tCI Comment
One of the pieces of legislation we’ve been closely following recently is the Medicines and Medical Devices Bill, currently undergoing its final stages in Parliament. The Bill looks set to make significant changes to the regulation of medicines and medical devices, and potentially lay the foundations for even more changes to follow. It is perhaps not surprising then that we see this news of a major consultation at the National Institute for Health and Care Excellence. As the third part of an ongoing review, it should be interesting to follow- major changes to procedures usually are.
Article
A new public consultation has been launched on proposals on changes to the processes which NICE uses to develop its guidance on medicines, medical devices, diagnostics and digital health technologies.
It forms part of the largest ever review undertaken by NICE, which will look at changes to the methods and processes the organisation uses to produce its guidance.
This new public consultation period – the third in a series NICE has now launched in recent months – will run until Tuesday April 15, 2021.
As part of the proposals, they will explore opportunities for:
- Aligning the current guidance programme processes.
- New process improvements and ways of working.
- Improving the commercial and managed access processes.
- Making the criteria for selecting topics for evaluation through NICE’s Highly Specialised Technologies programme clearer and more specific, and the outcome easier to understand and more predictable for stakeholders.
Meindert Boysen, Deputy Chief Executive and Director of the Centre for Health Technology Assessment at NICE, said: “Ensuring rapid access to clinically and cost-effective health technologies is critically important to patients and their families, the NHS and the life sciences industry. To continue to support the needs and aspirations of all parts of the healthcare and life sciences ecosystem, NICE must ensure that its processes of health technology evaluation maintain and improve upon key objectives regarding quality, dependability, speed, flexibility and cost.
“These proposals present an important opportunity to achieve these objectives. By doing so, not only will NICE be better able to support patients and the NHS in accessing clinically and cost-effective health technologies, it will also ensure that we can play our part in ensuring the UK remains a first-launch country for important and promising new health technologies.”
“We’ve learnt a great deal over the past 21 years during which we have continued to evolve and adapt our processes and methods to meet the challenges of an ever-changing healthcare environment.
“These proposals build on that experience. They outline how we aim to focus our health technology evaluations on not just final guidance as the main ‘output’, but on moving towards ‘health technology management’, where support for early development, early advice, adoption, real world performance and reassessment are targeted to ensuring that the needs of patients and the NHS are front and centre in our activities.”
Article originally appeared on National Health Executive.
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