NICE Proposes Office of Market Access

New name for a NICE Innovation Office

Ahead of its May 20 meeting NICE Board papers set out the case for the development of an Office of Market Access (OMA) within the Institution. This is in response to what NICE describes as a rapidly changing landscape for research and development, regulation and adoption of promising new medicines. NICE cites the Early Access to Medicines Scheme (EAMS) from the Medicine and Healthcare Products Regulatory Agency (MHRA) and Adaptive Pathways from the European Medicines Agency (EMA). Diplomaticly, NICE also mentions the ‘active’ support of the UK Government to life sciences. These together mean that NICE has to balance the gatekeeper and facilitator roles; essentially NICE needs to keep saying no when new technologies just aren’t up to scratch but enable timely patient access when they are.

The name is interesting; NICE has been talking about an Innovation Office, partly in response to the roundly rejected proposals that they tabled under Value Based Assessment (VBA) back in September 2014. There is already an MHRA Innovation Office so maybe the name change is as simple as trying to avoid confusion.

The move to an Office of Market Access is acknowledged as a potential risk; perhaps NICE will be perceived as being too close to industry. And NICE should be worried, there’s been a couple of papers and comments from Karl Claxton and Alan Maynard, both well known health economists, suggesting NICE has been too generous.

Not entirely new

The OMA would not be entirely new though, much of the proposal as currently configured is about pulling together much of what NICE already does. As the paper from NICE admits, what NICE already does to help companies isn’t always visible. That includes discussions on EAMS.

Bringing agencies together and signposting

The OMA would be a ‘hub’; one that helps bring together regulators, the National Institute for Health Research (NIHR), Innovate UK, and UK Trade and Investment (UKTI) and trade associations.

The OMA would also signpost companies so that they can get advice and information as appropriate from within, and outside of, NICE. Co-ordination is actually pretty crucial; NICE is really an umbrella to cover a host of work and a lot of work is outsourced, such as the independent academic centres whose job is to critique industry submissions and the Decision Support Unit (DSU) who provide technical support. OMA will work with the Patient Access Scheme Liaison Unit (PASLU), the Observational Data Unit (ODU), the Medical Technology Evaluation and Technology Appraisal Programmes, the Adoption and Impact Programme, NICE Scientific Advice (NSA), and guidance programmes.

Companies can expect the opportunities to discuss much earlier discussion Patient Access Schemes (PAS) or how to secure a recommendation that includes evidence development. According to NICE, companies would then be able to adjust their plans.

Self-funding model

Much like regulators, NICE is looking for the OMA to be eventually self-funding within 4 years. The model would be a fee for service approach, which builds on the same approach that applies to early scientific advice from NICE, as well as NICE International. There’s also potential for a subscription service. The model will therefore embed incentives to respond to companies needs, as long as they can afford to pay.

A reality check

Part of the ambition of many recent changes is earlier access; NICE too is hoping to contribute to ‘timely’ access. But that is difficult since what is timely to a clinician or patient or manufacturer may not be timely to regulators, NICE or commissioners in the NHS who want enough time to figure out if it’s an effective and in the case of the latter two, cost effective new medicine. NICE has a target of producing either the Appraisal Consultation Document under a Single Technology Appraisal or the Final Appraisal Document under a Multiple Technology Appraisal within 6 months of licensing in the UK. Even if you agree that this is timely (the Scottish Medicines Consortium aims for 3 months for their guidance), NICE hasn’t been able to meet it over the last year. NICE says that’s in part due to when products went on to the work programme. If the OMA can help speed up even if this small part of the process, it could help in delivering earlier access.

One of the challenges that still surrounds NICE guidance is consistent uptake across the NHS. That is not due to a lack of effort on NICE’s part, in fact NICE has been a player in the Innovation Scorecard, is the secretariat for the NICE Implementation Collaborative (NIC) Board and has an uptake database. These are all part of the effort that have already been made to understand uptake by the NHS and working to improve on it. Uptake is a function not only of the legality of guidance, as only positive Technology Appraisals (TAs) have to be funded, but also the readiness of the NHS to be able to update pathways including any training, diagnostics etc that may be needed when guidance from NICE makes the move from the written page to the reality of the NHS. It’s also down to what else won’t be done to free up resources. Just having an OMA at NICE won’t necessarily drive through adoption even of cost effective new medicines but you’ve got to hand it to NICE to be willing to try!

Board discussion

The NICE board will be discussing the proposal on May 20, 2015, and if all goes well, the OMA could be open as soon as October this year.

Leela Barham is an independent health economist. You can access website here and contact her at leels@btinternet.com