543 09 cetuximab (Erbitux)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- cetuximab (Erbitux) for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, Kirsten rat sarcoma (KRAS) wild-type metastatic colorectal cancer in combination with chemotherapy (restricted)
Further Details:
CETUXIMAB (ERBITUX)
- Cetuximab (Erbitux) is accepted for restricted use within NHSScotland for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, Kirsten rat sarcoma (KRAS) wild-type metastatic colorectal cancer in combination with chemotherapy.
- Post hoc analyses from one phase III and one phase II study in patients with KRAS wild-type status who had not previously received chemotherapy for metastatic disease, showed an increase in overall response rate and a small, but statistically significant, increase in median progression free survival time, when cetuximab was added to standard first-line combination chemotherapy.
- Cetuximab is restricted to use in patients who have not previously received chemotherapy for their metastatic disease, with liver metastases only that are considered non-resectable but in whom potentially curative liver metastasis resection would be undertaken if the lesions became resectable after treatment with chemotherapy and cetuximab.
- This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of cetuximab. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
- The manufacturer estimated the gross drug budget impact of using cetuximab would be £274k in year one rising to £1.7m in year five. Accounting for additional drug administration costs the manufacturer estimated an overall budget impact of £1.8m in year five. Two hundred and eighteen patients were assumed to be eligible in year one rising to 228 in year five.
Notes for editors – Glossary:
- Metastatic colorectal cancer – A cancer of the large bowel and rectum which has spread to other parts of the body. KRAS is a gene that commonly mutates in 35-45% of colorectal cancer patients. The presence of the KRAS mutation helps to decide appropriate treatment as patients with tumours exhibiting the KRAS mutation do not respond to conventional treatment with epidermal growth factor inhibitors.
- Patient Access Scheme – In March 2009, it was announced that an agreed national framework would be introduced to allow the operation of PAS in NHSScotland. A patient access scheme assessment group (PASAG) will be established to review and advise NHSScotland on the feasibility of proposed schemes for implementation. PASAG will operate separately from SMC in order to maintain the integrity and independence of the assessment process of SMC. At present, a transitional PASAG has been established under the auspices of NHS National Services Scotland to support the development of a national framework for the assessment of PAS.
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.