Biosimilars in the UK: where are we now and where does the NHS want to go?

The UK health service has well over a decade’s experience of dealing with biosimilars, but the NHS acknowledges that it has yet to make the most of these drugs.

That was certainly one of the messages from a ‘state of the biosimilar nation’ event I attended over the summer in London, and it’s not a surprising one.

The first European biosimilar approval in 2006 for a version of a human growth hormone was, to some extent, a false dawn for the sector, in as much as it didn’t pique widespread financial interest from healthcare stakeholders.

That only came more recently, as patent expiries for the blockbuster anti-TNF class of arthritis drugs approached. Now that the likes of Remicade (infliximab), Enbrel (etanercept) and, most importantly, Humira (adalimumab) have to compete with biosimilar versions, the NHS is grappling with how to make the most of this opportunity.

Thus, it made sense for Anne Marie Morris MP, who is also chair of the All-Party Parliamentary Group on Access to Medicines and Medical Devices, to outline the “huge opportunity” that biologics present.

“Biosimilars are clearly a new and big issue for us,” she said, introducing Westminster Health Form’s Biosimilars in the NHS – Commissioning, Development and Engagement with Clinicians and Patients event in London.

“We need to ensure that there is access to NHS patients for these biosimilars and we need to be an attractive market so that biosimilars are developed here and not, dare I say, in the USA. But we also need to take patients with us, because these are different medicines,” she said.

The place for biosimilars within the NHS

Exactly how the NHS is working to ensure biosimilar access was comprehensively explained by Suzy Heafield, a commissioning pharmacist who works for NHS England and NHS Improvement as head of medicines value and sits within its relatively new Commercial Medicines Directorate.

Prior to that she was a clinical pharmacist in Nottingham and then a commissioning pharmacist working for Clinical Commissioning Groups (CCGs) and the Primary Care Trusts (PCTs) that preceded them.

She noted that, from a commercial point of view, there are two key recent policy documents that drive NHS England and NHS Improvement’s commercial policy, including its approach to biosimilars. One is the NHS Long-Term Plan and the other the Voluntary Scheme for Branded Medicines Pricing and Access.

The Commercial Medicines Directorate’s mission was, she said, commercially-focused, but clinically-led.

“So, our commercial activity is fundamental to supporting patient access. Our priority is to allow access to the latest innovative and most clinically-effective new healthcare treatments and solutions. But at the same time, we want to make sure we secure maximum value for the NHS and taxpayers from its ever-growing spend on medicines and other healthcare solutions.”

And there are big numbers at stake. Last October Humira (adalimumab), still the world’s biggest-selling drug, came off patent in Europe, after which the NHS struck an historic biosimilar deal that represented the biggest saving in its history from a single drug negotiation.

Looking further ahead, NHS England envisages savings as a whole from biosimilars of some £400 - £500 million per year by 2021, if it can increase uptake of ‘best value biologic medicines’.

This would give the health service “headroom to be able to fund new treatments and to improve access to patients”, Heafield said, adding that NHS England is eyeing up being able to use some of the money saved for new investments into improving care pathways.

To do this, the Commercial Medicines Directorate is running the Best Value Biologics Project to enable appropriate use and uptake – whether of the originator product or a biosimilar version.

She explained: “Where a best value biologic isn't the originator, we're looking at switching and how we can enable switching. The introduction of biosimilars drives greater competition and releases cost-efficiencies through competition, and it also supports increased access to biological medicines.

“So, we may be looking at access to biologics at an earlier stage in the treatment pathway. Or we may be looking at access to new innovative medicines.”

As examples of some of the newer, expensive treatments coming through that would need to be funded somehow, Heafield cited CAR-T and gene therapies.

NHS biosimilar uptake

The NHS has a steep uptake target for adoption of the best value biologic product, aiming for 80% of patients to be using it within one year of a biosimilar version first becoming available.

It didn’t achieve that with Remicade and Enbrel, which were the first two anti-TNF biologics to face competition. In fact, Remicade took 28 months to reach the 80% target, and after 12 months Enbrel had only reached 50% of eligible patients.

That changed with the next two biosimilars to come online, which were versions of the cancer drugs MabThera (rituximab) and Herceptin (trastuzumab). This time around incentives were put in place under a Commissioning for Quality and Innovation (CQUIN) framework and there was closer working with the Cancer Vanguard and NHS Improvement.

“We saw a massive change in the uptake of rituximab and trastuzumab – with rituximab we achieved 80% uptake at month ten after launch, and trastuzumab at month eight,” Heafield said.

After MabThera and Herceptin it was all eyes on Humira for the NHS and uptake of the ‘best value biologic’ versions of the arthritis drug was heading towards 67% at month seven, but it still faces regional variation in uptake.

“It just shows that something like adalimumab requires a whole system approach to drive the change that we required, and it has been successful. But obviously we won't be resting on our laurels,” said Heafield.

One of the next priorities for biosimilars in the future is to plan for the next Humira tender, because the initial NHS agreement was only signed for a year so will in theory expire in December. But Heafield and the NHS’ Commercial Medicines Directorate also have plans for a more nuanced approach to the use of biosimilars.

“We need to work with clinicians and patient groups to determine if, and when, we should look at biosimilar-to-biosimilar switching. Up to now all we've been saying is originator-to-biosimilar. There's now evidence emerging around biosimilar-to-biosimilar, but again this can't be a ‘done to’, it has to be a ‘done with’, and at the appropriate time,” she concluded.