Reviews should focus on delivering funded access to innovation in 100 days

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Pat Williams is the managing director of Edwards Lifesciences for Australia, New Zealand and Korea. In a special comment, he says Australians are waiting too long for new medical technologies and that the range of existing and new reviews need to be broad and look beyond one or two specific areas with the goal of an in-principle objective of achieving funded patient access within 100 days.

The new federal health minister will have a full plate of reviews, including the National Medicines Policy (NMP) and Health Technology Assessment (HTA) - two processes that will have a lasting impact on patient access to innovative healthcare solutions.

Solutions that can allow patients to return home faster, return to work, reduce costs and ultimately resume being fully productive members of their communities.

Prior to it being shelved until after the election, patient groups raised concerns publicly about the rushed nature of the NMP review.

Now it is happening with the HTA review. In a pre-election rush to clear the decks, the former federal government announced the proposed appointment of Dr Peter Boxall AO to chair the review.

A number of stakeholders, including Medicines Australia, complained about the proposed chair given his prior role in the 2014 National Commission of Audit. That Audit recommended increasing co-payments for medicines reimbursed through the PBS.

On a positive note, we welcome the proposed inclusion of two patient advocates on the HTA review's reference committee.

We hope the review considers the full range of life sciences, including therapeutics, medical technology (devices and diagnostics) and pharmaceuticals.

At Edwards Lifesciences, we strive for big, bold advancements that will fundamentally change the practice of medicine. We are dedicated to providing evidence-based innovative solutions for people fighting cardiovascular disease. These bold advancements challenge the current HTA system and unfortunately in 2022 the system has not adapted to the rapid changes in medical technology.

The Albanese Government has inherited and can draw from over 200 submissions from industry, patients and other healthcare stakeholders to the bipartisan House of Representatives ‘Inquiry into approval processes for new drugs and novel medical technologies in Australia’.

The message from that inquiry was clear - the pathway to market in Australia is complex, lengthy, and inconsistent.

Yet the Department of Health has only proceeded with a consultation on cost-recovery for the Medical Services Advisory Committee (MSAC) despite the fact the government has not even formally responded to the inquiry's recommendations.

The costs-recovery consultation does not place requirements on MSAC to become more accountable nor improve its review timeframes over time. 

We propose that patient input and non-traditional data sources play an increasingly important part.

As a sponsor, we gladly contribute our fair share - with the expectation that results are measurable and commensurate. Thus far, MSAC consultation has fallen short in addressing the vital concerns that industry and patient groups have previously highlighted in the Inquiry.

The trend is equally prevalent across medical technology.

For example, severe symptomatic aortic stenosis patients at low risk of dying from aortic valve replacement have been eligible to access TAVI in the US and Europe since 2019 and yet we will finally achieve that milestone on 1 July 2022 in Australia.

Some 1,050 days (a little under 3 years) later, we can do better.