Keeping up with biosimilars


Pharmacy has a prominent role in the supply and provision of biosimilar medicines, and the profession has been slow to come to terms with this. Is the situation now changing?

In 2015, the Pharmaceutical Benefits Advisory Committee (PBAC) made the decision to consider the marking as equivalent—or “a” flagging—of biosimilar medicines and their reference products.

In August of that year, the PBAC “a” flagged Inflectra (infliximab), a biosimilar of Janssen’s Remicade, used to treat a number of inflammatory conditions including rheumatoid arthritis and psoriatic arthritis.

The move was welcomed by groups including the Generics and Biosimilar Medicines Association, but other groups expressed concern and the PBAC moves towards “a” flagging sparked a debate about whether it was appropriate for pharmacists to substitute biosimilars for originator drugs.

The central role of pharmacy in the provision and substitution of biosimilars has been highlighted recently with four adalimumab biosimilars listed on the PBS in April, an event described by an industry speaker at APP2021 as “a significant day for community pharmacy”.

A valuable addition

The Federal Department of Health’s Biosimilar Awareness Initiative says: “The introduction of biosimilar medicines encourages competition in the Australian market leading to a reduction in the cost of medicines, and savings to the healthcare system. These lower prices improve affordability of, and access to new treatments for seriously ill patients.”

The Biosimilar Awareness Initiative calculated in 2017 that there would be around $367 million cost saving if biosimilar versions of selected biological medicines were available and subsidised on the PBS.

However, “the speed of uptake and adoption of biosimilars in Australia has been slower than originally expected,” the Department of Health has said.

Despite this initial slow uptake, the market share for biosimilars is expected to increase and manufacturers will continue to register biosimilars in Australia.

“The introduction and uptake of biosimilars is expected to deliver significant savings, improve competition and increase access for patients in Australia,” the Department of Health says.

Pharmacist preparedness on the rise

Introducing a session on biosimilars at APP2021 this year, Lisa Golden, Group General Manager—Marketing, Arrotex Pharmaceuticals, said Australian pharmacists hold “quite a unique position, very different to other pharmacists around the world, in so far as you’re able—through the ‘a’ flagging on the PBS—to switch a patient at point of dispense.”

Given this unique role, how are pharmacists understanding this role, now more commonly dispensed medicines, such as adalumimab, are available as biosimilars?

The 2021 UTS Community Pharmacy Barometer found that the level of preparedness among pharmacists to deal with biosimilar medicines has increased.

The Barometer, which surveyed 360 pharmacists, found the level of preparedness in biosimilar substitution was up by 17% from the previous year (increasing to 52% of respondents).

However, the level of confidence remained similar to previous waves (36% versus 34% in 2020 and 29% in 2019). The increased preparedness may begin to translate into increased confidence, the report’s authors speculated.

“Biologics continue to remain one of the highest PBS expenditures. Increased continuing professional development has supported the increased preparedness of pharmacists to deal with biosimilar medicines, and it is hoped that a growth in confidence will ensue,” they said in the report conclusions.

The UTS panel said it was “promising” that fewer pharmacists expressed having limited confidence in biosimilar substitution—down by 8% this year (from 15% to 7%).

However, the majority of respondents (57%) were neutral about substitution, while the percentage expressing confidence remained stable at 36%.

“A larger increase in confidence would have been expected given the education programs in place. It took time to build confidence in the early days of generics and biosimilars seem to be on a similar trajectory,” said UTS Associate Professor John Montgomery.

“Increased support has been made available to pharmacists through continuing professional education materials to aid substitution and build confidence. We are yet to see the full impact, suggesting the strategy to improve substitution may need to be reconsidered,” he said.

“It appears the educational activities are having some effect in preparing pharmacists for biosimilar substitution, however more work needs to be undertaken to improve pharmacist confidence so the potential cost savings can be reflected in health budgets.”

The awareness challenge

While pharmacist awareness of biosimilars was improving, there were still gaps in the knowledge of prescribers and patients alike, said Anthony Tassone, Pharmacy Guild of Australia (Victoria).

