SCOTTISH MEDICINES CONSORTIUM

NHS SCOTLAND

Providing advice about the status of all newly licensed medicines

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401 07 capecitabine 150mg and 500mg tablets (Xeloda)

The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:

Capecitabine (Xeloda) for first line treatment of patients with advanced gastric cancer in combination with a platinum-based chemotherapy regimen.

Further Details:

CAPECITABINE (XELODA)

Capecitabine (Xeloda) is accepted for first line treatment of patients with advanced gastric cancer in combination with a platinum-based chemotherapy regimen.
Capecitabine was non-inferior to continuously infused intravenous 5-FU in terms of progression-free survival when each was used in combination with a platinum-based drug in patients with advanced gastric cancer. It also demonstrated non-inferiority in overall survival compared with continuously infused intravenous 5-FU in patients with advanced gastric cancer when each was used in a triple regimen containing a platinum-based drug and an anthracycline drug.
Capecitabine is more expensive than 5-FU, however, the convenience of oral administration may allow changes to service delivery that have individual patient or organisational benefits.
The manufacturer estimated that the direct drug cost of oral capecitabine would be £32k in year 1 for 100 patients, rising to £169k in year 5 for 367 patients. The manufacturer estimated savings due to reduced administration costs which resulted in a net saving of £58k in year 1 and £303k in year 5.

Notes for editors – Glossary:

1. Gastric cancer - Also called stomach cancer. It can develop in any part of the stomach and may spread throughout the stomach and to other organs; particularly the oesophagus and the small intestine. Stomach cancer causes nearly one million deaths worldwide per year.

2. Anthracycline - A class of chemotherapeutic agents used to treat a wide range of cancers.

Notes for editors – About SMC:

1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).

2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.

3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.

4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

For further information, contact Stephen Ferguson on 07779 329 689 or Colin McAllister on 07813 095930

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