Zimmerman heads for MelbourneBy Megan Brodie 3 years ago | In Cell and gene therapies, Companies, Industry
- 3 years ago
19 March 2021
The Zimmerman parliamentary inquiry into approval processes for new medicines and medical technologies will head to Melbourne next month, with Victorian-based company leaders lining up to speak to their submissions.
While the committee has set aside next Friday for a hearing in Canberra, Melbourne companies have been advised the committee will be holding sessions in the Victorian capital in April, with leaders now waiting on a formal invitation.
BMS’ managing director Neil MacGregor is keen to address the committee on issues pertinent to his company, while Gilead boss Jaime McCoy will also be keen to appear given the company’s struggle with its CAR-T cell therapy product YESCARTA.
CSL should also be looking to have its say on issues other than its COVID-19 vaccine production capacity and Specialised Therapeutics Australia boss Carlo Montagner will want to talk on how he was pushed to implement a new funding arrangement for his breast cancer test after six failed attempts at reimbursement.
Ipsen, UCB and ViiV also put in submissions and may seek to address the committee but as GSK surprisingly did not put in a submission, it is off the invitation list.
While the format for the Melbourne hearings has not yet been set, it is likely to follow the Sydney hearings whereby seven companies were jammed into a two hour timeslot – although some Melbourne leaders are hoping for solo appearances.
Gilead’s CAR-T was recommended by MSAC in January 2020 but has not yet appeared as a reimbursed product. Gilead raised the delay in its submission and with the delay approaching 15 months, the company has strong grounds to highlight the issue.
BMS put in an extensive submission and will have a range of issues to canvass, including its own interest in CAR-T therapies. Its submission called for clear, fit-for-purpose reimbursement pathways for cell therapies and a framework to deliver precision medicines to Australian patients, making it a good partner for Gilead should they be paired.
However, BMS’ submission was much more extensive and solution focused, particularly in regard to clinical trials – an issue being raised in numerous circles at the moment. BMS is expected to have much to say on this topic, as well as managed entry schemes for new medicines and the use of real world evidence in evaluating medicines.
CSL’s submission focused on access to new blood and blood related products, calling for an expert appraisal panel to manage submissions and a broader consideration of value for rare disease and blood products. It wants much greater transparency and accountability for products funded by the National Blood Authority, and may struggle to keep the committee focused on the real issues faced by patients reliant on its core products.
The committee has already held four of its nine days of hearings with the fifth day scheduled for next Friday. With 40 Melbourne-based organisations making submissions, it is expected the committee will spend two days in the Victorian capital, with Brisbane likely to be the next location on its travel schedule.