Influence of clinical benefit and cost-effectiveness on reimbursement decisions for lung cancer drugs in Spain

Our plain-English summary of Influence of clinical benefit and cost-effectiveness on reimbursement decisions for lung cancer drugs in Spain, by P. Nieto-Gómez, C. Castaño-Amores, A.J. García-Ruiz, et al (Cost Effectiveness and Resource Allocation, 2026).

The study

• Authors: P. Nieto-Gómez, C. Castaño-Amores, A.J. García-Ruiz, J. Oliva-Moreno
• Journal: Cost Effectiveness and Resource Allocation
• Published: 2026;24(1)
• Read it: PubMed · Publisher · Free full text

Abstract

Background: In principle, reimbursement decisions for oncological drugs in Spain hinge on clinical benefit and cost-effectiveness, yet factors guiding these decisions are not fully explained in reimbursement reports. This study examines these criteria for a cohort of lung cancer drugs in Spain and estimates and describes the cost-effectiveness, clinical benefit, and reimbursement decisions for lung cancer and mesothelioma drugs authorized in Spain between 2010 and 2023.

Materials And Methods: Clinical benefit was assessed using four scales from medical societies and Health Technology Assessment Agencies (HTAA). Cost-effectiveness was estimated using notified and reimbursed prices, and effects were obtained from HTAA reports. Reimbursement decisions were reviewed from official sources (BIFIMED). Statistical analyses and models were carried out to determine influencing factors.

Results: 28 drugs and 55 indications were analysed. A total of 50 drugs and 165 indications were excluded from the analysis as they were not related to lung cancer. A positive association was found between clinical benefit and reimbursement decision (OR: 3.20; CI95%: 1.46-7.44; p < 0.01). The median of the estimated incremental cost-utility ratio (ICUR) was €91,568 (IQR 43,944 - 133,384) per Quality-Adjusted Life Year (QALY) gained with notified prices and €41,030/QALY (IQR 22,213 - 76,390) with reimbursed prices (p < 0.0001). Statistical models showed that substantial clinical benefit increased the probability of positive reimbursement decision by 35-40% points. Cost-effectiveness, presence of therapeutic alternatives, disease incidence or presence of uncertainty had no significant influence.

Conclusions: Our study reveals a positive association between clinical benefit and reimbursement decisions for lung cancer drugs in Spain. No evidence was found that cost-effectiveness is associated with reimbursement decisions.

© 2026. The Author(s).

In plain English

This cross-sectional study examined what was linked to public reimbursement in Spain of lung cancer and mesothelioma drugs authorised 2010 to 2023. It did not study asbestos exposure. Only 2 of 55 indications (from 28 drugs) were for mesothelioma. The authors rated clinical benefit on four scales. They estimated additional drug purchase cost per additional quality-adjusted life year (QALY) gained versus a comparator, such as another treatment or observation. Substantial or major clinical benefit scores were associated with reimbursement (odds ratio 3.20, 95% CI 1.46 to 7.44). Of 100 such scores, 88 were for reimbursed indications, versus 66 of 95 lower scores. The median estimated incremental cost-utility ratio was €91,568 per QALY gained at notified prices and €41,030 at reimbursed prices. In the models, substantial benefit was associated with a 35 to 40 percentage-point higher probability of reimbursement. Cost-effectiveness, therapeutic alternatives, incidence and trial uncertainty showed no significant influence. The authors concluded that clinical benefit was associated with reimbursement and found no evidence that cost-effectiveness was. They noted a small sample and drug-only cost estimates, calling the findings indicative, not conclusive.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Cross-sectional analysis of authorised drug indications. It combined clinical benefit ratings, simplified cost-effectiveness estimates and official reimbursement decisions, and used statistical models (Fisher's test, Spearman correlation, probit models).
• Who was studied: Drug indications (not patients) for lung cancer and mesothelioma authorised in Spain between 2010 and 2023: 28 drugs with 55 indications, of which 2 indications were for mesothelioma
• Exposure: No asbestos exposure was studied. The factors examined for each drug indication were: its clinical benefit on four rating scales (ESMO-MCBS, ESMO-MCBS adapted by AIHTA, ASMR and IQWIG); its estimated incremental cost-utility ratio at notified and at reimbursed prices; whether a therapeutic alternative existed; uncertainty in the pivotal trials; and incidence.
• Main results:
  • In total, 28 drugs with 55 indications were included; only 2 indications were for mesothelioma
  • Clinical benefit scores of substantial or major were associated with a higher probability of reimbursement: odds ratio 3.20 (95% CI 1.46 to 7.44; p less than 0.01). Of 100 substantial-or-major scores, 88 (88.0%) belonged to reimbursed indications, compared with 66 of 95 (69.5%) lower scores.
  • Median estimated incremental cost-utility ratio (additional drug cost per additional QALY versus each indication's comparator, which could be another treatment, best supportive care or observation), base case at notified prices: €91,568 per QALY (IQR 43,944 to 133,384)
  • Median estimated incremental cost-utility ratio using confidential reimbursed prices: €41,030 per QALY (IQR 22,213 to 76,390). The difference from notified prices was statistically significant (p less than 0.0001).
  • No correlation was found between the cost-utility ratio and the reimbursement decision, either at notified prices (r = 0.07; p = 0.64) or at reimbursed prices (r = 0.11; p = 0.46)
  • In probit models, substantial clinical benefit was associated with a 35 to 40 percentage-point higher probability of public reimbursement, compared with indications without substantial clinical benefit
  • The cost-utility ratio, presence of therapeutic alternatives, incidence and trial uncertainty were not statistically significant in the models
  • At a willingness-to-pay of €25,000 per QALY, 6.82% of indications would be cost-effective at notified prices, compared with 31.82% at reimbursed prices
• The authors' conclusion: The authors concluded that clinical benefit was positively associated with reimbursement decisions for lung cancer drugs in Spain. They found no evidence that cost-effectiveness was associated with reimbursement decisions, and said the results should be interpreted with caution.
• Limitations the authors state:
  • Cost-effectiveness ratios were based only on drug acquisition costs, leaving out other costly resources
  • The sample was small and some data were missing, which may reduce statistical power and generalisability; the findings are indicative rather than conclusive
  • The data cannot establish causal links, only statistical associations
  • Budget impact could not be estimated; incidence was used as an imperfect proxy
  • Price data were lacking for non-reimbursed single-indication drugs, which could introduce bias

Topics

Medical terms in this study, explained in our Lexicon: Lung Cancer, Mesothelioma.

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