Posted: 12 September 2024
Have you ever had to wait for an important and expensive medicine to be subsidised?
A new independent review aims to address what has been a longstanding issue in the health system as part of a study of inequitable access to medicines in the hope of bringing about widespread change.
The most remarkable recommendation could see waiting times for subsidised treatments — particularly for ultra rare diseases — slashed from several months to just four weeks.
The federal Health Minister Mark Butler has heralded the Health Technology Assessment review as “visionary”.
But what does it recommend?
Let’s take a look.
What was the review looking at?
As its name helpfully suggests, the review was looking at what’s known as “health technology assessment,” which refers to the process where experts look at health technology like devices, vaccines and drugs to determine how safe, effective and cost-effective they are.
That assessment informs federal government decisions about what to subsidise on programs like the National Immunisation Schedule (all the free vaccines you get at different stages of your life), or the Pharmaceutical Benefits Scheme (PBS), where patients receive important and sometimes lifesaving medicines at a small portion of the cost — currently about $30.
Often these medicines would otherwise cost hundreds of thousands of dollars, and patients like Luna, who the ABC spoke to in June, are left in limbo waiting for them to be listed on the PBS.
There’s long been criticism from patients and pharmaceutical companies that the process to assess health technology takes too long and involves excessive red tape.
This report was charged with examining that and was the first complete review of the system in nearly 30 years.
What did it find?
The review found there were areas of inequitable access to medicines, particularly for children and First Nations people.
It found many medicines integral to the health and wellbeing of Indigenous Australians aren’t on the PBS, and noted the average amount spent on the PBS was $167 for Indigenous Australians, compared to $427 for non-Indigenous Australians.
“These figures bring into sharp focus the issues First Nations people face in gaining equitable access to medicines,” the report said.
It also found access to PBS-listed medicines for Australians under 18 needed to be addressed, saying that’s because it’s harder to source the clinical data needed for regulatory approval for children, which in turn slows down the process.
Overall, the review found people are waiting a median time of 22 months for medicines to be listed on the PBS (which means that only 50 per cent of new drugs are subsidised in that time period – some take longer).
What are its key recommendations?
The review makes 50 recommendations to streamline processes so that people can access medicines earlier.
One is that submissions to the Therapeutic Goods Administration (TGA), the regulator that approves medicines, and to the Pharmaceutical Benefits Advisory Committee (PBAC), which recommends medicines for the PBS, should be done at the same time.
Doing that would mean 90 per cent of promising new medicines could be listed on the PBS within six months of TGA registration, the review said
That’s compared to the current median time frame of 22 months.
Vaccines could be subsidised in 18 to 22 weeks, while treatment for ultra rare diseases could be placed on the PBS in as little as four weeks.
Another recommendation would see the assessment for therapies expanded so that rare cancer patients could gain access to medicines already subsidised for common cancers.
The review also recommends establishing a First Nations Advisory Committee to address the inequities in access for Indigenous Australians.
What’s been the response?
The findings have been welcomed from advocacy and pharmaceutical groups, that say it will mean Australians will be able to get vital medicines much more easily.
Rare Cancers Australia (RCA) said the review offered promise for “long-awaited reforms”.
“People living with rare, less common and complex cancers have been waiting for change that will deliver timely and affordable access to the medicines they need; now they need an urgent response and action from the government to make these recommendations a reality,” RCA CEO Christine Cockburn said.
Medicines Australia CEO Liz de Somer said the report had found urgent need for a system overhaul.
“Without these changes, Australians will continue to miss out on the best medicines available now, and the revolutionary treatments that are on the horizon,” Ms de Somer said.
Mr Butler said the federal government would set up an implementation group to consider and oversee the recommendations.
“The HTA Review Report is far-sighted enough to be visionary, while being firmly grounded in the practicalities of the here and now,” Mr Butler said.
“The goal is faster access to the best therapies, at a cost that patients and the community can afford. Value for money remains paramount, because value is at the heart of patient benefit.”
