NICE launches wide-ranging consultation to update health technology evaluation

The National Institute for Health and Care Excellence (NICE) has launched its most wide-ranging review into the way it develops recommendations across its health technology evaluation programmes.

NICE is seeking feedback until 13 October on proposed changes to its health technology assessment methods and processes. NICE states that the reason for the review is so it can evolve alongside advances in medicines and data synthesis.

The organisation hopes that the changes will provide predictability for industry, greater transparency for stakeholders and enable swift decision making for its committees.

NICE hopes that the proposals are able to provide earlier access to valuable new treatments; more equitable access to treatments for those with severe diseases; greater clarity and predictability of health technology assessment outcomes; enhanced flexibility in the use of a comprehensive evidence base, including use of real-world data; and support for the life sciences vision of making the UK a more attractive place for life sciences companies to succeed and grow.

Professor Gillian Leng CBE, NICE chief executive, said: “As NICE grows in importance for the health service in England, so do expectations from all our stakeholders for what our methods and processes can do for them. Chief among these is how we can reflect and enable the broader vision of the life sciences industry, patients and the service for accelerated access to innovative health technologies while managing risk and ensuring the NHS gets value for money.

“Taken together, these proposals will bolster the ability of NICE to support access to valuable innovative technologies that bring health benefits for patients and good value to the NHS – staying robust, efficient and future-proof to meet the challenges of advances in health technologies.”

NICE is ensuring that the consultation will address key areas for improving its methods and processes of health technology evaluation.

This will include implementing a severity modifier to replace the current end of life modifier. NICE is also proposing applying additional modifier weight to incremental QALYs gained by treatments for the most severe diseases. This is to broaden the modifier to include technologies for a wide range of diseases, such as musculoskeletal, inflammatory and mental health conditions and childhood genetic diseases.

More so, from the consultation, NICE hopes it can provide more flexibility in accepting uncertainty in specific situations, such as when considering treatments for rare diseases or diseases which affect children where it is recognised that generating evidence is complex and difficult.

NICE will put more emphasis on the role of a comprehensive evidence base, including non-randomised-controlled trials and real-world evidence, and clarifying the circumstances in which different types of evidence have strengths or limitations. In terms of data, NICE aims to make improvements in how evidence is collected, presented and considered.

To make health technology evaluation more flexible, NICE will develop a final draft guidance document after the first committee meeting extended to diagnostics and medical technologies guidance. This will enable all NICE health technology evaluation committees to make recommendations for managed access where significant uncertainties otherwise prevent a recommendation for routine use.

NICE is also seeking feedback on its eligibility criteria for devices, diagnostics and digital technologies and the aim and routing criteria for topics for evaluation through NICE’s Highly Specialised Technologies programme.

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: “Operating at the interface between the world in which new treatments are developed and the NHS in which they are used, NICE occupies a unique position in managing the lifecycle of innovative health technologies.

“Our methods and processes are central to an internationally attractive life sciences offer in which we work collaboratively with our partners across the regulatory and life-sciences landscape on speeding up access to promising innovative new health technologies, including through the Cancer Drugs Fund, Innovative Licensing and Access Pathway, the forthcoming Innovative Medicines Fund and activities of the Accelerated Access Collaborative such as the MedTech Funding Mandate.

“Ensuring that our methods and processes are clear, transparent and predictable, these proposals further emphasise our commitment to making the journey for promising new health technologies even faster, and patient access fairer.”

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, commented: “This is a major milestone in an important review, and a significant opportunity to update the methods and processes NICE uses to support access to the life changing medicines of today and tomorrow.

“The ABPI and our members will be working hard over the coming months to help make sure the proposals meet the ambition of the UK’s Life Sciences Vision and deliver meaningful change for patients, their families, and the NHS.”

Following the completion of the review, NICE will move to a dynamic, modular approach to updating its methods and processes combined with improved horizon scanning for emerging methodological developments and challenges. This will ensure it can proactively adapt to new innovations and secure seamless evaluation and rapid access. Future modular updates for the methods will include health inequalities, digital technologies, genomics and antimicrobials alongside processes for managing technologies with multiple indications and rapid entry to managed access.