Reforms in methods and processes are complex but are key to ensure that HTA keeps pace with innovation. Changes at NICE have, at times, taken too long, for example for the implementation of a severity modifier. On many other occasions, NICE has addressed challenges promptly and led the way on many methods and process challenges.
A recent example, mentioned at OHE future of NICE webinar, is the publication of the Real World Evidence (RWE) framework, which has led to better use of RWE in submissions and helped NICE committees consider a broader range of evidence.
Another example of leadership is the introduction of the evidence standards framework for Digital health Technologies (DHTs), representing one of the few attempts to formalise evidence requirements for these technologies. However, challenges remain, including reconciling process timelines with a fast-paced sector, as discussed at the OHE future of NICE webinar.
NICE has, since its inception, invested in a system of well-defined processes and methods, and publicly available outputs of its decision-making processes. This is one of the key drivers of NICE impact in other HTA systems, as shown in a recent OHE report. A trade-off remains between predictability of HTA methods and flexibility left to decision-making committees to exercise their judgement to reach a recommendation (Boysen and Watson, 2021).
From establishing a cost-effectiveness threshold, to the inclusion of environmental impact and the assessment of new antibiotics, OHE has raised challenges and shaped the debate around NICE activity and impact over the years. The Institute has not shied away from raising and debating publicly the challenges posed by innovative technologies.
However, its solutions have not always been optimal, given its constraints. At its last method review, not all topics were addressed, with some requiring further revisiting and others radical changes, including the role of committee deliberation in dealing with uncertainty (as outlined at the OHE future of NICE webinar), the formal inclusion of inequalities, and the consideration of a societal perspective.
Looking ahead, not all the challenges need to be addressed only by an HTA agency such as NICE (for example, health technologies environmental impact as discussed at OHE future of NICE webinar). Surely, to deal with the evolving HTA landscape and the pace of medical innovation, NICE will have to anticipate major changes and develop increasingly transformative solutions that could strike a balance between quality of assessment and pragmatism.
