The National Institute for Health and Care Excellence (NICE), which evaluates the cost effectiveness of medicines and other health technologies for use on the National Health Service in England, is proposing to improve the way it identifies and selects those products for the development of guidance.
Under the proposals, which are out for consultation until 19 November, the criteria for selecting medicines, devices and diagnostics would be clarified, particularly in cases where costs and impacts were expected to be “significantly cost incurring or cost saving,” or the likely costs and impacts for the NHS were uncertain. The plans are part of NICE's wider review of the methods and processes it uses to develop guidance.
“Topic selection plays an important role in the development of NICE guidance and is designed to ensure that the guidance we produce is on topics that support healthcare professionals and others to provide care of the best possible quality,” said Helen Knight, NICE’s director for technology appraisals (TAs) and highly specialized technologies (HSTs). “These proposals will ensure we can continue to meet these ambitions at a time of unprecedented change in the healthcare system.”
Responsibility for topic selection lies with NICE’s Centre for Health Technology Evaluation (CHTE), which develops guidance on TAs, HSTs, diagnostics, medical technologies and interventional procedures.
The selection processes have undergone significant changes over the years, and rather than continuing to update them, NICE has decided to consolidate the various approaches in a single “topic selection manual” to make the information easier to find and understand.
Decision making and stakeholder engagement processes will be aligned to improve efficiency and become more transparent, which NICE said would help stakeholders and the public find the information they need quickly and easily. “Updating these processes gives us the opportunity to ensure good governance and oversight,” it noted.
There are currently three stages to the selection process: identification, selection and routing (ie, determining which guidance procedure a technology should undergo).
The identification criteria will be updated and consolidated to reflect new NICE responsibilities for guidance on topics such as products for hemophilia and HIV. The new criteria will increase the number and type of topics considered for guidance, so NICE's capacity to develop technology appraisals guidance, medical technologies guidance and diagnostics guidance will be expanded accordingly, the institute said.
In the area of medicines, all new active substances as well as “significant” license extensions to add a new therapeutic indication will be selected, except where there is a clear rationale not to do so, for example if the topic is a duplicate or has a significant overlap with an existing topic, according to the consultation document.
Devices likely to be identified as suitable for assessment will include medical devices, other non-diagnostic health technologies, and digital health technologies in tier 3b of the evidence standards framework to treat or prevent a health condition. Diagnostics likely to be identified include products that diagnose, prognose, predict or screen health conditions, including companion diagnostics and those using AI.
New selection criteria will be put in place to replace more than 15 different criteria that are currently used by the CHTE teams to determine whether a topic requires NICE to assess cost and effectiveness evidence.
Medicinal products targeted will include therapeutic vaccines and advanced therapies such as gene therapies and stem cells.
Devices and diagnostics are likely to be selected if they have benefits that are “likely to be highly disruptive or lead to a stepwise change to an established care pathway in the UK,” and where a systematic assessment of the cost and system impacts is needed.
The Routing Procedure
NICE is also looking at improving the routing procedure. “More clarity needs to be provided to indicate how NICE determines which type of guidance-producing programme a particular topic should be routed to,” it said. “Options for routing are based on the type of technology and its value proposition.”
Medicines will continue to be the subject of a technology appraisal guidance or highly specialized technology guidance.
As for diagnostics, NICE says that historically products that offered a value proposition requiring an assessment using cost consequences analysis were typically routed to the Medical Technologies Evaluation Programme, while those that required a cost utility health economic analysis went through the Diagnostics Assessment Programme. “It is proposed that all diagnostics, irrespective of the value proposition, will now be routed to the Diagnostics Assessment Programme.”
Devices requiring a cost-effective analysis will continue to be appraised within the technology appraisal program but NICE’s Medical Technologies Advisory Committee will act as the independent decision maker, the institute said.
NICE also plans to do away with the requirement to develop and consult on a scope to inform selection and routing decisions before a topic is selected for the TA or HST programs. "Instead, scope development and consultation will occur closer to the guidance development stage" with the aim of confirming a routing decision into either of those programs.
In addition, a formal process will be introduced for stakeholders wanting to challenge topic selection routing decisions.
A separate review is being conducted into the criteria used to decide whether to route a new technology to the highly specialized technologies program. “The purpose of reviewing the criteria is to make them clearer and more specific, and the outcome easier to understand and more predictable for our stakeholders,” NICE says. A consultation on this issue will be held in due course.
New Topic Selection Panel
NICE also foresees some changes to the decision-making process. Currently three different topic selection panels meet at different times and there is some crossover in their membership, which could introduce some inefficiency into the system.
In future the institute proposes that the three panels be merged into one – the Topic Selection Oversight Panel – to oversee the identification, selection and routing criteria. The panel will include senior NICE staff and will retain the capacity for external expertise to be provided by the Department of Health and Social Care and NHS England and Improvement. Its remit will include selecting topics for guidance development, identifying routes to the appropriate guidance-producing programs, and deciding whether to select topics for development as Medtech Innovation Briefings.
Topic Selection Manual
The single topic selection manual is intended to make it easier for those involved and interested in this subject to find and understand relevant information “with the ultimate aim of increasing transparency of NICE processes," according to the institute.
Steps will also be taken to standardize the way that information is presented on topic selection and to provide it more clearly on the NICE website. Standardized information will include topic identification number, technology name and type, indication, the decision, and the reason for and date of the decision.
NICE also plans to change the wording of the “remit” – NICE’s name for the formal ministerial referral of products to the technology appraisals programme and to the highly specialised technologies programme.
These are currently in two different formats. For technology appraisals the current wording is: “To appraise the clinical and cost effectiveness of [insert technology name] within its marketing authorization for treating [insert indication].” For HSTs it is: “To evaluate the benefits and costs of [insert technology name] within its marketing authorization for treating [insert indication] for national commissioning by NHS England.”
In future NICE proposes that the wording for technology appraisals be used for HSTs as well.