Alison Moore reports on an HSJ roundtable which explored how the biosimilars market can be expanded, what the potential benefits and challenges are, and what needs to be done to increase uptake

 

Panellists

Alastair Henderson, chief executive, the Association of Royal Medical Colleges – chair

Keith Ridge, chief pharmaceutical officer, NHS England

Kavya Gopal, head of specialty, Sandoz and chair, British Biosimilars Association

Vin Diwakar, medical director, NHS London

Kalveer Flora, specialist pharmacist rheumatology and biosimilars, London North West Healthcare Trust

Tim McCarthy, drug resource manager and clinical commissioning pharmacist, Royal Marsden Foundation Trust

Stephen Brown, regional pharmacist, NHS Improvement and NHS England, south west and south east

Andrew Davies, professional lead for hospital pharmacy, NHS Improvement

Paula Wilkinson, chief pharmacist, Mid Essex CCG

Claire Jacklin, director of external affairs, National Rheumatoid Arthritis Society

Vanessa Burgess, assistant director, NHS Lambeth

In association with

 

 

 

Summary

One of the opportunities for the NHS to save money and improve patient access to drugs over the next few years lies in increasing the use of biosimilars – cheaper copies of existing complex drugs.

Biosimilars are already used in some specialties – such as rheumatology – but as more come to market, potential savings increase. This HSJ roundtable looks at how these can be maximised, what the potential benefits are, and asks what needs to be done to maximise uptake.

Communication and education – whether with doctors, nurses or patients – was seen as key, together with payment systems which incentivise use of biosimilars where appropriate.

There was also a recognition that the market for biosimilars needed to be sustainable to persuade companies to put resources into developing more of them.

Opportunities

Biosimilars offer opportunities for the NHS to save money – and potentially to improve access to some costly drugs. But despite much success in encouraging uptake, it is still patchy and more can be done to ensure that these benefits are realised.

That was the overriding message of an HSJ roundtable looking at biosimilars – medicines which are increasingly being used to replace “originator” biologic drugs.

The savings for the NHS are significant and are already beginning to be realised. “We are at a point where drug expenditure in England is £17.4bn a year,” said Keith Ridge, chief pharmaceutical officer, NHS England. “It remains the biggest spend after staff. In that context we need to get the best value.”

Biosimilars offer the opportunity to make £200-300m in savings up to 2020-21, he added – “a very significant contribution to the sustainability of the NHS.” The positive news is that there has been a good uptake for some existing biosimilars, with £170m saved for the NHS in the first 10 months of 2017-18, added Andrew Davies, professional lead for hospital pharmacy at NHS Improvement.

But with more originator medicines going off patent – including adalimumab later this year, which is used for Crohn’s and rheumatoid arthritis and costs the NHS hundreds of millions of pounds a year – there are additional opportunities to make savings.

A commissioning framework for biologics including biosimilars is now in place, aimed at rapid uptake as more of them become available.

Benefits for patients

But will there also be benefits for patients? Vin Diwakar, medical director for NHS England’s London region, said using biosimilars could improve access for patients. “For the individual patient or group of patients the benefit of bringing in biosimilars mean that they are more likely to be available and used much earlier in your care,” he said.

There was evidence that the introduction of biosimilars had led to more people getting access to the medication as overall prescribing had increased.

However, director of external affairs at the National Rheumatoid Arthritis Society Clare Jacklin pointed out that access to medicines was often determined by National Institute for Health and Care Excellence guidance.

The positive news is that there has been a good uptake for some existing biosimilars, with £170m saved for the NHS in the first 10 months of 2017-18

With rheumatoid arthritis, this means patients have to reach a certain level of disease activity and should have tried a different medicine before the biologic or biosimilar is used. Individual patients will benefit only if that level is lowered, allowing them to get access to biosimilars earlier in the progression of their condition.

While cost savings might enable more patients to be treated in principle, for the individual patient there would be no difference unless NICE changed its guidance, she added.

Mr Ridge suggested clinical commissioning groups could chose to fund these drugs at a lower level and added he was meeting with NICE and NRAS to discuss the particular issues around this.

