HTA BEST PRACTICE - NICE FAST TRACK APPROVALS: 2-YEAR REPORT CARD
Author(s)
Campbell J1, Macaulay R2
1PAREXEL International, London, UK, 2Parexel International, London, UK
BACKGROUND: NICE evaluates the clinical-and cost-effectiveness of pharmaceuticals to inform recommendations on whether they should be publicly-reimbursed in England and Wales. Once a NICE funding directive is applied, the National Health Service has 90 days to make this treatment available . In April 2017, NICE introduced a new Fast Track Appraisal (FTA) process, under which drugs which offer exceptional value for money (defined as an incremental cost per QALY gained of <£10,000, or where a cost-comparison case can be made that similar/greater benefits can be provided at similar/lower cost). Such therapies will be made available to patients within 30 days (as opposed to the standard 90 days). This research evaluates all NICE STAs approved under the FTA process to date. METHODS: Publicly-available NICE Single Technology Appraisal (STA) guidance were screened, FTAs were identified, and key data extracted (01/04/2017-31/12/2019). RESULTS: 176 NICE STAs were identified, 60% (106/176) of which were recommended or optimized. Only 0.05% (5/106) were recommended under the FTA process (TA486 for aflibercept, TA497 for golimumab, TA521 for guselkumab, TA572 for ertugliflozin, TA596 risankizumab). 5/5 were recommended, 0/4 were optimized, and 4/5 utilized a PAS. 5/5 utilized cost-consequence analyses and 0/5 were based on <£10,000 QALY cost-utility assessment. CONCLUSIONS: The FTA process has only been used in a small proportion of NICE STAs since its inception. This may reflect a lack of awareness amongst manufacturers, a low valuation of the incentives provided (faster appraisal and adoption) or a restriction due to the exceptional value for money criteria. Payers offering faster evaluations with reimbursement incentives for new therapies at comparable costs could offer a best-practice HTA process for incentivizing lower company pricing. However, process awareness must be high, criteria must be relevant, and incentives must be sufficient.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PNS133
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Specific Disease