National Institute for Health and Clinical Excellence (NICE)
NICE welcomes life sciences review recommendations
NICE’s priority is to get the best care to patients fast while ensuring value for the taxpayer.
The Pro-innovation Regulation of Technologies Review: Digital Technologies Review, published today, recognises the work we have done to further speed up and streamline our processes, taking a proportionate approach to the evaluation of medicines and providing early conditional recommendations on the use of medtech in the NHS.
Over the past year we embarked on a new model of working, a model where we:
- Focus on what matters most
- Develop guidance that’s useful and usable
- Continually learn from data and implementation
As part of this new model, during the last 12 months we have applied light-touch, faster evaluations to simpler, low-risk treatments. This proportionate approach has helped practitioners and commissioners get the best care to people fast – these appraisals have been 45% faster on average than our standard process - while still maintaining rigorous standard and ensuring value for the taxpayer.
For example, our evaluation of vutrisiran resulted in final draft guidance 20 weeks faster, or nearly 60%, than our standard appraisal process. This approach has also increased capacity in our programme. So far around 176,000 people have benefitted from the 5 treatments recommended through this proportionate approach.
In the last year we have increased the speed of our appraisals overall by 25%. In reality, we are now much faster than that. For example, we issued positive final guidance for faricimab for two eye conditions 29 days after the drug was licensed, meaning 300,000 people could benefit much earlier.
Industry data shows that the UK is third globally in the number of medicines commercialised within one year of their first approval.
We look forward to working with industry to continue the acceleration of our evaluations of medicines and with the MHRA to align our work for the benefit of patients, as recommended in the review.
The review also recommends the creation of a cloud-based data sharing platform to allow regulators and NICE to work in tandem. We look forward to working with partners on how this can become a reality.
The review has made recommendations on speeding up access to innovative Medtech. Here, NICE has already successfully piloted Early Value Assessments (EVA), which look at medical technologies that address national unmet needs, contributing to the NHS Long Term Plan. This scheme offers a rapid assessment of potential clinical effectiveness and value for money so that services and patients will be able to benefit sooner. It allows promising technologies to be put into use and valuable real world evidence gathered.
In 2022/23 we piloted 7 EVAs – fast-tracking patient access to promising innovations twice as fast as normal. For example, just this month we recommended the use of 9 digital technologies for adults with depression or anxiety that could the capacity of mental health services meaning patients receive the help they need sooner.
In addition, we have:
- Developed a new rapid review process to update recommendations on the cost-effectiveness of COVID-19 treatments. This is so that they can be made available more quickly to patients if they show promise against new variants and are found to be cost-effective.
- Issued guidance on treatments for COVID-19 that for the first time, considered evidence from in vitro studies. These lab-based studies can be used to quickly assess how well treatments work against new variants, and therefore predict whether they will work in the real world to protect people.
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