At a recent meeting of the All-Party Parliamentary Group (APPG) on Access to Medicines and Medical Devices, NICE’s Chief Executive, Sir Andrew Dillon discussed the long anticipated NICE methods review. Here are five key takeaways:
NICE has always stated that it is accountable to the Department of Health and Social Care (DHSC) but independent from government. Whilst Sir Andrew looked to reaffirm this, he was clear that NICE has to work within the wider system – there is clearly no point in creating a system that works for NICE and industry if the DHSC and NHS England can’t or won’t deliver it. The NHS’ restructuring over the past decade, including the creation of bodies such as NHS England, has reduced the autonomy and ease at which NICE can make decisions. NICE will have to collaborate more closely with these bodies to receive buy-in from across the healthcare system.
As a result, the first set of discussions will be within the health system rather than external, with the initial scope of the methodology review determined by the DHSC, NHS England and NICE.
Meindert Boysen, Director of the Centre for Health Technology Evaluation (CHTA) at NICE, confirmed that the Working Committee tasked with setting the scope of this methodology review will initially only invite representatives from the Association of British Pharmaceutical Industry (ABPI).
This decision raised some questions from industry partners who felt the ABPI may not be able to represent all views. Some industry representatives may not appreciate being unable to influence to scope of the methodology in its early stages. Boysen was quick to stress that following the initial working group, there will be technical groups looking at specific topics, involving representations from a whole range of the pharma industry.
It is likely that NICE will also continue to face pressure from other industry representatives, such as the Ethical Medicines Industry Group (EMIG), as it pushes for a say on the scope of the methodology earlier on in the process.
NICE has not yet set an anticipated date for the completion of this methodology review, and it is likely to be a complex and consultative task. For NHS England and government, there is a distinct upside to having an extended review which keeps everyone occupied in a holding pattern – putting off difficult decisions until further down the line. While the review was certainly positively received, many regard it as long overdue given the rapid advancements in medical technology over the last decade.
Unsurprisingly, there were many questions around the system for appraising treatments for rare diseases. Sir Andrew recognised that this is clearly an area in need of consideration and stressed that one of the key things the review will look at is the criteria used to put products in the highly specialised treatment programme.
A holistic look at the challenge of how to balance limited resource with costly treatments for very small patient populations will be welcome, but Sir Andrew made it clear that there were no easy answers.
Anne Marie Morris MP, Chair of the APPG, has launched a call for written evidence on NICE’s review of its methods for appraising treatments for use on the NHS. The consultation document offers industry representatives an alternative route to have their say on the methods review. However, the APPG are only accepting submissions until 29 April 2019. It will therefore it will be important for industry partners to determine the key messages and requests they want to highlight to the APPG, before it submits its findings to the CHTA.
So what next?
Appraisal and access routes have developed somewhat organically over time. For example, there are now around 10 access routes in the medicines process so a streamlining and sharpening of processes is vital.
While the review will seek to address challenges currently faced, this is also an exciting opportunity for NICE to have a longer-term vision and prepare for the future. As innovation in treatments accelerates at pace, will we now see a genuine consideration of new access models such as value-based or variable pricing across multiple indications? Or will the risk of undermining ‘a QALY is a QALY is a QALY?’ win the day?