Cost Effectiveness of CDK4/6 Inhibitors in the First-Line Treatment of HR+/HER2− Metastatic Breast Cancer in Postmenopausal Women in the USA

Masurkar, P.; Damgacioğlu, Haluk; Deshmukh, Ashish A.; Trivedi, Meghana V.

doi:10.1007/s40273-023-01245-y

Cited by 11 publications

(3 citation statements)

References 64 publications

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“…They calculated quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios using clinical efficacy and quality-of-life scores (utility) data from clinical trials, Medicare charges reported in US dollars per 2022 valuation, and a discount rate of 3% applied to costs and outcomes. Their model indicates that the combination of CDK4/6 inhibitors and letrozole is not cost-effective, with a modest increase in quality-adjusted life-years (QALYs) at a high cost, at a willingness to pay of $100,000/QALY gained [ 60 ].…”

Section: Discussionmentioning

confidence: 99%

An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer—A Systematic Review of Randomized Phase II and III Clinical Trials

Stanciu,

Parosanu,

Nitipir

2023

Biomolecules

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Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6is) have transformed the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) breast cancer over the last decade. These inhibitors are currently established as first- and second-line systemic treatment choices for both endocrine-sensitive and -resistant breast cancer populations alongside endocrine therapy (ET) or monotherapy. Data on targeted therapy continue to mature, and the number of publications has been constantly rising. Although these drugs have been demonstrated to prolong overall survival (as well as progression-free survival (PFS) in breast cancer patients), changing the paradigm of all current knowledge, they also cause important adverse events (AEs). This review provides the latest summary and update on the safety profile of the three CDK4/6 inhibitors, as it appears from all major phase II and III randomized clinical trials regarding palbociclib, ribociclib, and abemaciclib, including the most relevant 15 clinical trials.

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Section: Discussionmentioning

confidence: 99%

An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer—A Systematic Review of Randomized Phase II and III Clinical Trials

Stanciu,

Parosanu,

Nitipir

2023

Biomolecules

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“…In a CEA published before Ribo was marketed in China for premenopausal women with HR+/HER2− breast cancer, Huang et al showed that the additional use of Ribo was not cost-effective in the United States, while it could be cost-effective when the price was less than $31.74/200 mg in China (in the year 2018, the three-times-per-capita GDP was $29,383/QALY), which is close to our estimate [ 36 ]. The latest commentary article conducted a cost-effectiveness analysis of the application of the three CDK4/6 inhibitors (Palbo, Ribo, and Abem) from the perspective of Europe and the USA, and found that the three CDK4/6 inhibitors plus endocrine therapy were not more cost-effective than endocrine therapy alone [ 37 , 38 ].…”

Section: Discussionmentioning

confidence: 99%

CDK4/6 Inhibitors in the First-Line Treatment of Postmenopausal Women with HR+/HER2− Advanced or Metastatic Breast Cancer: An Updated Network Meta-Analysis and Cost-Effectiveness Analysis

Zhang

Han

Liu

et al. 2023

Cancers

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(1) Background: This study aimed to conduct a NMA and CEA combined study to compare the effectiveness and cost-effectiveness of different CDK4/6 inhibitors (Abem, Palbo, and Ribo) plus NSAI with placebo plus NSAI in the first-line treatment of postmenopausal women with HR+/HER2− ABC from the perspective of payers in China. (2) Methods: Studies which evaluated CDK4/6 inhibitors plus NSAI for HR+/HER2− ABC were searched. A Bayesian NMA was carried out and the main outcomes were the hazard ratios (HRs) of overall survival (OS) and progression-free survival (PFS). The costs and efficacy of first-line therapies for HR+/HER2− ABC were evaluated using the Markov model. The main outcomes in the CEA were incremental cost–utility ratios (ICURs), incremental monetary benefit (INMB), and incremental net-health benefit (INHB). The robustness of the model was assessed by one-way, three-way, and probabilistic sensitivity analyses. Then, we further simulated the impact of different prices of CDK4/6 inhibitors on the results. (3) Results: Seven studies involving 5347 patients were included in the NMA. The three first-line CDK4/6 inhibitors plus NSAI groups provided significant PFS and OS superiority to NSAI alone. Abem + NSAI represented a significant statistical advantage onPFS (HR 0.74, 95% CI 0.61–0.90, p = 0.009) and indicated a trend of being the best OS benefit compared to the placebo + NSAI group (HR 0.89, 95% CI 0.72–1.08). The Abem + NSAI, Palbo + NSAI, and Ribo + NSAI groups resulted in additional costs of $12,602, $20,391, and $81,258, with additional effects of 0.38, 0.31, and 0.30 QALYs, respectively, leading to an ICUR of $33,163/QALY, $65,777/QALY, and $270,860/QALY. Additional pairwise comparisons showed that Abem + NSAI was the only cost-effective option in three CDK4/6 inhibitors plus NSAI groups at a willingness-to-pay (WTP) of $38,029/QALY. The sensitivity analyses showed that the proportion of receiving subsequent CDK4/6 inhibitors and the cost of Abem significantly influenced the results of Abem + NSAI compared with placebo + NSAI. (4) Conclusion: From the perspective of Chinese payers, Abem + NSAI was a cost-effective treatment option compared with placebo + NSAI at the WTP of $38,029/QALY, since only the ICUR of $33,163/QALY of Abem + NSAI was lower than the WTP of $38,029/QALY in China (2022). The Palbo + NSAI and Ribo + NSAI groups were not cost-effective unless drug prices were adjusted to 50% or 10% of current prices ($320.67 per cycle or $264.60 per cycle). (5) Others: We have prospectively registered the study with the PROSPERO, and the PROSPERO registration number is CRD42023399342.

