Abstract

In April 2016, NHS England in collaboration with the National institute for Health and Care Excellence (NICE) produced guidance on the appraisal of oncology drugs by NICE aiming to provide guidance within 90 days of marketing authorisation (MA). Additionally, since 29th July 2016 patients can have access to recommended treatments via the new Cancer Drug’s Fund (CDF) from publication of the Final Appraisal Determination (FAD) on the NICE website. To assess the number of new oncology Technology Appraisals (TA) with final NICE guidance produced within 90 days of MA and to estimate the average length of time in days from MA to publication of FAD, in line with the accelerated appraisal timetable of the new CDF. The NICE website was thoroughly searched to include all TAs with final guidance published or under development until 18th May 2018. Only newly licensed indications/products with MA granted by EMA before the cut-off date were included. Indications under consideration should have had an appraisal committee meeting post 1st April 2016. Multiple technology appraisals (MTAs) and transition drugs which were previously in the CDF, have been excluded. Sixty one TAs have been identified across 13 cancer categories as presented on the NICE website. Only two (3.3%) of those had guidance produced within 90 days of MA, with the remaining TAs having published guidance on average 354 days post MA. From 40 TAs recommending new products/indications for routine commissioning or use within the CDF (26 and 14 respectively), FADs were published on average 292 days post MA. On average, patients with cancer in England have access to innovative therapies 8.3 months post MA. The reasons for the delays are complex and have been explored. NICE has recently introduced a new process to TAs, aiming to closely align appraisal and regulatory timelines.

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