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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)




   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 356e2fdb-c4b8-4015-b240-bb4db0e01f59.doc
                                                 NOTIFICATION


                             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 356e2fdb-c4b8-4015-b240-bb4db0e01f59.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.”




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