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“…11 The use of frontline CDK4/6 inhibitors along with ET was not found to be cost-effective across multiple studies at current market prices, even in the United States. 12,13 A costeffectiveness analysis from India also revealed that both palbociclib and ribociclib are not cost-effective, for second-line treatment of advanced HR1 breast cancer, either at prevailing market prices or in government insurance reimbursement rates. 14 Although these studies show that CDK4/6 inhibitors are not cost-effective for HR1 advanced breast cancer, the costeffectiveness of CDK4/6 inhibitors is not known for their use in adjuvant settings, especially from the perspective of LMICs.…”

Section: Introductionmentioning

confidence: 99%

Cost-Effectiveness of Adjuvant Abemaciclib and Ribociclib in High-Risk Hormone Receptor–Positive Early Breast Cancer: An Indian Perspective

Sra,

Sasi,

Batra

et al. 2024

JCO Glob Oncol

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PURPOSE Incorporating adjuvant cyclin-dependent kinase (CDK) 4/6 inhibitors abemaciclib and ribociclib along with endocrine therapy has been shown to improve invasive disease-free survival (iDFS) for hormone receptor–positive (HR+) human epidermal receptor 2–negative (HER2–) early breast cancer (EBC). This study assesses the cost-effectiveness of this strategy, along with adjuvant aromatase inhibitors from an Indian perspective. METHODS A Markov chain model evaluated the cost-effectiveness of abemaciclib and ribociclib with letrozole compared with letrozole alone for HR+/HER2– EBC from a payer perspective in India. Key measures included lifetime quality-adjusted life-years (QALY), life-years (LY), and total costs. This study explores two scenarios for effectiveness: a best-case (BC) scenario, where the benefit of CDK4/6 inhibitors in improving iDFS lasts a lifetime, and a worst-case (WC) scenario, where benefits disappear after 5 years. Probabilistic sensitivity analyses (PSA) were used to account for simulation uncertainty. RESULTS In the BC scenario, abemaciclib added 2.17 QALY and 4.96 LY, incurring ₹2,317,957.7 ($27,756.65 in US dollars [USD]) in additional costs. However, the incremental cost-effectiveness ratio (ICER) for abemaciclib exceeded India's willingness-to-pay threshold in the BC and WC scenarios. In the BC scenario, ribociclib added 0.98 QALY and 2.58 LY with added costs of ₹1,711,504.32 ($20,494.6 USD). The ICER for ribociclib also surpassed India's threshold in both scenarios. PSA showed that neither drug was cost-effective at the current market prices in either BC/WC scenario. The cost of abemaciclib and ribociclib needs to be reduced by at least 78.61% and 87.19%, respectively, to be cost-effective in the BC scenario. CONCLUSION The combination of adjuvant abemaciclib or ribociclib with letrozole is not cost-effective for HR+/HER2– EBC in India in either the BC or WC scenario.

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Cost Effectiveness of CDK4/6 Inhibitors in the First-Line Treatment of HR+/HER2− Metastatic Breast Cancer in Postmenopausal Women in the USA

Cited by 11 publications

References 64 publications

An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer—A Systematic Review of Randomized Phase II and III Clinical Trials

An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer—A Systematic Review of Randomized Phase II and III Clinical Trials

CDK4/6 Inhibitors in the First-Line Treatment of Postmenopausal Women with HR+/HER2− Advanced or Metastatic Breast Cancer: An Updated Network Meta-Analysis and Cost-Effectiveness Analysis

Cost-Effectiveness of Adjuvant Abemaciclib and Ribociclib in High-Risk Hormone Receptor–Positive Early Breast Cancer: An Indian Perspective

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