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H. Tadokoro
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MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:M. Reck, D.R. Spigel
- Coordinates: 12/06/2016, 16:00 - 17:30, Strauss 2
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MA14.11 - An Estimate of the Economic Impact of Immunotherapy Relative to PD-L1 Expression in Brazil - An Update with Brazilian Costs (ID 4251)
16:00 - 17:30 | Author(s): H. Tadokoro
- Abstract
- Presentation
Background:
Delivering high quality cancer care at an affordable cost is one of the main challenges for health care professionals and policy makers, especially in low- and middle-income countries. The objective of our study is to assess the economic impact of nivolumab and pembrolizumab with and without the use of PD-L1 as a biomarker in Brazil.
Methods:
We developed a decision-analytic model to determine the cost-effectiveness of PD-L1 assessment and the second-line treatment with NIVO or PEMBRO versus docetaxel. The model used outcomes data from randomized clinical trials and drug acquisition costs were estimated using current prices in Brazil. Thereafter, we used Brazilian epidemiologic data to estimate the economic impact.
Results:
We included three RCTs (two with NIVO and one with PEMBRO). The estimated number of cases eligible for therapy with immune checkpoint inhibitors is 4,733. Treating all patients with NIVOLUMAB would cost US$ 173 million dollars each year, representing an increase of 21% in current Brazilian expenses for cancer drugs acquisition. Treating only patients with PD-L1 > 1% with NIVOLUMAB would cost 93 million dollars every year, leading to an increase of 11.3% in expenses for cancer drugs acquisition. However, with such selection, up to 46% of cases would not be treated and 315 years of life would be lost compared to treating all patients regardless of PD-L1 expression. The cost of each year-of-life saved was improved by PD-L1 selection (from US$ 196,000 to US$ 164,000). Table 1 summarizes our findings for five different scenarios of treatment. The results were similar with NIVOLUMAB and PEMBROLIZUMAB.SCENARIO QALY GAIN ICER (US$) LIFE-YEARS SAVED YEARS OF LIFE NOT SAVED % NOT TREATED TOTAL COST (US$) IMPACT ON TOTAL CANCER DRUG EXPENDITURE COST/LYS (US$) NIVO ALL COMERS 0.148 129 K 885 0 0% 173 Million 21.1% 196 K NIVO PD-L1 > 1% 0.201 108 K 570 315 46% 93 11.3% 164 K PEMBRO PD-L1 > 1% 0.138 137 K 666 NA 34% 100 12.1% 150 K NIVO ALL SQ/ > 1% NSQ 0.216 99 K 738 147 35% 116 14.0% 157 K PEMBRO PD-L1 > 50% 0.164 116 K 285 NA 72% 43 5.2% 151 K
Conclusion:
The use of PD-L1 expression as a biomarker for treatment with immune checkpoint inhibitors decreases the overall economic impact and the cost per life-year saved. Further study and societal discussion is needed in order to find the optimal strategy for patient selection.
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OA17 - Aspects of Health Policies and Public Health (ID 397)
- Event: WCLC 2016
- Type: Oral Session
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:M. Kneussl
- Coordinates: 12/06/2016, 16:00 - 17:30, Schubert 1
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OA17.01 - Estimate of Economic Impact of Immune Checkpoint Inhibitors for NSCLC Relative to PD-L1 Expression in the US (ID 4133)
16:00 - 17:30 | Author(s): H. Tadokoro
- Abstract
- Presentation
Background:
Delivering high-quality cancer care at an affordable cost is the main challenge for health care professionals and policy makers. Immunotherapy achieved encouraging results in NSCLC. PD-L1 expression is being studied as a predictive biomarker. The objective of our study is to assess the economical impact of NIVO and PEMBRO with and without the use of PD-L1 as a biomarker in the US.
Methods:
We developed a decision-analytic model to determine the cost-effectiveness of PD-L1 assessment and second-line treatment with NIVO or PEMBRO versus docetaxel. The model used outcomes data from RCTs and costs from the US. We included the costs of adverse events and post-progression therapies. Thereafter, we used American epidemiology data to estimate the impact of the treatment.
Results:
We included three RCTs (two with NIVO and one with PEMBRO). The estimated number of cases eligible was 37,638. Treating all patients with NIVOLUMAB would cost 1.6 billion dollars each year, increasing total oncology drug expenditure in the US by 4%. Treating only patients with PD-L1 > 1% with NIVOLUMAB would cost US$ 850 million each year and would increase total oncology drug expenditure by 2%. However, with such patient selection up to 46% of cases would not be treated and 2,509 fewer life-years would be saved. The cost of each year-of-life saved was improved by PD-L1 selection (from US$ 223,000 to US$ 186,000 thousand). Table 1 summarizes our findings. Results were similar with NIVOLUMAB and PEMBROLIZUMAB.Scenario QALY gain ICER U$ Life-Years Saved Years of life not saved Not Treated % Total Cost U$ Impact on Total Cancer Drug Expenditure Cost/LYS U$ 37,638 100 NIVO ALL COMERS 0.148 124K 7,043 0 0 0 1.6 bi 4% 223K NIVO PD-L1 > 1% 0.201 91K 4,534 2,509 17,389 46 850 mi 2% 186K PEMBRO PD-L1 > 1% 0.138 116K 5,302 NA 12,685 34 971 mi 2% 183K NIVO ALL SQ/>1% NSQ 0.216 93K 5,868 1,175 13,303 35 1 bi 3% 178K PEMBRO PD-L1 > 50% 0.164 97K 2,270 NA 26,912 72 420 mi 1% 184K
Conclusion:
The use of PD-L1 expression as a biomarker for treatment with immunotherapy decreases the overall economic impact and the cost per life-year saved. Nevertheless, the number of life-years saved with this strategy would be significantly smaller than if we choose to treat all patients. Further study and societal discussion is warranted in order to find the optimal strategy for patient selection.
