Will the promise of biosimilars ever be realised in Australia?

8 minute read

Four new biosimilars recently launched against blockbuster Humira. What can be done to encourage their use?

According to the Department of Health’s website, “the introduction of biosimilar medicines encourages competition in the market and lowers prices. This makes these medicines more affordable to the system and ensures that the PBS will be sustainable into the future.

“Biosimilar medicines on the PBS are expected to deliver significant savings which can be reinvested into other areas of the health system and improve access to biologic medicines by expanding treatment options when medicines become more affordable.”

A few years back there was much fanfare from the government about biosimilars and their potential impact on the PBS.

Initially there were concerns with safety data because biosimilars aren’t like generics which have exactly the same chemical makeup as their original patented target. Biosimilars are what is termed “highly similar”.

But there’s enough data now from the US and Europe on the major biosimilars for regulatory bodies and most clinicians all over the world to start approving and using them.

In 2019 the UK’s National Health Service (NHS) claimed to have saved £294 million ($A526 million) from its drug budget. A third of the saving, according to the NHS, came from switching to Humira (adalimumab) biosimilars.

The NHS says it now aims to have 90% of new patients being on the best-value biological medicine within three months of product launch, and 80% of existing patients within 12 months.

But that may not happen. There has been quite a bit of dissatisfaction from patients who claimed they were either not asked for their consent to switch (up to 40%) or felt that while given the opportunity for consent they were pressured into switching.

In Australia’s rheumatology market, which is the largest market next to oncology for savings, only the infliximab biosimilars have had much impact on pricing. Aside from the new-to-PBS Humira biosimilars, the only other currently available biosimilar is the Brenzys etanercept biosimilar for Enbrel, which has reached about 25% of market share without much impact on pricing.

The government provided incentives to rheumatologists to prescribe Brenzys by giving it a special streamlined prescribing status where rheumatologists could avoid a lot of paperwork and time normally associated with obtaining authority to prescribe. Patients, especially remote patients, also benefited from the streamlined authority.

For biosimilars predominately dispensed in retail pharmacy, the PBS creates no signal for anyone in the prescribing chain to change their prescribing behaviour when it comes to biosimilars, other than the availability of streamlined authority and encouraging the use of biosimilars for treatment-naïve patients.

Patient advocates, rheumatologists and regulators are wondering where biosimilars are heading, particularly now that there are four Humira biosimilars listed on the PBS with another planned for later in the year.

In a webinar on the topic held at the end of last year by Rheumatology Republic, a leading privately practising rheumatologist, Dr Irwin Lim, told an audience of interested parties (clinicians, regulators and pharmaceutical company representatives) that when faced with writing the script for a patient, “more choice is good but when there is more choice and it’s a very similar product then more choice can become confusing”.

“If you stop to explain to a patient that one will save the government more it’s very unlikely to lead to switching. You’d be taking a patient off something that they know is working and which they are used to.

“In many ways if you are going to have four biosimilars for one drug it makes life simpler if you just tell a doctor which one is the cheapest and we go for that.”

Dr Lim points out that the patient does not pay any differently for the originator biologic or the biosimilar.  

“The question I have for biosimilar companies will always be: why should I choose yours if it is not obvious to my patient or myself what is your advantage?

“There needs to be a signal, probably a pricing one,” Dr Lim told the webinar audience. 

He stressed that the signal didn’t need to be to him as the doctor, or even the patient, but the signal had to somehow inform the patient of what was going on.

That mechanism doesn’t currently exist in Australia.

Seth Ginsberg, global patient advocate and founder of CreakyJoints, told the webinar audience that ultimately the decision needs to be about what is best for the patient.

“Switching folks for non-medical reasons must be done with safety and care. 

“When you have a rheumatological condition and it takes you a lot of time in a relationship with your HCP to reach the right combinations of medicines, neither the patient or the physician is likely to want to change medicines. This is a real issue on uptake of biosimilars.

