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What next for biosimilars?

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James Roach, Director at West Essex ICP, looks at the future for biosimilar medicines, surveys a future landscape where medicines management will be performed at ICS level, and suggests that pharma can be a crucial player in NHS transformation

Establishing a firmer position for biosimilars in the medicines supply chain represents a huge opportunity; an opportunity for the pharma industry, the NHS and, most importantly, patients.

Is the NHS serious about capitalising on these opportunities? Well, a good measure of intent is commercialisation and the recently established Commercial Medicines Directorate within NHS England demonstrates its ambition to achieve maximum value within the increasing medicines spend.

The vehicle for the new directorate is the ten-year NHS Long Term Plan (LTP) and the 2019 Voluntary Scheme and a key area of its focus will be biosimilars. Already it is clear that driving up competition in this area of the supply chain could produce major savings, forecast at up to £300 million per year by 2021.

There are now over 20 biosimilar drugs available to patients in the UK and the picture is promising, with good rates of adoption across the country, although some regional variations remain stubborn – As recently as 2017, one NHS Trust in central London had an uptake of biosimilar infliximab of only 25%, whilst another just 16 miles away achieved an uptake rate of 99%. The situation is changing year on year and uptake of biosimilars to treat autoimmune conditions is strong, with biosimilar Etanercept hitting 82 per cent and biosimilar rituximab for cancer treatment, 73 per cent. However, while the supply chain is developing well with policy and pricing structures in place, if we are to complete the commercial equation, we need to increase demand. The standard ‘push and pull’ marketing approach operates here as it does in other markets and without this the commercial opportunities and savings potential will not be realised.

We all know that what we need is a policy and regulatory framework that frees up some of our senior clinical decision-makers to make things happen. That will create the ‘push’, but we also need to stimulate the ‘pull’.

We need to be more ambitious in the way we engage with patients and more challenging. Ultimately, this is a partnership. The industry needs to be ready and agile enough to align with the ambitions of the LTP and the Voluntary Scheme and make the goals of system-wide savings and better patient access and outcomes just as much its own as the objective of increasing market share. Biosimilars are the ‘win: win’ and as we invest more time in biosimilars we will create the space to test, diagnose and treat more people; all achieved in an NHS environment that is cash strapped. Because there is no new money, it is ever more important that we maximise the opportunity associated with biosimilars.

The future: strategic influence via integrated care systems

It is about engaging with impact and making biosimilars relevant in a changing NHS and capitalising on the opportunities for the biologics environment. One such opportunity is to be found in medicines management, which from 2021 will operate at an Integrated Care System (ICS) level. We will see somewhere between 40 and 60 ICSs across the NHS and that is where we start to look at strategic influence in engagement and scale, which means we can influence adoption and uptake of biosimilars at a regional level. It also means we can increase meaningful dialogue while seeing a decrease in the number of people with whom we need to speak. Getting a seat at the table and going through fewer doors to be heard.

At a local level, the advent of primary care networks (PCNs) brings further supply chain opportunities. It is becoming a space ripe for optimisation, adherence, switching and patient engagement. Often, prescribing is still done in a very clunky, old-fashioned way and modalities like electronic prescribing can unlock the prospects for change. It is an area where engaging with patients on options that suit their lifestyles, and put them in control, creates shared responsibility that supports choice and creates the ‘pull’ in the market.

What do we need from Pharma as it adjusts to operating within the LTP and the Voluntary Scheme?

The answer lies in how the NHS fits together. It represents a vast enterprise, a sum of its parts that should operate in concert but does not always achieve that. The word ‘concert’ suggests a useful analogy. At a concert, the prize-ticket is an ‘access-all-areas’ pass and that is what Pharma needs to have. The current conditions, structures and designs offer the right climate. Pharma needs to secure access by leading with evidence of impact, making the industry relevant to the whole health economy.

Whether at a population health or local level, Pharma must get buy-in. This can be achieved by using the data at its disposal to stimulate and manage dialogue with both decision-makers and patients. It is the intelligent use of data that will demonstrate the need to address upturn in demand, work harder to secure better outcomes and reduce health inequalities.

We need to view this not as creating more work but creating more powerful long-term benefits for patients and the health care system. Pharma can play a central role in supporting and reinforcing dialogue between health professionals and patients. The UK is unique in its relationship between the patient and the healthcare professional and Pharma needs to be part of that. There are openings for engaging in ways that are more relevant to a changing NHS.

Pharma underpins transformation

The NHS is about transformation and innovation, however, for some time now the received view of this is that innovation is all about procedures and devices. Pharma may have succumbed to this view and it now needs to address this. Medicines are the big game changer and the industry needs to do more to secure its place along the transformational trajectory.

The Pharma industry, its research and development work and access to life-changing, innovative drugs is well-felt within society. From antibiotics, NSAIDs and hormonal drugs to antiretrovirals, antimalarials and contraceptives, the lives of people across the world have been changed. Drugs have been, and remain, at the forefront of innovation and transformation.

None of this has been achieved without pharmaceutical and clinical underpinning; academic evidence on disease prevalence and opportunity to treat. Pharma needs to be bold in bringing that to the table to ensure that medicines have an equal place along with procedures and devices in the innovation dynamics.

In terms of prevalence, we need to be clear on the cost of prevalence and biosimilars can play a key part in addressing this in ways that serve the objectives of the LTP and the savings potential. Working with health systems, clinicians and patients to optimise therapies and medication will make a difference. Reducing need in the patient pathway and managing complexity differently requires the industry to be ambitious, confident and self-assured. There might be a degree of reluctance but there is a new clinical dialogue to be had and the time is right for it. The traditional NHS/pharma relationship is changing and biosimilars can drive it in new directions. The evidence is there in the fact that the product is already approved.

Conclusion

Biosimilars bring many opportunities, which can be better suited to the NHS, the conversation now needs to emerge around mutuality. We know the scale of ambition within the LTP and we know the size of the investment going in. We can align with the ambition and seek a share of the investment, however, the focus needs to fall beyond that. The critical point is how we maximise the benefit coming out of the new strategy. The new Medicines Directorate signals a growing commercial awareness and appetite within the NHS and it is about how the benefits are reinvested. Not just in the front-line care but also back into those companies that have taken the risk, have resourced a product and have invested accordingly. The risk and gain share has to be mutual and it is time for the industry to lead the conversation with the NHS about how we share the gain over the lifetime of the LTP. Biosimilars are the ‘starter-for-ten’.