Prm157 - The Impact of Landmark Response on Overall Survival: Implications for the Economic Evaluation of Immune-Therapy (I-O) Treatment in Small Cell Lung Cancer (Sclc)

Santi, Irene; Smare, Caitlin; Juarez-Garcia, A.; Camidge,; Schoenherr, N.; Penrod, JR; Abraham, Pranav; Korytowsky, Beata; Yuan, Yong

doi:10.1016/j.jval.2018.09.2277

Cited by 3 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Partitioned survival models are a well-established approach in economic evaluations of immuno-oncology agents, and the base-case used in this paper was validated by a number of sensitivity analyses. An earlier landmark response analysis of nivolumab data from CheckMate 032 (November 2017 database lock) showed that response at the 4-month landmark time point was associated with significantly longer OS [27]. The findings at this time point were also consistent with sensitivity analyses with alternative 2-and 6-month landmarks.…”

Section: Discussionsupporting

confidence: 59%

See 1 more Smart Citation

Cost-effectiveness of nivolumab monotherapy in the third-line treatment of small cell lung cancer

Smare

Dave

Juarez-Garcia

et al. 2021

Journal of Medical Economics

View full text Add to dashboard Cite

Aims: Present cost-effectiveness analysis of nivolumab monotherapy vs commonly prescribed third-line (3L+) treatment in small cell lung cancer (SCLC). Materials and methods:A three health states partitioned survival model (progression-free, progressed disease, and death; US payer perspective) was developed. Systematic literature review identified no randomized controlled or single-arm trials with separate outcomes for 3L+ SCLC patients. Topotecan was chosen as comparator because it is frequently prescribed in realworld practice for 3L SCLC. Clinical inputs for topotecan were derived from the Flatiron database with inclusion/exclusion criteria matched to patients treated with 3L+ nivolumab in CheckMate 032. Intravenous (IV) and oral topotecan clinical efficacy were assumed equivalent.Base-case analysis used a 20-year lifetime horizon. An annual discount rate of 3.0% for costs and outcomes was applied. Uncertainty was assessed using sensitivity analyses adjusted for key parameters.Results: Incremental cost per quality-adjusted life-year (QALY) gained with nivolumab was US$153,312 vs IV topotecan and US$123,003 vs oral topotecan, respectively. When results were disaggregated, nivolumab-related costs were mainly driven by drug acquisition costs, and topotecan-related costs were primarily due to adverse event treatment. Mean overall survival (OS) was 21.69 months with nivolumab and 5.80 months with IV or oral topotecan. More favorable outcomes were found by the landmark response analyses. Deterministic sensitivity analyses showed that changes to the discount rate for costs and outcomes and body weight had the greatest impacts on results. A c c e p t e d M a n u s c r i p t Limitations: Included use of real-world data for OS outcomes associated with 3L topotecan, use of second-line topotecan data for progression-free survival, and no indirect costs. Conclusions:Based on the literature on willingness-to-pay for a QALY in metastatic cancer, nivolumab monotherapy might represent a cost-effective option for 3L+ treatment of SCLC compared with IV and oral topotecan. Sensitivity analysis using response-based methods yielded further favorable cost-effectiveness estimates.

show abstract

Section: Discussionsupporting

confidence: 59%

“…The landmark response analysis is an alternative approach to the standard partitioned survival model that allows for the modeling of long-term survival by response status [27,28]. A landmark response analysis was conducted for the nivolumab monotherapy data from CheckMate 032 [17].…”

Section: Landmark Response Analysismentioning

confidence: 99%

Cost-effectiveness of nivolumab monotherapy in the third-line treatment of small cell lung cancer

Smare

Dave

Juarez-Garcia

et al. 2021

Journal of Medical Economics

View full text Add to dashboard Cite

show abstract

Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective

Quinn¹,

Garrison

Pownell³

et al. 2020

J Immunother Cancer

View full text Add to dashboard Cite

Immuno-oncologics (IOs) differ from chemotherapies as they prime the patient’s immune system to attack the tumor, rather than directly destroying cancer cells. The IO mechanism of action leads to durable responses and prolonged survival in some patients. However, providing robust evidence of the long-term benefits of IOs at health technology assessment (HTA) submission presents several challenges for manufacturers. The aim of this article was to identify, analyze, categorize, and further explore the key challenges that regulators, HTA agencies, and payers commonly encounter when assessing the long-term benefits of IO therapies. Insights were obtained from an international, multi-stakeholder steering committee (SC) and expert panels comprising of payers, economists, and clinicians. The selected individuals were tasked with developing a summary of challenges specific to IOs in demonstrating their long-term benefits at HTA submission. The SC and expert panels agreed that standard methods used to assess the long-term benefit of anticancer drugs may have limitations for IO therapies. Three key areas of challenges were identified: (1) lack of a disease model that fully captures the mechanism of action and subsequent patient responses; (2) estimation of longer-term outcomes, including a lack of agreement on ideal methods of survival analyses and extrapolation of survival curves; and (3) data limitations at the time of HTA submission, for which surrogate survival end points and real-world evidence could prove useful. A summary of the key challenges facing manufacturers when submitting evidence at HTA submission was developed, along with further recommendations for manufacturers in what evidence to produce. Despite almost a decade of use, there remain significant challenges around how best to demonstrate the long-term benefit of checkpoint inhibitor-based IOs to HTA agencies, clinicians, and payers. Manufacturers can potentially meet or mitigate these challenges with a focus on strengthening survival analysis methodology. Approaches to doing this include identifying reliable biomarkers, intermediate and surrogate end points, and the use of real-world data to inform and validate long-term survival projections. Wider education across all stakeholders—manufacturers, payers, and clinicians—in considering the long-term survival benefit with IOs is also important.

show abstract

Real-World Relationship of Early End Points to Survival End Points in Patients with Resectable Non-Small-Cell Lung Cancer

Nadler,

Vasudevan,

Wentworth

et al. 2023

Future Oncol.

View full text Add to dashboard Cite

Aim: Pathologic response has been shown to be a promising surrogate for survival in non-small-cell lung cancer. We examined the real-world relationship between these end points in patients with resectable stage IB-IIIA non-small-cell lung cancer receiving neoadjuvant chemotherapy/chemoradiotherapy (CT/CRT). Methods: Electronic health records/medical charts were analyzed. Overall and event-free survival (OS/EFS) were assessed by Kaplan-Meier stratified by pathologic response. Associations between the end points were assessed by Cox analyses. Results: A total of 425 patients were selected for the study; 147 and 278 received CT and CRT, respectively. Pathologic complete response (pCR) was associated with longer OS (adjusted HR = 0.50; 95% CI: 0.29–0.85) and EFS (adjusted HR = 0.44; 95% CI: 0.28–0.68) versus no pCR, and EFS was associated with OS (HR = 0.51, 95% CI: 0.38, 0.69). Conclusion: In patients receiving neoadjuvant CT/CRT, pCR and EFS were associated with improved survival in this real-world dataset.

show abstract

Prm157 - The Impact of Landmark Response on Overall Survival: Implications for the Economic Evaluation of Immune-Therapy (I-O) Treatment in Small Cell Lung Cancer (Sclc)

Cited by 3 publications

References 0 publications

Cost-effectiveness of nivolumab monotherapy in the third-line treatment of small cell lung cancer

Cost-effectiveness of nivolumab monotherapy in the third-line treatment of small cell lung cancer

Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective

Real-World Relationship of Early End Points to Survival End Points in Patients with Resectable Non-Small-Cell Lung Cancer

Contact Info

Product

Resources

About