“This is where we get to the concept of the nocebo effect.

“Some manufacturers and governments have chosen to ignore the nocebo effect. Ignoring it is not in the best interest of patients.”

[Nocebo is the effect when a harmless substance or treatment offered to a patient or taken by one is  associated with harmful side effects or worsening of symptoms due to negative expectations…the opposite of placebo].

“Biosimilars are essentially for all intents and purposes generic biologics,” Ginsberg explained.

“Some patients won’t care if they’re switched, but it is wrong to assume that all patients will fall into this category, especially in rheumatology”.

Ginsberg points out that biosimilar manufacturers and governments in the US have been “tone deaf” when it comes to the most compelling arguments to switch to biosimilars, whether they are biologically naïve or not.

He says that the most common promotion of biosimilars really revolves around money and how much money they [the government] saves.

But there are two problems with that argument he says:

“People don’t see these savings at the point of care, or reflected off the back of their wallets. They may see them indirectly but indirect or future savings isn’t really a compelling argument for a consumer.

“Secondly, the innovator biologic has 20 years of profits and brand recognition and distribution and all that experience so they can just meet or beat any biosimilar price they want.”

In the US when a biosimilar for Remicade hit the market the manufacturer of the original biologic, infliximab, simply met the lower price, resulting in a substantial price drop. The biosimilar manufacturer was left with no market.  

In the short term that meets a government’s desire to reduce its bills on expensive pharmaceuticals. But if it became a significant pattern it would lead to market moulding, so fewer companies may invest in biosimilars and less price competition will result.  

The most influential mechanism in place so far to encourage prescribing of a biosimilar is streamlined authority.

Dr Lim says there are other differentiators that patients might take into account on initiation if the prescribing rheumatologists remains neutral to the use of a biologic or biosimilar, for example the comfort and ease of using the injection device.

Another possible differentiating factor is what patient support programs each manufacturer offers with their drug. AbbVie has a long-established and comprehensive program because of its history with Humira.

Dr Lim says that most people will ask the doctor’s opinion if there is a choice and then it is going to depend on the doctor’s position.

In the case of Humira biosimilars, it feels like the government will move to offer streamlined authority to any product they decide to give PBS listing, which would give that product a similar advantage in gaining market position as was given Brenzys over Enbrel.

But when there are four new biosimilars? That’s when things could become confusing for patients and doctors.

At the pharmacy end, the potential for confusion is huge under current legislation because if any of these new biosimilars are ‘a’ flagged, technically a pharmacist can substitute for Humira in that circumstance.

Dr Greg Kossena, community pharmacist and managing partner at Cowes Pharmacy in Victoria, assured the webinar audience that pharmacists would not be substituting in the case of biosimilars because biosimilars were a very different prospect to generics in the prescribing relationship with doctors.

He said that the path to establishing a patient on a biologic was a complex one which pharmacists would not want to interfere with. He also said the financial equation in the case of biosimilars versus generics was very different.

“There is no meaningful financial incentive for pharmacists to switch given the situation, and you wouldn’t for safety reasons anyway,” he told the webinar audience, referring to the difficulties patients might have in recognising and using different devices.

Which brings the biosimilar issue back to the point of there being no meaningful signals, other than a streamlined authority on prescription for anyone in the chain of prescribing, including the patient, to either initiate or switch from an originator compound.

“We were excited when biologics came online, and we were just as excited when biosimilars came online. The stakeholders – government, prescribing physicians and patients – are willing and should be embracing biosimilars because they represent hope and promise and improved access and lower cost. But we have to work together to make that happen,” said Ginsberg.

It will be interesting to see how that will play out for the Australian PBS, for doctors and for patients over the coming years.

This article was written by RR Staff. The Webinar from which parts of this article were written was sponsored by Sandoz, one of the biosimilar companies to get a PBS listing for a Humira biosimilar this year.

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