ArticleInternational journal of clinical pharmacy2026
Cost-effectiveness of first-line pembrolizumab monotherapy in PD-L1-high metastatic non-small cell lung cancer in Australia: evidence from trials and real-world practice.
Article in International journal of clinical pharmacy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
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Abstract
introductionPembrolizumab monotherapy improves survival in advanced non-small cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 50%. However, survival in randomised trials may not fully reflect outcomes in routine practice, with implications for economic evaluation.
aimTo evaluate the cost-effectiveness of pembrolizumab monotherapy compared with platinum-based chemotherapy from an Australian health-payer perspective, integrating both randomised controlled trial (RCT) and real-world evidence (RWE).
methodA semi-Markov model with three health states (progression-free, progressed disease, death) was developed over a 3-year horizon. Clinical inputs were derived from KEYNOTE-024 for the RCT scenario and from nationwide Australian real-world data for the RWE scenario, with chemotherapy outcomes retained from the pivotal trials in both scenarios. Direct medical costs (2024 AU$) and quality-adjusted life years (QALYs) were estimated. Incremental cost-effectiveness ratios (ICERs) were calculated, probabilistic and deterministic sensitivity analyses conducted.
resultsCompared with chemotherapy, pembrolizumab monotherapy was associated with incremental costs of AU$87,399 (RCT-based) and AU$75,935 (RWE-based), and incremental QALY gains of 0.23 and 0.11, respectively. Corresponding ICERs were AU$385,561/QALY (RCT) and AU$705,729/QALY (RWE). At a AU$75,000/QALY willingness-to-pay (WTP) threshold, the probability of cost-effectiveness was < 1% in both scenarios. Differences in overall survival between trial and real-world cohorts likely contributed to the variation in ICERs.
conclusionAt current pricing and Australian WTP thresholds, pembrolizumab monotherapy is unlikely to be cost-effective, with RWE-informed scenarios yielding less favourable cost-effectiveness estimates than from trial data. These findings highlight that cost-effectiveness estimates may be sensitive to differences between trial-based and real-world effectiveness inputs.
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Registered trials
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