April 17, 2024
NICE Decision

Improving the Quality of Clinical Data for NICE Decision-Making

A recent analysis published in the journal BMJ Open has revealed that the quality of clinical data submitted to the National Institute for Health and Care Excellence (NICE) for informing its decisions on treatments in the NHS is often poor. The analysis, which covers a 20-year period from 2000 to 2019, shows that there has been no improvement in the quality of evidence submitted during that time.

NICE provides guidance to the NHS on the clinical and cost-effectiveness of new and existing technologies. Its decisions are based on reports from independent technology assessors, as well as input from various experts and stakeholders. In recent years, NICE has expanded the types of evidence it considers to include registry data, national statistics, surveys, clinical practice recommendations, expert opinions, and manufacturer knowledge.

To evaluate the quality of clinical evidence submitted to NICE, researchers systematically reviewed all active technology appraisals published between 2000 and 2019. They examined the quality of evidence from randomized controlled clinical trials (RCTs) and the overall quality of evidence submitted for decision-making.

The analysis included a total of 409 technology appraisals, consisting of 104 multiple technology appraisals (MTAs) and 305 single technology appraisals (STAs). The appraisals covered a range of products, devices, therapies, procedures, and drugs.

The findings revealed that in 55% of appraisals (224 out of 409), the overall quality of evidence was judged to be poor, while in 10% (41 out of 409), it was deemed unacceptable. Only 1% of appraisals (5 out of 409) had evidence of good quality. Furthermore, in 39% of STAs (119 out of 305), the quality of comparative evidence was considered poor, and in 17% (51 out of 305), it was judged to be unacceptable.

The analysis also highlighted that a significant number of clinical trials presented by manufacturers were of poor or unacceptable quality. This was often due to weak or insufficient evidence, as well as unsuitable comparators for decision-making in the NHS context. The quality of life data submitted by manufacturers was also found to be of poor or unacceptable quality in many cases.

Over the 20-year period, there was no improvement in the overall quality of evidence submitted to NICE. The researchers pointed out the lack of clarity regarding the methodologies used by manufacturers in systematic reviews and indirect comparisons. They also noted that comparator data often did not reflect the UK population and routine treatment pathways.

The limitations of the study include the subjective scoring system used to assess the quality of evidence and the focus on certain elements of the evidence submitted by manufacturers. However, the researchers concluded that the primary components of clinical evidence that influence patients and are crucial for NICE’s decision-making framework are of poor quality.

To address this issue, the researchers recommended that health technology assessment bodies and payers collaborate to strengthen the generation of evidence submitted to NICE. They also emphasized the need for organizations to invest more effort in generating high-quality evidence before and after market entry.

Improving the quality of clinical data submitted to NICE is essential to ensure patients receive effective and cost-effective treatments in the NHS. By addressing the shortcomings identified in this analysis, NICE can make more informed decisions and provide better guidance to the healthcare system.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it