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G. Lopes



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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
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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): G. Lopes

      • Abstract
      • Presentation
      • Slides

      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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    OA04 - Epidemiology and Prevention of Lung Cancer (ID 370)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Epidemiology/Tobacco Control and Cessation/Prevention
    • Presentations: 1
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      OA04.04 - Discussant for OA04.01, OA04.02, OA04.03 (ID 6943)

      11:00 - 12:30  |  Author(s): G. Lopes

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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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
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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): G. Lopes

      • Abstract
      • Presentation
      • Slides

      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
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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): G. Lopes

      • Abstract
      • Presentation
      • Slides

      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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    P1.01 - Poster Session with Presenters Present (ID 453)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Epidemiology/Tobacco Control and Cessation/Prevention
    • Presentations: 1
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      P1.01-033 - EGFR Mutation and ALK: Are Patients Being Adequately Tested in Brazil? (ID 5818)

      14:30 - 15:45  |  Author(s): G. Lopes

      • Abstract
      • Slides

      Background:
      Lung cancer is one of the most common malignancies in the world. In Brazil, it is estimated that 28,200 new cases will be diagnosed in 2016. This cancer affects more men and is usually caused by tobacco exposure. The most common histology is adenocarcinoma and many of these patients have driver mutations which help guide therapeutic choice. The aim of this study was to delineate the epidemiological profile of patients with NSCLC in Brazil and to evaluate the prevalence of testing for ALK translocations and EGFR mutations in patients in the public and private settings in Brazil.

      Methods:
      Observational, descriptive, retrospective, multicenter study involving 230 public and private institutions in Brazil. We obtained data from a commercial database with 1642 Non Small Cell Lung Cancer (NSCLC) patients treated in the country between January and December 2015. Variables analyzed: age, sex, smoking, presence of EGFR and ALK mutation.

      Results:
      Out of 1642 patients, 814 were treated in the public service (49.57%) and 828 in private services (50.42%). Most patients were men (58.28% vs. 41.71% female). The mean age at diagnosis was 61.8 years (median 62 years), 32.58% were former smokers, 31.12% current smokers, 19.48% never smoked and data were not available for 16.8% of subjects. Most patients had metastatic disease at diagnosis (65.04%), 23.20% had stage III, 9.31% stage II and 2.43% stage I. 68.57% had adenocarcinoma, 27.52% squamous cell cancers, 1.4% large cell and 2.67% had other histological types. Among the 534 patients with non-squamous histology treated in public settings, 244 patients were tested for EGFR (46,69%) and only and only 36 were tested for ALK (6,74%).In private services, of 656 patients with non-squamous subtypes, 454 were tested for EGFR (69,2%) and 77 for ALK (11,73%).

      Conclusion:
      Overall, testing for EGFR mutations was below ideal, especially in the public setting. More worryingly, and likely due to the lack of availability of crizotinib in Brazil until 2016, very few patients were tested for ALK translocations in 2015. Much work needs to be done in education and advocacy to improve testing patterns in the country.

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    SC29 - Access, Value Assessments and Affordability of Novel Therapies (ID 353)

    • Event: WCLC 2016
    • Type: Science Session
    • Track: Chemotherapy/Targeted Therapy/Immunotherapy
    • Presentations: 1
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      SC29.04 - Solutions for Low-Income Countries (ID 6724)

      11:00 - 12:30  |  Author(s): G. Lopes

      • Abstract
      • Slides

      Abstract not provided

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