PHP38 Market Access for Pharmaceuticals in UK: Number and Speed of Drug Reviews to Improve After Introduction of Value Based Pricing

Abstract

This study seeks to evaluate the impact on market access for pharmaceuticals in the UK following the introduction of Value Based Pricing (VBP). SMC advice and final NICE guidance issued between 1 June 2010 and 31 May 2011 were assessed to determine the number and outcome of total appraisals, of Single Technology Appraisals (STAs), and of appraisals based on a manufacturer submission. The current duration of a NICE STA review and the time required to provide guidance under the NICE Scientific Advice Programme were also reviewed. Under VBP, all new originator drugs entering the market and all new indications of existing medicines will be reviewed: as is the case currently in Scotland. Over the 12-month period, the SMC reviewed a total of 101 new drugs or indications, of which 18 were resubmissions, so a total of 83 original reviews were performed. NICE – which only reviews treatments it is commissioned to review by the DH – conducted 28 STAs. Some 47% of SMC drug reviews resulted in positive guidance – rising to 58% among reviews based on a manufacturer submission. The average length of a NICE technology appraisal is 18 months; however, NICE scientific guidance can be provided in as little as 15 weeks. Pharmaceutical market access in England and Wales will potentially improve following the introduction of VBP as more products are reviewed in a more timely manner. Three times more originator medicines or new indications will be reviewed in comparison to the number currently reviewed by NICE. The average duration of an appraisal under VBP could to be just 15 weeks – 19.2% of the time currently required. On the negative side, manufacturers would be expected to offer products at an acceptable price – calculated in accordance with yet-to-be-finalised criteria – in exchange for gaining reimbursement.