OBJECTIVES:

Macimorelin is a novel, oral growth hormone stimulation test approved by EMA and FDA for the diagnosis of adult growth hormone deficiency (AGHD). The objective of this study is to investigate the budget impact arising from the introduction of macimorelin as a diagnostic test for AGHD across France, Germany, Italy, Spain and the United Kingdom.

METHODS:

A budget impact model was developed from the health care perspective, using only direct costs, over a 3-year time horizon. Analyses were run to compare the macimorelin test against two separate comparators: the insulin tolerance test (ITT) and the GHRH-arginine test. A micro-costing approach was taken to calculate the total cost of each test; estimates of resource utilisation for each test were based on clinical guidelines. Costs included were drug acquisition, treatment administration, nurse time, clinical specialist time and adverse event management. Cost inputs were sourced from national databases and, where available, literature.

RESULTS:

The results from the budget impact analysis suggest that the introduction of the macimorelin test is associated with reduced resource utilisation and therefore cost-savings for healthcare systems across all countries included in the analysis. This is the case when compared against both the ITT and the GHRH-arginine test. Cost savings are driven primarily by reductions in clinical time taken to administer the test, leading to lower clinical resource utilisation and savings in staff costs. However, savings also arise from an improved safety profile leading to fewer mild and transient adverse events.

CONCLUSIONS:

From a financing perspective, the adoption of macimorelin for AGHD diagnosis represents the best alternative to reduce costs to healthcare systems across the countries considered. The macimorelin test is also associated with fewer adverse events, leading to a potentially better patient experience. Finally, macimorelin test requires less clinical staff time and may ultimately increase hospital capacity through efficient resource utilisation.