Patient NHS No



[pic]

Notification for the use of BOTULINUM TOXIN A, in accordance with Locally Agreed Protocol, issued September 2009

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 hertsdrugrequests@

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: |      |Consultant Making Request: |      |GP code / Practice code: |      |

|Patient initials |      |ENHCCG |GP Post code: |      |

|& Dob: |     /     /      |Herts Valleys CCG | | |

|Botulinum Toxin injection is routinely funded for the following indications: - |Please tick to confirm indication and adherence to the |

| |policy requirement |

|Severe blepharospasm in adults (treatment will be funded no more frequently than 3 monthly) | |

|Hemifacial spasm in adults (treatment will be funded no more frequently than 3 monthly) | |

|Laryngeal dystonia (treatment will be funded no more frequently than 3 monthly) | |

|Cervical dystonia in adults (treatment will be funded no more frequently than every 10 weeks) | |

|Chronic anal fissures in adults only after topical diltiazem and GTN have been unsuccessful in healing chronic anal fissures and when surgery would be the next | |

|treatment option. | |

|Drug Tried | |

|Date Started | |

|Date Stopped | |

| | |

|Glyceryl trinitrate topical | |

|      | |

|      | |

| | |

|Diltiazem topical | |

|      | |

|      | |

| | |

|Severe axillary hyperhidrosis in adults – under specialist supervision only – after other medical treatments including antiperspirants and anticholinergics have | |

|been unsuccessful / contra-indicated and where surgical intervention would be the next treatment option. (treatment will be funded no more frequently than every 16| |

|weeks) | |

|Treatments Tried | |

|Tried? | |

|Date Stopped/Ongoing | |

| | |

|Antiperspirants | |

|Y / N | |

|      | |

| | |

|Anticholinergics | |

|Y / N | |

|      | |

| | |

|Other treatments tried       | |

| | |

|Frey’s syndrome | |

|Achalasia - in patients at high risk of perforation with pneumatic dilatation treatment. (treatment will be funded no more frequently than 3 monthly) | |

|NB. Separate proformas are available to be completed for headache prophylaxis in chronic migraine, focal spasticity in adults and over active bladder |

|Brand to be administered |      |Dose to be administered |      |

|What is acquisition cost of drug including VAT (if applicable)? |£       per treatment |

|Activity cost associated with treatment |£       per treatment |

|Planned date of administration |     /     /      |

|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. 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.   |

|I acknowledge and adhere to the cost-effective use of botulinum toxin type A 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):       |If this patient is being jointly managed by a second consultant, please state name here: |

|Signature (electronic signature):       |Name:       |

|Date:      /     /      |Date:       |

| |Signature (or email confirmation) by Trust Chief Pharmacist (or nominated deputy) |

| |Name:       |

| |Signature:       Date:      /     /      |

Botulinum Toxin A Policy September 2009

|Indication |Evidence |Policy |

|Severe blepharospasm in adults |Cochrane review |Approved for severe blepharospasm |

| |No high quality, randomised, controlled efficacy data to | |

| |support use but other studies suggest highly effective. | |

|Hemifacial spasm in adults |Cochrane review |Approved for use |

| |Safe and effective treatment. | |

|Laryngeal dystonia |Cochrane Review. Considered gold standard treatment and |Approved for use |

| |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 adults |Cochrane review |Approved for use |

|(repetitive contraction of the |Single injection is safe and effective. | |

|neck muscles) | | |

|Chronic anal fissure in adults |Cochrane review |Approved for use only after topical diltiazem and GTN |

| |No more effective than GTN and less effective than surgery|have been unsuccessful in healing chronic anal |

| |(although reduced risk of incontinence). Alternative to |fissures and when surgery would be the next treatment |

| |topical nitrates without headaches, but is invasive and |option. |

| |expensive. | |

|Severe axillary hyperhidrosis in |Prodigy guidelines. American Academy of Neurology – Good |Under specialist supervision only - Approved for |

|adults |evidence that it is safe and effective for the treatment |severe axillary hyperhidrosis after other medical |

| |of axillary hyperhidrosis. |treatments including antiperspirants and |

| |Under specialist supervision only. Bedfordshire and |anticholinergics, have been unsuccessful / |

| |Hertfordshire Priorities Forum7 1st line treatment. |contra-indicated and where surgical intervention would|

| | |be the next treatment option. |

|Frey’s syndrome-facial |Bedfordshire and Hertfordshire Priorities Forum7 draft |Approved for use as a first line treatment for Frey’s |

|hyperhidrosis secondary to |policy: Botox® is recommended as a first line treatment |syndrome and can be used in conjunction with or |

|parotidectomy |for Frey’s syndrome and can be used in conjunction with or|instead of oral anticholinergic medication. |

| |instead of oral anticholinergic medication. | |

|Achalasia |There are three treatments for achalasia, Botulinum, |Approved for use in patients at high risk of |

| |pneumatic dilatation and surgery. Evidence as per the |perforation with pneumatic dilatation treatment. |

| |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. | |

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



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



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. [?] 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.”

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download