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URGENT --Submissions to support application - PBS Botox - DUE 13 JUNE

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From: Kaleen
84 total posts
Currently suffering :(
Hi All

I just got this emailed to me - I hope it's not inappropriate to post on this forum, but it's a call for submissions to support a second try at getting botox treatments for chronic migraine on PBS - I guess if it gets up for migraines there is a chance it could be PBS for cluster headaches too.

I've posted the full email below


Pharmaceutical company Allergan is in the process of seeking listing for BOTOX (botulinum toxin type A) treatment on the Pharmaceutical Benefits Scheme (PBS) for the prevention of headaches in people with chronic migraine who have not responded to, or who cannot tolerate, current medications.

The first submission was unsuccessful; however a resubmission will be made for review at the July 2012 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC), who make recommendations regarding PBS listing.

During the review process, the PBAC welcomes input from patients and their families, carers, members of the public, health professionals and members of consumer interest groups. These submissions provide real-life accounts of how the medication under consideration impacts individuals' lives.

Public submissions will be received for a two week period between 30th May and 13th June 2012. Comments can be made using an electronic form available from the Australian Government website:

On the form, in the field "Medicine to which submission relates" type:
BOTOX treatment for chronic migraine.

This form can be submitted online or printed and sent in via fax or posted to the PBAC Secretary using the contact details below.

Website information:
The PBAC Agenda can be accessed at the following website:

The electronic submission form is available at:

Contact details for the PBAC Secretary:

Mail: PBAC Secretariat
MDP 952,
Department of Health and Ageing
GPO Box 9848
Canberra ACT 2601
Facsimile: (02) 6289 4175

Yours sincerely,
Gerald Edmunds
Secretary General
Brain Foundation and Headache Australia
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766 total posts
Currently suffering :(
Thanks to Katherine to bringing this to our notice!
I have completed this form on line--NOTE--the first link to the form does not work--take the second link.

PLEASE CONSIDER completing this form whether you have tried Botox or not.
On the form, in the field "Medicine to which submission relates" type:
BOTOX treatment for chronic migraine. (do not be deterred by the reference to migraines)
Whilst you may not have been offered this as a treatment--please still consider these questions from the perspective of being offered a treatment that could stop the pain of your headaches--what do you reckon the benefits would be to you etc.

The questions are:
What treatment (if any) are you using now?
What do you see as the benefits of this new medicine for you?
How will your life and that of your family and carers be improved by this new medicine?
What other benefits can you see from having this medicine on the PBS?

This is the first time I can see that we can actually have some personal input into the possible outcome of "anything". Whilst Botox may not be your treatment--it certainly is being offered to migraine sufferers and now to we CH sufferers. Please help by completing the on line form.
Thank you again Katherine.
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29 total posts
Not currently suffering :D
Everything you might want to know on Botulinum Toxin in Headache:

Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy.

Durham PL, Cady R, Cady R.
Source: Department of Biology, Southwest Missouri State University, MO, USA.


To determine the effect of botulinum toxin type A on calcitonin gene-related peptide secretion from cultured trigeminal ganglia neurons.

The ability of botulinum toxins to cause muscle paralysis by blocking acetylcholine release at the neuromuscular junction is well known. Previous studies and clinical observations have failed to demonstrate sensory changes related to botulinum toxins or the disease of botulism. Recent studies, however, have suggested that botulinum toxin type A injected into pericranial muscles may have a prophylactic benefit in migraine. This observation has renewed the debate of a mechanism of sensory inhibition mediated by botulinum toxin type A.

Primary cultures of rat trigeminal ganglia were utilized to determine whether botulinum toxin type A could directly decrease the release of calcitonin gene-related peptide, a neuropeptide involved in the underlying pathophysiology of migraine. Untreated cultures or cultures stimulated with a depolarizing stimulus (potassium chloride) or capsaicin, an agent known to activate sensory C fibers, were treated for 3, 6, or 24 hours with clinically effective doses of botulinum toxin type A or a control vehicle. The amount of calcitonin gene-related peptide secreted into the culture media following the various treatments was determined using a specific radioimmunoassay.

A high percentage (greater than 90%) of the trigeminal ganglia neurons present in 1- to 3-day-old cultures was shown to express calcitonin gene-related peptide. Treatment with depolarizing stimuli (potassium chloride), a mixture of inflammatory agents, or capsaicin caused a marked increase (4- to 5-fold) in calcitonin gene-related peptide released from the trigeminal neurons. Interestingly, overnight treatment of trigeminal ganglia cultures with therapeutic concentrations of botulinum toxin type A (1.6 or 3.1 units) did not affect the amount of calcitonin gene-related peptide released from these neurons. The stimulated release of calcitonin gene-related peptide following chemical depolarization with potassium chloride or activation with capsaicin, however, was greatly repressed by the botulinum toxin, but not by the control vehicle. A similar inhibitory effect of overnight treatment with botulinum toxin type A was observed with 1.6 and 3.1 units. These concentrations of botulinum toxin type A are well within or below the range of tissue concentration easily achieved with a local injection. Incubation of the cultures with toxin for 24, 6, or even 3 hours was very effective at repressing stimulated calcitonin gene-related peptide secretion when compared to control values.

These data provide the first evidence that botulinum toxin type A can directly decrease the amount of calcitonin gene-related peptide released from trigeminal neurons. The results suggest that the effectiveness of botulinum toxin type A in the treatment of migraine may be due, in part, to its ability to repress calcitonin gene-related peptide release from activated sensory neurons.

Durham PL, Cady R, Cady R (2004). Regulation of calcitonin
gene-related peptide secretion from trigeminal nerve
cells by botulinum toxin type A: implications for migraine
therapy. Headache 44: 35–43.

Botulinum toxin type A

Botulinum neurotoxin type A (BoNT) has been increasingly utilized to treat migraine, tension-type headache, and other primary headache disorders. BoNT has been used clinically for the treatment of neuromuscular disorders, including focal dystonias and relief of pain associated with cervical dystonia and oromandibular dystonias. It is well established that BoNT blocks the presynaptic release of the neurotransmitter acetylcholine at neuromuscular junctions by cleaving the vesicle docking protein SNAP-25, a member of the soluble N-ethlymaleimide- sensitive factor attachment receptor (SNARE) proteins.

However, blockage of acetylcholine release is not likely the primary mechanism by which BoNT functions as a prophylactic treatment of migraine and other headaches, since reduction in pain is often noted by patients before muscle changes. Rather, the clinical benefits of BoNT may involve regulation of neuropeptide release from trigeminal ganglia neurons (Durham et al., 2004). Recent animal studies have provided evidence that BoNT can block the stimulated release of CGRP, glutamate, and substance P from trigeminal neurons as well as reduce c-fos gene expression in second-order neurons.
In addition, data from inflammatory pain models have clearly demonstrated an antinociceptive effect of BoNT. Taken together, it is likely that the therapeutic benefit of BoNT involves inhibition of peripheral sensitization, which results in a reduction in central sensitization and blockage of pain transmission.

In a recently completed assessment of botulinum neurotoxin in the treatment of autonomic disorders and pain by the Therapeutics and Technology Subcommittee of the AAN, two class I (Silberstein et al., 2000; Evers et al., 2004) and two class II (Elkind et al., 2006; Relja et al., 2007) studies were reviewed. The committee concluded that there was insufficient evidence to support or refute the benefit of these injections for the prevention of migraine. Consequently, it may be concluded that, based upon the current evidence, it appears that botulinum toxin injections are not effective for the treatment of episodic migraine headache, and clinical studies are assess efficacy in chronic migraine.

Elkind AH, O’Carrol P, Blumenfeld A et al. (2006). A series
of three sequential, randomized, controlled studies of
repeated treatments with botulinum toxin type A for
migraine prophylaxis. J Pain 7: 688–696.

Evers S, Vollmer-Haase J, Schwaag S et al. (2004). Botulinum
toxin A in the prophylactic treatment of migraine –
a randomized, double-blind, placebo-controlled study.
Cephalalgia 24: 838–843.

Relja M, Poole A, Schoenen J et al. (2007). A multicentre,
double-blind, randomized, placebo-controlled, parallel
group study of multiple treatments of botulinum toxin
type A (BoNTA) for the prophylaxis of episodic migraine
headaches. Cephalalgia 27: 492–503.

Silberstein S, Mathew N, Saper J et al. (2000). Botulinum
toxin type A as a migraine preventive treatment. For the
BOTOX Migraine Clinical Research Group (comment).
Headache 40: 445–450.This post was edited on 01/06/2012 at 10:06 pm
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766 total posts
Currently suffering :(
Hi K
Dont think the "everything" quite fits the bill, however, did read the abstract and most of the article in full.
There still seems to be enough people and specialists around to consider it worthwhile to continue the drive to get Botox on the PBS, including me--even if only for a trial for myself; which in itself is a selfish outcome.
Chronic migraine is the reason for the submission. We could get technical and say--but we get CHs--but this does not stop us taking Imigran and Relpax etc which require the authority for migraine patient use.
If this is a drug and hence treatment that can be made available for more of our chronic CH sufferers whose headaches continue day in and day out without remission--would they not try it as an option? I know I would--as I have.
I urge others to consider supporting the submission, if not for themselves, then for others who may benefit from the treatment.
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766 total posts
Currently suffering :(
Hi all--a reminder of the date for final submissions for the Botox back for PBS review. Please consider this as something you can contribute to that may help others or maybe even you in the future.
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Silent Planet

From: Freshwater
261 total posts
Currently suffering :(
Hi All,

I have made my submission for Botox to be listed on the PBS system, I hope that this does go through so it can help many more of us that suffer with this condition. I urge anyone and everyone that uses this website to fill in the submission form even if you don't use Botox someone else may get the benefits from this. You never know one day we might have to apply for a medication that you are on that is not on the PBS system.

Silent Planet
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From: unknown
130 total posts
Currently suffering :(
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