2021 Parliamentary Inquiry into Approval Processes for New Drugs

Carl Cincinnato represented Migraine & Headache Australia and the patient community at a hearing for the Parliamentary Inquiry into the approval processes for new drugs. The inquiry considered drug development and research, as well as the Pharmaceutical Benefit Scheme (PBS). This was a unique patient advocacy opportunity to discuss how delays in PBS listings have affected our community.

The inquiry began in August 2020 and asked people to submit testimonies to evaluate the processes in place. The parliamentary hearings have called on some of these representatives to testify and provide further feedback in person. Migraine & Headache Australia were one of only a few organisations who were asked to present, out of over 100 formal submissions made from other advocacy groups.

Our testimony included an example of a patient who had a life-changing response to the new generation preventive migraine treatment but yet could not continue on the treatment because they could not afford it. This is despite submissions first being made over 2 years ago for PBS listing.

Key points mentioned included:

• It has been 2 years since the first calcitonin gene-related peptide (CGRP) antibody was submitted to the PBAC from Novartis, called Aimovig.
• It’s been over a year since Teva’s CGRP Ajovy was positively recommended by the PBAC – yet it remains unlisted.
• It had been 19 months since the 3rd CGRP from Lilly called Emgality was approved by the PBAC. It was still unlisted at the time of the hearing.
• These new generation treatments are proven to be safe and effective.
• In the meantime, many Australians living with chronic migraine are unable to get affordable access to CGRPs.

Updates since March 2021

Emgality has now been listed on the PBS, allowing people with chronic migraine to access this medication for a fraction of the previous cost. However, the problems that led to this delay are still present. Without changes to PBS approval processes, future treatments may face the same delays.

The inquiry has considered the following topics:

1. The range of new drugs and emerging medical technologies in development in Australia and globally.

2. Incentives to research, develop and commercialise new drugs or medical technologies for conditions where there is an unmet need. In particular, they will consider rare disease treatments, personalised treatments, and off-label prescription (drugs that could treat multiple conditions). 3. Measures that could make Australia a more attractive location for clinical trials. 4. Whether the approval process for new drugs and medical technologies could be made more efficient, without compromising safety, quality, or cost-effectiveness. This might involve greater use of international approval processes, aligning registration & reimbursement processes, or postmarket assessments. The final hearing was on the 24th of June. We expect to see the results of the inquiry in the near future. Hopefully, with more efficient approval processes for new drugs in place, we will see other CGRPs added to the PBS soon.

Further information

Advocacy – read more about our advocacy work

Calcitonin Gene-Related Peptide Antibodies (CGRP) for Migraine – learn more about what CGRPs are and how they work

New Treatments Update – regularly updated page for the most recent information on PBS approvals

Inquiry into approval processes for new drugs and novel medical technologies in Australia – government page on this inquiry