2001/16 NICE issues guidance on gemcitabine for pancreatic cancer

Press release

NICE 2001/ 016 Issued: 8 May 2001

The National Institute for Clinical Excellence has today issued the following guidance on the drug gemcitabine for pancreatic cancer:

• Gemcitabine may be offered as first line chemotherapy to patients with advanced pancreatic cancer, if they have a Karnofsky performance score of 50 or more (Karnofsky is a measure given by a health professional to a patient's ability to perform certain ordinary tasks)
• Patients who are suitable for curative surgery or who have a Karnofsky performance score of less than fifty should not be offered gemcitabine.
• There is insufficient evidence to support the use of gemcitabine as a second line treatment for patients with pancreatic cancer.

Andrew Dillon, (NICE Chief Executive and Executive Lead for this appraisal) said: "Pancreatic cancer is fairly common affecting over 5000 people a year, it can severely affect a patient's quality of life, and outcomes are generally poor. Gemcitabine is a clinically and cost effective way to offer patients additional months of life, and I am very pleased to be issuing this guidance today."

Notes for Editors

Background

1. Pancreatic cancer (pancreatic adenocarcinoma) is a common cancer affecting around 12 people in every per 100,000 each year. In 1997 an estimated 5,730 people (2,740 men and 2,990 women) were diagnosed with pancreatic cancer in England and Wales. Of these 75% were over 65 years of age. Survival rates are generally poor, 12% of people who are diagnosed with pancreatic cancer survive one year after diagnosis, and about 3% survive for 5 years.

2. The symptoms of pancreatic cancer include jaundice, nausea, diarrhoea, weight loss, loss of appetite and severe abdominal pain. These symptoms can severely reduce a patient's quality of life.

3. Treatment of pancreatic cancer can include potentially curative surgery. About 4% of patients will be suitable for this treatment. However, because pancreatic cancer is not usually diagnosed until it is quite advanced, most patients can only be offered palliative care. In some circumstances a palliative surgical procedure may be carried out to relieve jaundice caused by the cancer blocking the bile ducts. This can improve the patient's quality of life.

4. Other treatments may include chemotherapy and radiotherapy to reduce the size of the cancer. Currently about 10% to 15% of patients receive chemotherapy for pancreatic cancer.

The Technology

5. Gemcitabine (Gemzar) is a chemotherapy treatment that is toxic to cancer cells. It works by preventing a part of the cancer cell replicating itself. The side effects of gemcitabine are fairly mild, but may include rashes and nausea.

Implications for the NHS

6. Of 6,000 patients diagnosed with pancreatic cancer each year, at least 80% of them (4,800 patients) are estimated to have locally advanced or metastatic disease. Assuming that 25-35% of those will be offered chemotherapy and only half of them are treated, the total number of patients on gemcitabine would be in the range of 600 to 840 patients per year.

7. The cost of gemcitabine treatment ranges between £1,360 and £3,550 per patient. If gemcitabine were to be made available for routine NHS use, based on the estimated number of eligible patients above, the total additional cost to the NHS is estimated to be between £816,000 and £3m per annum. This includes the direct costs to the NHS such as drug costs and utilisation of health services.

General Information

8. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from Tuesday 8th May 2001.

9. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance 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.

10. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.

11. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.

12. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.