Last Review Date: 10/02/2025

Date of Origin: 10/01/2021

Dates Reviewed: 10/2021, 03/2022, 04/2022, 03/2023, 03/2024, 10/2025

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]:

• 200 billable units (200 mg) every 21 days

3. Initial Approval Criteria ¹

Prior authorization validity 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 of the anterior segment of the eye, and an assessment of normal eye movement) at baseline, prior to every cycle for the first nine cycles, and as clinically indicated; AND

Cervical Cancer † ‡ ^1-5

• Used as subsequent therapy; AND
• Patient has recurrent or metastatic disease; AND
• Patient has adenocarcinoma, adenosquamous, or squamous cell carcinoma histology; AND
  • Used as single agent therapy †; OR
  • Used in combination with pembrolizumab ‡; AND
    • Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; AND
    • Patient is immuno-oncology therapy naïve

Vaginal Cancer ‡ ^2-4

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

v If confirmed using an FDA-approved assay – http://www.fda.gov/companiondiagnostics

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

4. Renewal Criteria ¹

Prior authorization validity 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 ^1,3,5

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; April 2024. Accessed September 2025.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) tisotumab vedotin. 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 September 2025.
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.
4. Vergote I, Gonzalez-Martin A, Fujiwara K, et al. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med 2024; 391:44-45. doi: 10.1056/NEJMoa2313811. PMID: 38959480.
5. Vergote I, Van Nieuwenhuysen E, O'Cearbhaill RE, et al. Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. J Clin Oncol 2023;41:5536-5549. doi: 10.1200/JCO.23.00720.

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

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