Presentation (CTI)

OBJECTIVES: Health technology assessment (HTA) agencies assess the economic value of therapies to inform reimbursement decisions. Denosumab is a safe and effective biologic approved to prevent skeletal-related events (SREs) associated with certain cancers. The high cost of reference product biologics limits reimbursement and access, but the introduction of more affordable biosimilars could expand patient access. A literature review was conducted to assess denosumab’s cost-effectiveness and reimbursement status.
METHODS: MEDLINE was searched for economic assessments of denosumab in oncology (01/2019 to 12/2025). Search terms included denosumab combined with budget impact, cost-consequence, cost-effect*, cost per responder, cost-utility, or economic model. The NAVLIN HTA database was used to assess reimbursement decisions in Australia, Canada, France, Ireland, Italy, Poland, Sweden, and the United Kingdom (UK). HTA decisions were categorized into fully reimbursed (according to label), partially reimbursed (e.g., based on severity), and do not recommend.
RESULTS: Of 70 records identified, six relevant economic studies were included. Denosumab was deemed cost-effective in five studies that evaluated multiple myeloma (MM), breast, prostate, and lung cancer from Austrian, Belgian, Greek, Italian, USA, and Turkish payer perspectives. Denosumab only exceeded the willingness to pay threshold in one study (India societal perspective). The impact of a denosumab biosimilar from the USA payer perspective provided an estimated $38 million in savings across five years. Denosumab was fully reimbursed across most indications and countries. Incremental cost-effectiveness led to partial reimbursement for bone metastases from solid tumors (UK) and do not recommend for MM (Australia). Lack of clinical evidence led to do not recommend for MM (France) and for giant cell tumor of bone (Poland).
CONCLUSIONS: Denosumab provides value for money through reductions in SRE-related costs, though affordability and access issues remain with the reference product. As reimbursement decisions are largely influenced by cost-effectiveness, use of denosumab biosimilars may provide much-needed savings and improved patient access.