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NOTIFICATION

Funding Application for use of BOTULINUM TOXIN A, in accordance with Locally Agreed Protocol, issued September 2009
Patient NHS No. Trust: GP Name:

Patient Hospital No. Consultant Making GP code / Practice
Request: code:
Patient initials & DoB: Consultant Contact GP Post code:
Details:
NHS Bedfordshire has agreed to fund the use of Botulinum Toxin for the following indications: - Please tick to confirm Please ensure this form is countersigned by Trust Chief
indication and adherence Pharmacist (or deputy) before onward transmission to PCT.
to the policy requirement.
1. Severe Blepharospasm in adults Only fully completed forms will be accepted by NHS
Bedfordshire for consideration.
2. Hemifacial spasm in adults
If the patient is to be treated with Botulinum toxin A for any
other indication, then a full Individual Cases Panel form
3. Laryngeal dystonia will need to be completed and these may be obtained
from the Individual Cases Panel Co-ordinator, NHS
4. Cervical dystonia in adults Bedfordshire, e-mail: drugsbeds.notify@nhs.net Secure
Fax: 01234 409431, Gilbert Hitchcock House, 21 Kimbolton
5. Chronic anal fissures in adults only after topical diltiazem and GTN have been Road, Bedford, MK40 2AW.
unsuccessful in healing chronic anal fissures and when surgery would be the next
treatment option. NHS Luton, Sam Newbury, Individual Case Panel Co-
ordinator, NHS Luton (samantha.newbury@nhs.net) ;
6. Severe axillary hyperhidrosis in adults – under specialist supervision only – after other Secure Fax: 01582 521036, Nightingale House, 94
medical treatments including antiperspirants, anticholinergics, venlafaxine have been Inkerman Street, Luton, Beds, LU1 1JD
unsuccessful / contra-indicated and where surgical intervention would be the next
treatment option.
7. Frey’s syndrome For PCT use only
8. Lower limb treatment in paediatric cerebral palsy in conjunction with physiotherapy
PCT Identifier
under a care management plan.
9. Overactive bladder in adults – when other treatments have been unsuccessful or
contra-indicated and the next treatment option would be surgery. Patients should be
informed about the lack of long-term data. Women should be willing and able to self-
catheterise where applicable in line with NICE guidance.
10. Achalasia - in patients at high risk of perforation with pneumatic dilatation treatment.

What is acquisition cost of drug including VAT (if applicable)?
£……………..…/month
Give cost/ code of activity associated with treatment?
Trust contact e-mail in case of PCT query:

Consultant Signature (electronic signature acceptable) Trust Chief Pharmacist (or deputy) signature (electronic signature acceptable)

Botulinum Toxin A Policy September 2009

The following policy was recommended by the Bedfordshire and Luton Joint Prescribing Committee.

Indication Evidence Policy
Severe Cochrane review Approved for severe
blepharospasm in No high quality, randomised, blepharospasm
adults controlled efficacy data to support use
but other studies suggest highly
effective.
Hemifacial spasm in Cochrane review Approved for use
adults Safe and effective treatment.
Laryngeal dystonia Cochrane Review. Considered gold Approved for use
standard treatment and treatment of
choice. However, evidence is
suboptimal as lower quality studies.
One small prospective RCT found
improvement in voice function in
patients with adductor spasmodic
dysphonia.
Cervical dystonia in Cochrane review Approved for use
adults (repetitive Single injection is safe and effective.
contraction of the
neck muscles)
Mechanical neck Cochrane review Not approved.
disorders No better than saline
Chronic anal fissure Cochrane review Approve for use only after
in adults No more effective than GTN and less topical diltiazem and GTN have
effective than surgery (although been unsuccessful in healing
reduced risk of incontinence). chronic anal fissures and when
Alternative to topical nitrates without surgery would be the next
headaches, but is invasive and treatment option.
expensive.
Severe axillary Prodigy guidelines. American Under specialist supervision
hyperhidrosis in Academy of Neurology – Good only - Approved for severe
adults evidence that it is safe and effective axillary hyperhidrosis after other
for the treatment of axillary medical treatments including
hyperhidrosis. antiperspirants, anticholinergics,
Under specialist supervision only. venlafaxine have been
Bedfordshire and Hertfordshire unsuccessful / contra-indicated
Priorities Forum7 1st line treatment. and where surgical intervention
would be the next treatment
option.
Arm spasticity in SMC does not recommend as small Not approved in line with SMC
conjunction with patient numbers in clinical studies and recommendations due to small
physiotherapy the benefits modest. The economic patient numbers in clinical
case was not demonstrated. studies with modest benefits.
The economic case was not
demonstrated.

