THE CANCER DRUGS FUND- THE EVOLVING ASSESSMENT PROCESS
Author(s)
Carroll MV1, Satherley A1, Miller PS2
1Evidera, London, UK, 2Miller Economic Ltd, Alderley Edge, UK
OBJECTIVES: In July 2016, the Cancer Drugs Fund will become a ‘transitional managed access’ fund with clear entry and exit criteria. It is anticipated this new system will re-assess all existing therapies funded by the CDF and provide conditional funding for those which appear promising but where the National Institute for Health and Care Excellence (NICE) has stated there is insufficient evidence to support routine commissioning. Drugs given a conditional recommendation will be granted access for up to 24 months whilst further evidence is collected, after which the drugs will undergo a NICE appraisal. This research aims to understand the drivers of drug inclusion in the CDF and determine how companies can prepare for the new assessment process. METHODS: Primary research was undertaken with UK health economic stakeholders and former National Healthcare Service budget holders to determine the drivers of CDF inclusion for new oncology therapies and drugs currently funded by the CDF; feasible data that can be generated for products awaiting NICE re-appraisal; and optimal approaches for access under the CDF. RESULTS: Manufacturers will be invited to submit clinical and cost effectiveness evidence at the same time as they submit to the European Medicines Agency (EMA). Submission requirements and pricing decisions must be prepared before marketing authorisation and account for any possible indication amendments that may be requested by EMA, which should be considered within post-hoc analyses and network meta-analyses. CONCLUSIONS: The new CDF model presents the opportunity for early and rapid market access for promising oncology drugs in advance of final cost-effectiveness results. Emphasising the value of pivotal trial data to payers, managing uncertainty and planning for rapid post-launch data generation will be critical to ensure CDF inclusion. Additionally, the new model provides an opportunity to establish optimal access arrangements to support confidential pricing and avoid mandatory price cuts.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCN269
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Oncology