The role of biosimilars in supporting the sustainable delivery of healthcare today and in the future
According to the Brundtland report, published in 1987 by the World Commission on Environment and Development, sustainability (and sustainable development) is most commonly described as “development that meets the needs and aspirations of the present without compromising the ability of future generations to meet their own needs.”
In relation to sustainable healthcare, for governments around the world, being able to deliver sustainable health services relies on maintaining a balance between three intimately connected pillars, namely the environment, society and the economy.
The Sustainable Development Strategy for the NHS, Public Health and Social Care System (2014) provides a more healthcare specific definition and talks about sustainable health systems working within the available environmental and social resources, protecting and improving health now and for future generations.
This means working to reduce carbon emissions, minimising waste and environmental pollution, making the best use of scarce resources, building resilience to a changing climate and nurturing community strengths and assets.
A critical element of this strategy focuses on leveraging effective commissioning and procurement strategies for products and services, including medicines, some of which are hugely expensive and are causing significant financial pressures.
Along with many stakeholders in healthcare, The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its member companies believe that outcome- or value-focused approaches to healthcare hold the key to a more sustainable, healthier future for Europe.
With over 7,000 medicines in development (as of 2014), a new wave of innovation will play a key role in addressing the challenges faced by patients, healthcare systems, and society. The irony is that patients will only be able to benefit from this innovation if it’s affordable now, and sustainable in the future. Managing the rising demand for healthcare and medical innovation in a sustainable way is perhaps one of the biggest challenges facing governments around the world today.
Biosimilars represent one of the most attractive enablers of sustainable healthcare as they offer the promise of lowering costs, improving patient access and supporting the delivery of better clinical outcomes.
According to the European Society for Medical Oncology’s (ESMO) past-President, Professor Fortunato Ciardiello, “Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale as well as significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world.”
According to IQVIA, the use of biosimilars in France, Germany, Italy, Spain and the UK alone stands to offer savings of more than €10 billion between 2016 and 2020. The challenge is that these savings must be delivered in a sustainable manner.
Significant discounts to previously expensive biologics, like Humira, might be attractive to governments in the short-term, but a race to the bottom in terms of price, and the commoditization of biosimilars is a significant threat to the market’s sustainability.
To sustain the market for biosimilars in the long-term, ongoing benefits for all stakeholders must be ensured. Sustainable policies must, therefore, provide for patient access and physician prescription choice, provide a means to manage existing healthcare budgets for payers, and safeguard a healthy level of competition, supply, and product safety and quality.
It would seem that the message is getting across to some of the bigger European nations. For example, in the UK, NHS England decided to put in place a special tender for Humira biosimilars in September 2018 in preparation for their launch in October 2018, and their eventual availability on the NHS from December 2018.
In 2017/18 the NHS spent over £400m a year on the original branded adalimumab product Humira, treating approximately 47,000 patients, making it the medicine on which the NHS currently spends the most each year.
NHS England’s procurement strategy for Humira biosimilars focused on two key objectives; plurality (i.e. to ensure plurality of supply for adalimumab over the longer term) and best price (i.e. enabling NHS England to achieve competitive prices from suppliers with guaranteed shares for more competitive bids).
The outcome of this has been a highly competitive market in the UK where no single adalimumab biosimilar has been awarded the entire market. Instead, four adalimumab biosimilars (Amgevita, Hyrimoz, Imraldi and Hulio) have been launched and are being used across the country. According to early market uptake data from IQVIA, Humira biosimilars captured 10% of the market in the UK within the first three months of launch.
Sustainable business models like these are required in order to deliver long-term benefits for biosimilars. Commercial strategies that focus on winning at all costs are short-sighted and are likely to result in companies withdrawing from the market and minimising the impact biosimilars could have on the health of patients around the world.