Patients are being hit with excessive costs on a range of everyday prescription medicines because of flaws in the way Australia subsidises essential pharmaceuticals.
The ABC has compiled a list of common medicines dispensed as what are known as private scripts, which are not subsidised under Australia’s Pharmaceutical Benefits Scheme (PBS).
It means these scripts do not fall under the $25 maximum price tag introduced to the scheme last month.
Australia’s PBS was designed to cover the cost of life-saving and disease-prevention medicines and it funds more than 900 medicines across more than 5,000 brands.
However, health advocates told the ABC there were some regularly purchased drugs that had fallen through Australia’s regulatory cracks.
These include a range of incontinence medicines, ear drops, eczema creams, inhalers, hormone replacement therapy and painkillers.
Many scripts sell at a moderate price point for $20 to $100 but, because patients often need to use them long-term, the costs can add up.
The ABC has found it is not that the medicines have failed to meet the scientific and cost-benefit evidence standards required for PBS subsidy; it is that for business reasons the makers have never even applied.
Patient advocates said that for pensioners and other disadvantaged groups, the failure to get the PBS subsidy meant they were not able to get their medicine at a $7.70 concession price and there was no relief under the PBS safety net scheme for long-term use.
Consumers Health Forum of Australia chief executive Elizabeth Deveny said for patients with chronic illness the costs of private scripts could add up to a significant financial burden.
“It 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,” she said.
Elizabeth Deveny says it is not always commercially viable for some drug makers to apply for PBS listing. (Supplied: Darryl Torpy)
In some instances, she said, medicines were not funded because makers could not justify spending nearly half a million dollars to apply for PBS listing in Australia’s small market and then negotiate a competitive price with the government.
“For some companies, they will make more money if they don’t go through that process because they can charge whatever they like,” Ms Deveny said.
“So it’s a commercial decision.”
Advocates say it is a flaw in Australia’s subsidy program, which relies on makers operating in a global market to submit their medicine for funding.
“For some people, their medicine and access to their medicine is actually more important than access to their GP,”
Ms Deveny said.
Medicines Australia, which represents pharmaceutical companies, said sometimes the patient cohort in Australia was too small to justify listing and in other instances medicines were cheaper than the new $25 co-payment — but not necessarily the $7.70 concession price.
“We do think there are some things that we can do to the system to improve equity of access,” chief executive Liz de Somer said.
Patients going without essential medicines
Specialist doctors say a key group of patients affected by the flaws are those suffering urinary incontinence — estimated to be up to one in three Australians over 15.
Four of the incontinence medicines available in Australia not subsidised under the PBS. Tamsulosin is only funded for veterans. (ABC News: Ben Wishaw)
There are at least six drugs on the market to help with the condition by restricting bladder muscle movement, but just one — oxybutynin — is funded under the PBS.
Urological Society of Australia vice-president Ashani Couchman said oxybutynin came with a risk of bringing on dementia and was unsuitable for many aging women — the group most likely to need them.
“It is a rather worrying medication that has worrying side effects,”
she said.
Oxybutynin is the only incontinence medicine subsidised under the PBS but comes with a risk of dementia. (ABC News: Dan Irvine)
Adelaide nurse Amanda Braund is among those patients who take oxybutynin and she is concerned about this risk, given she has a family history of dementia.
“I’ve seen what my mum went through, but if you’re taking a medication that may exacerbate dementia, that’s the last thing I want to do,” she said.
“There’s not many affordable options. You think, ‘I’ll go for the cheaper one and hope for the best.'”
Amanda Braund takes a medication for incontinence but it comes with a risk of dementia. (ABC News: Marco Catalano)
Dr Couchman said it often meant her older patients had pay up to $80 a month for an alternative, which added up to nearly $1,000 a year.
But she said many patients simply could not afford the cost and instead put themselves at risk of falls and skin ulcers associated with incontinence, along with its many social impacts.
“This is certainly a significant issue and it’s a shame because continence impacts so many in the community,” she said.
Sanofi, which makes oxybutynin, told the ABC its product, sold under the brand name Ditropan, should be used with caution in the elderly and this was in the production information.
Heart drugs come with PBS restrictions
Similarly, cardiologists told the ABC they were concerned about drugs that had a PBS listing but carried so many restrictions on their subsidised use that they regularly had to prescribe them as private scripts.
These include a cholesterol medicine called Repatha, triglyceride medicine Vazkepa, blood thinner Eliquis and beta-blocker bisoprolol.
The blood thinner Eliquis is among the heart medications with many PBS funding criteria attached, meaning it is often prescribed as private script. (ABC News: Rebecca Armitage)
According to the federal Department of Health, the PBS is supposed to provide timely, reliable and affordable access to “necessary” medicines.
