Issue № 31 | 2018 (1)
Introduction. In December 2015, preliminary results of the study of clinical effectiveness and safety of afatinib compared with gefitinib as a first-line therapy of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) and activating mutations in the EGFR gene were published. Based on these data, a pharmacoeconomic study of the use of afatinib and gefitinib in treatment of lung cancer was performed. The main limitation was the lack of the full data of LUX-Lung 7 study and of the final data on overall survival rate (OSR). LUX-Lung 7 study is now completed, and its results were published. This provides an opportunity to adjust the results of the previously conducted pharmacoeconomic study, and to model the impact of the increase of share of afatinib as a first-line therapy of NSCLC on the budget of the Russian health care system.
The aim was to update the results of the previously performed pharmacoeconomic study, and to assess the budget impact of the use of afatinib as a first-line therapy in prolonged treatment of locally advanced or metastatic NSCLC, and of partial replacement of gefitinib with afatinib in patients with frequent activating mutations of the EGFR gene.
Materials and methods. Pharmacoeconomic analysis was performed using budget impact method based on Markov model of the first, second and third line of NSCLC therapy. The results of LUX-Lung 7 clinical trials, data of state statistical monitoring, and literature data were used to create the model. The following direct medical costs were considered: first and second line drug therapy of NSCLC; palliative care; addressing adverse events; and observation of patients during the treatment. In a basic scenario, financial implications of the use of afatinib as the first line therapy in prolonged treatment of NSCLC were assessed irrespective of the frequency of mutations; the cost of treatment of patients with Del19 mutation was additionally analyzed. A probabilistic analysis of the sensitivity of the results to fluctuations of initial parameters was performed.
Results. Budget impact analysis of a more extensive use of afatinib in a target population of 1 382 patients demonstrated that this approach resulted in 23,553,000 RUB less total cost of NSCLC treatment in the second year, and 43,310,000 RUB in the third year. If the average annual cost of therapy with afatinib was 968,857 RUB per patient, this would enable to treat additional 24 patients in the second year, and 45 patients in the third year of the modeled therapy. It was also shown that the change of the share on afatinib from 13% of patients in the first year of therapy to 30% in the first year and 50% in the third year reduced the total cost of treatment of patients with NSCLC for 66,800,000 RUB in the basic scenario. This would enable to treat additional 69 patients. The total budget cost of treatment of the subpopulation of patients with Del19 mutation of the EGFR gene reduced by 34,200,000 RUB, which would enable to treat additional 35 patients.
Conclusions. The use of afatinib is cost-effective for the health care system.
afatinib, gefitinib, Del19 mutation of EGFR gene, budget impact analysis.
Fedyayev D. V., Zyryanov S. K. Pharmacoeconomic Analysis of Afatinib and Gefitinib for the Treatment of Lung Cancer. Medical Technologies. Assessment and Choice. 2018; 1(31): 68–83.