Patient Specific Funding Application Pro-forma for bladder wall injection of Botulinum toxin type A for Overactive Bladder
Syndrome (OAB) in adults
Only fully completed forms will be accepted for consideration
The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team at enhccgdrugrequests@nhs.net
If the patient does not fulfil routine commissioning criteria
 The responsible commissioner will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient
specific funding application form.
 Following a clinical trial, the responsibility for ongoing funding remains with the provider or pharmaceutical company. The commissioner will only fund
treatment that meets the commissioned pathway.
 Applications can be made via the Individual Funding Requests process ONLY where the patient has exceptional clinical circumstances. Please
check the commissioner websites for contact details of the IFR team.
Patient NHS No.
Trust:
GP Name:
Patient Hospital
Number:
Patient initials
Consultant Making
Request:
Dob:
GP code / Practice
code:
GP Post code:
/
/
Initiation criteria
Patient is >18 years of age
Symptom severity (mean number of episodes from
patient completed bladder diary of at least 3
days):
o void episodes per day
Yes/
No
Idiopathic or neuropathic OAB?
Date recorded:
Received and not responded to a trial of lifestyle interventions where
these may have a contributory effect:
o modified high or low fluid intake
Yes/
No/ N/A
o
incontinence episodes per day
o
reduced weight
Yes/
No/
N/A
o
urgency episodes per day
o
reduced caffeine intake
Yes/
No/
N/A
Urodynamic confirmed detrusor overactivity
Yes/
No
Date undertaken
Received and not responded to appropriate
behavioural management programme (e.g.
bladder training - lasting at least 6 weeks)
Yes/
No
Date undertaken
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Willing and able to self-catheterise.
For patients with mixed urinary
incontinence: received and not responded to
pelvic floor muscle training lasting at least 3
months
Patient informed that treatment may be outside of UK marketing authorisation and given informed consent
o
o
Yes/
No/
N/A
Yes/
No/ N/A
Date undertaken
Yes/
No/
N/A
Record of prior pharmacological therapies (refer to page 4 for HMMC recommendations)
Please provide details of previous or current treatment with antimuscarinics, mirabegron and intravaginal oestrogen (in postmenopausal women
with vaginal atrophy only).
Please note that within discontinuation section, the generic term ‘adverse effects’ is unacceptable. Please state intolerance. Inefficacy is
acceptable. State contra-indication if relevant.
Drug name
Drug dose
Drug frequency
Start date if
known
Discontinued?
Yes/
No
Yes/
No
Yes/
No
Yes/
No
Stop
date/duration
Rationale for
discontinuation
Botulinum toxin type A product, dose and costing information – complete section for initiation and retreatment
Botulinum toxin type A product (brand) and dose to be administered
Product (brand):
Dose:
Drug cost to be charged (including VAT)
Activity code and cost to be charged for administration
Code:
Cost:
Retreatment criteria
o
o
In patients meeting initiation criteria to receive treatment, response should be assessed at 3 months following administration.
Patients assessed as having a 50% or greater improvement per day in incontinence episodes or urgency episodes are designated as responders
and are eligible for further doses at least 6 months after the previous dose if required.
Date of previous treatment with botulinum toxin type A
Symptom severity assessed at 3 months following treatment with botulinum toxin type A
o
void episodes per day
o
incontinence episodes per day
o
urgency episodes per day
Date assessed:
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Clinician’s Declaration
I confirm that I have discussed with the patient and that they understand and consent to their personal information being shared with
commissioning organisations and commissioning support organisations for the purposes of funding approval and validation of subsequent invoices. I
have also recorded this discussion in the patient’s notes.
I confirm the risks and benefits of treatment have been fully discussed with the patient and documented.
I confirm that funding approval is subject to initiation and follow up of treatment response being undertaken by a specialist urology team.
I acknowledge and adhere to the cost-effective use of botulinum toxin type A for OAB in accordance with the HMMC recommendations and
believe that within this Trust the above patient would be best managed using the agent as requested above.
Name of consultant (or clinician delegated by consultant):
Signature (electronic signature):
Date:
/
/
If this patient is being jointly managed by a second consultant, please
state name here:
Name:
Date:
Signature (or email confirmation) by Trust Chief Pharmacist (or
nominated deputy)
Name:
Signature:
Date:
/
/
Pharmacy and Medicines Optimisation Team
East & North Herts Clinical Commissioning Group (ENHCCG)
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Hertfordshire Medicines Management Committee recommendations for Bladder wall
injection of Botulinum Toxin Type A for the treatment of OAB in adults
Name: generic
Indication
Botulinum toxin
type A
OAB syndrome
Date decision last
revised
April 2014, update of
November 2012
HMMC
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
 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 (where contributory):
 Lifestyle interventions including:
o modify high or low fluid intake
o reduce weight if patient is overweight
o reduce caffeine.
 Appropriate behavioural management programme (e.g. 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 treatments for overactive bladder, including anti-muscarinic drugs and mirabegron where
not contraindicated, tried for 3 months each.
 In postmenopausal women with vaginal atrophy, intra-vaginal oestrogen for 3 months.
3. Urodynamic confirmed detrusor overactivity.
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 (may not be applicable for patients with MS who may receive
botulinum toxin to help them tolerate catheters and stop bypass around catheters)
6. Been informed that treatment may be outside of UK marketing authorisation for this indication
(where relevant; Botox is licensed for overactive bladder and neurogenic detrusor overactivity) 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 6 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®.
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