Analysis of Recent HTA Appraisals for NSCLC in England, France, Canada and Australia
Introduction
My colleagues from ICON’s global Pricing and Market Access practice and I recently conducted an analysis to assess the value of real world evidence (RWE) in recent Health Technology Assessment (HTA) appraisals for non-small cell lung cancer (NSCLC) in England, France, Canada, and Australia. We presented our research at ISPOR Europe 2018 conference and were delighted to be recognized among the top 10% of poster presentations, based on abstract review score.
While randomised clinical trials (RCT) have been the ‘gold standard’ study design for health technology assessment (HTA), real world evidence (RWE) gathered outside of RCTs and derived from data from non-randomised trials, observational studies, registries, electronic health records, and other sources is increasingly also used by HTA bodies to understand the value of new technologies and timely patient access.
Methods
The team extracted RWE and reimbursement outcomes from publicly available appraisal reports for NSCLC drugs, between January 2013 and June 2018 from the National Institute for Health and Care Excellence (NICE), Haute Autorité de Santé (HAS), the Canadian Agency for Drugs and Technologies in Health (CADTH) pan-Canadian oncology drug review (pCODR) and the Pharmaceutical Benefits Advisory Committee (PBAC).
Results
Our analysis assessed 16 NSCLC technologies and determined that RWE was submitted in 56% of the appraisals, as follows:
The analysis shows that RWE from registry data, observational studies, and retrospective analyses was submitted to identify treatment patterns and patient characteristics, for evidence synthesis, and as supportive evidence for the economic evaluation (such as extrapolation of long-term survival data and validation of economic model inputs).
From a country perspective, RWE was a NICE requirement to gain access to the Cancer Drug Fund; whilst per PBAC, manufacturers were requested to collect survival data via registry study to meet the requirements for a managed entry scheme, where reimbursement was previously not recommended.
Conclusion
From this analysis it is clear that HTA bodies accept RWE as supportive data particularly for economic evaluations, potentially to allow expedited access in an area of high unmet clinical need through managed access schemes.
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