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OA23 - EGFR Targeted Therapies in Advanced NSCLC (ID 410)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:O.T. Brustugun, S. Lu
- Coordinates: 12/07/2016, 14:20 - 15:50, Stolz 2
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OA23.01 - Anti-EGFR Monoclonal Antibodies plus Chemotherapy in the First-Line Treatment of Advanced NSCLC: A Meta-Analysis (ID 4135)
14:20 - 15:50 | Author(s): H. Tadokoro
- Abstract
- Presentation
Background:
Monoclonal Antibodies (mAbs) against the Epidermal Growth Factor Receptor (EGFR) in association with platinum-based doublet chemotherapy have emerged as a potential first-line treatment option for advanced non-small cell lung cancer (NSCLC). This study was conducted to systematically review available data and evaluate the efficacy and toxicity of anti-EGFR mAbs plus chemotherapy vs chemotherapy alone for advanced NSCLC.
Methods:
We carried out a search on network databases and oncology conference abstracts for studies between 1990 and January 2016. Only prospective randomized clinical trials were included. Primary endpoints were overall survival (OS) and toxicity frequency. Secondary endpoints were progression-free survival (PFS) and overall response rate (ORR). Subgroup analysis was performed assessing histological subtypes, EGFR protein expression by immunohistochemistry (IHC), EGFR gene copy number by fluorescence in-situ hybridization (FISH), EGFR mutation status, and smoking status.
Results:
Seven studies (2 with necitumumab and 5 with cetuximab) were included with 5,057 patients. Compared to chemotherapy alone, significant benefits were demonstrated by the addition of anti-EGFR mAb to chemotherapy in OS (HR 0.90; 95%CI 0.84-0.95), PFS (HR 0.93; 95%CI 0.87-0.98), and ORR (OR 1.27; 95%CI 1.06-1.51). In subgroup analyses, the association of anti-EGFR mAb was associated with improved OS among patients with squamous histology (HR 0.84; 95%CI 0.76-0.92), tumours with high EGFR expression by IHC (HR 0.83; 95%CI 0.70-0.98), and smokers (HR 0.87; 95%CI 0.79-0.96). Patients with squamous histology and high EGFR expression by IHC achieved the highest benefit with the association (HR 0.71; 95%CI 0.59-0.86). The OS with the association also seemed to be higher in EGFR FISH negative and in EGFR wild-type tumours, but without statistical significance. Chemotherapy plus anti-EGFR mAb caused more grade 3 or worse adverse events (OR 1.73; 95%CI 1.50-2.00), remarkedly these known to be associated with anti-EGFR therapy, such as acne-like rash (OR 34.13; 95%CI 16.40-71.00) and hypomagnesemia (OR 6.23; 95%CI 3.04-12.77).
Conclusion:
Anti-EGFR therapy plus platinum-based doublet chemotherapy as first-line treatment demonstrated significant efficacy benefits with acceptable toxicity for advanced NSCLC. This benefit is more expressive among squamous histology with high EGFR expression. EGFR protein expression by IHC seems to be a predictive marker for survival in the association group. Further research is needed to corroborate these findings.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-081 - Comparative Outcome Assessment of EGFR TKIs for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Network Meta-Analysis (ID 4904)
14:30 - 15:45 | Author(s): H. Tadokoro
- Abstract
Background:
Patients with advanced non small-cell lung cancer (NSCLC) whose tumors harbor activating mutations in the epidermal growth factor receptor (EGFR) gene, derive substantial clinical benefit from treatment with first and second-line EGFR tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib, erlotinib and afatinib. However, their comparative effectiveness in this setting has not been evaluated, due to the paucity of randomized comparative clinical trials.
Methods:
We performed a comprehensive literature search in PUBMED, EMBASE, SCOPUS and ISI databases for randomized clinical trials evaluating either of the aforementioned EGFR-TKIs in first- and subsequent-lines treatment of EGFR-positive advanced NSCLC. All sensitizing mutations to EGFR-TKI inhibition were included in the current analysis. Patients with active brain metastases, with ECOG performance status of more than 2, as well as trials comparing the combination of EGFR-TKI with chemotherapy to chemotherapy alone were excluded. Comparative study outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and rate of adverse events (AE). Cochrane guidelines were used for statistical analysis.
Results:
13 randomized trials incorporating 3,853 patients were eligible for the analysis. In the first-line setting, all EGFR TKIs showed improved outcomes with respect to ORR and PFS when compared to standard platinum-doublet chemotherapy. Comparative ORR rates for gefitinib, erlotinib and afatinib in first-line were 71.5%, 70.2% and 50.1% respectively. HRs for PFS were 0.40 (95% CI: 0.31- 0.50) for gefitinib, 0.25 (0.11-0.56) for erlotinib and 0.40 (0.28-0.57) for afatinib, all three with p<0.001. Respective HRs for OS were 0.89 (0.72-1.10) for Gefitinib, 0.91 (0.76-1.13) for erlotinib and 1.05 (0.88-1.25) for afatinib. No significant diferences were detected regarding common AEs (rash, diarrhea) among the three agents. Evidence data for gefitinib were less heterogeneous than those for erlotinib and afatinib.
Conclusion:
When compared indirectly, gefitinib exhibited the more consistent results from a statistical point of view and erlotinib had the more favorable profile regarding PFS prolongation. These data challenge the current landscape of first and second generation EGFR-TKIs in EGFR mutant advanced NSCLC and especially those of the recently reported LUX-LUNG 7 trial.
