Historically, the NICE process was known to be inefficient, for instance, Remap Consulting analysis has previously found that approximately 60% of products initially receiving a negative draft recommendation and 80% of products receiving a positive final recommendation. This meant most products were undergoing two appraisal committee meetings prior to gaining access, ultimately delaying access and increasing workload for NICE.
The updated STA process announced in 2018 aimed to address this through the introduction of an early engagement step with companies to resolve technical and commercial issues prior to the first appraisal committee meeting. Essentially, this meant that following the evidence review group (ERGs) report, NICE would assess key issues and develop a technical report, which would be sent out to consultees (including the company, patients, and relevant clinical experts). Consultees would have approximately 30-days to review the technical report (known as the technical engagement phase), prior to having a teleconference with the NICE assessment team to discuss key issues.
Two years on, the efficiency NICE had desired have not materialized. Most appraisals are still requiring two appraisal meetings. In addition, a recognition of feedback received from stakeholders and of the additional resource requirements of the step on NICE has resulted in a need for changes.
As such, NICE has decided to adapt the technical engagement step in a hope to improve stakeholder inclusion, NICE and committee capacity. The technical report will be replaced instead by a re-framing of the evidence review group (ERG) report so that it is presented in an issues-based style. The final ERG report will be circulated to consultees with a structured reply form for stakeholder feedback, along with consultee evidence submissions. This is likely to provide companies with a “right to reply” to the ERG report, which will be a welcome change to companies. In addition, NICE will be moving from a single teleconference with all consultees to two teleconferences: one with the company and one for patient and professional experts. The amendments will be implemented in all technology appraisals that started after the beginning of May 2020 (that is, when the invitation to participate was issued).
This new approach aims to improve stakeholder inclusion and provide the NICE technical team with a better opportunity to prepare for the appraisal meeting, with a hope that this will enable more appraisals to only require a single committee meeting. In addition, the reduced resource intensity (with the removal of the technical report) will release NICE resource to clear the backlog of topics that have been delayed due to resource constraints and reprioritization due to the COVID-19 pandemic.
It should be noted that further changes to the NICE process are also expected in June 2021 after completion and implementation of NICEs methods review. Stay up to date with these changes through subscribing to the Remap Consulting newsletter – fill in this form, or send us an email.