An Early Development Budget Impact Model for the Use of Melatonin in the Treatment and Prevention of Osteoporosi

In the U.S., there are approximately 9 million adults with osteoporosis (OP) and an additional 43 million at-risk. By 2030, this number is expected to increase to 68 million adults. The economic impact is estimated to be $23 billion by 2025. Current drug therapies either decrease bone resorption (e.g., bisphosphonates) or stimulate bone formation (e.g., teriparatide). Melatonin may be a potential treatment option because research has shown it impacts bone metabolism by promoting osteoblast differentiation and activity and by suppressing osteoclast differentiation and activity. As shown in the Melatonin Osteoporosis Prevention Study (MOPS; NCT01152580), melatonin improved bone health in perimenopausal women by renormalizing bone marker turnover. Also, it is well-tolerated and has a high safety profile. Given the chronic nature of OP, coupled with high treatment costs, economic evaluation of melatonin with existing treatments could be very useful for those who manage and plan healthcare budgets. The objective of this work was to determine the budgetary impact of the addition of melatonin to treat and prevent OP from a payer perspective. A 1-year budget impact model with a hypothetical plan population of 1 million was utilized. Whole sale acquisition costs of melatonin and comparators were taken from Red Book; market share and prevalence data were obtained from the literature. Sensitivity analysis was performed to assess if changes in market share and drug costs affected the results. All costs are in 2013 U.S. dollars. The introduction of melatonin produced as Per Member Per Month (PMPM) change of -$0.11 for OP and a PMPM of -$0.20 for osteopenia. In conclusion, the addition of melatonin to a formulary will provide substantial cost offsets to the payer in the treatment and prevention of OP under the assumption that the effectiveness of melatonin is equal to its comparators.