But reservations remain about the government’s selective streamlining process Government efforts to promote biosimilar use through streamlined authority prescriptions appear to have worked, with more than double the use of the etanercept biosimilar, Brenzys. The government has been gunning for an increased uptake in biosimilars, considering the major expense biologics are to the taxpayer. While […]
But reservations remain about the government’s selective streamlining process
Government efforts to promote biosimilar use through streamlined authority prescriptions appear to have worked, with more than double the use of the etanercept biosimilar, Brenzys.
The government has been gunning for an increased uptake in biosimilars, considering the major expense biologics are to the taxpayer.
While far less frequently prescribed than most other drugs on the PBS, the hefty price tags of biologics put them among the most expensive drugs in the healthcare system.
Rheumatologists seem keenly aware of the need to ensure treatment is sustainable, however questions surround the safety of the biosimilars in certain contexts.
The government’s 2015 decision to default to treating biosimilars as generics, enabling switching at the pharmacy level, was treated with alarm by specialists and community groups, who worried about the lack of evidence for the safety of switching between the original biologic and a biosimilar.
However, the ability for prescribers to tick a box preventing brand substitution initially appeared to stall uptake of the biosimilars. Up until December last year, Brenzys only accounted for around 2% of the etanercept market, but it has since jumped to 5% or more.
From 1 December, doctors have been able to use a streamlined prescribing authority for any subsequent continuing prescriptions of biosimilar etanercept, Brenzys (MSD), the biosimilar equivalent of Pfizer’s Enbrel. However, prescribing the original etanercept, Enbrel, still requires the formal application for authority, creating a blatant deterrent to its use.
AMA President Michael Gannon raised concerns about the selective streamlining process last year when it was proposed, calling it a “blunt regulatory tool” and a “heavy-handed” approach. The move lacked logic, given both the biologic and biosimilar were listed on the PBS at the same price, and neither drug was clinically superior, he said.
“The AMA cannot support this measure which has nothing to do with safety and quality, and appears mostly to benefit certain pharmaceutical companies.”
Former president of the Australian Rheumatology Association, Dr Mona Marabani, also expressed reservations about the streamlining process, saying the decision to allow patients on biosimilars a quicker and more efficient authority process while preventing the same for users of other biologics was a matter of “equity”.
The association has advocated for streamlined prescribing for all biologics for a number of years.
“That a patient who is appropriate for any biologic other than biosimilar etanercept is unable to access streamlining, and has to go through the whole formal application process every single time, is unfair,” she said. “Those patients may have to wait several weeks for their scripts to be processed. The current wait time is around a month.”
She said the figures showing only modest results from the uptake drivers indicated clinicians were also cautious about transitioning patients established on originator biologics to the new biosimilar drugs.
“The fact that there hasn’t been a stampede to either not prescribe by brand, or not tick the box, suggests that people do have concerns,” Dr Marabani said.
“At the moment there is no good reason to switch an existing patient who is stable and doing well, other than because the government is removing the paperwork. Is it an advantage to the patient? Is it going to be cheaper for the patient? Is the biosimilar cheaper for the system? No.
“The doctor will have less paperwork, but I don’t think that’s a very good way of making a clinical judgment about what’s best for a patient.”
While she said that switching old patients who were being successfully treated to a biosimilar was “not logical”, Dr Marabani supported the initiation of treatment-naïve patients onto biosimilars.
A white paper released by the American College of Rheumatologists earlier this year recommended the use of biosimilars as a method of bringing healthcare costs down.
“We are now confident that providers can recommend biosimilars as a safe, effective and affordable option to patients, where appropriate,” lead author and college spokesperson Dr S. Louis Bridges Jr said.
“The frequency of binding and neutralising antidrug antibodies has been similar between biosimilars approved in the US to date and their reference products, and there have been no signals to suggest a differential effect of antidrug antibodies on efficacy, safety, or patient outcomes between biosimilars and their reference products,” the authors wrote.
However, they did note that there were no biosimilars considered “interchangeable” and thus able to be switched multiple times at the pharmacy level, unlike the default position Australia has taken.
Dr Marabani said there was some evidence around multiple switches, but the studies were “very small, few and of short duration”.
“Etanercept isn’t especially immunogenic, but we don’t know what would happen with month-to-month switching between biologic originator and its biosimilar/s.”
“More evidence is needed to reassure prescribers that repeated switches would not lead to loss of efficacy or unexpected toxicity,” she said.
Dr David Liew, consultant rheumatologist and clinical pharmacology fellow at Austin Health in Melbourne, said that ongoing pharmacovigilance will be vital in the wake of these measures.
It was also an area in which it was important for clinicians to take more responsibility than simply following the PBS guidelines, he said.
“Doctors need to be intelligent about the way they use medications. Just because doctors are allowed to switch multiple times, it doesn’t mean that they should.”
