The pressure is growing on Australia’s Pharmaceutical Benefits Scheme (PBS). The difference between approved effectual medications and the ones that get subsidies continues to lag further behind. In recent months, industry experts have sounded the alarm on the viability of drug listings. They focus on the damage done to patients’ economic fortunes and the immediate actions needed to help patients get access to the essential medicines they need.
As Elizabeth Deveny, Chief Executive of Medicines Australia, explains, this misconception creates a critical problem. She explains that for many pharmaceutical companies, pursuing PBS listings can be economically unviable. Over the last 10 years, Australia’s Therapeutic Goods Administration (TGA) approved close to 1,000 medications. However, shortly after the Pharmaceutical Benefits Advisory Committee (PBAC) rejected them. The PBAC continuously considers each drug to assess whether or not it is value for money. This process leads to the rejection of many promising treatments that could improve patient health.
The PBS was established with the intention of providing life-saving and disease-preventing medications, currently covering over 900 medicines across more than 5,000 brands. However, statistics reveal a troubling trend: only one in four new medicines introduced globally receives subsidization in Australia.
Financial Viability and Submission Challenges
The monetary cost of applying for a PBS listing weighs heavily, preventing many drug manufacturers from even taking this route. Deveny’s points to a much larger and more troubling problem. This leads many companies to be reluctant to invest close to $500k on a PBAC submission, especially when they doubt their chance of success.
“For some companies, they will make more money if they don’t go through that process because they can charge whatever they like,” – Elizabeth Deveny
This economic factor further muddies the waters for the patients who rely on these medicines. Deveny further notes that patients often face multiple out-of-pocket expenses when visiting pharmacies, suggesting a systemic issue in how medicines are accessed and funded.
“May not be that they’ve got one medicine to buy, but maybe it’s half a dozen every time they go to the pharmacy,” – Elizabeth Deveny
The industry and advocates alike have been calling for some urgent reforms to make the process more efficient and less burdensome. Currently, the average time for PBAC approval stands at 466 days, a delay that many argue is unacceptable given the rapid advancements in medical science and treatments.
Impact on Patient Access
Health Minister Mark Butler has recognized the urgent demand for more rapid access to new medicines. He understands that for patients, they are growing ever restless to get faster access to advanced, new treatments that can promise them much better life and function.
“We know patients want fast access to cutting-edge medicine and treatments,” – Health Minister Mark Butler
For patients with chronic conditions like urinary incontinence, it can be especially difficult. At least one in three Australians over the age of 15 live with chronic pain. Only Oxybutynin is currently on the PBS subsidised. One antidepressant is actually associated with serious adverse side effects, including development of dementia.
Dr. Ashani Couchman pointed to the lack of affordable incontinence medicines as putting patients between a rock and a hard place financially. For example, getting just four boxes of non-subsidized incontinence medications can get cost-prohibitive.
“It is a rather worrying medication that has worrying side effects,” – Dr Ashani Couchman
Another medication, Tamsulosin, is funded only for veterans, which means many Canadians don’t have access. The Avamys inhaler is an instructive, if simplistic, example. Its manufacturer decided against seeking PBS listing as they felt there was no commercial future in it for them.
“So, in short, the environment would never have supported a PBAC submission for Avamys.” – GSK
The Need for Reform
Indeed, the landscape around pharmaceutical funding within Australia is changing quickly and dramatically. Leaders in the industry counter that it is keeping up with the scientific developments. According to Liz de Somer from Medicines Australia, Australia is at a crossroads. As a consequence, it is rapidly becoming a more unattractive place to launch new medicines.
“Australia is becoming a less attractive destination for bringing new medicines,” – Liz de Somer
De Somer laments the unsustainable practice of making those payments based on ancient comparators. This reliance prevents companies from being able to meaningfully prove the value of their products.
“The system uses very old comparators, obsolete or older unused medicines as comparators, and that does make it very difficult for companies,” – Liz de Somer
As well as outlining these achievements, de Somer reiterates that progress needs to move faster, as advocates make attempts to reform systems to make access to vital medicines easier. She argues that the reform’s snail-like pace is more and more seeming counterproductive and obvious.
“Progress has been too slow and we certainly think that the rubber is hitting the road now.” – Liz de Somer
