This report indicates that manufacturers can expect delays in the publication of national IPTs. Furthermore, manufacturers can still expect their products to be evaluated at a regional level, regardless of undergoing the national procedure. Regional decisions may still be taking place due to the prolonged time taken for the publication of these national reports.
A27Objectives: Cost effectiveness analyses play a critical role in determining coverage of novel drugs and devices. Increasingly, payers are demanding subgroup analyses to determine indications which would be covered by the national health system or insurance agency. MethOds: To understand and review trends in the use of subgroup cost effectiveness analysis, we analyzed NICE HTAs for products approved between 2011-2012. Manufacturer submissions for CEA were compared to final review and decision by HTA agency. Analogs were identified and case studies were developed to further understand the use of subgroup analyses and cost effectiveness models. Results: Decisions made by NICE in 2011-2012 show increasing trends towards the use of subgroup analysis for determining indications for coverage by national payer bodies. Between 2011-2012, 80% of the assessments included subgroup analyses. Approximately half of them included cost effectiveness analyses for various subgroups. Interestingly, the ICER values estimated by NICE for the same subgroups showed a large variation (1X-3X fold difference) compared to ICER values estimated by manufacturers. Selected case studies highlighted that for several products, NICE is recommending treatments only for subgroups whose ICER values are within the cost effectiveness threshold. cOnclusiOns: New products need robust broader population and subgroup analyses for insurance coverage.
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