NICE has today launched a public consultation on proposed changes to the way it develops recommendations across its health technology evaluation programmes.

From today until 13 October 2021, NICE is seeking feedback on proposed changes to its health technology assessment methods, and processes. The consultation is the culmination of the most wide-ranging and comprehensive review NICE has ever carried out, which has involved health system partners as well as industry, healthcare professionals, academia, and patients.

The proposed changes signal how NICE is evolving alongside technological advances in medicines and data synthesis to continue to deliver excellence for patients, the NHS and the life sciences industry. These changes aim to provide greater predictability for industry, greater transparency for stakeholders and enable swift decision making for our committees.

The over-arching ambition of the proposals are to provide:

• Earlier access to valuable new innovative 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.
• 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.”

The consultation addresses several key opportunities for improving and enhancing NICE’s methods and processes of health technology evaluation. They include:

• Implementing a severity modifier to replace the current end of life modifier. NICE proposes applying additional weight to incremental QALYs gained by treatments for the most severe diseases. This broadens the modifier to include technologies with indications across a wide range of diseases, for example musculoskeletal, inflammatory and mental health conditions and childhood genetic diseases, depending on their severity, in addition to cancer (which end-of-life most commonly focussed on). NICE will also commission research to establish the extent to which society is willing to displace possible health gains elsewhere in the system – and therefore the QALY weighting that should be applied – in order to provide more treatment options for people with severe diseases. NICE is also seeking feedback on the proposal to prioritise further work to support products that help to reduce health inequalities.
• Providing 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. The proposals also suggest there should be more flexibility when considering highly innovative and complex technologies.
• Putting 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.
• Making broad and comprehensive improvements in how evidence is collected, presented and considered. This will provide important clarity, predictability and transparency for industry and our committees – ensuring high-quality evidence and hence rapid, robust evaluation and fast, efficient decision-making.
• Proposals to make the processes of health technology evaluation more flexible and responsive, to support rapid patient access to health technologies that are both clinically effective and value for money. These include the option to develop a final draft guidance document after the first committee meeting extended to diagnostics and medical technologies guidance and enabling all NICE health technology evaluation committees to make recommendation for managed access where significant uncertainties otherwise prevent a recommendation for routine use. Proposals also include earlier identification of patient and clinical experts and the provision of a 'Summary of information for patients' within a company submission.

The methods review identified a case for changing the preferred discount rate from 3.5% to 1.5% per year for costs and health effects. NICE recognises the wider policy and fiscal implications and interdependencies raised by system stakeholders to such a change, including the potential impacts on NHS spending and resource allocation, that extend beyond the reach of this review. NICE accepts the need for further policy discussions and welcomes the opportunity to be able to work with stakeholders.

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.

NICE has also today published proposals for changes to the way topics across its medicines, medical devices, interventional procedures and diagnostics programmes are selected. These proposals, which are also the subject of public consultation, include the creation of a single topic selection oversight panel to replace three different groups to select topics for NICE guidance. This will make topic selection cohesive, clearer and provide consistent decision making. It is also proposed that topic selection decisions will be routinely published on the NICE website.

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.”

NICE has confirmed that, following the completion of this review, it will move to a dynamic, modular approach to updating its methods and processes combined with improved horizon scanning for emerging methodological developments and challenges. The aim is to 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.