One obvious challenge around biosimilar substitution is when prescribers have chosen the ‘brand substitution not permitted’ option.

In some cases prescribers had written letters for patients to present at the pharmacy saying: “This is the medication that my patient will be prescribed”, he said.

“Some pharmacists can take that to mean a massive don’t argue, and don’t want to speak about it. I still encourage myself, and my pharmacist team, to reach out to that prescriber and make them aware of the biosimilar products available.”

“Another challenge can be the lack of a price differential for out-of-pocket cost for the patient, if it’s the same price to them, and also just awareness, which we’ll go through as well, that it is improving, but at the moment it can be a lack of awareness around biosimilars,” Mr Tassone said.

“We’ve encountered this [lack of awareness] before… 10 years ago when we spoke about generic substitution and these days we’re very adept and confident in saying that, albeit it’s a new conversation, slightly nuanced, but we’re more than capable of doing it and if we’re capable, speaking about it.

“Patients will feel more comfortable hearing it and practice makes perfect, as well, so the more times you try, the more confident you’ll become.”

The right language

Professor Michelle Leech, head of the Rheumatoid Arthritis Clinic, Monash Health, said given the lack of patient knowledge, we need to be careful with the terminology and framing around biosimilar substitution.

“The way we speak to patients, the amount of fear we instil, has a hugely powerful effect on the take-up of medicines. We also have a responsibility to instil hope in our patients, to reduce their fear and anxiety,” she said.

“We need to think about the way we speak about biosimilars, using language like ‘it’s the identical twin’ or ‘the twin brother or sister’.

“Saying to patients: ‘I expect you should respond to this in the same way [as to the reference]’, it’s not a guarantee, or, ‘I don’t anticipate any side-effects that you wouldn’t have seen with your original medicines’.

“You could frame things like ‘3% of patients had a terrible outcome’ or you could say, by contrast ‘97% had an excellent outcome’.

“The framing is very important as is simplifying the language and reducing the language of fear. If we do this, I think cost-effective therapies can be taken up in this country as they should be.”

“If I were starting all over again, I’m not sure I’d choose the name biosimilar,” she said. “Similar is not strong enough to describe what these things are… Bioequal or bioequivalent better describe what these medicines are and do.”

Startling stability

Prof Leech said the stability of disease activity on patients switched to a biosimilar had been “startling”, highlighting the efficacy of the medicines, but also the lack of public awareness at the moment.
Her clinic conducted a cross-sectional study of 127 of patients who were using the biosimilar for etanercept.

Only 6% of the group had heard of biosimilars when first asked—in 2019.

“Once we’d explained it to them, 75% said they would be comfortable to use a biosimilar if it was recommended by their rheumatologist.”

“About 25% were unsure or would refuse a switch.

“Concerns included: not sure about new medicines, efficacy, cheaper things don’t work as well, new syringe, safety, scared of change.

“We’ve since started new patients on the etanercept biosimilar, and have switched over most existing patients, and anecdotally we haven’t seen any change in therapy response.”

The reasons for substituting

Anthony Tassone said biosimilar substitution would form an essential part of future PBS affordability measures.

“Why should we suggest a biosimilar? For one, the PBS is a world class system that needs to be carefully looked after in terms of investment. Biosimilars give us a significant opportunity to create headroom in our major health insurance scheme for medicines.

“Back in 2018/19, eight of the 10 highest expenditure PBS medicines were biologics, and these were for managing chronic conditions. So their biosimilar substitutes give headroom for our taxpayers.”

Mr Tassone said biosimilars also offer patients greater choice.

“Biosimilars have different products, and we’re seeing it with adalimumab with regards to the pen devices that are coming. There’s a lot of innovation. The manufacturers of biosimilar products are investing in these devices that may be preferable for some patients, more convenient to use.”

“Don’t be afraid when you’re having a conversation about a biosimilar—actually get the product out of the fridge and show them,” he said.

“Manufacturers of biosimilar products also have put together a range of patient support programs, and these can be really useful and beneficial for patients because patients don’t know what they don’t know.”

For the full article, including an industry perspective, see our July magazine or e-magazine 

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