The Pharmaceutical Benefits Advisory Committee (PBAC), which decides on subsidies, is made up of health economists, doctors and drug experts.
It meets every three months and makes its decisions based on value for money compared to a drug’s potential health benefit.
The PBS funds more than 900 medicines across more than 5,000 brands.
Ashani Couchman says patients are struggling to access affordable incontinence medicines. (ABC News)
Dr Couchman said specialists and patient groups should be able to have more input into PBS funding decisions.
“There are times where you might go actually this medication, which has been on the PBS for so long may not be fit for purpose. Perhaps we could revisit how we want to spend that dollar,”
she said.
A spokesperson for the Department of Health and Aged Care said it regularly considered requests from patient groups and clinicians to improve access to specific products.
“Other entities or individuals are permitted to make formal applications to the PBAC to have health technologies funded, or have funding arrangements for health technologies changed. However, practically, these applications require cooperation and assistance from the supplying companies.”
Medicines falling through the cracks
The ABC found in other instances ownership of a drug had been passed between companies and PBS listing had fallen by the wayside.
Or there was an assumption at the company level that the Pharmaceutical Benefits Advisory Committee (PBAC), which decides on subsidies, would not look on the drug favourably because of prescribing trends.
It has prompted Medicines Australia to call for the government to speed up reforms to the PBS funding process outlined in its recent Health Technology Assessment (HTA) review.
Statistically only one in four new medicines introduced to the global market get subsidised in Australia.
Up to 1,000 drugs are approved over a decade by the safety regulator the Therapeutic Goods Administration but rejected by the PBAC.
Medicines Australia’s Liz de Somer said the PBS funding system had not kept pace with scientific advances. The PBAC assesses the economic merits of a potential drug by weighing it against older “comparator” drugs — but sometimes the two drugs are not necessarily closely related.
Liz de Somer says reforms from a recent government review should be fast-tracked. (ABC News: Joel Wilson)
“The system uses very old comparators, obsolete or older unused medicines as comparators, and that does make it very difficult for companies,” she said.
The industry wants proposed reforms to be fast-tracked, including speeding up approval times which are on average 466 days.
“Australia is becoming a less attractive destination for bringing new medicines,”
Liz de Somer said.
“Progress has been too slow and we certainly think that the rubber is hitting the road now.”
Even then, those changes could not force companies to submit their drug for consideration and Elizabeth Deveny said other avenues for help should be considered, especially for those who cannot claim scripts on their private health insurance.
“The PBS is a safety net. It can only catch people if their medicine is on the PBS,” she said.
So why are the drugs not funded?
Echo Therapeutics, the owners of pain killer Temgesic, bought the medicine in 2022.
Its general manager, Jude D’Silva, said because it was an addictive opioid for short-term use they decided not to apply for PBS listing “to help promote the safe and responsible use of opioids”.
Avamys inhalers are among the items not on the PBS. (ABC News: Alison Branley)
GSK, which sponsors Avamys nasal spray, said it was first registered in 2008 and prior to that intranasal corticosteroids were being removed from the PBS.
“So, in short, the environment would never have supported a PBAC submission for Avamys.“
In the case of HRT, one pharmaceutical insider told the ABC that until the recent announcement by the federal government to list Estrogel, they would not have considered PBS listing for their HRT product as it was unlikely to pass.
Novo Nordisk, the makers of HRTs including Trisequens, Kliovance, Kliogest, and Estrofem, said they did not apply for listing for reasons that were “commercial in confidence”.
A spokesperson said they supported recent federal government announcements to invest in women’s health and “we support initiatives that improve patient access”.
Many HRT patches do not get a PBS subsidy but that is starting to change. (Getty Images: BakiBG)
Similarly Bayer, the maker of contraceptives and endometriosis treatments, welcomed recent moves to the PBS to list more women’s health medicines and said it was re-evaluating whether to submit some of its drugs for listing.
“Bayer has been heartened by the PBAC’s renewed consideration of these long-standing medicines,” a spokesperson said.
Government trialling new approaches
Dr Couchman said many issues could be resolved with regulatory reform.
“It takes a small investment to make a large change. We’re not talking about billions here; we’re talking about small, low-cost medications that can make a huge impact.“
In a statement, Health Minister Mark Butler said the government had added or changed 385 products to the PBS since 2022 including new contraceptive, menopause and endometriosis treatments.
He said the government was working through HTA review recommendations with the help of consumer and medical experts, and they were working to improve patient engagement.
They were also trialling new ways to streamline medicine assessments and doing rapid research into unmet clinical need.
“We know patients want fast access to cutting-edge medicine and treatments,” he said.
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