{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T16:42:29Z","timestamp":1785256949161,"version":"3.55.0"},"reference-count":37,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100004735","name":"Natural Science Foundation of Hunan Province","doi-asserted-by":"publisher","award":["2021JJ80080"],"award-info":[{"award-number":["2021JJ80080"]}],"id":[{"id":"10.13039\/501100004735","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Technol Cancer Res Treat"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Inavolisib, a novel highly selective PI3K\u03b1 inhibitor, is approved for treating PIK3CA-mutated, hormone receptor-positive\/human epidermal growth factor receptor 2-negative advanced breast cancer (PIK3CA-mutated, HR+\/HER2\u2212 ABC). Given its significant efficacy, as confirmed by the updated INAVO120 III trial, but also its high price, a comprehensive evaluation of its value is warranted. The purpose of this study was to investigate whether inavolisib plus palbociclib\u2013fulvestrant is cost-effective for patients with PIK3CA-mutated, HR+\/HER2\u2212 ABC from the U.S. healthcare system perspective.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A Markov model comprising three health states was developed to simulate the progression of PIK3CA-mutated, HR+\/HER2\u2212 ABC. Parametric survival models, fitted to and extrapolated from survival data, were used to estimate long-term clinical outcomes. Lifetime costs and health outcomes were calculated. Willingness-to-pay (WTP) thresholds were set at $100,000, $150,000, and $200,000 per quality-adjusted life year QALY to reflect general and more affluent regional standards. One-way and probabilistic sensitivity analyses were conducted to assess model robustness, and subgroup analyses explored the variation in benefits across patient clinical characteristics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Compared with placebo, inavolisib provided an additional 0.6 QALYs while increasing costs by $160,490.07, resulting in an incremental cost-effectiveness ratio (ICER) of $268,457.82 per QALY. Sensitivity analysis identified the utility of the progression-free state as the most sensitive factor in the model. Within the WTP threshold range of $100,000 to $200,000 per QALY, the inavolisib regimen was not considered cost-effective. To achieve cost-effectiveness at WTP thresholds of $100,000, $150,000, and $200,000 per QALY, the per-cycle price of inavolisib would need to be reduced to 59.5%, 72.0%, and 86.5% of its current price, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>For patients with PIK3CA-mutated HR+\/HER2\u2212 ABC, the inavolisib regimen is not cost-effective in the U.S. healthcare setting. Negotiating price reductions and adjusting decision thresholds based on patient characteristics may be viable strategies to meet the extensive treatment demand in the U.S.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15330338261444965","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T12:09:12Z","timestamp":1776341352000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Economic Evaluation of Inavolisib Combined With Palbociclib\u2013Fulvestrant for PIK3CA-Mutated, HR+\/HER2\u2212 Advanced Breast Cancer in USA"],"prefix":"10.1177","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5521-5461","authenticated-orcid":false,"given":"Hanqing","family":"Zeng","sequence":"first","affiliation":[{"name":"Central South University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li-Ying","family":"Song","sequence":"additional","affiliation":[{"name":"Central South University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren","family":"Guo","sequence":"additional","affiliation":[{"name":"Central South University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Ding","sequence":"additional","affiliation":[{"name":"Central South University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohui","family":"Zeng","sequence":"additional","affiliation":[{"name":"Central South University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiao","family":"Liu","sequence":"additional","affiliation":[{"name":"Central South University"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,4,16]]},"reference":[{"issue":"6","key":"e_1_3_6_2_2","first-page":"477","article-title":"Breast cancer statistics","volume":"74","author":"Giaquinto AN","year":"2024","unstructured":"Giaquinto AN, Sung H, Newman LA, et al. 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