Download • May be considered as a treatment option in patients who fulfill the

HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE
BOTULINUM TOXIN TYPE A FOR OVERACTIVE BLADDER (OAB) IN ADULTS RECOMMENDED for RESTRICTED USE
Name: generic
Indication
Botulinum toxin
type A
OAB syndrome
Date Decision last
revised
November 2012
Decision
Status
Final
NICE / SMC Guidance
NICE Clinical Guidelines - recommended for
restricted use
SMC - None
HMMC Recommendation: Bladder wall injection of botulinum toxin type A is RECOMMENDED
for RESTRICTED USE for the treatment of OAB in adults:
• Treatment should only be administered in appropriate settings by physicians with
appropriate qualifications, training, expertise and competence in the treatment including the
required injection technique and equipment.
• Requesting specialists to complete a funding application pro-forma for each patient (available
at http://www.hertfordshire.nhs.uk/pharmacy/index.php/commissioningcontracting-high-cost-drugs ).
• May be considered as a treatment option in patients who fulfill the following
eligibility and continuation criteria:
1. Received and not responded to a trial of conservative management:
• Lifestyle interventions including:
o modify high or low fluid intake
o reduce weight
o reduce caffeine.
• Appropriate behavioural management programme (eg bladder training - lasting at least 6 weeks).
• For patients with mixed urinary incontinence – pelvic floor muscle training lasting at least 3 months.
2. Received and not responded to drug trials of (unless contra-indicated or not tolerated):
• At least 3 anti-muscarinic drugs tried for 3 months each.
• In postmenopausal women with vaginal atrophy intra-vaginal oestrogen for 3 months.
3. Urodynamic confirmed detrusor over activity.
4. Symptom severity of (mean from patient completed bladder diary of at least 3 days):
• 8 or more frequency episodes per day and
• 6 or more incontinence episodes per day and/or
• 8 or more urgency episodes per day.
5. Willing and able to self-catheterise.
6. Been informed that treatment may be outside of UK marketing authorisation for this indication
(where relevant) and given informed consent to treatment (which should be documented).
7. Continuation criteria assessed at 3 months following treatment of:
• a 50% or greater improvement in incontinence episodes or urgency episodes per day.
8. Repeat injections to be given no less than 10 months following previous injection.
• Requesting specialists to complete the relevant retreatment section of the funding application proforma for each patient.
In accordance with the business case the expected doses to be administered per treatment are
as follows:
• 300 units (for idiopathic) to 500 units (neurogenic) for Dysport®.
• 100-150 units (for idiopathic) to 200 units (neurogenic) for Botox®.
HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE
Assessment against Ethical Framework
EFFICACY
•Evidence from mainly small, short term trials
demonstrate that botulinum toxin injected into the
bladder wall appears to be effective for improving
OAB symptoms (reduced frequency, urgency and
incontinence episodes) compared to placebo.
•Lack of long term efficacy information and limited
information on repeat injections.
COST
•Total costs per administration including drug and
activity costs is £450-£900.
•Cost effectiveness is uncertain.
SAFETY
•Main adverse events are UTIs and urinary
retention requiring catheterisation.
•Lack of long term safety information.
PATIENT FACTORS
Evidence of Clinical Effectiveness
• From the evidence available from mainly small, short term trials botulinum toxin injected into the bladder wall appears to
be effective for improving OAB symptoms (reductions in frequency, urgency and incontinence episodes) compared to
placebo. The clinical significance of some of the improvements seen is uncertain.
• A recent study in 240 women with OAB symptoms and detrusor overactivity refractory to drug treatment reported the
following statistically significant outcomes for botulinum toxin treated patients compared to placebo (at 6 months): median
per 24 hours of: 1.34 less voids; 4.33 less incontinence episodes; 2.5 less urgency episodes.
• Lack of long term efficacy and safety information and limited information on repeat injections.
• Uncertainty with regards to the optimal dose and injection technique.
• Limited direct head to head comparisons with alternative treatment options.
• Main adverse events are UTIs and urinary retention requiring catheterisation.
Cost of treatment and Cost Effectiveness
• Total costs per administration including drug and activity cost is £450-£900.
• Cost effectiveness is uncertain.
• Estimated annual costs for Hertfordshire by year 4 (treating 30 new patients per year and administering repeat injections
(when needed) to responders) - £38,000-£48,000.
The Needs of the population
• There are limited treatment options for patients with severe symptoms not responding to behavioural/lifestyle
interventions and drug treatment. These include invasive surgical interventions. This need is for a small group of patients
i.e. up to 30 (on the basis of the figures in the business case).
The Needs of the community
• The needs of the community are small as this will benefit a very small proportion of the population. However, the
opportunity costs by year 4 will be significant which would create a cost pressure which may have an impact on the local
health economy which already has to identify savings.
• The Consultant Urological Surgeon applicants supported recommendations to review patients prescribed dutasteride for
BPH for a change to finasteride as a saving area.
Equity
• NHS- Cambridgeshire and Peterborough – not recommended until its place in therapy has been defined as part of a
complete treatment pathway for OAB drugs.
• NHS Suffolk – recommended for restricted use.
Policy Drivers
• NICE Clinical Guidelines only – recommended for restricted use (see links to guidelines below).
Implementability
• No issues anticipated.
Selected References (all references available in HMMC application papers)
• East of England Priorities Advisory Committee New Medicine Review – Botulinum toxin A for overactive bladder. January 2012 (draft)
• Price et al, February 2011. NHS Evidence – women’s health; Urinary Incontinence Evidence Update. http://www.evidence.nhs.uk/
• Duthie, J. et al. 2011. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane database of systematic reviews (Online).
Available at: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005493.pub3/abstract
• NICE, 2006. Urinary incontinence: The management of urinary incontinence in women (NICE Clinical Guideline 40)
http://www.nice.org.uk/nicemedia/live/10996/30282/30282.pdf
• NICE, 2010. Lower urinary tract symptoms: The management of lower urinary tract symptoms in men (NICE Clinical Guideline 97)
http://guidance.nice.org.uk/CG97/NICEGuidance/pdf/English
• NICE 2012. CG148. Urinary incontinence in neurological disease (NICE Clinical Guideline 148) http://guidance.nice.org.uk/CG148
• Tincello et al, 2012. Botulinum Toxin A Versus Placebo for Refractory Detrusor Overactivity in Women: A Randomised Blinded Placebo-Controlled Trial
of 240 Women (the RELAX Study). European Urology, Volume 62, Issue 3, September 2012, Pages 507–514
http://www.sciencedirect.com/science/article/pii/S0302283811014412