For Danielle Formosa, the difference between having access to her MS medication and not having it isn’t abstract. It’s the difference between walking her dog and being unable to get out of bed. Between working full-time and being too exhausted to work at all. Between a brain scan showing no new damage and one showing three fresh lesions in six months.
Danielle, 46, was diagnosed with Multiple Sclerosis in July 2025, on top of a lifelong diagnosis of Neurofibromatosis Type 1. “Lucky me,” she says, with the kind of dark humour that people carrying more than their share of illness often develop.
For the past year, she has managed her MS with Kesimpta (ofatumumab), one of a small group of high-efficacy disease-modifying therapies that have transformed what an MS diagnosis means in Australia.
In July, the federal government confirmed that Kesimpta, along with Ocrevus (ocrelizumab) and Lemtrada, would remain listed on the Pharmaceutical Benefits Scheme (PBS), at least for now. But buried in that announcement was a second decision: a “rapid review” of how these MS drugs are used on the PBS, due to report back in December. Until then, nothing is truly settled.
For thousands of Australians like Danielle, that means another five months of not knowing.
Danielle describes what Kesimpta has meant for her life in stark, physical terms. Before starting treatment, she was living with daily pain, migraines four times a week, and could not walk for more than ten minutes without her strength giving out. She was going to bed at 6pm from exhaustion and still waking up depleted. She dropped from full-time to four days a week at work, fearing she would soon have to drop further, or stop working altogether.
“I was in constant pain and in tears on some days as I didn’t know what was happening to my body,” she says.
Since starting Kesimpta, that trajectory has reversed. Her most recent brain and spine MRI showed no new lesions, a striking contrast to the scan taken before treatment began, which showed three new lesions had appeared in just six months. She is more active, sleeping properly, and is now considering a return to full-time work.
“To say this treatment has changed my life is truly an understatement,” she says. “I just want to enjoy my life like I am now and not go back to being scared of the unknown.”
That is what makes the prospect of another review so unsettling: not because the drugs have been removed from the PBS, but because the possibility hasn’t gone away. It has simply been deferred.
The numbers make clear why this matters so much. Off the PBS, Kesimpta costs around $2,231.82 per injection, administered monthly, which works out to more than $26,000 a year. On the PBS, that cost falls to roughly $25 a month, or $300 a year. For Danielle and for many others, that gap is not a matter of tightening the belt. It’s the difference between staying on a treatment that works and going without.
“Without the PBS subsidy, many vulnerable Victorians and Australians like myself will face rapid physical and neurological deterioration simply because we cannot afford treatment,” Danielle says.
The current uncertainty traces back to a pricing dispute triggered by the PBS listing of a cheaper, comparable drug, Briumvi, in late 2025. Under the PBS’s reference pricing rules, drugs considered clinically similar are often expected to align in price. That put pressure on the makers of Ocrevus, Kesimpta and Lemtrada to accept substantial price cuts, reportedly as steep as 50 per cent, or risk their drugs being delisted or restricted.
The Pharmaceutical Benefits Advisory Committee (PBAC), the independent body that assesses which medicines are cost-effective enough for public subsidy, met over three days to consider the issue. Health Minister Mark Butler said the committee’s advice was clear.
“The experts confirmed what the MS community has told us – that there are clinical benefits from continuing to list Ocrevus, Kesimpta and Lemtrada on the PBS to make sure these drugs continue to be available for people that need them at the PBS price,” Minister Butler said.
But the PBAC also recommended something else: a rapid review of how these drugs are actually being used, to make sure their PBS listings and relative pricing reflect current clinical evidence. The government accepted that advice.
“To that end, PBAC recommend a rapid review be completed by December this year and I have accepted that advice,” Butler said. “Ocrevus, Kesimpta and Lemtrada will remain on the PBS while the rapid review takes place.”
Roche, which manufactures Ocrevus, welcomed the government’s public commitment but was direct about the stakes involved. In a statement issued the day before the announcement, the company said a potential delisting “would have far-reaching consequences for thousands of MS patients, their families and medical teams.”
What’s often missing from the policy language of “rapid reviews” and “therapeutic relativities” is the toll the process itself takes on people who are already managing a chronic, unpredictable illness.
Stress is not a neutral bystander in MS. It is well established that psychological stress can worsen the disease’s daily burden, heightening fatigue, amplifying pain perception, disrupting sleep, and in some patients, correlating with increased relapse activity. For a community already contending with a condition defined by uncertainty, not knowing when the next relapse will come, or what part of the body it will affect, a five-month wait to find out whether an effective treatment will remain affordable adds an entirely separate, avoidable layer of psychological strain.
MS Australia has acknowledged as much, describing the initial threat to PBS listings as a source of “significant uncertainty” for patients, families, carers and clinicians. The organisation’s relief at the interim announcement was real, but so is its recognition that the underlying question hasn’t been resolved, only postponed.
It’s worth remembering how recent this progress actually is. For decades, MS had no disease-modifying treatments at all, only therapies to manage individual relapses. The first disease-modifying drug, interferon beta, wasn’t approved until the 1990s, and even then it offered only modest reductions in relapse rates for a subset of patients.
The past fifteen years have changed that picture dramatically. A new generation of high-efficacy therapies, including B-cell depleting drugs like ocrelizumab and ofatumumab, target the immune mechanisms driving MS more precisely than earlier treatments, and have been shown in clinical trials to substantially reduce relapses and slow disability progression. For many patients, these drugs haven’t just slowed the disease; they’ve allowed people to keep working, keep raising families, and keep living lives that a diagnosis once threatened to upend.
That is precisely why their PBS status matters so much, and why any perceived threat to that access, even one paired with reassurances, lands so heavily on a community that has watched treatment options expand within living memory, and worries about that progress going into reverse.
For the next five months, Ocrevus, Kesimpta and Lemtrada remain listed on the PBS. The Department of Health will work with the companies that make them while the review is carried out. MS Australia says it will participate in that process and continue advocating for outcomes that reflect the reality that, as the organisation puts it, MS is “a complex and highly individual disease” for which “no single therapy is right for every person or at every stage of disease.”
For Danielle, the review’s outcome in December will determine a great deal. But the months in between are not neutral, either.
“I can’t reiterate how much I need this medication,” she says, “along with many, many other MS sufferers with a similar story.”
Regardless of the talks between companies and the government these drugs should remain on the BPS
Drug companies basically do whatever they like until someone stops them. The price of testosterone depots almost tripled last year after the pharmaceutical company split a three pack of individual injections into packs of one injection in order to sell them at an inflated price. I complained to the watchdog which did not even bother to get back to me. This isn’t a free market this is a monopoly that uses standover to privatise profit and socialise loss.
I use Fampyra and its not even on Pbs Why?