Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Tivdak (tisotumab vedotin) requires prior authorization.

2)    Tivdak is a specialty drug covered under the medical benefit.

3)    Tivdak is used to treat cervical cancer.

Tivdak (tisotumab vedotin-tftv) is considered medically necessary for members meeting the following criteria:

Cervical Cancer

1)    Diagnosis of cervical cancer; AND

2)    Disease is recurrent or metastatic; AND

3)    Prescribed by or in consultation with an oncologist; AND

4)    Age > 18 years; AND

5)    Member has received no more than two prior systemic regimens in the recurrent or metastatic setting; AND

6)    Failure of single-agent or combination chemotherapy regimen, with or without bevacizumab (e.g., cisplatin/paclitaxel/bevacizumab, cisplatin/paclitaxel, cisplatin alone), unless contraindicated or clinically significant adverse effects are experienced; AND

7)    Documentation of member’s current weight in kilograms; AND

8)    Request meets one of the following (a or b)*:

a.    Dose does not exceed 2mg/kg (up to a maximum dose of 200mg for members > 100kg) every 3 weeks;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Approval Duration: 6 months

Reauthorization (12 months duration)

1)    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Tivdak for a covered indication and has received this medication for at least 30 days; AND

2)    Member is responding positively to therapy; AND

3)    Member is receiving at least 0.9mg/kg every 3 weeks; AND

4)    Documentation of member’s current weight in kilograms; AND

5)    If request is for a dose increase, request meets one of the following (a or b)*:

a.    New dose does not exceed 2mg/kg (up to a maximum dose of 200mg for patients > 100kg) every 3 weeks;

b.    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

*Prescribed regimen must be FDA-approved or recommended by NCCN.

1)    Tivdak Prescribing Information. Bothell, WA: Seagen Inc.; September 2021. Available at: https://www.tivdakhcp.com. Accessed October 18, 2021.

2)    A Trial of Tisotumab Vedotin in Cervical Cancer. ClinicalTrials.gov Identifier: NCT03438396. Available at: https://clinicaltrials.gov/ct2/show/NCT03438396. Accessed October 18, 2021.

3)    Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2016. Available at: http://www.clinicalpharmacology-ip.com/.

4)    Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed October 18, 2021/

5)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed June 16, 2010.

6)    Kitagwa R, Katsumata N, Shibata T, et al. Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Cisplatin in Metastatic or Recurrent Cervical Cancer: The Open-Label Randomized Phase III Trial. J Clin Oncol 2015; 33(19)2129-2135.

7)    Tewari KS, Sill MW, Penson RT, et al. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017;390(10103):1654-1663.

8)    Monk BJ, Sill MW, McMeekin DS, et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009;27(28):4649-4655. doi:10.1200/JCO.2009.21.8909.

9)    Redondo A, Colombo N, McCormack M, et al. Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer. Gynecol Oncol. 2020;159(1):142-149. doi:10.1016/j.ygyno.2020.07.026.

10)  Long HJ 3rd, Bundy BN, Grendys EC Jr, et al. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005;23(21):4626-4633.

11)  Rose PG, Ali S, Watkins E, et al. Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007;25(19):2804-2810. doi:10.1200/JCO.2006.09.4532.

12) Weiss GR, Green S, Hannigan EV, et al. A phase II trial of carboplatin for recurrent or metastatic squamous carcinoma of the uterine cervix: a Southwest Oncology Group study. Gynecol Oncol. 1990;39(3):332-336

Addendum:

Effective 01-01-2022: New Policy