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NICE has launched a public consultation that sets out the case for changing the methods it uses to develop guidance on drugs, medical devices, and diagnostics 1 The review was first announced in July 2019 but has been delayed because of covid-19 2 The consultation document says that there should be no change to the general preference for randomised controlled trials (RCTs) to inform estimates of treatment effects but that there should be “an emphasis on the role of a comprehensive evidence base, including non-RCTs and real world evidence ” Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said, “As we develop a new regulatory and access environment for drugs, medical devices, diagnostics, and digital health technologies, our methods should be aimed at supporting early patient access at a reasonable cost to the NHS, for example by encouraging companies to launch their products in the UK first ” Nick Meade, director of policy at the Genetic Alliance UK, said the review is a necessary and important step to improving access to treatments, adding, “This is just one part of a much bigger picture—in a week where NHS England have refused to fund sapropterin for phenylketonuria, a medicine licensed in 2008 and available in 23 European countries—it’s clear there are wider access problems for people living with rare conditions in the UK ”
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