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已发表论文
依那伏利西布治疗 PIK3CA 突变的晚期男性乳腺癌的成本效益分析
Authors Huang X, Lin S, Lin R, Luo S, Huang P, Zeng D
Received 25 September 2025
Accepted for publication 17 December 2025
Published 26 December 2025 Volume 2025:17 Pages 1385—1396
DOI https://doi.org/10.2147/BCTT.S566088
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Professor Pranela Rameshwar
Xiaoting Huang,1,2,* Shen Lin,1,2,* Rongfang Lin,1,2 Shaohong Luo,1,2 Pinfang Huang,1,2 Dayong Zeng1,2
1Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China; 2Department of Pharmacy, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, 350212, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Pinfang Huang, Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China, Tel +8613600898956, Email abstract2016@163.com Dayong Zeng, Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China, Tel +8613860613541, Email dydyzeng@qq.com
Background: The Phase III INAVO120 trial established inavolisib-based therapy as a superior first-line treatment for PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer, a finding of particular importance for the historically underrepresented male population with high unmet need.
Methods: A lifetime Markov model was developed from a US payer perspective to evaluate the cost-effectiveness of inavolisib plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in men with PIK3CA-mutated advanced breast cancer. Primary outcomes were life-years (LYs), quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER).
Results: The inavolisib group provided an additional 1.23 LYs and 0.69 QALYs compared to the placebo group, resulting in an ICER of $886,440 per QALY. One-way sensitivity analysis identified the price of inavolisib as the primary driver of the ICER. Probabilistic sensitivity analysis showed a 0% probability of inavolisib being cost-effective at a willingness-to-pay threshold of $150,000 per QALY.
Conclusion: Inavolisib-based therapy is not cost-effective for treating PIK3CA-mutated advanced male breast cancer at its current price. Significant price reductions or adjustments to value assessment frameworks are required to ensure equitable access for this underserved population.
Plain Language Summary: 1. First Economic Model for Ultra-Rare Subgroup
This study presents the first economic evaluation of inavolisib for the treatment of PIK3CA-mutated male breast cancer—an ultra-orphan population with an incidence rate of 0.5– 1.3 per 100,000 individuals, and significant unmet medical needs.
2. Clinically Effective but Cost-Prohibitive
Although inavolisib extends median progression-free survival by 10 months, its incremental cost-effectiveness ratio (ICER) is $886,440 per quality-adjusted life year (QALY), which exceeds conventional US cost-effectiveness thresholds ($150,000/QALY) by nearly six-fold, resulting in a 0% probability of affordability under current benchmarks.
3. Orphan-Specific Value Distortions
Standard cost-effectiveness models fail to account for male-specific health utilities and societal productivity costs, thereby underestimating the true therapeutic value.
4. Policy Solutions for Rare Cancers
To improve access and equity, policy interventions should include prevalence-adjusted ICER thresholds, cross-indication drug subsidy mechanisms, and universal PIK3CA mutation screening.
Keywords: inavolisib, PIK3CA-mutated, male breast cancer, cost-effectiveness
1Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China; 2Department of Pharmacy, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, 350212, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Pinfang Huang, Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China, Tel +8613600898956, Email abstract2016@163.com Dayong Zeng, Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China, Tel +8613860613541, Email dydyzeng@qq.com
Background: The Phase III INAVO120 trial established inavolisib-based therapy as a superior first-line treatment for PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer, a finding of particular importance for the historically underrepresented male population with high unmet need.
Methods: A lifetime Markov model was developed from a US payer perspective to evaluate the cost-effectiveness of inavolisib plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in men with PIK3CA-mutated advanced breast cancer. Primary outcomes were life-years (LYs), quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER).
Results: The inavolisib group provided an additional 1.23 LYs and 0.69 QALYs compared to the placebo group, resulting in an ICER of $886,440 per QALY. One-way sensitivity analysis identified the price of inavolisib as the primary driver of the ICER. Probabilistic sensitivity analysis showed a 0% probability of inavolisib being cost-effective at a willingness-to-pay threshold of $150,000 per QALY.
Conclusion: Inavolisib-based therapy is not cost-effective for treating PIK3CA-mutated advanced male breast cancer at its current price. Significant price reductions or adjustments to value assessment frameworks are required to ensure equitable access for this underserved population.
Plain Language Summary: 1. First Economic Model for Ultra-Rare Subgroup
This study presents the first economic evaluation of inavolisib for the treatment of PIK3CA-mutated male breast cancer—an ultra-orphan population with an incidence rate of 0.5– 1.3 per 100,000 individuals, and significant unmet medical needs.
2. Clinically Effective but Cost-Prohibitive
Although inavolisib extends median progression-free survival by 10 months, its incremental cost-effectiveness ratio (ICER) is $886,440 per quality-adjusted life year (QALY), which exceeds conventional US cost-effectiveness thresholds ($150,000/QALY) by nearly six-fold, resulting in a 0% probability of affordability under current benchmarks.
3. Orphan-Specific Value Distortions
Standard cost-effectiveness models fail to account for male-specific health utilities and societal productivity costs, thereby underestimating the true therapeutic value.
4. Policy Solutions for Rare Cancers
To improve access and equity, policy interventions should include prevalence-adjusted ICER thresholds, cross-indication drug subsidy mechanisms, and universal PIK3CA mutation screening.
Keywords: inavolisib, PIK3CA-mutated, male breast cancer, cost-effectiveness