OBJECTIVES

: Pertuzumab (P) in combination with trastuzumab and docetaxel (TD) has been recommended as an option for neoadjuvant treatment of HER2 positive locally advanced, inflammatory or early stage breast cancer (BC) at high risk of recurrence. The aim of this study was to determine the cost utility of PTD vs.TD and estimate the budget impact of the introduction of P in the treatment in R. Macedonia.

METHODS

: A Markov state transition model (event free survival, disease relapse and death) was developed to perform a CUA over 20 years time horizon. Patients progressed or died based on the PFS and OS curves derived from NeoSphere trial. Health states utilities were taken from the published literature. Only direct costs (drugs, treatment administration and monitoring) were included. Unit costs were collected from official, health system data. Expected costs were measured in EUR and benefits in QALY. Discount rate of 3.5% was applied. Probabilistic sensitivity analysis (PSA) with 1000 iterations was performed. Spreadsheet model, taking into account the prevalence, incidence and mortality of BC, HER2+ prevalence, license - eligible patient population and proportion of patients treated with new medicine (market share) was created to assess the 5 year budget impact (BI). An alternative BIA scenario was performed where trastuzumab drug associated costs were fully covered by the manufacturer.

RESULTS

: Pertuzumab combination (PTD) was associated with gain of 0.27 QALY at an additional cost 12,332.67 € relative to standard treatment (PD). The estimated incremental cost effectiveness ratio (ICER) for the addition of pertuzumab was 45,427.07 €/QALY. PTD was cost effective in 75% of all PSA simulations. The 5-year net BI was €285,640.86. The BI of the alternative scenario ranged from €24,630.31 to € 39,758.55, with maximal cost of €49,133.95 at 4^th year.

CONCLUSIONS

: Neoadjuvant pertuzumab is a potentially cost-effective treatment option for HER2 positive BC patients in R. Macedonia.