- 5 years ago
5 May 2021
The parliamentary inquiry into approval processes for new drugs and novel technologies in Australia being chaired by Trent Zimmerman appears to be looking for some quick wins that it can include in its recommendations, expected to be delivered later this year.
Having now heard around 35 hours of evidence from pharmaceutical and medical technology companies, industry associations, patients, clinicians and research organisations, the committee members would have to be deaf to miss the one area that appears to have been continually overlooked in health governance – the Medical Services Advisory Committee, or MSAC as it is known.
Over and over again, examples have been given of how this committee operates in the dark. Unlike its sister committee, the Pharmaceutical Benefits Advisory Committee (PBAC), the MSAC does not have a set timetable for releasing an agenda for its meetings, and while there is a ‘guideline’ that decisions be published eight weeks after a meeting, time and again the committee has heard examples of where this has not happened.
For example, in 2019, the committee took five months to reveal the outcome of its decision on Novartis’ CAR-T KYMRIAH.
PBAC chair Professor Andrew Wilson continues his push for greater transparency with the support of government and even with industry in certain areas – BMS is helping to draft executive summaries for two of its cancer submissions to provide guidance for patients looking to have an input. In a seemingly parallel universe, the MSAC muddles along in the dark hoping no one will notice.
And from the response of the Zimmerman inquiry to date, it looks like they are getting away with it.
At its Melbourne hearings, Specialised Therapeutics Australia boss Carlo Montagner gave evidence on how he had to use Freedom of Information laws to access MSAC information about the assessment of a rejected test submission, noting he “didn’t ask for the nuclear codes or the password for Pine Gap”.
“I just asked for what were the deliberations around our multiple rejections for our drugs,” he said. “Just show me the presentation that was given to the committee? No. Show me who the person was who presented to the committee? What expertise did they have? No, you can’t have that. Can I actually see the discussion that occurred after the presentation? No, it’s no, no, no, no, no. Why is that?”
Gilead boss Jaime McCoy also did her very best to shed light on her own company’s problems dealing with the MSAC, which recommended Gilead’s first CAR-T product 15 months ago. Ms McCoy pulled out four pages of the company’s ongoing interactions with the Department of Health over MSAC, saying “the absence of a clear process with target timelines makes this a difficult and slow process for both parties”.
“There are no milestones or deadlines post-MSAC recommendations, no sense of urgency, no opportunity for patients or healthcare practitioner input,” she said.
Furthermore, patient advocate Louise Healy described MSAC’s processes as “murky” and lacking transparency when compared with the PBAC.
Accessibility and accountability
While Prof Wilson makes himself available to companies, patients and even the media, MSAC chair Professor Robyn Ward appears to avoid any media exposure. Patient groups also appear to have limited access to the MSAC chair, who has held the role continuously since 2009.
PBAC deputy chair and consumer representative Jo Watson is widely praised in patient circles for her accessibility, willingness to help and, perhaps most importantly, her willingness to listen. In comparison, what interactions do MSAC’s two consumer representatives have with patients? Can anyone actually name either of them?
There is no doubt MSAC is made up of highly qualified medical experts committed to doing their very best to assess new technologies for funding but from the outside, its operations appear Kafkaesque – obscured behind a shroud of secrecy neither appropriate nor acceptable in the public health arena.
While the medicines industry’s focus to date has been strongly on the PBAC as the gateway for recommending new drugs in Australia, as new technologies are increasingly assessed by the MSAC, the ‘transparency black hole’ in which this committee operates needs to be closed.
If the Zimmerman inquiry is looking for a quick win, this is it. Recommend the Department of Health publish a calendar for MSAC meetings just as it does for PBAC, including when the agenda, outcomes and Public Summary Documents are posted online.
Link submissions and outcomes to these meetings and enable consumer input into the submission process, along with fast resubmission pathways for novel therapies and companion tests rejected by the committee.
Recommended products should be funded within a stipulated timeframe, ensuring the Department of Health does not engage in protracted post-recommendation negotiations that result in delays such as those which Gilead is currently experiencing.
Shining a light on MSAC and making it transparent in its deliberations, accountable for its decisions and engaged with the companies and patients whose lives and livelihoods depend on its decisions is not just an easy win, it is an essential and urgent step in restoring public trust in this important regulatory committee.