Author: Laurent Abuaf
Published: December 2020
As clearly stated by Andrew Dillon in his latest article about the international impact of NICE, the National Institute for Health and Care Excellence (NICE) has indeed managed to achieve wide international impact. It has led the way into more evidence-based value assessment of medicines which has helped health systems, patients and clinicians around the world to focus their medical practice where it matters most from a Healthcare and cost effectiveness perspective.
An assessment of NICE from an industry perspective
The innovative and comprehensive methodologies used by NICE, the independence of the organisation (including committees with a balance of clinicians and health economists as well as patient and industry representatives), and the full endorsement by Health Authorities and the NHS have been the key pillars of NICE’s success and impact. We recognise the visionary leadership and the ‘make it happen’ attitude of Andrew Dillon over his years as the leader of this organisation.
However, over the recent years, some of the shortfalls of the system have become apparent. In particular, patient outcomes in critical diseases in the UK have not been progressing as rapidly as in other comparable countries, showing that, ultimately, the health system is not delivering in full despite its improvements in important areas.
Ensuring access to innovative medicines to patients in the UK remains slower than in other comparable countries. This highlights the increasing disconnect between MHRA (Medicines and Healthcare products Regulatory Agency) regulatory approval, NICE’s cost-effectiveness review, NHS England’s commercial agreement, and the delivery of medicine to patients by NHS clinicians within GP practices and NHS Trusts.
The medicines that are coming to market are evolving as well as the data which is available to assess their impact. These medicines are addressing more complex types of diseases, and targeting smaller but more critical patient groups. The datasets that they provide are different from classical datasets, for example, assessing quickly the overall survival data for immunotherapies, where the respondents can be potentially “cured” presents a real challenge. These medicines are typically more expensive due to the technologies involved in their development, the low success rate of finding the right candidates, and the amount of clinical trials needed, which seems to crystallise many discussions in the UK.
Additionally, innovative drugs, especially in cancer, are experiencing a greater struggle to reach the full extent of the eligible patient populations in the UK compared to other markets. This is largely due to the disagreement on value assessment between NICE and pharmaceutical companies, which raises a question on whether NICE’s methods and thresholds – which have been kept broadly the same since its creation – should be changing significantly instead of evolving slowly.
The UK remains undoubtedly one of the most efficient countries in the world in healthcare spending as a percent of GDP, especially considering that it offers universal coverage at point of care compared to patient co-payments in other countries. The UK is, however, still lagging behind its peers in improvement of patient outcomes in cardiovascular, metabolic, cancer and respiratory diseases, to name a few. This cannot be attributed to NICE alone, but is rather emphasising the need for step changes instead of incremental ones.
The challenges ahead
The budget pressures on the NHS have been intense even in the face of an agreed envelope of greater levels of funding. Inevitably, this translates into greater pressure on the NHS to contain costs, including drugs. COVID-19 will likely further increase the pressure on the NHS budget, and that is despite the availability of short-term funding for COVID as it will be tightly controlled.
This has led to considerable misalignment between the government’s commitment to a Life Sciences strategy for post-Brexit Britain – which relies on life sciences companies seeing the UK as an attractive place to undertake research, manufacture and launch drugs – and a desire to simply contain costs, which limits price and uptake.
The VPAS agreement attempted to tolerate low prices with the promise of rapid access through a framework that limits drugs cost to 2% growth. Most of the life sciences industry feels that the promise of support of rapid uptake has not materialised with the exception of a few targeted areas. Despite this agreement – which places the burden of spend, on top of the capped growth, on the Industry – the NHS has pursued, in addition to the existing method of NICE, a Budget Impact Test (since 2017) and other procurement practices which usually extracts an additional confidential discount, as well as a new approach on tendering entire classes of branded medicine which are applied after the objective and neutral NICE assessment.
There is a concern that, on top of assessing both the clinical and cost effectiveness of medicines, NICE is now increasingly reflecting the affordability of the system to pay for the innovative treatments. Due to budget pressures, the balance of decision-making power towards the NHS and a lack of political willingness, this critical topic is not moving in the right direction for both patients and the pharmaceutical industry. In addition to that, the increasing budget pressures, the inertia of the clinical practice, and the growing prevalence of NHS procurement agenda for medicines, are making it all the more difficult for NICE to retain full objectivity and independence, to the point of hindering the adoption of NICE guidance in real practice.
Potential way forward
The NICE methods review presents a unique opportunity to change critical aspects of the value assessment of innovative medicines. Most importantly, to ensure the alignment between politics and NHS England on how to restore the UK’s position as a leading country for patient care and outcomes. In order to do so, the methods review needs to address some of the key issues being considered on discount rate, a premium for severe conditions and the use of a wider range of data sources. However, resolving these issues will not be sufficient on its own.
The more fundamental point is a need for the UK to consider the value of life sciences and what it can contribute to society through better outcomes, reduced system costs, and the growth of the life sciences industry post Brexit. The example of successful collaboration that led to the development and recent approval of innovative vaccines for COVID, should act as a precedent of what a system fully aligned towards patient health and care can truly deliver. Massive opportunities remain in the fields of cancer, cardiovascular and other chronic disease.
NICE remains a staple of the healthcare system in the UK, as it has been leading and inspiring the world for many years. The UK offers fertile ground for early science and innovation, which is made possible through a well-renowned and advanced education system, and a historical investment in advancing science. However, it is now critical to bring about fundamental change to the health system – and NICE is facing unprecedented challenges to do so – to ensure that patient care and outcomes in the UK do not continue to fall behind other countries. The COVID-19 pandemic has increased the urgency to achieve this, and I am optimistic that, ultimately, the Government, the NHS, NICE and pharma companies will jointly find a way forward, as the partnership pathway is key to moving the needle.