Time for a NICE change

The National Institute for Health and Care Excellence (NICE) is world-renowned for their work assessing the clinical and cost-effectiveness of new treatments. In recognition of how the world has changed over its history, NICE is coming to the end of a period of review and consultation on their processes and methods. Leela Barham takes stock.

Drivers for the reviews

NICE has never stood still since it started its work in 1999. The current consultation – review of the health technology processes – is just the latest and closed on 15 April. An earlier consultation that closed on 18 December 2020, covered methods. NICE also consulted on topic selection as well as a case for change for methods for health technology evaluation.

NICE’s consultations have generated attention because what NICE says matters, not only for treatments launched in the UK, but because the institute makes their guidance available to anyone, anywhere. Many agencies model their own work on what NICE does. Some countries even formally reference the agency’s recommendations when making their own pricing and reimbursement determination.

NICE itself has positioned the latest methods and process reviews as helping the institute support the healthcare and life sciences ecosystem. Lots of buzzwords feature: flexible, agile, robust, future proof, rapid access. From an internal perspective, the process review is a chance to help the institute deliver quality, dependability, speed, flexibility and cost. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too.

Taking a health technology management approach

The proposals set out in the process consultation includes the shift to NICE taking a health technology management approach, including disinvestment, and suggests a move to ‘living’ guidelines.

The idea of disinvestment is not new and resonates with the arguments that have been tabled in the past about providing headroom for innovation – showing that what goes around, comes around.

These process changes are complementary to much in the methods consultation. NICE has pitched the idea of modifiers that capture severity of disease and refining how uncertainty is dealt with, which will mean allowing for evidence generation. It’s the evidence generation that will link to the idea of managing an intervention over time, and responding to how the evidence changes is part of the approach to a technology over its lifecycle. That’s not all that new, but perhaps the change in emphasis is welcome.

Aiming for consistency

NICE has recognised that it has, mostly because of the different starting points of the different areas of its work, been using different terminology and different processes. The process review is not just for the Technology Appraisal programme, and that means it’s a chance to remove some anomalies and bring in some consistent processes across programmes including diagnostics and digital. For example, allowing for a technical engagement process across the work of the organisation.

But there is a danger too from this; every technology will get the same opportunity but the opportunity might be a pick and mix approach determined by NICE – and that may worry some stakeholders. NICE is going to decide if they’ll be doing a long consultation (20 working days), short (5-20 working days) and/or having a scoping workshop.

For companies, the underpinning message from NICE is clear; they need to get their ducks in a row far in advance of a NICE evaluation, both in terms of planning ahead to put together the most appropriate analysis of the data to provide the best evidence, but also for any commercial discussion with NHS England & Improvement (NHSE&I).

Companies need to recognise that much of what NICE sets out in their process consultation is really about NICE driving the process. For example, NICE will determine if an evaluation is to be terminated not because of a company not submitting – the approach taken to date – but because the value proposition is higher than the standard threshold and it can’t be solved through a commercial deal. It’s going to be a NICE – and NHSE&I – run show. Even more advantageous discount rates and more modifiers as proposed in the methods consultation won’t change the drive for better value for money.

But allowing for differences

Whilst consistency is an underpinning theme, there is scope for differences when that makes sense too. The methods proposals allow, for example, for consistent modifiers to apply across evaluation programmes but acknowledges that how they are used may differ.

The process proposals include the option for some steps to be skipped. For example, the proposals include opportunities to route promising technologies directly into management access without a full health technology evaluation. The challenge is that it’s hard to unpick from the consultation document when this might be an option and whether that would be attractive to a company.

Industry may need to pay more to NICE

Companies already have to pay a charge – that differs according to type of Technology Appraisal and size of company – to pay for the work that NICE does. The NICE process consultation recognises that some of the proposals for change they are making could save them time, but others may need more. The net impact hasn’t been worked through, but the institute has noted that the changes could result in modified charges to companies. My money is on higher charges.

My money too is on companies needing to do more in their submissions; the danger of the methods proposals is that NICE is extending the range of data and analysis, and hence the evidence, that might be needed for an appraisal. The problem with that is this increases the existing temptation for NICE staffers, those at the Evidence Review Groups (independent academics), and committee members to go fishing; just to see what change a different approach makes to the results of economic models. It’s easy to ask for (another) analysis or tweak when it’s not your time and money. With many companies using agencies to help them do submissions, it’s likely to become a more costly exercise.

Proposals need to become concrete

The NICE proposals, both on methods and process, are light on detail. For example, NICE proposes to develop a single list of considerations for use by NICE technology evaluation committees to guide the development of recommendations for use in managed access. But what these considerations are isn’t spelt out.

For methods, to illustrate the same point, the proposals suggest that there may be a case to adopt the same 1.5% discount rate for both costs and health effects, but that the wider consequences of this change – affordability being one key issue cited – need to be worked through before a change can be made by NICE.

In some cases, NICE is tying itself in knots to express its intention too – with the idea that new criteria to determine what will be considered under the Highly Specialised Technology (HST) programme should be “precise, carefully defined, ‘yes/no’ criteria where possible, but worded such that flexibility and judgement is permitted when appropriate”. Good luck to the NICE staffer who can deliver on this.

This makes it hard to know whether the changes proposed are really an opportunity for industry and other stakeholders, not least patients, or simply warm words.

Next consultation in August 2021

NICE’s workplan still includes a great deal more to deliver, including a consultation on the draft programme manual in August 2021. December 2021 is the pencilled in day for the publication of the final version and that will be a key document shaping future submissions to NICE and how they’ll manage the process and ultimately inform how decisions will be made by committees. Changes won’t come through until July 2022.

Whatever people think about the proposals, NICE staffers should be acknowledged for their staying power as the in-house work on these consultations must feel never-ending. Realistically whatever NICE does change, it won’t deliver on the different agendas of the stakeholders with an interest in the institute’s work.

Leela Barham is a researcher and writer who has worked with all stakeholders across the health care system, both in the UK and internationally, on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).

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