PharmacoEconomics & Outcomes News 774, p34 - 25 Mar 2017 NICE introducing fast-track appraisals UK’s National Institute for Health and Care Excellence (NICE) is introducing a fast-track option for drug appraisals, which is expected to make the drugs available for use in the National Health Service (NHS) within a month after licensing. Another change which has been approved by the NICE board is a budget impact test which will trigger discussions between the drug company and NHS England if a drug costs over $20 million per year within the first three years. If an agreement cannot be reached to minimise the budget impact of such a drug, NHS England could apply to introduce the drug in a phased manner over an extended period of up to three years. Another change approved is for evaluation of drugs for very rare diseases against a sliding scale, with more costly drugs being required to provide a greater health benefit in order to be approved for routine use within the NHS. "We believe these and the other changes that have now been approved will enhance our ability to optimise access to innovative treatments in the light of the significant financial challenge facing the NHS," said Sir Andrew Dillon, Chief Executive of NICE. Fast track appraisals will apply to drugs that appear to be very cost effective, with expected costs of below £10 000 per QALY gained (well below NICE’s standard willingness-to-pay [WTP] threshold of £20 000–£30 000 per QALY). NICE intends to consider broadening fasttrack appraisals to include medical devices and diagnostics within the next two years. Under NICE’s Highly Specialised Technologies programme, treatments for vary rare diseases that provide significant QALY improvements could be evaluated against a WTP threshold of £300 000 per QALY gained. "We listened carefully to the feedback received during the consultation and have adjusted our proposals by trebling, for the most transformative treatments, the threshold for determining routine funding - raising the upper limit to ten times that used for standard treatments," said John Stewart, Acting Director for Specialised Commissioning at NHS England. NICE. NICE gets go-ahead to fast-track more drug approvals Internet Document : 15 Mar 2017. Available from: URL: https://www.nice.org.uk/news/article/nice803233416 gets-go-ahead-to-fast-track-more-drug-approvals

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PharmacoEconomics & Outcomes News 25 Mar 2017 No. 774

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