In August 2024, the Association of the British Pharmaceutical Industry (ABPI) released the second report in its Continuous NICE Implementation Evaluation (CONNIE) series, assessing the real-world impact of the updated NICE Health Technology Evaluation (HTE) Manual. With the new manual being in place for over two years, the latest CONNIE report offers crucial insights into how these changes have affected the evaluation of health technologies in the UK.
Key takeaways
- Severity modifier utilisation:
- The severity modifier, designed to replace the end-of-life (EOL) criteria, has been applied in 21% of topics. However, the average QALY weighting (1.073) is lower than both NICE’s design (1.119) and the previous EOL criteria (1.125). This conservative application risks limiting access to innovative treatments, particularly for severe diseases, which could hinder patient access
- Challenges with uncertainty:
- Despite NICE’s intentions, only 10% of topics reflected greater acceptance of uncertainty in decision-making. Companies report that while NICE has improved communication about uncertainty management, this has not translated into the broader acceptance of uncertainty outlined in the HTE Manual
- Non-reference case flexibilities:
- Although 21% of topics made a case for non-reference case flexibilities, such as a 1.5% discount rate or wider societal perspectives, none were granted these flexibilities. This restrictive approach could negatively impact patient access to treatments with long-term benefits
- Positive experiences with additional flexibilities:
- Companies reported mostly positive experiences when additional flexibilities like surrogate endpoints, carer quality of life (QoL), and real-world evidence (RWE) were utilised. These flexibilities were crucial in navigating the complex landscape of health technology evaluations
Recommendations
- Review and adjust the severity modifier: ABPI urges NICE to revise the severity modifier, lowering the thresholds for severity to ensure more medicines can benefit, aligning with the original intention of the changes
- Adopt an evidence-based approach: Replace the opportunity cost-neutral approach with one that better reflects societal preferences for helping those with severe diseases access innovative treatments
- Enhance flexibility and collaboration: NICE should actively explore ways to accept greater uncertainty and offer non-reference case flexibilities, working closely with the industry to ensure that evaluation processes support patient access to vital treatments
The report underscores the importance of continuous monitoring and adaptation of NICE’s methods and processes to ensure they remain fit for purpose in delivering timely access to innovative and life-saving treatments for patients across the UK.
Source:
Association of the British Pharmaceutical Industry. Reviewing Implementation in Practice of the NICE Health Technology Evaluation Manual (CONNIE) August 2024. Available at: https://www.abpi.org.uk/publications/reviewing-implementation-in-practice-of-the-nice-health-technology-evaluation-manual-connie-august-2024/. Accessed August 16, 2024.