 

 

Barriers

However, there can be barriers to using biosimilars including the level of knowledge and willingness of clinicians to change. In some cases, they are willing to prescribe them but need an opportunity to discuss the move.

In the south west, the clinical senate spent a day considering biosimilars, with input from national bodies and regulators as well as patient organisations. The outcome was positive support for them, said Stephen Brown, regional pharmacist NHS Improvement and NHS England, south west and south east.

Awareness among clinicians may vary from place to place and is likely to be higher in specialties where biosimilars are already prescribed – such as rheumatology.

Awareness among clinicians may vary from place to place and is likely to be higher in specialties where biosimilars are already prescribed – such as rheumatology

Paula Wilkinson, chief pharmacist at Mid Essex CCG, said she had found this in her area, where the rheumatologists were very much on board with the idea of using biosimilars but the gastroenterologists less so. In Lambeth, giving clinicians the chance to learn from different specialties who had already made the move to biosimilars had been tried, explained Vanessa Burgess, assistant director at NHS Lambeth.

Dr Diwakar said that knowledge varied between specialties with the cancer vanguard project on biosimilars, for example, producing a lot of information. He added that clinical champions were important – which was also highlighted by Kalveer Flora, specialist pharmacist rheumatology and biosimilars London North West Healthcare Trust, who said that investment in clinician time was important.

“When we get our clinicians champions and give them time to see patients in clinic, it is realistically the only way patients will transition,” she said. Mr Ridge said some clinics had large numbers of patients. The speed of progress on switching to biosimilars was limited by the number of conversations which needed to be had, he said.

Making the switch

Sometimes invest-to-save can help smooth the transition to biosimilars by providing additional support. Ms Wilkinson said: “We realised very early on that when you are making a change like this you needed some additional investment to make the change.”

A bad switch could result in the patient not feeling confident and wanting to switch back, she said. Her CCG had invested in a pharmacist to help get everyone on board but savings should also be used to look at medicines optimisation around biologics as well.

She stressed that starting work early – in advance of a medicine coming off patent – was important. Mr Brown suggested that one useful approach might be for patients to be told when they are started on biologic medicines about the possibility of switching to biosimilars at some point in the future, so that any proposed transition does not come as a surprise.

Switching to biosimilars is not as easy as changing a patient from a branded pill to a generic one. Because many are infused or injected, there can be an increased need for education of patients and the healthcare professionals around them.  In the cancer vanguard, there had been a lot of work around educating patients and also working with patient groups, said Tim McCarthy, drug resource manager at the Marsden Foundation Trust.

Because many biosimilars are infused or injected, there can be an increased need for education of patient and the healthcare professionals around them

Savings from using biosimilars had been used to invest in extra specialist nurses and pharmacists, and improve access for some niche groups, Ms Wilkinson added. However, a national steer on some of this would be helpful in avoiding a postcode lottery.

Switching to biosimilars is ultimately a decision by a clinician and a patient, and is likely to involve a discussion about the best thing to do. Ms Jacklin was concerned about the position of clinical nurse specialists who are often the main point of contact for patients who need advice or to talk things through. In some district general hospitals, there would only be a single CNS to deal with this.

There’s an important role for data in helping trusts and CCGs understand how they are doing on biosimilars and where the remaining opportunities lie. Biosimilars feature in the model hospital work under the Carter review.

Three out of 10 of the top medicines in the model hospital were biologics with biosimilars available, said Mr Davies, and uptake of them was being tracked on a monthly basis with data being fed into the medicines optimisation dashboard. Regional medicines optimisation committees are also important in promoting uptake.

But however much data can help at a local level, relationships are important in the transition to biosimilars. Ms Burgess said: “Where the relationships are not in place it is quite difficult and they struggle.”

As in so many changes in the NHS, what is needed is clinical time and headspace, strong local relationships and good communication, concluded Mr Henderson. “It’s possibly nothing intrinsically different it is about doing those things right that will get the benefits,” he said.

What are biosimilars?

