Pharma and biosimilars in the medicines supply chain

Pharma, biosimilars in the medicines supply chain

Establishing a firmer position for biosimilars in the medicines supply chain represents a huge opportunity for pharma, the NHS and, most importantly, patients. James Roach and Johnny Skillicorn-Aston explain more.

Is the NHS serious about capitalising on the opportunities presented by biosimilars? 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 spend on medicines.

The vehicle for the new directorate is the ten-year NHS Long Term Plan (LTP) and the 2019 Voluntary scheme for branded medicines pricing and access, and a key area of 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 etanercept biosimilar hitting 82% and biosimilar rituximab for cancer treatment reaching 73%.

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.

Comparison with other markets

Looking at other markets, there is a useful analogy to be found in the automotive aftermarket industry. A significant element of its commerce is the manufacture and supply of non-original replacement car parts. These are parts that have no meaningful difference to those produced by the original car manufacturer and yet offer choice and competitive pricing for the consumer; market opportunity for manufacturers, independent service agents and suppliers and stimulate competition.

The UK automotive aftermarket revenue stands at just under £22bn, supports 345,000 jobs and contributes just over £12.2bn to the economy. Moreover, it creates savings for the end consumer by reducing the average annual spend per car. Customers in the auto aftermarket are aware of how to operate within it. Both supply-side and demand-side policies and approaches combine effectively and relationships between policymakers at national and European government level and industry organisations are strong and active. Moreover, engagement with consumers is a key focus for the industry with the number of independent manufacturers, distributors and retailers remaining buoyant.

An example of increasing sales can be found in the value of online transactions, with a growing confidence in ‘click and fit’, where vehicle owners buy replacement parts online for later fitting at their convenience. In 2016, this stood at just under £1bn and it is anticipated to rise to around £1.65bn by 2023 (Society of Motor Manufacturers and Traders SMMT)

Where does this analogy lead us? Similitude exists in other industries and there are lessons to be learned. The transactional and financial attainments within the automotive aftermarket haven’t happened by chance. They are the result of lobbying and dialogue that have created a policy and regulatory framework.

Back to pharma

Let’s get back to our own industry and biosimilars. 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 them we will create the space to test, diagnose and treat more people; all achieved in an NHS environment that is cash-strapped. As there is no new money, it is ever more important that we maximise the opportunity associated with biosimilars.

It is necessary to engage with impact and make biosimilars relevant in a changing NHS and capitalise 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 44 ICSs across the NHS and that is where we start to look at strategic influence in engagement and scale, meaning 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.

At a local level, the advent of primary care networks 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 ‘pull’ in the market.

Roll of pharma

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 doesn’t always achieve that. The word ‘concert’ suggests another 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 healthcare system. Pharma can play a central role in supporting and reinforcing dialogue between healthcare professionals and patients. The UK is unique in its relationship between patient and 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.

The NHS is about transformation and innovation, however, for some time now the perceived 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.

Opportunities of biosimilars

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 frontline 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 have to be mutual and it is time for 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’.

James Roach is Director of Conclusio Limited. Email jamesprroach@yahoo.co.uk

Johnny Skillicorn-Aston is Engagement and Communications Lead at Conclusio Limited.