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In draft guidance published today (22 October 2010), NICE recommends prucalopride (Resolor, Movetis) as an option for the treatment of chronic constipation in women, in whom laxatives have failed to provide adequate relief.

Prucalopride1 should only be considered for women who have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had relief from constipation, and invasive treatment is being considered. Prucalopride should only be prescribed by a clinician with experience of treating chronic constipation, who has supervised the woman's previous course of laxatives. If treatment with prucalopride is not effective after four weeks, the patient should be re-examined and the benefit of continuing treatment reconsidered.

Constipation is defined as passing abnormally delayed or infrequent dry, hardened faeces (stools), often accompanied by straining and/or pain. People with chronic constipation have no more than two spontaneous complete bowel movements per week, and one or more of the following symptoms, for at least six months:

• straining, lumpy or hard stools
• a sensation of incomplete evacuation

Constipation may be caused by dietary changes, stress, or immobility. It may also be the consequence of an underlying condition. Other known causes of constipation include: not eating enough fibre, not drinking enough fluids, and various medical conditions, such as an underactive thyroid, irritable bowel syndrome, some gut disorders, and conditions that cause poor mobility, particularly in the elderly.

The first step in managing constipation should be appropriate diet and lifestyle changes. If this does not work, laxatives may relieve the symptoms and restore normal bowel function. Prucalopride is recommended for those women with long term constipation, whose condition has not responded to standard laxatives.

Chronic constipation affects on average two to three times as many women as men, with prevalence rates of around 10% in women under 65 years of age in the UK. Rates are often higher (around 20%) in women over 65 years of age.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: "We are pleased to be able to provisionally recommend prucalopride as a clinically and cost effective treatment for women with chronic constipation who have not had adequate relief from at least two prior laxative treatments. The evidence presented to the Appraisal Committee shows prucalopride is a helpful addition in treating women with chronic constipation which has not been managed with standard laxatives."

The draft guidance can be found on the prucalopride web page.

Final guidance is likely to be published in December 2010.

This is not NICE's final guidance on this technology and the recommendations may change should there be an appeal.

Notes to Editors

About the appraisal

• The proposed guidance (final appraisal determination/FAD) is with consultees, who now have the opportunity to appeal.
• View the prucalopride draft guidance for further information.
• If there are no appeals, or an appeal is not upheld, the final recommendations are issued as NICE guidance.
• Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments
• Through the data presented, prucalopride was shown to be clinically effective in providing relief to some patients with chronic constipation. It was also shown that prucalopride was a cost effective use of NHS resources for women with laxative-refractory chronic constipation. The costs of managing chronic constipation in laxative-refractory patients included in the information presented, such as referrals to secondary care, rectal irrigation and surgery could also be reduced by the use of prucalopride.
• Prucalopride is administered orally. The summary of product characteristics (SPC) states that the recommended dose of prucalopride is 2 mg once daily for adult women (up to 65 years old) and 1 mg once daily for older women (over 65 years old). The dose for older women can be increased to 2 mg once daily if needed. If the intake of once daily prucalopride is not effective after four weeks, the patient should be re-examined and the benefit of continuing treatment reconsidered.
• The SPC reports that the most common adverse effects that may be associated with prucalopride treatment include headache and gastrointestinal symptoms (abdominal pain, nausea or diarrhoea). Most adverse effects occur at the start of treatment and usually subside within a few days of continued treatment.
• Prucalopride is available in 1mg and 2mg tablets. The acquisition cost of prucalopride 1 mg is £38.69 for a pack of 28 tablets. The acquisition cost of prucalopride 2mg is £59.52 for a pack of 28 tablets (excluding VAT; British National Formulary BNF, 60th edition). The manufacturer estimated that the annual cost of treatment with prucalopride is £622 for adult women and £403 for older women, excluding any monitoring costs, assuming that each patient receives treatment for an average of 220 days each year. Costs may vary in different settings because of negotiated procurement discounts.

About NICE

• The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
• NICE produces guidance in three areas of health:

1. public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.

2. health technologies - guidance on the use of new and existing medicines, treatments, procedures and medical technologies within the NHS.

3. clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.