PBAC

PBAC

BACKGROUND

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.

The Pharmaceutical Benefits Advisory Committee (PBAC) advises the Federal Government on which medicines to subsidise on the Pharmaceutical Benefits Scheme (PBS).

An important part of the reimbursement process involves the Government and the PBAC hearing from doctors, researchers, patients, their families and other medical and patient groups to incorporate everyone’s perspective into the decision to cover, or include a particular type of treatment, or not.

When a submission is made to the PBAC, there is a window of time for public comments to be sent to the PBAC for review. The submissions from the public are not published nor are the names of any individuals revealed.

The PBAC are required to review every submission that is sent before the deadline.

UPDATES SINCE APRIL 2018

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.

NEW SUBMISSIONS FOR OCTOBER 2019

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.

Submit your comments to the PBAC on their website >>

Your submission is confidential.

WHAT SHOULD I SAY ON MY SUBMISSION?

See above if this is not your first submission. Previous comments are already taken into account by the PBAC.

Below are the form questions and response suggestions.
Click here to begin the form

Medicine Name: FREMANEZUMAB – Ajovy® or ERENUMAB – Aimovig® (select from the drop-down menu). 
Submitted by: Individual (select from the drop-down menu). 
Email: Your email
Phone number: Your phone
Street address: Your address
Suburb: Your suburb
State: Your state
Post code: Your post code

Declaration of interest:

Please include any declarations you wish to make regarding your PBAC submission. If you have no declarations to make, please respond “nil”.

Consumer input:

Please indicate whether you are a person with this medical condition, a friend or family member, a prescriber, a representative of an organisation or other interested person.

What comments would you like the PBAC to take into account when it considers this submission?

This is where you post your personal experience.

Consider highlighting:

  • What are 3 things other people don’t know about migraine if they don’t have it themselves?
    • How does migraine affect your relationships with friends and family, your ability to work or your career, your quality of life?
    • Has migraine led to other issues such as rebound headaches, depression, anxiety, or other challenges?
  • If you have used this new medicine, what was your experience of the beneficial effects?
  • If you have used this new medicine, did you experience any side effects or toxicities
  • How satisfied are you with your current treatment?
  • What symptoms or side effects can’t be controlled with your current treatment?
  • If you haven’t used the new medicine yet, what would you like most from it?
  • If you currently have access to the treatment, what will happen to you, your family and/or work if it does not get covered to by the PBS?

Note that this is not a “test” and all submissions will be reviewed by the committee and are appreciated for their personal and private nature. Be honest, direct, polite and respectful.

How did you learn about this submission process?

Headache Australia monitored the submission process and notified the community about this comment period.

READY TO SUBMIT?

Submit using the form on the government website or email your response to CommentsPBAC@health.gov.au

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