A wake-up call


time for change clock

A recent survey found that pharmacist comfort with supplying biosimilars is going backward, so what can be done to turn this around?

In 2018, 361 community pharmacists were surveyed across Australia about various facets of their role, including their level of comfort with supplying biosimilars and providing information on their use.

The UTS Pharmacy Barometer found comfort levels had decreased within 12 months—33% of those surveyed said they felt comfortable providing information to patients on the use of biosimilars, compared to 37% in 2017.

About 58% were neutral while 9% felt uncomfortable with providing biosimilar information.

There was also an overall decline in pharmacists’ level of confidence in substituting biosimilars: only 26% said they felt confident doing so, compared to 29% in 2017.

Sixteen percent stated they felt uncomfortable with substituting biosimilars altogether.

“It is disappointing to see that at this critical time for biosimilars, pharmacist comfort with supplying information has gone backwards,” says John Montgomery, Adjunct Professor at the UTS Graduate School of Health (Pharmacy).

“This is a wake-up call for all the stakeholders in this area given how important pharmacists are to biosimilar uptake.”

Additionally, when asked their overall level of preparedness to dispense to new patients, the proportion of pharmacists who said they were “prepared” declined from 33% in 2017 to 29% in 2018.

“Another key indicator such as preparedness going backwards solidifies the view that most pharmacists are not yet ready for biosimilars. This can be turned around, but action must be taken soon to address this issue if the promise of biosimilars is to be realised,” says Prof Montgomery.

“Pharmacists need to be confident in substituting as we’ve seen with generics. Without this, biosimilars will continue to struggle.”

Alongside a lack of confidence regarding biosimilars is a lack of awareness about resources for biosimilars that are available for pharmacists to access.

For example, the UTS Barometer pointed out a fifth (20%) of survey respondents were unaware the Department of Health’s ‘biosimilar awareness initiative’ existed.

The initiative aims to support awareness of, and confidence in, the use of biosimilar medicines for healthcare professionals and consumers.

“It appears little is being done to increase the awareness among pharmacists of the Department of Health ‘biosimilar awareness initiative’ introduced in 2015,” said the report.

These results highlight the need for greater effort to be made in educating pharmacists about resources they have available to them to assist the biosimilar substitution process, said UTS.
“Such a sustained low level of awareness shows that the initiative is simply not cutting through,” said Prof Montgomery.

Education and raised awareness are key to curbing falling levels of confidence and restore comfort in the provision of biosimilars.

consult pharmacy pharmacist patient consultation medication prescription

Biosimilars: complex, but not to be feared

Biosimilars are highly complex structures, but pharmacists can rest assured that those that have made it to market have gone through “very rigorous” testing, explains Associate Professor Michael Ward, discipline leader of Pharmacy Education at the University of South Australia.

“A biosimilar is a biologic medicine, be it insulin or a monoclonal antibody, that is produced by a second or alternate manufacturer once the patent has expired on the original branded product,” says A/Prof Ward.

“The process undergoes highly rigorous evaluation to assess the chemical structures of the reference product—the original branded product—and the biosimilar.”

Studies must demonstrate that there is no difference in safety or efficacy between the biosimilar and the original reference product, he told the AJP.

While there have been some concerns expressed about the safety to biosimilars, A/Prof Ward adds that based on all the data, biosimilars that have made it to market have gone through this highly rigorous chemical evaluation, in addition to Phase I and Phase III studies, before going to the regulator.

“We very much follow the European model of regulation here, it’s very detailed—some would describe it as a totality of evidence. And so that gives us a whole lot more confidence.”

What to know about substitution

Brands of biologicals and biosimilars that can be substituted by pharmacists are indicated in the Schedule of Pharmaceutical Benefits by an ‘a’-flag.

This is denoted by a small ‘a’ located immediately before brand names of a particular strength of an item.

A/Prof Ward points out that if a biosimilar has been a-flagged and the prescriber hasn’t ticked the ‘do not substitute’ box, pharmacists are able to substitute them without having to go back to the doctor.

“That’s a bit contentious, because some of the doctors would prefer to be notified,” he says.
“But the possibility is there.”

The Pharmacy Guild of Australia says it accepts that biosimilar substitution can be complex, and that some prescribers or patients may choose not to change their medicine regiments.

“This choice should be respected,” says the Guild.

“Where the patient requests substitution against the stated intention of the prescriber … the pharmacist should either discuss the matter with the prescriber or refer the patient back to the prescriber.”

David Ford, executive director Pharmacy and Redevelopment, North East Health, in an educational video for the Generic Biosimilar Medicines Association (GBMA), says community pharmacists who are not confident in substitution could consider speaking to prescribers before doing so.

“For community pharmacy, if they’re perhaps exposed to one of their first times of a substitution or a switching between biosimilar and they’re not quite sure whether they should or not, I would encourage them to speak to the clinician directly and just ask them whether they are comfortable to substitute one to the other,” he says.

“Now the clinician may have a view to say—‘look no, I want this person to stay on the originator because they’ve been a refractory patient in the past, and I’ve now got them stable and I really don’t want to mess with their therapy’. Or they might say, ‘actually I’m quite happy for you to substitute’.

“I think it would be worthwhile for that to happen,” says Mr Ford.

Professor Mark Naunton, Head of Pharmacy at the University of Canberra agrees that pharmacists should approach the clinician if there is any doubt.

“The data around biosimilar switching will continue to grow and pharmacists should be aware of this in case recommendations change,” he told AJP.

“If there is any doubt, pharmacists should consult the prescriber and patient before substituting any biosimilar.”

A biosimilar is an opportunity for patients to gain access to an expensive therapy, however it is important that only ‘a’-flagged medicines can be substituted by the pharmacist, he points out.

