CurrentCentenePolicy CP PHAR.685

Tarlatamab-dlle (Imdelltra) — Coverage Criteria for ES-SCLC

Defines medical necessity and prior authorization criteria for Imdelltra (tarlatamab-dlle) for treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy; applies to Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyTarlatamab-dlle (Imdelltra) — Coverage Criteria for ES-SCLC

Policy CodePolicy CP PHAR.685

Change TypeNo material changes

Effective DateSep 1, 2024

Next Review Date

Key ActionPrior authorization is required and the provider must submit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial approval duration

12 monthsContinuation approval duration

J9026HCPCS code

BoxedWarnings

1 mg, 10 mgVial sizes

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval for Imdelltra: 1. Diagnosis of extensive-stage small cell lung cancer (ES-SCLC). 2. Prescribed by or in consultation with an oncologist. 3. Age > 18 years. 4. Disease has progressed on or after receiving platinum-based therapy. 5. Prescribed regimen is FDA‑approved or recommended by NCCN OR dosing is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). 6. Step‑up dosing schedule for Cycle 1 (1 mg on Day 1; 1 mg and 10 mg on Days noted per cycle as specified in the regimen) with Cycle 2 and beyond dosing not to exceed 10 mg on Days 1 and 15 of each cycle.

Approval duration: 6 months

inv-02: Continuation Therapy

Covered when ALL of the following are met for continuation:

Continuation Approval for Imdelltra: 1. Member is responding positively to therapy. 2. Member is currently receiving medication via Centene benefit, or documentation supports member has received Imdelltra for at least 30 days. 3. If the request is for a dose increase, the new dose does not exceed 10 mg on Days 1 and 15 of each cycle OR the new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Approval duration: 12 months

Non‑FDA approved indications not addressed in this policy are not authorized

Uses that are off‑label and not supported by the referenced off‑label policies (CP.CPA.09 for Commercial, HIMPA.154 for Health Insurance Marketplace, CP PMN.53 for Medicaid) are considered not authorized and therefore not covered under this policy.

Initial Therapy and Dosing

inv-14: Initial Therapy and Dosing

Initial approval criteria and dosing:

Initial dosing and criteria: 1. Diagnosis of ES-SCLC; 2. Prescribed by or in consultation with an oncologist; 3. Age > 18 years; 4. Disease progressed on or after platinum-based therapy; 5. Step‑up dosing schedule for Cycle 1 with Cycle 2 and beyond dosing of 10 mg on Days 1 and 15 each cycle; maximum dose 10 mg.Maximum dose: 10 mg

Prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label dosing must be supported by practice guidelines or peer‑reviewed literature. Approval duration: 6 months

Continuation (Renewal) Criteria

inv-15: Continuation Therapy

Continuation (renewal) approval requires:

Continuation: 1. Member is responding positively to therapy. 2. Member is currently receiving medication via Centene benefit or has received Imdelltra for at least 30 days (documentation required). 3. Any request for a dose increase must either not exceed 10 mg on Days 1 and 15 of each cycle, or be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).Maximum dose for continuation: 10 mg

Approval duration: 12 months

Coding and Quantity Limits

HCPCS CodesHCPCS

J9026

Injection, tarlatamab-dlle; 1 mg

Maximum Dose — inv-06: 10 mg

Maximum single dose10 mg

inv-17: Tarlatamab-dlle (Imdelltra) — Vials and Max Dose

Maximum single dose10 mg

Available vial sizes1 mg and 10 mg single-dose vials

Dosage regimen noteStep-up dosing schedule; cycle 2 and beyond: 10 mg on Days 1 and 15

Provider Action Requirements

Prior Authorization
Prior Authorization Required
Prior authorization is required. Approval will be granted only when all clinical criteria are met and supporting documentation is provided.
Prior authorization required for Imdelltra (CP PHAR.685).
Approval granted when criteria in the policy are met and supporting documentation is submitted.

Documentation Required
Regimen Requirement
Prescribed regimen must be FDA-approved or recommended by NCCN. Off-label dosing or regimens not in the label require submission of supporting practice guidelines or peer‑reviewed literature demonstrating the dosing is appropriate for the requested indication.
Prescribed regimen must be FDA‑approved or NCCN‑recommended.
Off‑label dosing requires guideline or peer‑reviewed literature support submitted by the prescriber.

Step Therapy Requirements

Step	Requirement / Notes
1	Member must have disease progression on or after a platinum-containing regimen (examples in Appendix B include: carboplatin + etoposide + atezolizumab; carboplatin + etoposide + durvalumab; cisplatin + etoposide + durvalumab; carboplatin + etoposide; cisplatin + etoposide; carboplatin + irinotecan; cisplatin + irinotecan).
2	Prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label dosing may be considered if supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Quantity Limits

inv-17: Quantity limits — Tarlatamab-dlle (Imdelltra)

Maximum single dose10 mg

Available vial sizes1 mg and 10 mg single-dose vials

Quantity limit unitmg per single dose

Definitions

inv-12: ES-SCLC — definition

TermES-SCLC (extensive-stage small cell lung cancer)

PopulationAdult patients with disease progression on or after platinum-based chemotherapy

ContextIndication for tarlatamab-dlle (Imdelltra)

inv-13: DLL3 — definition

TermDLL3 (delta-like ligand 3)

RoleTarget of the bispecific CD3 T-cell engager tarlatamab-dlle

RelevanceReferenced as the drug's directed target in the policy description

Background

Tarlatamab‑dlle (Imdelltra) is a bispecific DLL3‑directed CD3 T‑cell engager indicated under accelerated approval for the treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC) with disease progression on or after platinum‑based chemotherapy. Continued approval is contingent on confirmatory trials; coverage here is limited to the FDA‑approved indication and uses supported per the policy.

Site of Care

Note
Site of care not specified
The policy does not specify an infusion center or site‑of‑care requirement.