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TAPublishedNeurological conditions / Urinary incontinence· 2024-09-04
TA999
Vibegron for treating symptoms of overactive bladder syndrome
15 item
Rekomendasi numbered
1.1
Vibegron is recommended as an option for treating the symptoms of overactive bladder syndrome in adults. It is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects.
1.2
If people with the condition and their healthcare professional consider vibegron to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account.
1.3
This recommendation is not intended to affect treatment with vibegron that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop. Why these recommendations were made Usual treatment for symptoms of overactive bladder syndrome is antimuscarinic medicines. If these are not suitable, do not work well enough or have unacceptable side effects, mirabegron is recommended as a treatment option. Vibegron works in a similar way to mirabegron. This evaluation only looked at vibegron for the same people who would be offered mirabegron. Clinical trial evidence shows that vibegron is more effective than placebo for treating the symptoms of overactive bladder syndrome. The evidence is limited because most people in the trial had not had antimuscarinic medicines. But the reduction in symptoms was similar for people who had had antimuscarinic medicines and people who had not. The licensed dose of vibegron (75 mg) has not been directly compared in a clinical trial with mirabegron, but an indirect treatment comparison suggests it is likely to work as well. Cost-comparison results suggest vibegron is likely to be cost saving compared with mirabegron. So, vibegron is recommended. For all evidence see the committee papers . For more information on NICE's evaluation of mirabegron, see the committee discussion section in NICE's technology appraisal guidance on mirabegron for treating symptoms of overactive bladder .
2.1
Vibegron (Obgemsa, Pierre Fabre) is indicated 'in symptomatic treatment of adult patients with overactive bladder (OAB) syndrome'.
2.2
The dosage schedule is available in the summary of product characteristics for vibegron .
2.3
The list price of vibegron is £26.68 per pack of 30 tablets (excluding VAT; company submission July 2024).
3.1
Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication. Because vibegron has been recommended through the cost-comparison process , NHS England and integrated care boards have agreed to provide funding to implement this guidance 30 days after publication.
3.2
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.
3.3
When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has overactive bladder syndrome and the healthcare professional responsible for their care thinks that vibegron is the right treatment, it should be available for use, in line with NICE's recommendations.
1.1
Vibegron is recommended as an option for treating the symptoms of overactive bladder syndrome in adults. It is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects.
1.2
If people with the condition and their healthcare professional consider vibegron to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account.
1.3
This recommendation is not intended to affect treatment with vibegron that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop. Why these recommendations were made Usual treatment for symptoms of overactive bladder syndrome is antimuscarinic medicines. If these are not suitable, do not work well enough or have unacceptable side effects, mirabegron is recommended as a treatment option. Vibegron works in a similar way to mirabegron. This evaluation only looked at vibegron for the same people who would be offered mirabegron. Clinical trial evidence shows that vibegron is more effective than placebo for treating the symptoms of overactive bladder syndrome. The evidence is limited because most people in the trial had not had antimuscarinic medicines. But the reduction in symptoms was similar for people who had had antimuscarinic medicines and people who had not. The licensed dose of vibegron (75 mg) has not been directly compared in a clinical trial with mirabegron, but an indirect treatment comparison suggests it is likely to work as well. Cost-comparison results suggest vibegron is likely to be cost saving compared with mirabegron. So, vibegron is recommended. For all evidence see the committee papers . For more information on NICE's evaluation of mirabegron, see the committee discussion section in NICE's technology appraisal guidance on mirabegron for treating symptoms of overactive bladder .
1.1
Vibegron is recommended as an option for treating the symptoms of overactive bladder syndrome in adults. It is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects.
1.2
If people with the condition and their healthcare professional consider vibegron to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account.
1.3
This recommendation is not intended to affect treatment with vibegron that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop. Why these recommendations were made Usual treatment for symptoms of overactive bladder syndrome is antimuscarinic medicines. If these are not suitable, do not work well enough or have unacceptable side effects, mirabegron is recommended as a treatment option. Vibegron works in a similar way to mirabegron. This evaluation only looked at vibegron for the same people who would be offered mirabegron. Clinical trial evidence shows that vibegron is more effective than placebo for treating the symptoms of overactive bladder syndrome. The evidence is limited because most people in the trial had not had antimuscarinic medicines. But the reduction in symptoms was similar for people who had had antimuscarinic medicines and people who had not. The licensed dose of vibegron (75 mg) has not been directly compared in a clinical trial with mirabegron, but an indirect treatment comparison suggests it is likely to work as well. Cost-comparison results suggest vibegron is likely to be cost saving compared with mirabegron. So, vibegron is recommended. For all evidence see the committee papers . For more information on NICE's evaluation of mirabegron, see the committee discussion section in NICE's technology appraisal guidance on mirabegron for treating symptoms of overactive bladder .