Many medicines are relatively simple molecules that are straightforward to manufacture and formulate. But biologics tend to be much more sophisticated molecules that are not as easy to make – but are extremely important and effective medicines to treat conditions, such as a range of cancers, rheumatoid arthritis and certain gastrointestinal conditions.  

“There are life-changing medications and they are very important therapeutically,” said Mr Ridge. However, this complexity of manufacture means expensive equipment is needed with a strong emphasis on safety. Biologics tend to be expensive: six of the top 10 medicines globally by spend are biologics.

Many biologics are now beginning to come off patent, offering opportunities for competitors to bring their own versions to market at potentially lower prices. These are known as biosimilars.

Many biologics are now beginning to come off patent, offering opportunities for competitors to bring their own versions to market at potentially lower prices

Mr Ridge says that the regulation around these focuses particularly on the manufacturing process to ensure they are getting the right molecules. Ms Gopal added that the European Medicines Agency required patient studies as part of the licensing process for biosimilars. “We have to show that in patients we get the same outcomes with biosimilars,” she said.

Biosimilars are still prescribed by brand name – unlike generics – and they can’t be automatically substituted for the originator medicine. One reason for this is that using a biosimilar is not like substituting one pill for another; many are infused and require equipment and processes around the administration which differ from brand to brand.

“You are not just prescribing a drug, you are prescribing a device,” said Ms Wilkinson. Brand prescribing also enables greater tracking of the medication given.

GPs are not likely to prescribe biosimilars – this is mainly done by hospital specialists – but both they and community pharmacists may deal with patients with other conditions who are also taking biosimilars.

Medicines that have come off patent and have biosimilars available include:

Infliximab – used for ankylosing spondylitis, rheumatoid arthritis and inflammatory bowel disease.

Etanercept – used for auto-immune diseases such as rheumatoid arthritis.

Rituximab – used for non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia and some auto-immune diseases.

Creating a sustainable market

Companies that start to produce biosimilars will need to make a major investment in manufacturing these medicines. Not surprisingly, they are concerned about whether the future market for them in the UK will justify that investment.

One way to help this may be through different payment models. Mr Brown said there were early discussions around whether there are better ways to pay for these medicines than the current system. Some areas – such as NHS Lambeth – have a value framework where they are looking at the value of the medicines in terms of patient and other benefits rather than just the cost.

But trusts may need incentives such as gainsharing – many biologics are funded on a “pass through” basis where the costs are passed onto the CCG. In specialised commissioning, a commissioning for quality and innovation has been used to encourage rapid uptake of new biosimilars.

Ms Wilkinson suggested one approach would be to agree an overall payment for managing a patient on a biologic or biosimilar and then leave it up to the clinician or trust to choose which one to use.

Price was not everything, Mr Brown suggested, and sustainability of supply was also important – something which was being built into the NHS tenders for biosimilars. For example, when one leading biologic goes off patent later this year there will be 57,000 patients who could be switched.

Because changing from one biosimilar to another is complex – patients will need to use different devices – switching suppliers may come at a cost

However, many of these patients receive their medication at home as an injection and need a reliable delivery of the drug and to be shown how to inject. Mr Brown pointed out: “Yes, we have to get a good price but we also have to get resilience of home care around it.”

And because changing from one biosimilar to another is complex – patients will need to use different devices – switching suppliers may come at a cost. “Flip flopping” between different biosimilars to get short term savings may not be good value if staff and patients have to adjust to new devices each time.  

Ms Jacklin pointed out that having patients on multiple different biosimilars could also be confusing for clinicians and nurses – and might be time consuming. Some biosimilars use devices and changes would need to be explained to patients, which was often down to specialist nurses.

Mr Brown stressed that the need for resilience of supply was being taken on board in the tendering process. “There is no way we can have a situation of a race to the bottom and everyone trying to overtake each other to get a slightly cheaper product,” he said.

Ms Gopal also warned that Brexit could add additional costs to the supply chain and could make releasing new products more challenging. The UK could also cease to be part of the first release of new medicines, which are often released earlier in the EU than elsewhere.