Last Review Date: 08/05/2025

Date of Origin: 03/04/2025

Dates Reviewed: 03/2025, 08/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for 6 months.
• Renewal: Prior authorization validity may be renewed every 6 months thereafter.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• 600 billable units every 21 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient does not have a history of interstitial lung disease (ILD)/pneumonitis requiring treatment with steroids or the presence of ongoing symptomatic ILD/pneumonitis; AND
• Patient does not have the presence of clinically significant corneal disease; AND
• Patient does not have active untreated brain metastases; AND
• Patient will have an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy best corrected visual acuity (BCVA) conducted at baseline and periodically during treatment; AND
• Patient has not previously received or will not be used concomitantly with other TROP2- (i.e., sacituzumab govitecan, etc.) or topoisomerase-I- (i.e., topotecan, irinotecan, etc.) targeted therapies; AND
• Used as a single agent; AND

Breast Cancer † ¹

• Patient has human epidermal growth factor receptor 2 (HER2)-negative disease*; AND
• Patient has hormone receptor (HR)- positive disease; AND
• Patient has unresectable or metastatic disease; AND
• Patient has progressed on and is not suitable for continued endocrine therapy; AND
• Patient has been treated with chemotherapy in the unresectable or metastatic disease setting

Non-Small Cell Lung Cancer (NSCLC) † ‡ ^1,8,9

• Patient has EGFR-mutated disease as detected by an FDA-approved or CLIA compliant testv; AND
• Patient has recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
• Used as subsequent therapy; AND
  • Patient has EGFR exon 19 deletion or L858R and nonsquamous cell histology; OR
  • Patient has received prior EGFR-directed therapy and platinum-based chemotherapy

v If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

† 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 the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: interstitial lung disease (ILD) or pneumonitis, severe ocular adverse reactions (including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, blurred vision), severe stomatitis (including mouth ulcers and oral mucositis), etc.; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• C9174 – Injection, datopotamab deruxtecan-dlnk, 1 mg; 1 billable unit = 1 mg (Discontinue use on 10/01/2025)
• J9999 – Not otherwise classified, antineoplastic drugs (Discontinue use on 10/01/2025)
• J9011 – Injection, datopotamab deruxtecan-dlnk, 1 mg; 1 billable unit = 1 mg (Effective 10/01/2025)

NDC:

• Datroway 100 mg lyophilized powder in a single-dose vial: 65597-0801-xx

7. References

1. Datroway [package insert]. Basking Ridge, NJ; Daiichi Sankyo, Inc.; June 2025. Accessed July 2025.
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer 6.2024. National Comprehensive Cancer Network, 2025. 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 Guidelines, go online to NCCN.org. Accessed January 2025.
3. Bardia A, Jhaveri K, Im SA, et al. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01. JCO 43, 285-296(2025). DOI:10.1200/JCO.24.00920
4. Wolff AC, Somerfield MR, Dowsett M, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: ASCO–College of American Pathologists Guideline Update. JCO 41, 3867-3872(2023). DOI:10.1200/JCO.22.02864
5. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
6. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
7. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for datopotamab deruxtecan-dlnk. National Comprehensive Cancer Network, 2025. 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 July 2025.
9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Small Cell Lung Cancer, Version 7.2025. National Comprehensive Cancer Network, 2025. 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 July 2025.
10. Sands J, Ahn MJ, Lisberg A, et al. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. J Clin Oncol. 2025 Apr;43(10):1254-1265. doi: 10.1200/JCO-24-01349. Epub 2025 Jan 6. PMID: 39761483; PMCID: PMC11949215.
11. Ahn MJ, Tanaka K, Paz-Ares L, et al; TROPION-Lung01 Trial Investigators. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2025 Jan 20;43(3):260-272. doi: 10.1200/JCO-24-01544. Epub 2024 Sep 9. PMID: 39250535; PMCID: PMC11771353.

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