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Promises of "more equitable access for those with severe diseases," "decision-making flexibility where it counts," and more in a bid to win post-Brexit business.
The UK is aiming to rejig its health technology evaluation processes through NICE, partly as a bid to win business post-Brexit. The wide-ranging changes are open to consultation until October 13, 2021, and can be viewed here. following a launch couched in terms more inspired by public relations than regulation, replete with "visions" and "deliverables", with "foundation stones" and "pivotal" action, and promises to provide "faster, fairer access to new drugs and devices." It invites ridicule by elevating statements of the obvious to the status of genius insights: "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." And just in case there was any doubt about the heroism of this commitment: "We navigate a complex environment of ensuring the NHS gets the best value out of the products it uses, while at the same time promoting innovation and supporting the life sciences industry in their journey through regulation, health technology evaluation and patient access".
The post-Brexit rhetoric makes an early appearance: "We are shaping a new offer for the life sciences sector in response to leaving the European Union", says NICE. "Being clear how our methods and processes can support early patient access will be even more important, as it encourages companies to launch their products first in the UK market." It will lead to "synergistic collaborations with health system partners across the landscape and countries of the UK."
"Being clear" will result, it emerges, in "a single, modular, guidance development program manual covering four health technology evaluation guidance programs (Diagnostic Assessment, Highly Specialized Technologies, Medical Technologies Evaluation and Technology Appraisal)." This is intended to remove multiple existing individual process and methods guides and reduce unnecessary duplication of content, it admits. The full details appear in the manual, and I leave ACT readers with more specific interests to peruse it at their leisure.
But among the highlights of the promised new approach is "more equitable access for those with severe diseases", which will be affected in part by new weightings for innovation support. This will "put the impact on patient’s lives at the heart of NICE’s work, while creating a more equitable platform."
There will also be "decision-making flexibility where it counts". The proposals are for NICE’s decision-making committees to "use their flexibility when challenged with complex innovative technologies and those for children or rare diseases, to ensure patients benefit from the most cutting-edge therapies sooner, without barrier or delay". The flexibility will however be "clearly defined, transparent and predictable", it adds.
An emphasis is put on "embracing the full evidence base and new data sources", explicitly including real-world evidence. Again, the description is phrased as if from the pen of a communications consultant inebriated with the exuberance of his or her own verbosity: it "will mean industry will have clarity and predictability for their submissions, while ensuring high quality data continues to provide the backbone for robust, rapid decision making from committees", and "allow companies to plan their evidence collection within the trial and data environment in the NHS."
Once the decorative wording has been disregarded and dismissed by those seeking information rather than spin, the responses to the consultation will doubtlessly be at least as interesting as the proposals themselves—and as the autumn advances, this columnist looks forward to hearing more about the review from stakeholders rather than from spin-doctors.