Non-cancer data is used by Leela Barham, shared by the UK Department of Health and Social Care (DHSC), to examine how long it takes the National Institute for Health and Care Excellence (NICE) to publish final guidance. For NICE to achieve the goal of releasing final guidance within 90 days of marketing authorization, the process for non-cancer single technology appraisals (STAs) and highly specialized technologies (HST) guidance needs to be expedited.
NICE internally monitors the speed at which it produces final guidance. Over the past year, the institute has increased transparency regarding the speed of its technology appraisals (TA) work and the factors contributing to delays, as evidenced in board papers, including the integrated performance report for the year-end of 2023/24. However, detailed TA-level statistics are not routinely available to the public.
Nevertheless, it is possible to analyze the speed at the TA level. Under the Voluntary Scheme for Branded Medicines Access and Pricing (VPAS), the speed of NICE TAs was a metric evaluated by both the government and the industry, with high-level reports published. The DHSC provided the underlying data from 2014/15 to 2022/23, which forms the basis of the most recent VPAS metrics report.
VPAS Monitoring Reveals Variations in Timelines for Cancer and Non-Cancer Appraisals
VPAS monitoring focused on a subset of TAs where referrals were timely and companies did not request delays. Over time, changes were made to reporting. For instance, TAs reported as part of VPAS metrics included license extensions in 2022/23 but not previously. By examining both KPIs and non-KPIs, a fuller picture emerges. Non-KPI STAs generally took longer to complete than KPI STAs every year since 2014/15, except for 2016/17.
There is considerable variation in the speed at which final guidance was published. For instance, the longest duration was 60 months, even for a TA within KPI data, while the fastest publication occurred less than a month after marketing authorization. In contrast, the longest duration for a non-KPI TA was 153 months, although some were also completed in less than a month.
VPAS reporting differentiates between cancer and non-cancer TAs because the scheme aimed to align non-cancer appraisal timelines with those for cancer medicines. This target is not included in the successor scheme, VPAG, and metrics for that scheme are yet to be finalized. Since 2018/19, STAs for cancer treatments have been faster on average than those for non-cancer treatments. The increase in the speed of cancer STAs corresponds with a rise in the average time taken to publish final guidance for non-cancer STAs.
NICE Aims to Expedite Non-Cancer Guidance Amid Challenges with ‘Divergent’ Cases
NICE has identified that speeding up publication is more challenging for ‘divergent’ guidance compared to ‘optimal’ guidance. The distinction between KPI versus non-KPI mirrors this, with optimal guidance referring to cases where the institute was notified of the topic at least 16 months before GB marketing authorization, and no delays were requested by the company, among other criteria. NICE has noted that guidance for highly specialized technologies takes significantly longer than for STAs, making it an area for future focus. HST data was not included in the DHSC dataset.
Addressing the speed of non-cancer STAs is another area for NICE to prioritize, especially given past trends. This effort requires collaboration not only within the institute but also with the companies involved. The most common reason for exemptions from KPI reporting, according to DHSC data, was late referral/notification (a factor in 87 STAs). The next most common reason was a request for delay, presumably by the company (46 STAs), aligning with NICE’s identified delay drivers.
For NICE to meet its goal of issuing final guidance within 90 days of marketing authorization, a focused effort on expediting the process for non-cancer STAs and HSTs is essential. By improving transparency, monitoring performance, and collaborating closely with involved companies, NICE can enhance the efficiency and speed of its guidance publication, ultimately benefiting patients and healthcare providers.
Resource: Pharmaphorum, June 26, 2024
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