2015/16 PBR Exclusions - Funding Application for Botulinum Toxin A (Botox®) for prevention of headaches in adults with chronic migraine

(Final version 1: Last updated 01/04/15)

Before providing patient identifiable data on this form, please confirm that the patient (or in the case of a minor or vulnerable adult with the parent/legal guardian/carer) has given appropriate explicit consent for sensitive personal information on this form to be passed to the CCG and/or CSU for processing this funding request and validating subsequent invoices. Consent given: Yes
Patient NHS No. / Trust: / GP Name:
Patient Hospital No:
Patient’s birth year: / (yyyy) / Consultant Making Request: / GP code / Practice code:
Confirm patient status:
(* select 1 option) / NHS Private Overseas / Consultant Contact Details: / GP Post code:

Please indicate whether patient meets the following NICE criteria

/

Please tick

/ Only fully completed forms will be accepted by CCGs/CSUs for consideration.
If the answer to any of these questions is NO, please consider if there are patient specific exceptional clinical circumstances demonstrated. If so, a full individual funding request (IFR) form will need to be completed. This may be obtained from the named contact at the relevant CCG/CSU/Trust. Please refer to the individual CCG IFR policy for further details.
Contact details:
Form completed by:
Email:
Phone:
Date of completion:
Additional information:
1.  Patient is aged 18 years or over? / Yes / No
2.  Patient has chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine) demonstrated by a headache diary.
Baseline headache days per month (≥ 15) Date:
Baseline migraine days per month (≥ 8) Date: / Yes / No
3.  Patient has not responded to at least three prior pharmacological prophylaxis therapies (given at maximum tolerated doses for a minimum of 2-3 months following dose titration*. Where possible discontinuation due to side effects should mean a further oral agent is tried). Please provide details below: / Yes / No
Start date / Stop date / Treatment and final dose / Reason for stopping
4.  Has this patient been assessed for medication overuse and has it been managed appropriately by reducing or stopping use? / Yes / No
5.  What is acquisition cost of drug (including VAT if applicable)? / £/treatment cycle
FOR CCG/CSU USE ONLY
Funding approved for first 2 cycles / Yes / No / Funding will only be re-approved if there is an adequate response after the initial 2 cycles. Treatment with botulinum toxin type A should be stopped in people whose condition:
·  is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles)
OR
·  has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months.
Funding re-approved? (every 2 cycles)
Trust to provide information on number of headache days per month before and after 2 treatment cycles (12 weeks= 1 cycle and period between injections with a maximum expected period of treatment of 2 years) / Yes / No

Botulinum toxin type A for the prevention of headaches in adults with chronic migraine (NICE TA 260: June 2012)

1.1 Botulinum toxin type A is recommended as an option for the prophylaxis of headaches in adults with chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine):

·  that has not responded to at least three prior pharmacological prophylaxis therapies and

·  whose condition is appropriately managed for medication overuse.

1.2 Treatment with botulinum toxin type A that is recommended according to 1.1 should be stopped in people whose condition:

·  is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles) or

·  has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months.

1.3 People currently receiving botulinum toxin type A that is not recommended according to 1.1 and 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop.

2.1 Botulinum toxin type A (Botox, Allergan) is a purified neurotoxin complex, which is derived from the bacterium Clostridium botulinum. It has neuromuscular transmitter blocking effects. It has a UK marketing authorisation 'for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine)'. The recommended reconstituted dose is 155–195 units, administered intramuscularly as 0.1 ml (5 units) injections to between 31 and 39 sites around the head and back of the neck. The recommended re-treatment schedule is every 12 weeks (see the summary of product characteristics).

3.12 …….The time horizon used in the model was 2 years, in line with the manufacturer's expected maximum treatment duration with botulinum toxin type A. For the first of the 2 years, trial data were used if possible, with extrapolation used for the second year, using the last observations from the trial.

3.20 The ERG found botulinum toxin type A to be effective regardless of the number of previous preventive medications taken. As the number of previous preventive medications rose, so did the relative effectiveness of botulinum toxin type A compared with placebo (reductions of 2.3 and 2.7 headache days per month for the one prior preventive medication and three or more prior preventive medications subgroups respectively). In addition, the ERG observed that the placebo effect decreased as the number of previous preventive medications increased.

British Association for the study of headache. Guidelines for all healthcare professionals in the diagnosis and management of migraine, tension-type headache, cluster headache, medication-overuse headache. 3rd Edition (1st revision) 2010 (ref :www.BASH.org.uk)

6.5.2 Dose-titration

Most prophylactics are used within a dose range, and in general must be up-titrated slowly to an effective dose (or to the maximum dose) in order to avoid side-effects that will precipitate premature discontinuation. This can lead to a delay in efficacy which itself, unfortunately, sometimes triggers discontinuation (see 6.5.3). Careful explanation is needed.

6.5.3 Duration of use

Migraine is cyclical: treatment is required for periods of exacerbation and uninterrupted prophylaxis over very long periods is rarely appropriate. Drugs that are effective should be continued for 4-6 months, then withdrawal considered to establish continued need. Withdrawal is best achieved by tapering the dose over 2-3 weeks. Prophylactic drugs that are apparently not effective should not be discontinued too soon since efficacy may be slow to develop, particularly when dose-titration is necessary (see 6.5.2). In practice patients usually decide when they stop medication, so careful explanation is needed lest they be labelled non-responders inappropriately (eventually, perhaps, to all drugs).

*There is no absolute guide but, in the absence of unacceptable side-effects, 6-8 weeks is a reasonable trial following dose-titration, and 3 cycles in the case of specific therapy for hormone-related migraine (see 6.5.9).