WHA

TIVDAK (tisotumab vedotin-tftv)

Office-Administered (intravenous)

 

Diagnosis considered for coverage:

 

  • Cervical Cancer – Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

 

Coverage Criteria:

 

For diagnosis of cervical cancer:
 

  • Dose does not exceed 2 mg/kg (up to a maximum of 200 mg for patients 100 kg or more); AND
  • Patient is 18 years of age or older; AND
  • Prescribed by or in consultation with an oncologist; AND
  • Disease is classified as recurrent or metastatic; AND
  • Disease has progressed on or after chemotherapy.

 

Reauthorization Criteria:

 

For diagnosis of cervical cancer:
 

  • Dose does not exceed 2 mg/kg (up to a maximum of 200 mg for patients 100 kg or more); AND
  • Patient does not show evidence of progressive disease while on therapy.

 

Coverage Duration:

 

  • Initial: 1 year
  • Reauthorization: 1 year

 

Authorization is not covered for the following:

 

  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:

 

  • Tivdak (tisotumab vedotin-tftv), a first-in-class tissue factor (TF)-directed antibody drug conjugate (ADC) for cervical cancer, was FDA-approved in September 2021 via accelerated approval and received a priority review designation.
  • NCCN guidelines for cervical cancer (version 1.2022; October 2021) make the following recommendations for the treatment of recurrent or metastatic cervical cancer (NCCN 2021):
    • For first-line treatment, cisplatin or carboplatin (both category 2A) are listed as preferred therapies. Several category 1 combination regimens that include pembrolizumab (for programmed death ligand 1 [PD-L1]-positive tumors), bevacizumab, and cisplatin/carboplatin, are also recommended.
    • For second-line treatment: there are several category 2B-rated agents listed as “other recommended regimens,” such as bevacizumab, albumin-bound paclitaxel, docetaxel, fluorouracil, gemcitabine, ifofosfamide, irinotecan, mitomycin, pemetrexed, topotecan, and vinorelbine. The only category 2A agent recommended in this group of “other recommended regimens” is tisotumab (Tivdak).
  • In clinical trials, Tivdak caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct an ophthalmic exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care before, during, and after infusion. Withhold Tivdak until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

 

Policy Updates:

 

02/15/2022 – New policy approved by P&T.

 

References:

 

  1. Coleman RL, Lorusso D, Gennigens C, et al. 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;22:609-619.
  2. Food and Drug Administration. FDA News Release: FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer | FDA. Accessed November 6, 2021.
  3. Food and Drug Administration. Tivdak multi-discipline review. Review (fda.gov). March 2021. Accessed November 10, 2021.
  4. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Cervical cancer, version 1.2022 – October 26, 2021. NCCN Web site. cervical_blocks.pdf (nccn.org). Accessed November 6, 2021.
  5. Tivdak [package insert], Bothell, WA: Seagen Inc; September 2021.

Last review date: February 15, 2022