Authors' objectives: Tisotumab vedotin (TIVDAK®) is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer after progression on or following systemic therapy. It is an antibody-drug conjugate consisting of a monoclonal antibody directed against tissue factor and a microtubule inhibitor. After binding to tissue factor, which is overexpressed on tumour cells, the complex is internalised, releasing the cytotoxic agent, which inhibits microtubules and leads to cancer cell death. The treatment is administered as an intravenous infusion every three weeks until disease progression or unacceptable toxicity occurs. The European Commission granted marketing authorisation in March 2025, with additional pharmacovigilance requirements.

Authors' recommendations: Tisotumab vedotin can be administered in existing oncology day clinics without major structural changes, but requires interdisciplinary collaboration, particularly between oncology and ophthalmology, for the prevention and management of ocular adverse events.

Authors' methods: The assessment of efficacy and safety is primarily based on the randomised phase 3 study innovaTV 301, supplemented by data from the broader clinical development programme. In innovaTV 301, tisotumab vedotin (n=253) demonstrated a statistically significant overall survival benefit compared with investigator’s choice chemotherapy (n=249), with a hazard ratio of 0.70 (95% CI:0.54-0.89), corresponding to an increase in median overall survival from 9.5 to 11.5 months. In addition, improvements in progression-free survival of approximately 1.3 months and a higher objective response rate were observed. However, no clear improvement in health-related quality of life was demonstrated. Treatment-emergent adverse events occurred frequently in both treatment arms, but grade ≥3 and serious adverse events were less common with tisotumab vedotin. A characteristic feature of the safety profile of tisotumab vedotin is ocular toxicity, which requires close ophthalmological monitoring but is generally manageable. Uncertainties remain regarding the risk of bias and the absence of long-term data, particularly as final safety analyses are still pending and the evidence is largely based on patients with good performance status (ECOG 0–1). In the context of healthcare delivery in Austria, no official pricing or health economic models from the manufacturer are currently available. Therefore, through parallel import, tisotumab vedotin is available at approximately €2,481 per 40 mg vial. Assuming a median treatment duration of five cycles, direct drug costs amount to around €53,849 per patient, with approximately 92% attributable to drug acquisition costs. In comparison, the weighted average cost of current standard therapy (topotecan 70%, gemcitabine 30%) is approximately €17,663 per patient. A budget impact analysis for Austria estimates additional annual costs of around €1.63 million, or €4.89 million over three years, assuming approximately 45 eligible patients per year. However, these estimates are subject to uncertainty regarding patient numbers and price development.

Project Status: Completed

URL for project: https://aihta.at/page/htas-fuer-bewertungsboard/en

Year Published: 2026

URL for published report: https://eprints.aihta.at/1611/1/Appraisal_Board_Document_008.pdf

URL for additional information: https://eprints.aihta.at/1611/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Austria

Organisation Name: Austrian Institute for Health Technology Assessment

Contact Address: Josefstaedter Strasse 39, A-1080 Vienna, Austria

Contact Name: office@aihta.at

Contact Email: office@aihta.at