NICE is undertaking a methods review to revisit approaches and identify areas for improvement in cost-effectiveness assessment and patient access. In this article, we discuss the NICE Health Technology Evaluation methods.
Five distinct sections are considered in the review:
- Valuing the benefits of health technologies: How modifiers are considered, including disease severity, health inequalities, uncertainty and evaluating the value of cost and health effects in the future
- Understanding and improving the evidence base: How evidence is sourced, reviewed, and presented
- Structured decision-making: How clinical and cost-effectiveness analyses are presented and considered, how decision making is carried out for lower cost treatments (even if priced at £0)
- Challenging technologies, conditions, and evaluations: How Advanced Therapy Medicinal Products, histology-independent cancer treatments, and novel technologies are reviewed
- Aligning methods across programs: Achieving consistency for cost comparison analyses, evidence similarity, and uncertainty
1. Removal of end of life criteria and the addition of ICER threshold weighting
The end of life criteria and £50k/QALY threshold will be removed and replaced by a modifier quantitatively taking into account severity of disease, encompassing burden of illness and unmet need. This would operate as a weighting on the QALYs, up to a maximum multiplier of 1.7, and we expect impact to be primarily in non-oncology therapies benefiting from accessing higher thresholds under these severity criteria.
2. Incorporation of RWE importance for medical devices
According to the review, NICE’s methods for medical devices require minimal changes and are more comprehensive than the EU regulations, however do not consider non-peer reviewed evidence. Conversely, such real world evidence is taken into account in other NICE health technology evaluations, with academic review taking place at the committee level. Therefore, NICE is looking to introduce “unpublished and post-marketing data” in medical technology evaluations.
3. Methods to incorporate the future broader remit of the latest health technology innovations
- Advanced Therapy Medicinal Products (ATMPs)
The advent of ATMPs has demanded close examination of how these high-cost and high-value treatments are assessed by NICE. While they potentially present cash-flow challenges to the NHS, this does not directly affect NICE’s assessments, and therefore the methods review does not consider a need for an ATMP-specific method. NICE does however recognize previous ATMP evaluations have been challenging, due to long term treatment uncertainties, unrecoverable and high upfront costs, and product values not captured in QALYs.
- Histology independent oncology treatments (HIOTs)
HIOTs hold the potential to shift how cancer is treated, though at present, challenges in clinical evidence arise from basket trials and a lack of appropriate comparators in subgroups. NICE is proposing that methods, which are broadly applicable, should be explored when performing such an evaluation, with Bayesian hierarchical models being pointed to as of particular value, and that HIOTs are treated as a single indication instead of a suite of tumor subgroups.
It is noteworthy that NICE considers the challenges faced in assessing ATMPs and HIOTs not to be unique to each class, and therefore necessary adaptations will be incorporated into general changes to methods, aiming to facilitate the review of these technologies in the future.
Conclusion and next steps
The proposed removal and replacement of the end of life criteria opens an opportunity for many emerging technologies. However, NICE continues to pursue a “one-size-fits-all” evaluation method, creating challenges for highly unique therapies to demonstrate their value.
The six-week public consultation period on the proposed changes to the NICE methods, “NICE methods of health technology evaluation: the case for change”, was open through November/December 2020. A consequent consultation on the NICE processes is scheduled for February/March 2021, with aims for implementation from October 2021.