Navigating the NICE Proportionate Approach: Insights from Our Journey during the First Phase

Our experience with the proportionate approach?

In 2022, NICE introduced the Proportionate Approach to Technology Appraisals (PATT). This pathway aims to apply a faster and lighter-touch approach to low-risk evaluations, enhancing efficiency and facilitating quicker patient access. Due to limited resources, NICE sought improved process efficiencies to manage its technology appraisal work program and provide tailored support for more complex evaluations.?

The first phase of the PATT, which lasted for about a year, demonstrated successful outcomes for six treatments, benefiting around 180,000 people. This included accelerating technology appraisals, with up to a 20-week (45%) reduction in the time taken for Vutrisiran, a treatment for amyloidosis, to be recommended compared to the standard process.??

NICE has also begun Phase 2 of the proportionate approach, which will include four sub-approaches: Pathway approach to technology appraisals, High value steps, Products with many indications, and Rapid Entry to Managed Access.?

Is it limitations-free??

At Cogentia Healthcare Consulting we firmly believe that this method should bring benefits to all parties involved: NICE, pharmaceutical companies, and, ultimately, the patients. However, as with any new program, it's anticipated to have some initial limitations, which we expect will be addressed in later stages. We aim to highlight the challenges we've encountered with the proportionate approach.?

The first limitation is the very tight timeline. For topics identified as cost comparison, submissions should be made using the cost comparison submission template, and the deadline for receipt of the evidence submission is 28 days from the invitation to participate, which can be extremely challenging for the company, given that the clinical effectiveness section requirements are almost identical to those of a single technology appraisal (STA).?

Sticking to Guidance Like Glue?

The second limitation involves the stringent requirement for identical populations, a topic that can sometimes be a subject of discussion. We encountered a situation where a product intended for both adults and adolescents was not selected for cost comparison due to the slightly differing population in the comparator's appraisal. Notably, this comparator lacked an adolescent license at the time of its appraisal; however, it later gained a license for adolescents and was subsequently routinely commissioned for adolescents by NHS England. In practice, the populations were identical, a fact accepted in previous technology appraisals of that indication.?

Another situation related to the population was with an oncology product that shared the same population as a previous technology. However, it was not selected for cost comparison because although the previous technology had been appraised within the same population, it had gained a restricted recommendation within a subgroup.?

The third and final limitation we encountered was with an oncology product that shared the same population as a previous technology. However, it was not selected for cost comparison because this previous technology was a comparator in the prior appraisals, not the intervention. This aspect is also worth further consideration.?

Regardless of some areas of concern we covered, broadly speaking, the first phase was positive and enabled NICE to produce guidance faster and more efficiently.?