The role of biosimilars in supporting the sustainable delivery of healthcare today and in the future
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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.