CurrentEmblemHealthPolicy N/A

Imdelltra (tarlatamab-dlle) — coverage and authorization

Defines indications, authorization expectations, exclusion criteria, billing code, and documentation standards for Imdelltra (tarlatamab-dlle) for members covered under Evolent-managed lines of business. Applies to providers requesting prior authorization for this medication.

Policy Summary

PayerEmblemHealth

PolicyImdelltra (tarlatamab-dlle) — coverage and authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; continuation requests are exempt when member has no disease progression, prior authorization was active within the last year without >30-day lapse, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1FDA indication (ES-SCLC)

J9026HCPCS code

10 mgSingle dose max

Commercial/Exchange/MedicaidLines of business

CRS/ICANSBoxed warnings

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Coverage and Clinical Criteria

inv-01: Initial therapy — ES-SCLC

Covered when ALL of the following are met

Initial therapy for ES-SCLC: Patient is an adult with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Based on indication statement in source document.

inv-02: Continuation therapy

Continuation therapy covered when ALL of the following are met

Continuation criteria: Member has not experienced disease progression on the requested medication AND the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND no additional medications are being added to the continuation request.

Continuation exemption per policy.

Use of Imdelltra (tarlatamab-dlle) is excluded when any of the following apply: disease progression while taking Imdelltra; concurrent use with other anticancer therapies; or dosing that exceeds a single dose limit of 10 mg. Requests may also be excluded when the requested use is investigational or off-label and the evidence does not meet the policy’s standards for sufficiency (see investigational/off‑label guidance). The policy defines sufficient evidence in alignment with CMS‑recognized compendia and acceptable peer‑reviewed literature, considering representativeness of the patient and regimen, clinically meaningful outcomes (for example ASCO‑recommended thresholds), study design appropriateness, and the generally limited weight given to case reports or abstracts without full articles.

Investigational or off‑label requests for Imdelltra will be denied when the indication is not supported by adequate evidence as defined by the policy. Adequate evidence must be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature and should demonstrate that the patient population and treatment regimen are represented in published studies, that outcomes are clinically meaningful (for example ASCO standards such as hazard ratios and survival benefit), and that study design is appropriate to answer the clinical question. Case reports and meeting abstracts without full peer‑reviewed articles are explicitly insufficient to support coverage.

Initial Therapy and Safety Requirements

inv-13: Initial therapy and safety

Initial coverage criteria and safety considerations

Indication requirement: Adult patient with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Indication requirement from policy.

Safety monitoring and dosing: Initiate treatment using the step-up dosing schedule; monitor for cytokine release syndrome (CRS) and neurologic toxicity/ICANS. Withhold or permanently discontinue tarlatamab based on severity of CRS or ICANS per boxed warning.

US boxed warnings and step-up dosing requirement.

Continuation Therapy Criteria

inv-14: Continuation exemption

Continuation requests exempt from denial when criteria are met

Continuation exemption: No disease progression on the requested medication AND medication used within the last year without a lapse of more than 30 days of active authorization AND no additional medications are being added to the continuation request.

Exemption conditions per continuation policy.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imdelltra (tarlatamab‑dlle). Continuation (re‑authorization) may be allowed when the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days from an active authorization, and no additional medications are being added to the continuation request. Providers must supply documentation supporting medical necessity (see supporting evidence callout).

Prior authorization required for all new starts
Continuation allowed when: no disease progression; prior use within last 12 months with ≤30 day lapse; no added medications

Step Therapy

Step‑Up Dosing Required (boxed warning)

Initiate tarlatamab using the FDA boxed‑warning recommended step‑up dosing schedule to reduce incidence and severity of cytokine release syndrome (CRS). Monitor for CRS and neurologic toxicity (including ICANS); withhold or permanently discontinue per severity and labeling.

Follow FDA prescribing information step‑up dosing schedule prior to maintenance dosing

Billing Codes and Limits

Covered HCPCS Drug CodeHCPCSCovered

J9026

Injection, tarlatamab-dlle, 1 mg

inv-06: Single dose limit — 10 mg

Single dose limitSingle dose must not exceed 10 mg.

Relevant exclusionRequests will be excluded/denied if dosing exceeds the 10 mg single-dose limit.

Unit of measureMilligrams (mg).

Dose and Quantity Limits

inv-16: Imdelltra (tarlatamab-dlle) — Single dose must not exceed 10 mg

Dose maximumSingle dose of Imdelltra (tarlatamab-dlle) must not exceed 10 mg.

Indication contextImdelltra is indicated for adult members with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Billing code (per mg)HCPCS: J9026 — Injection, tarlatamab-dlle, 1 mg.

Step-up Dosing Schedule

Dose day	Planned dose	Purpose/notes
Day 1 (step-up dose 1)	Administer initial lower step-up dose as specified in FDA labeling (see prescribing information).	Reduce initial cytokine release risk; begin safety monitoring for CRS/ICANS per boxed warning; withhold if significant toxicity occurs.
Day 8 (step-up dose 2)	Administer second step-up dose (intermediate dose) per FDA labeling prior to full dose escalation.	Further mitigate CRS risk while assessing tolerability; continue neurologic monitoring for ICANS.
Day 15 (full dose)	Administer target therapeutic dose per FDA labeling after successful step-up doses and clinical assessment.	Initiate ongoing treatment phase if no unacceptable CRS/ICANS; withhold or discontinue based on severity per boxed warning.

Infusion Site and Monitoring Requirements

Note

Ensure infusion site can monitor/manage CRS and ICANS

Provide treatment at a site of care prepared to monitor and manage cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS); ensure appropriate resources and monitoring are available during infusion and for prompt management of neurologic toxicity.

Monitor patients for signs/symptoms of neurologic toxicity (including ICANS) during treatment and treat promptly.
Withhold tarlatamab until ICANS resolves or permanently discontinue based on severity.

Key Definitions

inv-12: ES-SCLC — definition of extensive-stage small cell lung cancer as used in this policy

DefinitionExtensive-stage small cell lung cancer (ES-SCLC): small cell lung cancer that has spread extensively and is the population for which Imdelltra may be used after progression on or after platinum-based chemotherapy.

PopulationAdults with ES-SCLC who have disease progression on or after platinum-based chemotherapy.

Policy useThis definition is used to determine eligibility for Imdelltra under this policy.

Background and Indication

Imdelltra (tarlatamab-dlle) is indicated for adult patients with extensive‑stage small cell lung cancer (ES‑SCLC) who have experienced disease progression on or after platinum‑based chemotherapy. The agent is a bispecific T‑cell engager (BiTE) that redirects T cells against tumor cells. Serious toxicities include cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS)