Sat. Jul 13th, 2024

It is one of the most prevalent, complex and misunderstood disorders affecting some 6 million Australians, and it’s not a headache.

Migraine has been redefined in recent years as a genetic sensory processing disorder. Thanks to the breakthrough research of Australian neuroscientist Peter Goadsby, geneticist Lyn Griffiths and others, the cause of all types of migraine is now understood as genetic differences that change how ions go through channels in the brain, making the brain ‘hyper-excitable’ – or in plain terms, makes the brain over-react to stimuli. When a threshold of stimulation is passed, a ‘migraine storm’ of chemical and physical reactions creates the migraine attack.

This fundamental change in understanding what migraine is means the term ‘migraines’ is no longer used. It is grammatically incorrect: migraine is there all the time and is singular, the symptoms people complain about are just the ‘attack’ or less commonly ‘flare’ – like an asthma attack or arthritis flare.

New medications to manage migraine effectively have been developed as part of the research breakthrough. Referred to collectively as CGRP medications, they work by blocking a naturally occurring chemical, Calcitonin Gene Related Peptide (CGRP) that Professor Goadsby’s research found surged during a migraine storm and was significantly involved in causing migraine attacks. However, because of the sheer number of people who live with migraine, they have struggled to get on the PBS.

What are the new medications?

The new medications are in two groups – the ‘mabs’ or monoclonal antibodies that work with the immune system to prevent migraine, and the ‘gepants’ which are small molecule medications that bind to the CGRP receptors for a short period of time.

Aimovig (erenumab): the first in class CGRP antagonist and the only ‘numab’, works by attaching itself to the CGRP receptor in the brain. Monthly injection using one or two auto-injection pens. Not listed on the PBS, private cost is $695 if you buy direct from their website, up to $850 through a chemist.

Emgality (galcanezumab): Second in class and the first of the ‘nezumab’s, this medication blocks CGRP by attaching to the CGRP ligand itself. This medication is also administered monthly in an auto-injecting pen. Available on the PBS for a limited number of people who have passed strict eligibility criteria (see below) or privately for $263 a month if you are enrolled in the drug company’s discount program, or around $600 if you order direct from a chemist.

Ajovy (fremanezumab): Closely following the release of Emgality, Ajovy works the same way but the medication can be taken monthly or every three months, and you can choose between the auto-injector or a syringe. Also available on the PBS with the same criteria as Emgality, a monthly dose is $284 if enroled in the drug company’s discount program or $850 per month ordered direct from a chemist.

Vyepti (Eptinezumab): This is a fast-acting medication that will begin to have effect in a matter of hours rather than the normal days for the other injectables. The medication is administered in a 30 minute infusion every three months. This medication was recommended to be listed on the PBS nearly a year ago but has not been listed yet, so will set you back $1800 per dose.

Nurtec (rimegepant): This is a tablet medication that can either be taken acutely – when a migraine attack hits – regularly as a preventative medication, or, quite unusually, can be taken in anticipation of a likely attack, for example, for a couple of days before a period for women who have menstrual migraine. The flexibility of this medication in managing the often variable condition of migraine means it has been hailed as a really significant breakthrough. It is not yet available but should be soon – it is currently being assessed by the TGA and considered for the PBS.

Quilipta (atogepant): is an acute medication for migraine attacks taken as a tablet when required. It is also currently being assessed by the TGA and considered for addition to the PBS.

Ubrelvey (ubrogepant) is another tablet gepant for acute management of migraine and Zavzpret (zavegepant) works the same way but is delivered as a nasal spray. These medications have not begun the process of coming to Australia as yet.

What’s going on with the PBS?

Advocacy organisation Migraine Australia was formed almost entirely to lobby to get these new medications on the PBS. They successfully advocated for 2 of the new medications to be listed: Emgality and Ajovy, but the restrictions and eligibility criteria mean that only those debilitated by migraine qualify.

Those who meet the following criteria will be able to get Emgality or Ajovy on the PBS. 

  • You must have Chronic Migraine (15 headache days, 8 of which are migraine days) for at least three months. 
  • You must have failed three older medications like propanolol, topiramate and amitryptiline
  • You must be managed for medication overuse headache
  • You must be under the care of a neurologist
  • Your neurologist must initiate treatment (your GP can do continuing scripts)
  • You cannot get both Emgality/Ajovy and Botox (OnabotulinumtoxinA) on the PBS. If you are combining a CGRP preventative and Botox you need to pay for one of them privately.

Vyepti was recommended to be listed on the PBS in July 2022 by the independent Pharmaceutical Benefits Advisory Committee. However, despite the ongoing claims by both sides of politics that they would ‘list whatever the PBAC recommends’, it has not been listed and there doesn’t appear to be a listing date on the horizon.

To get PBS listing, five things need to happen: TGA registration, recommendation from PBAC, negotiation of a supply agreement with the Department of Health, Minister approval, and for any medication over $20m per year – which is almost all migraine medications because of the sheer number of patients involved – approval of the whole Cabinet. Vyepti is stuck on step 3 – in the Department.

A spokesperson for the Department of Health and Aged Care said they are currently working to finalise arrangements with the company as quickly as possible.

“Whilst a positive PBAC recommendation is an essential requirement in the process of a PBS listing, other processes need to be completed before a medicine can be given approval for listing. This includes pricing negotiations with the manufacturer, finalisation of the conditions for listing, availability checks, and consideration by Government,” the spokesperson said.

“Although the PBAC recommended the listing of eptinezumab in July 2022, the pharmaceutical company responsible, Lundbeck Australia Pty Ltd, first submitted a listing proposal to the Department on 20 January 2023.”

A spokesperson for Lundbeck Australia gave a similar response.

“Vyepti is progressing through discussions with the Government. A PBS listing date has not been announced.”

Founder of Migraine Australia (and publisher of the New England Times) Raphaella Kathryn Crosby was on the forefront of the fight to get Emgality and Ajovy on the PBS. She personally is on Aimovig, which was withdrawn from consideration for the PBS after three failed attempts costing drug company Novartis millions, and does not benefit from any of the listings, but is still furious on behalf of others.

“It is simply not good enough to delay listing of medications for a year or more – as happened with Emgality and Ajovy, and is now happening with Vyepti.”

“How would you feel if the government told you that you can’t function, can’t look after your kids, can’t work for over a year.”

“It absolutely can’t happen with Nurtec,” she insists.

“There are so many people hanging on this drug coming to Australia, waiting for their chance to finally manage their migraine.”

“It has to be listed on the PBS, without the stupid, baseless restrictions that have been applied to the previous monoclonal antibodies, and made available everywhere as quickly as possible.”

Crosby and Migraine Australia have previously called for a Royal Commission into the PBS.

The Medicine Status Website enables you to search and monitor the status of medicines as they progress through the PBS listing process. The website is updated monthly and is available at: www.pbs.gov.au/medicinestatus/home.html

If you live with migraine and need support or want to know more, follow Migraine Australia on Facebook or join their facebook group.

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