UPDATE – APRIL 2018
In April 2018, Headache Australia called on our community to support patient access to a new generation migraine treatment submitted to the Pharmaceutical Benefits Scheme for inclusion.
The submission referred to a new treatment called Aimovig®, also known as ERENUMAB. This treatment involves a CGRP monoclonal antibody designed to specifically target molecules released during migraine to help prevent attacks. Trials have shown that this treatment is safe and effective with a significant number of patients experiencing a significant reduction in their migraine frequency.
Without PBS support, the cost of this treatment will be beyond the affordability of the average patient with migraine.
We had an overwhelming response from the community who generously took the time to share their personal experience about the burden of migraine and the need for more effective treatments.
Thank you to everyone who submitted their response. The Pharmaceutical Benefits Advisory Committee (PBAC) reviewed every single submission. The PBAC also acknowledged the “unmet clinical need for new treatments for sufferers of migraine”. However this is only one of several factors which are examined by the PBAC for a new submission.
ERENUMAB – Aimovig® has been submitted on two seperate occassions and has recently been declined a second time (from the March 2019 meeting) for inclusion.
Here are their comments:
“The PBAC did not recommend the Authority Required (STREAMLINED) listing of erenumab for the treatment of patients with chronic migraine. The PBAC considered the magnitude of the clinical benefit, and the claim of non-inferior efficacy compared with Botox, were uncertain due to being based on a subgroup of the trial population and clinical data for only the 140 mg dose.
There were significant issues with the economic model, and the cost-effectiveness of erenumab versus BSC (best supportive care) at the price proposed in the resubmission is highly uncertain. The expected financial impact of listing erenumab on the PBS was very high and uncertain. Given the significant burden of disease and the high number of patients that may benefit from treatment, the PBAC considered it was important to ensure any PBS listing was based on the best available data, was appropriately targeted to the right patients and was cost-effective in those patients.”
“The PBAC did not recommend the Authority Required (Streamlined) listing of erenumab for the treatment of chronic migraine. The PBAC considered that the submission had neither adequately justified the place in therapy nor justified the proposed PBS listing, which excluded migraine patients that may benefit from this treatment. The evidence used for the basis of the clinical claim that erenumab was more effective than botulinum toxin had significant limitations, resulting in a clinical effectiveness and cost-effectiveness estimates that were highly unreliable for decision making. In addition, the PBAC considered that the cost to Government was underestimated by the submission, both because the number of patients with chronic migraine was underestimated by the submission and because of the significant risk of leakage outside the proposed limited PBS listing (for example, patients with episodic migraine). The PBAC acknowledged the unmet clinical need for new treatments (including erenumab) for sufferers of migraine, and looks forward to engaging with the company to find a way forward.”
It is important to understand that it typically takes more than one submission for approval from the PBAC and it does not mean this treatment will not be covered in the future.
The manufacturer, Novartis Pharmaceuticals Australia, released a statement saying they look “forward to working with Government to support appropriate patient access via the Pharmaceutical Benefits Scheme (PBS).”
UPDATES IN 2019
In 2019 two more major new treatments have been submitted from different manufacturers. They are both also CGRP monoclonal antibodies but each work slightly differently to each other. The triptans simiarily, are from the same class of treatment but each work slightly differently.
The two new treatments are called Ajovy® (also known as Fremanezumab) from Teva Pharmaceuticals and Emgality® (also known as Galcanezumab) from Lilly. Ajovy® is being submitted for the October meeting (see below) while Emgality® was submitted earlier this year.
In July 2019 Emgality received a positive recommendation from the PBAC for coverage on the PBS subject to some considerations. This is what they released in their Outcome Statement:
“The PBAC recommended the Authority Required (STREAMLINED) listing of galcanezumab for the treatment of chronic migraine in patients who have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications.
The PBAC considered galcanezumab was an alternative treatment to botulinum toxin type A (Botox®) for patients with chronic migraine and provided a similar reduction in migraine headache days.
The PBAC considered the cost minimisation analysis should be based on equi-effective doses of 120 mg galcanezumab every 30 days and 164IU of Botox every 12 weeks over 2 years of treatment.
Additionally, the PBAC considered it would be appropriate for galcanezumab and Botox to be combined in the same subsidisation caps under a Risk Sharing Arrangement.”
Negotiations are now being held between the two parties in relation to this last paragraph that suggests how the government would like to subsidise the new treatment. There is no definite timing on when these negotiations are expected to be concluded, if any agreement will be met or when the subsided treatment drug may be listed and available to patients.
Headache Australia hopes for an equitable outcome for all parties that faciliates a fair and resonable price for patients with appropriate access for those in need of an effective migraine pevention. Updates on this outcome will be posted on this page.
Two treatments have been submitted for the October 2019 PBAC meeting. One is a re-submission of ERENUMAB – Aimovig® and the other is the first submission FREMANEZUMAB – Ajovy®. Both these treatments have now been approved by the Australian medical authority (Therapeutic Goods Administration – TGA) as safe and effective options for migraine prevention.
Comments are now open to the public and must be received by 9 October 2019. Comments from previous submissions about the burden and disability of migraine are kept on file and are referred to as relevant in consideration of this treatment. Members of the public are encouraged to make a new submission if they have additional or new information to help inform the PBAC.
Your submission is confidential.