NHS Luton: This form should be returned to Sam Newbury, the Individual Case Panel Co-ordinator, NHS Luton (Samantha.newbury@nhs.net [secure fax:
01582 521036], Nightingale House, 94 Inkerman Street, Luton, Beds, LU1 1JD.) NHS Bedfordshire This form should be returned to Christine Garrett, Individual
Cases Panel Co-ordinator, NHS Bedfordshire, e-mail: drugsbeds.notify@nhs.net Secure Fax: 01234 409431, Gilbert Hitchcock House, 21 Kimbolton Road,
Bedford, MK40 2AW 6160923f-f135-49f0-830f-16f5c450f2e5.doc
Indication Evidence Policy
Hidradenitis One case reported in 2005 showed Not approved as lack of robust
suppurative benefit which lasted 10 months. Usual evidence and cost-effectiveness
management of hidradenitis suppurative data.
is antibiotics, steroids,
immunosuppressants, surgery. A review
of Hidradenitis suppurativa was published
in the British Journal of Surgery in April
2009 [vol 96 (4) p350-360; Buimer M.G.,
Wobbes T. et al], did not mention use of
botulinum toxin.
http://www3.interscience.wiley.com/cgi-
bin/fulltext/122256011/PDFSTART?CRETRY=
1&SRETRY=0
Frey’s syndrome- Bedfordshire and Hertfordshire Approved for use as a first line
facial hyperhidrosis Priorities Forum7 draft policy: Botox® treatment for Frey’s syndrome
secondary to is recommended as a first line and can be used in conjunction
parotidectomy treatment for Frey’s syndrome and with or instead of oral
can be used in conjunction with or anticholinergic medication.
instead of oral anticholinergic
medication.
Lower limb Cochrane review Approve for lower limb treatment
treatment in Evidence base for lower limb use is in paediatric cerebral palsy in
paediatric cerebral stronger than for upper limb, although conjunction with physiotherapy
palsy1 still limited. under a care management plan.
Local audit data suggests it is a safe
option and delays amount of surgery
required in that child’s life and delays
need for Achilles tendon and
hamstring lengthening.
Focal spasticity Cochrane – under review Not approved in line with SMC
associated with SMC did not recommend In May recommendations and HMMC
stroke in adults 2004. Botox® produces a localised Nov 07.
reduction in muscle tone in patients
with post-stroke hand and wrist
spasticity and improves disability at
least up to 12 weeks. However, there
is very little direct evidence of cost –
effectiveness of this approach.
Overactive bladder NICE guideline recommends this for Approved for use where other
in adults women who have not responded to treatments have been
conservative treatments and who are unsuccessful or contra-indicated
willing and able to self-catheterise. In and the next treatment option
use at the L&D for around 7 years for would be surgery. Patients
this indication and found to be of should be informed about the
benefit. lack of long-term data. Women
should be willing and able to
self-catheterise where applicable
in line with NICE guidance.

3
Indication Evidence Policy
Achalasia There are three treatments for Approved for use in patients at
achalasia, Botulinum, pneumatic high risk of perforation with
dilatation and surgery. Evidence as pneumatic dilatation treatment.
per the Cochrane review and the
JAMA review - the treatment is
effective but not long lasting.
Cochrane Review showed sustained
benefits at 6 and 12 months, but
pneumatic dilatation showed greater
benefit with 3 times more patients
sustaining benefit compared to
botulinum. About 10% patients (5%
quoted locally) are at risk of
perforated oesophagus with
pneumatic dilatation. HMMC
recommendation: Low priority for all
patients. Medium priority for patients
at high risk of perforation with
alternative pneumatic dilatation
treatment. – endorsed by JPC.

References
1. Cochrane website, May 2007.
2. Prodigy guidelines, May 2007.
3. NICE guidelines
4 .FDA website. Early Communication about an Ongoing Safety Review Botox and Botox Cosmetic(Botulinum toxin Type A) and Myobloc
(Botulinum toxin Type B). February 8, 2008
http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm
5. MHRA website. Important safety information regarding botulinum toxin products, Botox, Dysport®, Neurobloc®, and Vistabel®: Risk of
serious adverse events due to spread of toxin. June 2007
http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=con2031672&RevisionSelectionMethod=Latest
6. Botulinum Review Paper, prepared by the London and SE Medicines Information Service March 2008.
7. The Use of Botox® Injections for the Treatment of Focal Hyperhidrosis. Bedfordshire and Hertfordshire Priorities Forum.
8. http://www.nice.org.uk/nicemedia/pdf/CG40NICEguideline.pdf The management of urinary incontinence in women, issued October 2006.
 Bladder wall injection with botulinum toxin A should be used in the treatment of idiopathic detrusor overactivity only in women who have not
responded to conservative treatments, and who are willing and able to self-catheterise. Women should be informed about the lack of long-
term data. There should be special arrangements for audit or research. The use of botulinum toxin A for this indication is outside the UK
marketing authorisation for the product. Informed consent to treatment should be obtained and documented.
 Botulinum toxin B is not recommended for the treatment of women with idiopathic OAB.
9. Bedfordshire and Luton Joint Prescribing Committee. Review of the evidence for botulinum toxin A indications. April 2009.

MHRA alert
In July 2007, the MHRA issued a safety alert to UK doctors about the serious adverse events related to the distant spread of botulinum toxin
products. Adverse effects included muscle weakness, dysphagia and aspiration with very rare reports of adverse events with fatal outcome.
Patients with underlying neurological disorders or swallowing difficulties were considered to be at increased risk of these adverse effects and
they should be treated and monitored with extreme caution.

The MHRA made the following recommendations:
• Botulinum toxin products should only be administered by physicians with appropriate experience including use of the required equipment.
• Patients or caregivers should be informed about the risk of spread of toxins and be advised to seek immediate medical care if swallowing,
speech or respiratory disorders arise.
• Botulinum toxin units are not interchangeable from one product to another.
• The recommended administration techniques and specific dosing guidance (including the recommendation to use the minimum effective
dose and titrate according to individual requirements) should be followed.

The letter stated “in the currently approved indications, the benefit-risk ratio is acceptable. In order to minimise the risk of serious reactions due
to spread of effect of toxin, it is essential that the posology, warnings and precautions are strictly followed as stipulated in the Summary of
Product Characteristics (SPCs) for the respective product.”