September 2024 • PharmaTimes Magazine • 22-23
// MEDICINES //
Days of reckoning
Our approach to new medicines must be fit for the future
The UK boasts immense potential in life sciences, supported by its robust health system infrastructure, renowned academic institutions, growing biotech industry and established global reputation for clinical innovation.
These assets can be the backbone of the Labour government’s mission to deliver better healthcare in Britain, and enhancing patient access to innovative medical treatments must be a top priority.
However, if we’re serious about advancing the health of the nation and ensuring timely access to new treatments, the way we value medicines must change.
With the NHS England Commercial Framework for New Medicines currently under consultation, we’re at a pivotal moment in determining whether our system will be fit for the future.
Off queue
Patients in the UK are at risk of being at the back of the queue for new medicines.
While patients around the world are benefiting from leaps forward in medical innovation, at home we’re falling behind. For every 100 patients that get a new medicine in its first year of launch in EU countries, just 21 patients in the UK will.
This stat is reinforced with recent data showing England ranked ninth in Europe for availability of medicines, down from seventh the previous year. For cancer medicines, England trails behind in thirteenth place.
The takeaway is clear – UK patients are missing out on proven treatment options that could improve the management of their condition, versus their counterparts in comparable countries.
Meanwhile, combination therapies are important for a number of diseases, including cancer where they are a rapidly advancing area, in some cases becoming a cornerstone of innovation for improving patient outcomes.
Access to these innovative combinations, however, often falls at the final hurdle, when the treatment is assessed by NICE for cost-effectiveness.
It is no secret the UK is lagging behind in access to innovative combination therapies compared to similar countries across Europe.
In November 2023, the Competition and Markets Authority (CMA) provided guidance to companies that will enable manufacturers of the component parts of combination therapies to enter into commercial dialogue, previously deterred by competition law concerns.
While this is an important step forward, it is as yet untested. Additionally, this has only resolved one part of the challenge.
Fundamental barriers remain meaning patients still face significant hurdles in gaining access to combination treatments.
Under NICE’s current methods, combination therapies are often found not to be cost-effective, even when the ‘add-on’ treatment is priced at zero.
This issue is particularly apparent when the ‘add-on’ treatment is added to a ‘backbone’ therapy that has already been reimbursed by NICE at the top end of the cost-effectiveness threshold. An additional challenge lies in the potential extension of life from the combination therapy.
This increase in survival results in the costs of treatment being incurred for a longer time compared with monotherapy treatment.
This can make the combination treatment appear less cost-effective, thereby limiting options for patients who have a shorter life expectancy without treatment.
Reforming approach
A further barrier hindering access to both combination therapies and ‘multi-indication medicines’ is NHS England’s uniform pricing approach, which only allows indication-specific prices to be agreed in exceptional circumstances.
This approach has the effect of discouraging launches for indications where the patient populations are smaller and present more challenges when it comes to demonstrating cost-effectiveness.
‘If we’re serious about advancing the health of the nation and ensuring timely access to new treatments, the way we value medicines must change’
In fact, an analysis of terminated NICE appraisals found 37,400 patients were prevented from accessing new multi-indication medicines between July 2016 and August 2023.
This is therefore more than a technical issue, which has a real-life impact on the patients who need treatments the most.
We welcome the publication of the consultation on the Commercial Framework and the recognition by NHSE that access for multi-indication medicines is a growing challenge, but it is not clear that the value of these medicines to patients has yet been fully recognised.
It is vital that a fully flexible approach is adopted, as seen in other comparable healthcare systems, to ensure that patients in England do not fall further behind.
Efforts to evolve
In recent years, efforts have been made to evolve the pricing and reimbursement framework to support more timely access to innovative medicines on the NHS.
Despite this, ensuring long-term availability will remain a challenge unless NICE’s assessment measures change to enable innovation to reach patients.
The Cancer Drugs Fund (CDF), for example, seeks to provide early access to innovative treatments while further evidence is gathered to allow for a full cost-effectiveness assessment for routine commissioning.
Despite providing access for a limited period, uncertainty often remains over whether the NHS will go on to routinely commission a therapy once it is no longer eligible for the CDF.
The Innovative Medicines Fund (IMF) is another example of a scheme introduced to allow earlier access to new medicines.
It is intended to help patients with other diseases (outside of cancer) to benefit from similar managed access to innovations while additional evidence is collected, but a number of barriers mean the IMF is currently underused.
Apathy in the UK
The UK is in danger of losing its competitiveness as a destination for medical innovation.
If our access framework fails to keep pace with innovations in medical treatment, one inevitable consequence is that the UK will be increasingly less likely to be chosen as the country to conduct clinical trials for innovative medicines.
One reason is that the prospect of those treatments being viable for launch following trial completion will be limited.
A second reason is that patient access is often a precursor for research – clinical trials investigating medicines versus comparator treatments, or those that require patients to have prior treatment exposure, inherently need that treatment to be reimbursed by the NHS.
Time for change
The UK is one of many countries vying to be a first launch market for innovative medicines.
Restoring the nation’s competitiveness is therefore critical for bringing effective therapies to patients as quickly as possible.
There is a clear need to collectively address how medical innovation can be facilitated and made more accessible, including through clinical trials.
With a new government, we have an opportunity for proactive and ambitious reform in how we value innovative medicines.
It is vital that we adopt a partnership approach between the government, the healthcare system, patient groups and the pharmaceutical industry to deliver an enduring benefit for patients, their families and the NHS.
Rippon Ubhi is General Manager at Sanofi UK & Ireland. Go to sanofi.co.uk
PharmaTimes
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