By Jayne Watson, Senior Analyst
In April, the National Institute for Health and Care Excellence (NICE) launched its 5 year strategy, outlining their key priorities between now and 20261. The launch of the strategy comes at an interesting time when government and healthcare authorities globally are considering their priorities. The UK is in a unique situation – not only is it facing the challenge of a rapidly evolving landscape and ongoing COVID-19 pandemic, but Brexit has placed pressure on the UK to remain an attractive place to market medicines.
With their strategy, NICE have made it clear that their purpose will not change and methods to evaluate technologies will remain as rigorous as ever. However, as outlined by NICE the healthcare landscape is rapidly evolving, with new innovative technologies becoming mainstream (including Advanced Therapy Medicinal Products (ATMPs), digital health, and hybrid products), and the digital and data revolution is forcing a change in the way evidence is considered. In the face of this, NICE have acknowledged that perhaps their traditional methods aren’t sufficient to evaluate these new technologies and understand the benefits they bring to patients.
To understand the challenges and opportunities facing health and social care over the next five to ten years, NICE interviewed key opinion leaders from across the globe. From the discussions six key trends were identified:
- Rapid pace of innovation
- Digital, data and real-world evidence (RWE)
- Integrated Care systems
- Increasing collaboration
- Tackling inequalities
- Economic challenges
Many of these key trends have no doubt been exacerbated by the ongoing COVID-19 pandemic; including the need for a comprehensive digital, data and RWE strategy and the need to tackle inequalities. Economic challenges is the final trend on the list, but infiltrates into each of the other five trends. NICE highlights the financial pressures on the UK healthcare system and the need to fund only technologies that offer the greatest benefits, and even disinvest in ineffective technologies to make room for innovative ones. “Commissioners will need to make difficult choices”, and this will reemphasise NICE’s role to provide clear guidance on the technologies that should be funded, and “those that should not”.
NICE seeks to tackle the six key trends identified above by employing the following four key pillars of work within its 5 year strategy:
- Rapid, robust and responsive technology evaluation
- Dynamic, living guideline recommendations
- Effective guidance uptake to maximise our impact
- Leadership in data, research, and science
“Dynamic” is a common theme running through the four pillars of the strategy for both the organisation itself and the methods NICE intends to apply, as it aims to be agile and anticipate change. Digital technologies and the increasing use of RWE to monitor data uncertainties will see a shift from static recommendations towards dynamic, living guidance – rather than health technology assessment there will be a move towards health technology management. The use of RWE to inform decisions in cases of data uncertainty is not new and is already considered by some to work well for the cancer drug’s fund (CDF).Specifying data collection requirements for RWE could be beneficial for innovative technologies, and in particular rare diseases, and give drug manufacturers the opportunity to devise a well-planned RWE strategy. The hope is that flexible evaluation methods will support the innovative regulation, access and reimbursement models that will be required to ensure rapid patient access to these technologies.However, there is no mention of what this will mean for drug pricing or how NICE’s cost-effectiveness thresholds will be calculated. Either way, drug manufacturers will need to think about their technologies being assessed over time rather than working towards gathering evidence for a single application. Early planning of a RWE generation strategy that is pragmatic yet clearly demonstrates value will ensure manufacturers are ready for health technology management at the point of NICE evaluation.
Partnership and collaboration also feature heavily in the strategy and throughout the four pillars. It is a key focus area among UK healthcare authorities at the moment, with collaboration being a key aspect of the Innovative and Licensing Access Pathway (ILAP) launched by the Medicine’s and Healthcare products Regulatory Agency (MHRA) at the beginning of 20212. UK partners (including NICE, the MHRA, and the Scottish Medicines Consortium (SMC)) hope that by working together resources can be optimised to overcome the challenges facing the public sector as budgets are tightened because of the pandemic. It is also hoped that partnerships will speed up patient access. NICE intend to overcome the problem that recommended technologies aren’t always adopted by the NHS by forming closer partnerships to monitor and increase uptake of recommended technologies.
The strategy indicates a willingness of NICE to be open and flexible while seeking to make England an attractive place for manufacturers to market innovative technologies in a post-Brexit world. It will be interesting to see how this 5 year strategy fits into NICE evaluations, and how it impacts drug manufacturers – the ongoing NICE methods review is due to be finalised Q4 2021 and might give us a better understanding of changes. Moving forward, it will be more important than ever for drug manufacturers to engage in multi-stakeholder discussions to understand how new dynamic approaches and the emphasise on RWE will impact how the value of their drugs is perceived throughout the health technology management process. Particularly for manufacturers of innovative products, early proactive engagement and working collaboratively with NICE will be vital in preventing delays to patient access.
- National Institute for Health and Care Excellence. NICE strategy 2021 to 2026
- MHRA. Innovative Licensing and Access Pathway. Available at : https://www.gov.uk/guidance/innovative-licensing-and-access-pathway