“Pharmacists should be consistent in the dispensing of biosimilar brands for patients on long-term therapy as multiple changes in brands may lead to confusion for patients and possibly prescribers,” says Prof Naunton.

“It is important for pharmacists to highlight that the dose and dosage regimen of their medicine will not change, because biosimilars are designed to be given at the same dose and dosage regimen as their reference biological medicine.”

He also highlighted that biosimilars may have a different device functionality that patients need to be made aware of.

“Pharmacists should be aware that biosimilars may have different injection device functionality so they should check that the patient can use the new biosimilar device, if being changed from the innovator brand or other biosimilar,” says Prof Naunton.

A/Prof Ward highlights that there is a requirement for pharmacists to educate the patient on this.

“The [biosimilars] we’re talking about for community pharmacy, they’re the ones that patients will administer—the subcutaneous injections,” he says.

“A biosimilar manufacturer has their own device, which is different to the device used by the original reference product. And so patients will see that it looks different and it maybe functions a little bit differently.

“That’s not necessarily a bad thing, it might in fact be that the newer device that the biosimilar manufacturer is using is a better device. But certainly that need for patients to be educated on that device is really important.

“One of the things that gets raised by some of the prescribers is that they might’ve had a nurse do a whole lot of education of the patient and it might have been around the originator product device.

And then they go to a pharmacy and they get a biosimilar, then the patient may not know how to use that product. So the awareness of the device is really important because that’s the thing that patients see.”

Patients who are unable to understand and manage change may be at increased risk of medicine misadventure from substitution, says the Pharmacy Guild.

“Pharmacists should assist patients and their carers when choosing medicines to reduce confusion or misadventure,” it says.

Mr Ford says there are various other forms of information to provide to patients when supplying biosimilars.

“Counselling patients for biosimilars is an important part of the process,” he says.

“I think the role of the pharmacist is to reassure those patients that this is quite appropriate and safe and that the effects that they can expect are equivalent and the same.

“If we had a patient who was starting on a biosimilar, we would ask the hospital pharmacist to go and speak to them, answer any questions or concerns that they may have.

“We would provide them a consumer medication information leaflet which have all the details on that,” adds Mr Ford.

“We may even provide them an information leaflet on the originator product so they can compare and see that they are relatively the same.

“We may refer them to various websites or perhaps studies that they might want to look up on their own and really give them the opportunity to ask the pharmacy department or the pharmacist at any time any questions or any concerns that they have.

“Really be quite open and provide the information to them so they are comfortable that this substitution to a biosimilar is safe and effective and will not cause any problems associated with their treatment.”

A review of the products

Many of the biosimilars available are not ones that community pharmacies would commonly deal with, A/Prof Ward said.

“Etanercept would be the one most common in community pharmacy, because that’s a subcutaneous injection that patients self administer,” he said.

graph made of medicines

The etanercept reference brand, Enbrel, is ‘a’ flagged, which means pharmacists can substitute it with the biosimilar product Brenzys for initial and first continuing phases of treatment under Written Authority.

‘A’-flagging was also recently reinstated by the Department of Health for subsequent continuing treatment with etanercept for eligible patients with severe psoriatic arthritis, ankylosing spondylitis, severe active rheumatoid arthritis, or severe chronic plaque psoriasis.

This change means pharmacists can now dispense Brenzys for patients who present with a Written Authority script for subsequent continuing treatment with Enbrel 50mg/mL.

Brenzys remains the only etanercept brand with a Streamlined Authority Approval for the subsequent continuing phase of treatment, explain sponsor MSD.

However the Streamlined Authority prescriptions for Brenzys are not ‘a’-flagged themselves and cannot be substituted for Enbrel.

“This means that Enbrel prescriptions at the subsequent continuing treatment phase with a Written Authority approval can be dispensed [as] the Brenzys biosimilar unless ‘brand substitution not permitted’ has been marked by the doctor,” says Margie Austin, Speciality Care Director at MSD Australia.

“This is an important change that reflects the government’s confidence in biosimilars and its commitment to support uptake of these medicines,” she says.

According to MSD, more than 8,000 Australians have been receiving etanercept each month through the PBS since April 2018.

During the month of April 2019, four in 10 (40.8%) of patients starting on etanercept 50mg/mL were initiated on Brenzys.

“This is a substantial group of patients that pharmacists can engage to discuss the potential for brand substitution through ‘a’-flagging,” said Ms Austin.

“It’s about giving patients choice while explaining the role of biosimilars and their importance in delivering potential savings to the PBS.”

With online education platforms now available, Mr Ford says community pharmacists need to actively seek out more information on biosimilars.

“For a community pharmacist now, they perhaps need to start thinking that complex proteins and fusion proteins and monoclonal antibodies are no longer the domain of hospital practice, that they will become the domain of primary care practice,” he said.

“They need to actively seek out education opportunities and start to make themselves aware of these products and what they do clinically, and the advice that they’re therefore going to have to give their patients when they come to them and ask them questions about biosimilars and substitutions, just like happens in hospital practice now.” •

A/Prof Michael Ward is an author of the International Biosimilar Medicines Quarterly Reviews for GBMA Education, for which compensation is received. In relation to this interview, no payment was received and the views are expressed are his own.

This article was originally published in the July 2019 print issue of the AJP.

Biosimilars resources

1. The Biosimilar Hub run by GBMA Education has extensive resources on all things biosimilars.

2. The Department of Health’s Biosimilar Awareness Initiative includes fact sheets on biosimilars.

3. The Australian Journal of Pharmacy has a CPD module on biosimilars that is available online, with accreditation available if completed by 12 September 2019.

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