NHS SCOTLAND
Providing advice about the status of all newly licensed medicines
Trastuzumab (Herceptin®) accepted for use by NHSScotland
The Scottish Medicines Consortium (SMC) today (Friday) announced that trastuzumab (Herceptin) will be accepted for use in the treatment of early breast cancer.
SMC has completed its assessment and advised that trastuzumab will be accepted for use in the treatment of HER 2 positive early breast cancer, following surgery, chemotherapy and, if applicable, radiotherapy. To ensure the highest quality of care, trastuzumab should only be prescribed by a breast cancer specialist.
It is estimated that around 300 patients a year will be prescribed trastuzumab in Scotland, at an estimated recurring annual cost of 7.7 million pounds. NHSScotland has advised SMC that this drug will be available to patients from now on, but in some places its safe introduction may first require additional service infrastructure to be put in place, for example, to support the requirement to monitor cardiac function before, during and after treatment. NHSScotland has further advised that this should take a matter of weeks.
(ENDS)
Notes for editors
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 requires pharmaceutical companies to make a submission before a product is launched. The aim is to make a recommendation 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 recommendation 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.
5. Trastuzumab has undergone assessment in line with normal SMC processes and timelines. Publication of the result of the assessment has been brought forward from the planned date of 10 July in order to coincide with publication of draft guidance in England and Wales. For further information regarding the draft guidance for England and Wales from the National Institute for Health and Clinical Excellence (NICE) contact Sarita Tamber on 0207 067 5915 or Lucy Betterton on 0207 067 5903.