In December 2020, the BIA responded to the first consultation on the case for change to NICE’s methods. This is the culmination of several months of work building on the expertise in our Rare Disease Industry Group, working with our groups in the sector and developing our position (see the Rare Chance for Reform report). The NICE Methods Review provides a unique opportunity to shape the principles that will frame the medicines access landscape for many years in the future.

We had previously secured member representation on several Task and Finish groups which looked in detail at the key areas for review. The reports from all of the groups can be found here. In addition to the Task and Finish Groups, we also secured representation on the Methods Review Working Group which coordinated the development of NICE’s proposals. This work resulted in effective engagement between NICE, industry, and patient groups, which has led to an open and effective process.

Overall, the BIA are encouraged with the content of the proposed changes and with the progress made since the beginning of the review in summer 2019.

There is positive movement on modifiers, including the proposal to replace the end-of-life modifier with a severity modifier. There are also welcome developments within uncertainty as it is recognised that a greater degree of uncertainty should be recognised for e.g. rare diseases, innovative technologies, and in managed access agreements. 

Although there have been previous discussions on introducing a rarity modifier, as expected, this is not included in this consultation. However, there is a recognition of the challenges for rare diseases, ATMPs, histology-independent cancer treatments and other emerging technologies.

Discounting has been deemed out of scope of the review due to the wider policy and affordability implications of implementing changes in this area. NICE do however recognise there is a case to change the reference-case discount rate to 1.5% per year for both costs and health effects. BIA continue to make the case for differential discounting rates in line with the Treasury Green Book.

In the first quarter of 2021, the review will enter a new phase where NICE will review consultation responses while industry will continue to engage with NICE on two new working groups which will further explore challenging technologies and NICE decision-making. Two further consultations will take place in 2021 and we look forward to responding to these.

'Case for change' consultation response

The second phase of the NICE Methods Review began in January 2021, with the launch of new task and finish groups to support review of the responses and to contribute to the new manual development. In addition, NICE published a second consultation on the process guide and manual.

It is broken down into four themes:

  • Alignment of current processes
  • Opportunities for new process improvements and ways of working (adapting to the changing healthcare environment and addressing key challenges)
  • Commercial & Managed Access processes
  • Objectives & vision of the Highly Specialised Technologies (HST) programme

While we have responded in full to the consultation, including welcoming some of the positive changes proposed, our focus has been on NICE’s proposals with regard the HST programme, which present significant concern in their current form. 

Process guide and manual consultation response