Biosimilars – how bio-simple are they really?
By Asha Patel, Keith Tsui, Jack Tabner and Bev Evans
Biosimilar / Definition:
A biologic medical product which is almost an identical copy of an original product and bears no clinical difference in quality, safety and efficacy when used.
Current NHS spend on the 8 most expensive biologic drugs is £1.66 billion, representing over 10% of total drug spend in the NHS. Our modelling as shown in Figure 1 below has found that adopting better value biosimilars represents a current opportunity of £671m by 2021 nationally – this would all be gained as direct savings, without compromising on quality of treatment for patients. This opportunity is likely to rise as more come to market.
Almost identical drugs. Much cheaper. Sounds simple.
This is the message being given to Medicines Optimisation teams across the country: switching patients over to biosimilars can be a silver bullet for driving down deficits. Furthermore, STPs are increasingly looking to accelerate this; eyeing biosimilars as a collaborative savings opportunity.
The NHS finds itself staring down the so-called ‘biologics patent cliff’ (see Figure 2); with many originator patents expiring, most notably, Trastuzumab (exp. December 2017) and Adalimumab (exp. 2018), the current highest spend drug in the NHS.
The time for action is now. Based on our experience working with multiple systems on medicines management initiatives, here are three lessons learned:
1. The availability of biosimilars is not money in the bank – savings are only delivered after a sustained programme of change
Biosimilar switching does not just happen overnight and requires a sustained delivery effort to educate clinicians and patients, and to change the behaviour of prescribers:
Firstly, we need to ensure prescribers understand the cost implications of their decisions – every time they prescribe the costly originator drug instead of the biosimilar, they are missing an opportunity to relieve a cost pressure. A cost saving should not undermine the principles of shared decision-making and patient choice. However, individual decisions have the potential to deliver huge savings for systems in aggregate.
Secondly, there is no quick and easy way to alter treatment for patients; they are the ones who ultimately deal with the consequences of these decisions and we must bear in mind that these drugs have the potential to be life-changing.
Thirdly, the adoption process for a new biosimilar can be time and resource intensive, involving:
- Engaging clinical specialists to gain buy-in and review data and adoption plan
- Agreeing adoption strategy and timeline
- Obtaining approval from Area Prescribing Committee
- Introducing product into pharmacy system and managing originator and biosimilar stock
- Communicating adoption process system-wide and to patients
- Updating prescribing systems for biosimilar
- Phasing out originator
- Tracking savings and analysing adoption rates – the list goes on...
Amidst operational pressures, this work can quickly be de-prioritised. More advanced STPs have mobilised programmes for pharmacy teams to work together to avoid unnecessary duplication of effort and share the lessons learned to expedite this process.
2. The current infrastructure does not incentivise organisations to prioritise this – whole systems need to drive the changes needed
Biosimilars should be a whole system priority. Drugs are currently a pass-through cost for providers and with the exception of Medicines Optimisation CQUIN payments, there is little incentive for providers to prioritise biosimilars switching.
The NHSE Commissioning Framework for biological medicines provides some helpful guidance, however infrastructural changes to truly incentivise switches are not forthcoming.
We have supported systems who have come together as CCGs and providers to collectively agree a 50:50 benefits sharing agreement to remedy this.
3. Biosimilars can present new risks to systems, which require careful monitoring to ensure resilience and continuity of supply
Recent supply chain crises, for example affecting the antibiotic Tazocin, have highlighted the importance of mitigating against potential shortages. If all systems adopt a gung-ho approach to switching over to the same biosimilar, this potential risk of shortages is intensified. Therefore, resilience needs to be built into the system with careful consideration of market dynamics.
Regional, or better still, national coordination is needed to ensure sufficient supplier spread and availability; to maintain flexibility of supply and to avoid price hikes from manufacturers.
To conclude, the biosimilars market is growing and many originator drugs will lose their patents in the coming years. Swift action is required now to realise the full extent of this opportunity and this starts with cultural and behavioural change. To consider biosimilars as a panacea for pharmacy services overstates their impact and underplays the project focus required. However, given the financial imperative, this is an opportunity too significant to be ignored.