Last Review Date: 03/05/2024

Date of Origin: 10/01/2021

Dates Reviewed: 10/2021, 03/2022, 04/2022, 03/2023, 03/2024

1. Length of Authorization

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

2. Dosing Limits

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

• Tivdak 40 mg single-dose vial: 5 vials every 21 days 

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

• 200 billable units (200 mg) 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 ^1,2

• Patient has had an ophthalmic exam (i.e., visual acuity and slit lamp exam) at baseline, prior to each dose, and as clinically indicated; AND
• Used as single agent therapy; AND

Cervical Cancer † ‡ ^1-3

• Used as subsequent therapy; AND
• Patient has recurrent or metastatic disease; AND
• Patient has adenocarcinoma, adenosquamous, or squamous cell carcinoma histology

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

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the 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: peripheral neuropathy, hemorrhage, persistent or recurrent grade 2 or greater pneumonitis, ocular adverse reactions (e.g., conjunctival adverse reactions, dry eye, corneal adverse reactions, blepharitis, ulcerative keratitis, etc.), severe cutaneous adverse reactions including Stevens-Johnson Syndrome (SJS), etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9273 – Injection, tisotumab vedotin-tftv, 1 mg; 1 billable unit = 1 mg

NDC:

• Tivdak 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution: 51144-0003-xx 

7. References

1. Tivdak [package insert]. Bothell, WA; Seagen, Inc; July 2023. Accessed January 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) tisotumab vedotin. 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.
3. Coleman RL, Lorusso D, Gennigens C, et al; innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 May;22(5):609-619. doi: 10.1016/S1470-2045(21)00056-5. Epub 2021 Apr 9.

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