Objective: To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human
granulocyte colony stimulating factor (
PEG-rhG-CSF), PP with recombinant human
granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage
breast cancer in China. Methods: Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ
breast cancer. The first phase modelled costs and outcomes of 4 cycles
docetaxel combined with
cyclophosphamide [TC×4,
febrile neutropenia (FN) risk>20%]
chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio (HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results: Compared to rhG-CSF PP and no prophylaxis, the cost of
PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times
GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with
PEG-rhG-CSF is, the more cost-effective primary prophylaxis with
PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with
PEG-rhG-CSF will be. Conclusion: Although the cost of PP
PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP
PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage
breast cancer whose FN risks are more than 20% in China.