2 The technology

2 The technology

Description of the technology

Trifluridine–tipiracil (Lonsurf, Servier Laboratories) combines 2 drugs: a nucleoside analogue (trifluridine) and a thymidine phosphorylase inhibitor (tipiracil). Trifluridine is taken into the DNA of tumour cells and inhibits tumour growth. Tipiracil slows the breakdown of trifluridine to prolong this action.

Marketing authorisation

'The treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF [anti-vascular endothelial growth factor] agents, and anti-EGFR [anti-epidermal growth factor receptor] agents.'

Adverse reactions

The most frequently seen adverse drug reactions are neutropenia, nausea, fatigue, anaemia and leukopenia. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The recommended starting dose of trifluridine–tipiracil in adults is 35 mg/m2/dose administered orally twice daily on days 1 to 5 and days 8 to 12 of each 28‑day cycle for as long as there is a benefit or until there is unacceptable toxicity. Each dose must not exceed 80 mg.

Price

The list price of a 20‑tablet pack of 15 mg trifluridine–tipiracil is £500, and that of 20 mg trifluridine–tipiracil is £667. Each dose is also available in 60‑tablet packs at pro rata prices.

The average cost per patient per cycle of treatment is estimated at £2,032 based on the list price.

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of trifluridine–tipiracil, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)