Osteoporosis treatment with biosimilars in Malaysia and Thailand: a budget impact analysis.

INTRODUCTION: Biologic treatments demonstrate long-term clinical benefits for patients with osteoporosis, but their cost is prohibitive, and access can be limited, particularly in low-income countries. This analysis determined the cost impact of introducing biosimilar denosumab for the treatment of osteoporosis in Malaysia and Thailand. METHODS: A budget impact model was developed to compare the cost of treating female patients aged ≥ 50 years with osteoporosis with biosimilar versus reference denosumab (60 mg/mL every 6 months) from a healthcare payer perspective in Malaysia and Thailand over 5-years. Model inputs included previously published, country-specific prevalence, incidence, mortality, and treatment data, supplemented by expert clinical advice where evidence was limited. Drug acquisition cost was assumed to cost 25% less than the reference product. Further assumptions included no change in osteoporosis incidence and mortality over the time horizon and consistent condition-related costs across both scenarios. RESULTS: Over 5 years, treatment with the reference denosumab was estimated to cost MYR ~ 864 million (USD ~ 217 million) in Malaysia and THB ~ 179.5 billion (USD ~ 5.2 billion) in Thailand. Biosimilar denosumab was estimated to cost MYR ~ 648 million (USD ~ 162 million) and THB ~ 134.6 billion (USD ~ 3.9 billion), resulting in potential savings of MYR ~ 216 million (USD ~ 54 million) and THB 44.8 billion (USD ~ 1.3 billion), respectively. CONCLUSION: The introduction of biosimilar denosumab in Malaysia and Thailand could yield significant cost savings and enhance access to biologic therapies for postmenopausal women with osteoporosis. The inclusion of biosimilar denosumab in national osteoporosis management programs could lead to increased uptake, but it is not explored in this analysis and requires further consideration.