Budget Impact of Glasdegib in Combination with Low-Dose Cytarabine for the Treatment of First-Line Acute Myeloid Leukemia in the United States

Introduction

Acute myeloid leukemia (AML) is an orphan disease and has one of the lowest five-year survival rates among myeloid malignancies in United States (US) adults (28.3% on average, 5% of which are aged 65 years or older). Older patients with AML have few treatment options and are often not candidates for intensive induction chemotherapy, therefore novel therapeutic strategies are needed. A phase II randomized study (Cortes et al. 2019) among newly diagnosed AML patients who were not candidates for intensive induction chemotherapy demonstrated improved overall survival (OS) in patients treated with glasdegib in combination with low-dose cytarabine (LDAC) compared to patients receiving LDAC alone. The present analysis estimated the budget impact of including glasdegib combined with LDAC as first-line treatment for these AML patients from a US health plan perspective.

Methods

The budget impact was assessed using a decision analytic model that compared the current market environment where glasdegib + LDAC was not included with a new market environment where glasdegib + LDAC was included. The comparators in the model were LDAC alone, azacitidine, decitabine, and venetoclax combined with LDAC, azacitidine or decitabine. The budget impact was calculated based on epidemiology inputs, market share inputs, clinical inputs and all relevant cost inputs (i.e. drug and administration cost, medical resource use cost, adverse event cost). The base case was calculated for a US commercial health plan of 1 million members with a time horizon of 3 years. The main outcomes were total costs of current and new market environments, incremental budget impact, incremental cost per member per month (PMPM) and incremental cost per treated patient per month (PTPPM). Both deterministic sensitivity analyses and scenario analyses were performed to assess the uncertainty of the structure and inputs of the model.

Results

The analysis estimated an eligible patient population of 19 AML patients per year (per million members) who are not candidates for intensive induction chemotherapy. Of these: 2, 4 and 6 patients were estimated to receive glasdegib + LDAC in years 1, 2 and 3, respectively. In the base case, the incremental budget impact of glasdegib + LDAC was $179,290 in year 1, $262,694 in year 2 and $346,098 in year 3. This translated into an incremental cost PMPM of $0.0149, $0.0219, and $0.0288 in years 1, 2, and 3, respectively. The model results were most sensitive to the mean OS of glasdegib + LDAC.

Conclusions

The introduction of glasdegib + LDAC as a treatment for newly diagnosed AML patients who are not candidates for intensive induction chemotherapy has a small impact on the budget of US payers, given the small size of the eligible patient population. The model results suggest glasdegib + LDAC provides an alternative treatment option while extending life at minimal incremental cost for health plans. As such, glasdegib + LDAC may provide substantial value for money spent on treatment of these AML patients in the US for which treatment options are few.