3 The technology
3.1 Topotecan (Hycamtin, GlaxoSmithKline) acts by inhibiting topoisomerase I, an enzyme that is required for DNA replication, leading to cell death. Topotecan is indicated as monotherapy for patients with relapsed small-cell lung cancer for whom re-treatment with the first-line regimen is not considered appropriate. The marketing authorisation for this indication was granted by the European Medicines Agency (EMEA) in 2006 for intravenous therapy, and an extension to the marketing authorisation was granted in 2008 for oral capsules.
3.2 Adverse effects commonly associated with topotecan include nausea, vomiting, neutropenia, leukopenia, anaemia, fatigue and alopecia. Topotecan is not recommended in patients with severe renal or hepatic impairment. For full details of adverse effects and contraindications, see the summary of product characteristics.
3.3 The acquisition cost for intravenous topotecan is £97.65 for a 1-mg vial or £290.62 for a 4-mg vial and for oral topotecan is £30 per 1 mg capsule (excluding VAT, 'British national formulary' [BNF] edition 58). The recommended dose of intravenous topotecan is 1.5 mg/m2 body surface area on 5 consecutive days with a 21-day interval between the start of each course. Oral topotecan is administered at 2.3 mg/m2 on 5 consecutive days with a 21-day interval between the start of each course. Assuming a body surface area of 1.8 m2, the cost per cycle is £1495 for intravenous topotecan and £638 for oral topotecan. Patients in the key clinical trials received intravenous topotecan and oral topotecan for approximately 4 cycles, equating to an average treatment cost per patient of £5980 for intravenous topotecan and £2552 for oral topotecan. Costs may vary in different settings because of negotiated procurement discounts.