Costing statement: chronic idiopathic constipation - Lubiprostone

Transcription

1 Putting NICE guidance into practice Costing statement: chronic idiopathic constipation - Lubiprostone Implementing the NICE guidance on Lubiprostone for treating chronic idiopathic constipation (TA318) July 2014

2 1 Introduction 1.1 The guidance on Lubiprostone for treating chronic idiopathic constipation (NICE technology appraisal guidance 318) is unlikely to result in a significant change in resource use in the NHS. 1.2 This is because the technology is an additional treatment option, and the cost is not significantly different from that of prucalopride which is currently recommended by NICE at a position in the treatment pathway that is alongside that proposed for lubiprostone. Prucalopride has a UK marketing authorisation for the 'symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. NICE recommends prucalopride as an option for the treatment of chronic constipation only in women for whom treatment with at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and invasive treatment for constipation is being considered. 1.3 Also, based on clinical opinion, no substantial change is expected in the overall number of people receiving treatment with either prucalopride or lubiprostone. 1.4 The guidance states that lubiprostone is recommended as an option for treating chronic idiopathic constipation, that is, for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered. 1.5 If treatment with lubiprostone is not effective after 2 weeks, the person should be re-examined and the benefit of continuing treatment reconsidered. 2 of 6

3 1.6 Lubiprostone should only be prescribed by a clinician with experience of treating chronic idiopathic constipation, who has carefully reviewed the person's previous courses of laxative treatments specified in Services for chronic idiopathic constipation are commissioned by clinical commissioning groups (CCGs). Lubiprostone can be prescribed in primary or secondary care settings. 2 Patient numbers affected 2.1 The prevalence of GP-diagnosed constipation in the UK differs with age and ranges from 4 per 1000 in patients aged years to 52 per 1000 in patients aged over Table 1 shows the prevalence of GP-diagnosed constipation in adults in England and the estimated number of people currently treated with prucalopride. 1 a. Shafe AC, Lee S, Dalrymple JS, et al. (2011) The LUCK study: Laxative usage in patients with GP-diagnosed Constipation in the UK, within the general population and in pregnancy. An epidemiological study using the General Practice Research Database (GPRD). Therap Adv Gastroenterol. 4(6): of 6

4 Table 1 Analysis of patients Details % Number of patients Prevalence of GP diagnosed constipation in England and 570,000 Wales a Proportion of England only a ,500 Proportion treated with laxatives for chronic constipation a ,200 Proportion considered partial or complete non-responders to ,900 cycles of laxatives b Estimated number of partial or complete non-responders to ,500 cycles of laxatives currently receiving prucalopride c a. Shafe AC, Lee S, Dalrymple JS, et al. (2011) The LUCK study: Laxative usage in patients with GP-diagnosed Constipation in the UK, within the general population and in pregnancy. An epidemiological study using the General Practice Research Database (GPRD). Therap Adv Gastroenterol. 4(6): b. Muller-Lissner S, Tack J, Feng Y, et al. (2013) Levels of satisfaction with current chronic constipation treatment options in Europe - an internet survey. Aliment Pharmacol Ther. 37(1): c. Based on clinical opinion. 2.3 Based on clinical opinion, the number of eligible patients (84,900) is unlikely to change. The number of eligible patients currently receiving treatment for chronic idiopathic constipation (25,500) is not expected to increase substantially upon implementation of the guidance, although a small increase is possible. 2.4 Clinical opinion also suggests that upon implementation of the guidance, it is likely there will be an equal proportion of patients receiving treatment with either prucalopride or lubiprostone. 2.5 Based on the manufacturer s submission, lubiprostone may be better tolerated than prucalopride and therefore, more people may switch from prucalopride to lubiprostone following initial treatment. However, because the probability of discontinuation on prucalopride is assumed to be the same as the probability of discontinuation on lubiprostone, the net effect of people switching is expected to be small. 4 of 6

5 3 Resource impact 3.1 Lubiprostone is an alternative treatment option to prucalopride, but with a UK marketing authorisation for use in men as well as women. 3.2 Clinical opinion suggests that prucalopride is commonly used in men (outside of its licensed indication), and therefore no substantial change is expected in the overall number of people receiving treatment at this point of the treatment pathway. 3.3 Table 2 shows the treatment costs of lubiprostone and prucalopride. There is an annual cost saving of approximately 80 if lubiprostone is used as an alternative to prucalopride 2 mg dosage, and an additional cost of 193 if lubiprostone is used as an alternative to prucalopride 1 mg dosage. Approximately 78% of patients currently use the 2 mg prucalopride tablets and 22% use the 1 mg tablets. Table 2 Treatment cost of lubiprostone and prucalopride a Drug name & pack size Dosage Daily cost Lubiprostone 24 micrograms (56- cap pack) b Prucalopride 2 mg (28-tab pack) Prucalopride 1 mg (28-tab pack) micrograms twice daily Annual cost mg daily mg daily a. Prices obtained from the emc Dictionary of Medicines and Devices Browser. Accessed on 19/05/2014. b. After an initial 2 week course of treatment patients are assessed and those people continuing treatment receive the 56-capsule pack at Given that no substantial change is expected in the overall number of people receiving treatment, it is unlikely that implementing this technology will incur significant additional costs (see section 2.3). Also the relatively small differences in treatment costs between 5 of 6

6 lubiprostone and prucalopride means the net effect of switching between the treatments is also likely to be small. 3.5 Being an alternative treatment option to prucalopride for chronic idiopathic constipation, lubiprostone is likely to provide similar savings and benefits 2. These include a potential reduction in the number of people referred to secondary care, requiring more invasive procedures or surgery such as stoma. It may also reduce the number of people presenting for non-elective treatment for acute episodes of obstructions. 4 Conclusion The guidance on lubiprostone is unlikely to have a significant cost impact on the use of NHS resources. This is because lubiprostone is an additional treatment option, and the cost is not significantly different from that of prucalopride, which is currently recommended by NICE at a position in the treatment pathway alongside that proposed for lubiprostone. Organisations are encouraged to review their local prescribing practices and assess costs at that level. 2 Prucalopride for chronic constipation in women Costing template: NICE Technology appraisal of 6