Edwards Life Sciences has used its submission to a parliamentary inquiry to call for change in Australia's "lengthy and inconsistent approvals process" that it says means patients are denied timely access to treatments.
The inquiry is chaired by Coalition MP Trent Zimmerman with deputy chair Labor's Dr Mike Freelander.
Edwards produces the transcatheter aortic valve implantation (TAVI) that enables a patient to receive a new heart valve through a keyhole procedure through a leg artery rather than open-heart surgery.
"Despite evidence of its clinical superiority and cost-effectiveness compared to open-heart surgery, there are many restrictions on TAVI’s use in Australia," says Edwards in its submission, pointing to inconsistent access across the public and private health systems.
It says, "Following the Therapeutic Goods Administration’s (TGA) approval, patients who are low-risk for open-heart surgery can now instead opt for TAVI in the public hospital system. However, there is inequitable access across the country with NSW Health lagging the rest of the country.
"Private patients can only access TAVI unless they are deemed too high-risk to survive open-heart surgery. The Medical Services Advisory Committee’s (MSAC) lengthy processes and the inconsistency of the Prostheses List Advisory Committee (PLAC) means many patients who would benefit from TAVI cannot access it so must either join public hospital waiting lists, consent to open-heart surgery with a significantly longer recovery time, pay out of pocket or simply die waiting, quite at odds with the principles of positive ageing.
"This is an absurd situation that confounds clinicians and patients."
The company calls for Australia to make greater use of international examples of approval processes.
It recommends the collection of data on structural heart disease through state governments and the Australian Institute of Health & Welfare as a way to better understand the disease and contribute to more informed decision-making.
Other key recommendations are to require the Medical Services Advisory Committee and Prostheses List Advisory Committee to appear before a Senate committee once per year. It also says the committees should be required to report to the parliament once per year on the number of applications submitted, approved and refused.
It says decision-making should give greater weight to other forms of evidence, including real-world and patient preference studies, and the parallel processes used for therapeutics should be adopted for medical technology.