The NHS plans to slash £300m from its annual pharmaceuticals bill by using biosimilar medicines – cheaper but equally clinically effective alternatives to the most complex to develop and therefore most costly drugs on the market, biologics.
Currently six of the 10 most expensive drugs in the UK are those derived from biological materials, such as viruses, and switching to biosimilars will not only deliver cost savings due to their lower price tag, it will also drive down the cost of the original drugs, as well as incentivising originator companies to bring new products to market.
Since biologics’ patents started expiring, the NHS has already seen significant cost savings, while continuing to deliver the same level of care to patients.
For example, biosimilar infliximab, which is used to treat rheumatology conditions and inflammatory bowel disease and came onto the market in March 2015, is currently being used by 80% of patients, while 58% of patients are using biosimilar etanercept, a rheumatology drug, which became available in April 2016.
Together, these treatments have already saved the NHS approximately £160m per year and as more biosimilars hit the market – most excitingly adalimumab, which next year will offer a biosimilar alternative to the medicine that currently accounts for the highest spend in hospitals – this impact will only become more pronounced.
Elly Earls sat down with Warwick Smith, director general of the British Biosimilars Association (BBA), which has worked closely with the NHS on its new policy, to find out why education will be crucial to its success and just how big an impact switching to biosimilars could have on patients.
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Elly Earls: How closely has the BBA been working with the NHS to develop this policy? Tell me a bit about the process to get to this point.
Warwick Smith: NHS England set up a committee called the National Biosimilars Medicines Programme Board (NBMPB) to bring together all stakeholders, which include ourselves, the ABPI [Association of British Pharmaceutical Industry], which represents originator companies, clinicians, patient groups, the MHRA [Medicines and Healthcare products Regulatory Agency] and NICE [National Institute for Heath and Care Excellence]. So everyone comes around the table and that group then inputs into NHS England’s decision on how biosimilars should be used.
For example, we’ve recently seen NHS England publish its commissioning policy to encourage the take-up of biosimilars and that was discussed with all of those groups around that one table, so when it was published, it had taken account of everyone’s views and all of the issues.
Separately, NHS England has set up four Regional Medicines Optimisation Committees (RMOCs) – their job is to review in each of the four regions of England the extent to which hospital trusts, commissioning groups and so on are following the commissioning guidelines.
NHS England really set up this infrastructure to take account of everybody’s views, publish a policy and then monitor and encourage its implementation.
EE: What have the main roles and contributions of the BBA been?
WS: The reason the BBA was first established was to provide an unbiased source of information about biosimilars. Biologics are a relatively new concept, although they have been around for 15-20 years. Our reason for establishing ourselves was to help the industry’s various stakeholders, such as clinicians, understand the science, understand the regulation and change their behaviour as biosimilars came onto the market. If you look at where biosimilars are not used to the extent they might be it is normally because of a lack of understanding. What we do is produce or signpost information that enables people to take properly informed decisions.
EE: What are the main things that healthcare stakeholders don’t understand?
WS: Firstly, if you look at the more traditional chemical medicines generics market, clinicians are trained to write the name of the active molecule – if you like the generic name – so the minute generics come into the market, because they’re less costly, pharmacists will tend to dispense them. With biologics, including biosimilars, the advice is that they should always be prescribed by brand name – so people have to understand that different way of prescribing them.
Secondly, the regulatory process and the science behind biologics are different. Because they are not synthesised chemicals – they are grown from cell cultures – there is always a degree of variability in them. It’s been necessary to reassure people that the degree of variability of the biosimilar is within the range of the degree of variability of the originator. Driving that understanding even amongst clinicians is actually quite difficult.
EE: As the policy gets underway, which patients will see the biggest impact?
WS: You can already see that the rate of use of biosimilars has increased for later launches. Three years ago, we were probably one of the slowest countries in Europe when it came to take-up, but we’re now becoming one of the fastest and I think that’s principally due to this process of education.
The diseases that have been treated by the initial launches are growth disorder, gastrointestinal conditions, such as Crohn’s Disease, and rheumatoid arthritis. And we are now seeing launches in the oncology space. So these are typically debilitating or life-threatening conditions, which are treated far more effectively by biological medicines than chemical ones.
The competition biosimilars bring in means two things. One, the price will reduce because that’s what competition always does, so the NHS can treat more patients for the same amount of money. And secondly, there might be other ways in which different manufacturers compete that are preferable for certain patient groups – this will result in increased choice for clinicians to get the most effective and easy-to-use product for their patients. At the end of the day, this is all about treating more patients in a better way for the same amount of money.
EE: What impact is this policy likely to have on originator companies?
WS: The experience with chemical generics is that competition after patent expiry acts as an incentive for them to research and bring to the market new products that don’t face that competition. I think we will see over time the same split that we’ve seen with originator chemicals and generics whereby the biosimilars will end up being the medicines of choice for patients who have conditions that we know how to treat and the originators will focus on meeting unmet clinical need by inventing new treatments. That becomes a virtuous circle with the patient at its heart.