APC Recommendations:

JPC Recommendations:

•  The Committee approved the addition of Prucalopride to the Joint Formulary for use in men in accordance with the criteria set out in NICE TA 211 for women.
• Specialist to initiate and GP to continue prescribing.

Key Points:-

• Prucalopride is a selective, high affinity, 5-HT4 receptor agonist with potent enterokinetic activity on gastric, intestinal and colonic smooth muscle.
• It is licensed for the treatment of chronic constipation when other laxatives fail to provide an adequate response.
• Prucalopride was previously licensed for use only in women, due to a lack of supportive data for use in men from clinical trials. The National Institute for Health and Care Excellence (NICE) Technology Appraisal 211 recommends prucalopride as a treatment option in women with chronic constipation who have tried at least two different types of laxatives at the highest possible recommended doses, for at least six months, in whom invasive treatment for constipation is being considered.
• The license extension for use in men was supported by a phase III, randomised, double-blind, placebo-controlled trial conducted in men only. This had a similar design and inclusion criteria as the earlier trials that supported the use of prucalopride in women, and enrolled patients with ≤ two spontaneous complete bowel motions (SCBM) per week for at least six months.
• There are no alternatives available to prucalopride at this stage of treatment as lubiprostone has been withdrawn from the market.
• In the last financial year, 239 patients were prescribed prucalopride in Bedfordshire CCG (total cost £99,900) and 207 patients in Luton CCG (total cost £71,694). A small increase in patient numbers of up to 12% is anticipated if usage is extended to men, although uptake would be gradual and offset by some existing prescribing in male patients.
• All Wales Medicines Strategic Group (AWMSG) recommend prucalopride as an option for use within NHS Wales for the treatment of chronic constipation in men in whom laxatives fail to provide adequate relief. A SPS review conducted in 2015 supports similar efficacy over placebo of prucalopride in men as well as women. The review therefore concludes that prucalopride is a suitable treatment option for men, in the same circumstances as women (as outlined in NICE TA 211).
• Other CCGs such as Somerset CCG, Midlands and Lancashire have since extended the use of prucalopride in men.
• Subsequent studies have confirmed efficacy and safety of prucalopride.
• There was an Equality and Diversity issue if this treatment was not approved by the Committee.

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