Trastuzumab Biosimilar HLX02 Versus Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-positive Breast Cancer: a Model-Based Economic Evaluation for China.

Plain Language Summary Metastatic HER-2 positive breast cancer poses a considerable cost to society due to limitations in health care resources. HLX02 is the first trastuzumab biosimilar produced in China and evaluated worldwide, and its emergence has opened the door to trastuzumab biosimilars in China. Although HLX02 has been shown to be clinically equivalent to the original drug in the treatment of metastatic HER2-positive breast cancer, it remains unclear whether its price reflects the potential benefit in terms of its value. In addition, the development of biosimilars in China is just beginning, and the state encourages health economic evaluation of newly marketed biosimilars. Based on the results of Markov model, at the willingness-to-pay threshold of $37,653/QALY in China, HLX02 is more cost-effective than trastuzumab under the condition of equivalent efficacy and safety. However, it remains challenging to adjust the development of the regulation of biosimilars, such as the price difference between biosimilars and original drugs. Background HLX02 is a newly marketed trastuzumab biosimilar in China, but whether its price reflects a potential benefit in terms of its value remains unclear. In addition, the development of biosimilars in China is just beginning, and the state encourages health economic evaluation of newly marketed biosimilars. Methods Based on the previously published randomized controlled trial data, a Markov model was used to perform health economic evaluation of HLX02 and trastuzumab in the treatment of HER2-positive recurrent or metastatic breast cancer, calculate quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER), and evaluate the robustness of the model with sensitivity analysis. Results The model results showed that the 5-year mortality rate was 84.4% in the HLX02 group, while the mortality rate was 91.2% in the trastuzumab group. When without accounting for the cost of second-line treatment, patients treated with HLX02 had an increased life expectancy of 0.138 QALYs and a $421.11 lower cost compared with patients in the trastuzumab group, with an ICER value of -$3,051.52/QALY. Conclusions At the willingness-to-pay threshold of $37,653/QALY in China, HLX02 is more cost-effective than trastuzumab. However, the relevant systems for the regulation of biosimilars still need to be improved.