Last Review Date: 06/04/2024

Date of Origin: 06/04/2024

Dates Reviewed: 06/2024

1. Length of Authorization ¹

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Imdelltra 1 mg powder for injection single-dose vial: 1 vial on day 1 only
• Imdelltra 10 mg powder for injection single-dose vial: 2 vials every 14 days

2. Max Units (per dose and over time) [HCPCS Unit]:
   • Cycle 1:
     • 1 mg on day 1
     • 10 mg on day 8 and 15
   • Cycle 2 and subsequent:
     • 10 mg on day 1 and 15

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient will be closely monitored for signs and symptoms of Cytokine release syndrome (CRS), neurologic toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) during treatment; AND
• Patient does not have a clinically significant active systemic infection; AND
• Patient does not have untreated or symptomatic brain metastases or leptomeningeal disease; AND

Small Cell Lung Cancer (SCLC) † Ф ^1-4

• Patient has extensive stage disease (ES-SCLC); AND
• Used as subsequent therapy following disease progression on or after platinum-based chemotherapy

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe cytopenias, severe infections, severe hepatotoxicity, severe hypersensitivity, etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – not otherwise classified, antineoplastic drugs

NDC(s):

• Imdelltra 1 mg powder for injection single-dose vial: 55513-0059-xx
• Imdelltra 10 mg powder for injection single-dose vial: 55513-0077-xx

7. References

1. Imdelltra [package insert]. Thousand Oaks, CA; Amgen, Inc; May 2024. Accessed May 2024.
2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) tarlatamab. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed May 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Small Cell Lung Cancer. Version 2.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2024.
4. Ahn MJ, Cho BC, Felip E, et al; DeLLphi-301 Investigators. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 30;389(22):2063-2075. doi: 10.1056/NEJMoa2307980. Epub 2023 Oct 20.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A