Is the tide finally turning on the UK access landscape?

We’re in the midst of a rapidly evolving UK environment for the life sciences industry, with a dynamic shift in our post-Brexit regulatory framework, a hugely ambitious life sciences Sector Plan and transformational changes proposed in the Government’s recent 10 Year Health Plan.

It’s been reported that the Government will make important changes to improve the commercial environment that will bolster actions already underway in support of commercial clinical research, investing in our world-leading data assets and the NHS digital app.

I’m also looking forward to the publication of the National Cancer Plan, which will see the NHS’s commitment to improve cancer outcomes evolve further.

All these proposals are welcome but can only be judged to be successful if – and when – fully implemented.

In the UK, we’re fortunate to have a rich life sciences ecosystem fuelled by excellent research taking place in small biotech and academia. But in a globally competitive environment, the UK should seek to lead the way in other parts of the ecosystem.  And industry has a key role to play.

The Government has successfully addressed the decline in commercial clinical trials in the UK following COVID via its implementation of the O’Shaughnessy independent review.

This shows its determination to improve the UK environment for trials, recognising their importance to the innovation ecosystem and patient care.

Companies that are agile and bold can find strategic points of differentiation and, at BeOne, we’re ahead of this curve having worked tirelessly to expedite clinical trial delivery.

By coordinating clinical research – from trial design and regulatory preparation to site engagement – within a single, integrated in-house team, we’ve successfully delivered improvements and acceleration in both trial approvals and set-up.

This leadership and agility are our most critical assets and we’re seizing the opportunities these new changes in the UK bring.

According to the EFPIA W.A.I.T indicator, the average time it takes patients in England to access a medicine after market authorisation is approximately a year. That’s a disappointing seventh fastest in Europe. We need to – and can do – better.

In the past year, important proposals for change have been announced in the UK that I believe can help turn that tide: measures that we as an industry must champion such as the Government’s investment in – and ambition for – the MHRA.

The International Recognition Procedure is one example that has enabled us to reduce time to approval and freed up colleagues’ workload through a mutual recognition of a Canadian dossier for one of our blood cancer indications.

The MHRA has also introduced other initiatives to accelerate approvals, such as the Innovative Licensing and Access Pathway (ILAP), and is taking significant steps to adopt global leadership in the regulation of AI in healthcare.

Perhaps of greatest interest is the proposal for the NICE and MHRA Aligned Pathway launched in October, which aims for same-time decisions on licensing and value, with the goal of reducing time to patient access by three months.

It has been widely reported, in the context of trade discussions with the US Government, that a 25 per cent increase to NICE thresholds is being considered.

An uplift of this nature is long overdue but is not ambitious enough, given that the NICE threshold has been unchanged for 25 years. If the upper end of NICE’s threshold had increased in line with inflation since 1999 it would be £56,794k per QALY instead of the current £30,000.

On a personal level, what keeps me awake at night are unnecessary barriers to access for patients.

As a former physician and now a pharmaceutical industry leader, I’ve witnessed the issues from both sides and my team and I are determined to actively collaborate with partners in the NHS to help remove these barriers so we can do more – and better – for patients.

I’m a fan of the three strategic shifts underpinning the 10 Year Plan as I believe they will actually make a difference to patients. Providing services closer to home will make it easier for people to access care and I believe this is where pharma distribution and patient support models could play a key role.

Greater use of digital and new technology will free up resources that can be rerouted to patient care and empower them to manage their own health through the NHS app in as convenient a way as online banking and shopping. This will transform healthcare delivery, enhance patient outcomes and provide better value for taxpayers.

It’s not enough for innovative drugs to simply exist – to be approved for reimbursement. Working closely with WMUK – the charity for Waldenström’s macroglobulinaemia – and Health-Equity.AI, we’ve demonstrated that in this rare blood cancer, there is still evidence of health inequity in treatment access across the UK, despite NICE approval.

Ultimately, we must ensure all patients who may need our medicines can receive them.

But I do believe the UK Government is highly invested in solving the current access inequalities. One example is the proposed introduction of a Single National Formulary (SNF) for prescribing in England, which aims to eliminate the ‘postcode lottery’ created by locally derived formularies and reduce duplication.

I’m concerned these proposals might constrain a health professional’s ability to choose the best therapy for a patient, despite current suggestions that although local prescribers will be encouraged to use products ranked highly in the SNF, they will retain clinical autonomy as long as prescribing within NICE guidance.

As with all these things, the devil will of course be in the detail and we need to see how it develops.

Despite the UK’s health spending being a clear outlier relative to its international peers – just 9% of our health spend is on medicines compared with 15% in France, 17% in Japan and Germany and 18% in Spain – my ambition is that the UK is a strategic priority for BeOne.

In the context of a cash-constrained NHS, the Government faces tough choices, but ministers must send a clear signal to global companies that the UK is serious about patient access to innovation.

Despite the challenging commercial environment, I’m optimistic for patients in the UK and believe the Government’s commitment to our sector is clear.

There is still a lot to shout about in the UK and I remain cautiously optimistic the changes that must happen are coming. We’ve heard the promise. Now we must see the proof.

Bobby Mulrooney is General Manager UK & Ireland at BeOne Medicines