NICE launches public consultation on technology assessment programs
NICE today launched a public consultation on proposed changes to the way it develops recommendations across its health technology assessment programs.
From today until October 13, 2021, NICE is soliciting comments on proposed changes to its health technology assessment methods and processes. The consultation is the culmination of NICE’s largest and most comprehensive review ever, which involved partners in the healthcare system as well as industry, healthcare professionals, academia and patients.
The proposed changes indicate how NICE is evolving alongside technological advances in medicines and data synthesis to continue to deliver excellence to patients, the NHS and the life sciences industry. These changes are intended to provide greater predictability for the industry, greater transparency for stakeholders and enable rapid decision-making for our committees.
The overall ambition of the proposals is to provide:
- Faster access to new innovative and valuable treatments.
- More equitable access to treatment for people with serious illnesses.
- Greater clarity and predictability of health technology assessment results.
- Increased flexibility in the use of a comprehensive evidence base, including the use of real world data.
- Supporting the life sciences vision of making the UK a more attractive place for life science businesses to succeed and grow.
Professor Gillian Leng CBE, Managing Director of NICE, said: “As NICE gains importance for healthcare in England, the expectations of all our stakeholders about what our methods and processes can do for them are also increasing. Chief among them is how we can reflect and enable the broader vision of the life sciences industry, patients and service for accelerated access to innovative health technologies while managing risk and enabling ensuring the NHS gets its money’s worth.
‘Taken together, these proposals will strengthen NICE’s ability to support access to valuable innovative technologies that bring patient health benefits and good value to the NHS – remaining robust, efficient and scalable to meet the challenges of advancement health technologies. “
The consultation covers several key opportunities to improve and strengthen NICE’s health technology assessment methods and processes. They understand:
- Implemented a severity modifier to replace the current end of life modifier. NICE proposes to apply additional weight to the incremental QALYs gained by the treatments of the most severe diseases. This expands the modifier to include technologies with indications in a wide range of diseases, for example musculoskeletal, inflammatory and mental health disorders and childhood genetic diseases, depending on their severity, in addition to cancer (including cancer). end of life most often focuses on). NICE will also commission research to determine the extent to which society is willing to shift possible health gains elsewhere in the system – and therefore the QALY weighting that should be applied – in order to provide more treatment options for those with the disease. serious illnesses. NICE is also seeking comments on the proposal to prioritize additional work to support products that help reduce health inequalities.
- Provide more flexibility in accepting uncertainty in specific situations, for example when considering treatments for rare diseases or diseases that affect children when it is recognized that the generation of evidence is complex and hard. The proposals also suggest that there should be more flexibility when considering highly innovative and complex technologies.
- Put more emphasis on the role of a comprehensive evidence base, including non-randomized controlled trials and real-world evidence, and clarify the circumstances under which different types of evidence have strengths or limitations.
- Make general and comprehensive improvements to the way evidence is collected, presented and considered. This will provide clarity, predictability and transparency important to the industry and our committees, ensuring high quality evidence and therefore rapid and robust assessment and rapid and efficient decision making.
- Proposals to make health technology assessment processes more flexible and responsive, in order to promote rapid patient access to health technologies that are both clinically effective and cost effective. These include the possibility of developing a draft final guidance document after the first committee meeting extended to medical technology diagnostics and advice and enabling all NICE health technology assessment committees to make recommendations for managed access when significant uncertainties otherwise preclude a recommendation for routine use. Proposals also include the earlier identification of patients and clinical experts and the provision of a “patient information summary” as part of a corporate submission.
The methods review identified a case for changing the preferred discount rate from 3.5% to 1.5% per annum for costs and health effects. NICE recognizes the broader policy and fiscal implications and interdependencies raised by system stakeholders to such a change, including potential impacts on NHS spending and resource allocation, which are beyond the scope 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, as well as the objective and routing criteria for subjects to be assessed under NICE’s Highly Specialized Technologies program.
NICE also today released proposals to change the way topics related to its drugs, medical devices, interventional procedures and diagnostic programs are selected. These proposals, which are also the subject of a public consultation, include the creation of a single subject selection oversight committee to replace three different groups to select subjects for the NICE guidelines. This will make the selection of topics consistent, clearer and allow for consistent decision making. It is also proposed that decisions on the selection of subjects be published regularly on the NICE website.
Meindert Boysen, Deputy CEO and Director of the Center 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 life cycle of innovative health technologies.
“Our methods and processes are at the heart of an internationally attractive offer in life sciences in which we work in collaboration with our partners in the regulatory and life sciences landscape to accelerate access to new innovative health technologies and promising, notably via the Cancer Drugs Fund, Innovative Licensing and Access Pathway, the future Innovative Medicines Fund and the activities of the Accelerated Access Collaborative such as the MedTech Funding Mandate.
“By ensuring that our methods and processes are clear, transparent and predictable, these proposals further underscore our commitment to further accelerate the journey to promising new health technologies and to make patient access more equitable.” “
NICE has confirmed that after the completion of this review, it will move to a dynamic and modular approach to update its methods and processes, combined with better forward-looking analysis of emerging methodological developments and challenges. The aim is to proactively adapt to new innovations and ensure transparent assessment and rapid access. Future modular method updates will include health inequalities, digital technologies, genomics and antimicrobials, as well as technology management processes with multiple indications and rapid entry into managed access.