question, and whether the evidence is more than uncontrolled case reports or abstracts without a full peer‑reviewed publication.

FDA-Approved Dosing and Regimens

Regimen	Indication	Dosing / Safety Requirements
Tarlatamab (Imdelltra) per FDA-approved dosing with step-up schedule	Adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy	Initiate treatment using the FDA-approved step-up dosing schedule to reduce incidence and severity of cytokine release syndrome (CRS); monitor for CRS and neurologic toxicity (including ICANS). Withhold until CRS/ICANS resolves or permanently discontinue based on severity.

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imdelltra (J9026). Requests will be approved when used in adult members with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy, and when the use is supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature meeting CMS standards.

Affected code: J9026

Step Therapy

Step-up Dosing and Safety Monitoring

Initiate treatment using the recommended step-up dosing schedule described in the FDA labeling to reduce the incidence and severity of cytokine release syndrome (CRS). Monitor for CRS and neurologic toxicity (including ICANS) and manage per labeling; withhold or permanently discontinue based on severity.

Documentation Required

Documentation Required to Support Use

Provider must support the requested use with one of the following: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Denial Risk

Exclusion Criteria / Denial Risk

Requests will be excluded for the following: disease progression while taking Imdelltra; concurrent use with other anticancer therapies; dosing that exceeds the single dose limit of 10 mg; investigational use for off-label indications lacking sufficient evidence or not generally accepted by the medical community (including uses not supported by CMS compendia or acceptable peer‑reviewed literature).

Adverse Event Definitions and Monitoring

Cytokine release syndrome (CRS) — description and monitoring/management note

DefinitionCytokine release syndrome (CRS) is a potentially serious or life‑threatening systemic inflammatory response that can occur in patients receiving tarlatamab.

Risk mitigationInitiate treatment using the step‑up dosing schedule to reduce the incidence and severity of CRS.

Management actionWithhold tarlatamab until CRS resolves or permanently discontinue based on severity.

MonitoringMonitor patients for signs and symptoms of CRS during treatment as part of safety precautions in the boxed warning.

ICANS (immune effector cell-associated neurotoxicity syndrome) — description and management guidance

DefinitionICANS (immune effector cell‑associated neurotoxicity syndrome) is neurologic toxicity that can be serious or life‑threatening in patients receiving tarlatamab.

MonitoringMonitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly.

Management actionWithhold tarlatamab until ICANS resolves or permanently discontinue based on severity.

Clinical importancePrompt recognition and management are required due to potential for serious or life‑threatening reactions.

Policy Background and Scope

Tarlatamab (Imdelltra) is indicated for adult patients with extensive‑stage small cell lung cancer (ES‑SCLC) with disease progression on or after platinum‑based chemotherapy. This policy applies to requests for coverage of Imdelltra under Neighborhood Health Plan of Rhode Island and defines the clinical criteria, required documentation, safety measures, coding, and prior authorization expectations for its use. Because treatment carries risks including cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity, the policy requires implementation of the FDA‑approved step‑up dosing schedule and monitoring with provisions to withhold or discontinue therapy based on severity of CRS or neurologic toxicity.