Profile of Women Initiated on Denosumab and Pattern of Use in a Restricted Postmenopausal Osteoporosis Indication: A French Database Analysis Over the Period 2013-2014.

Introduction: French authorities have approved the reimbursement of denosumab as a second-line therapy after bisphosphonates (BPs) in women presenting with postmenopausal osteoporosis (PMO) at high risk of fracture. By using a nationally representative claims database, we analyzed the pattern of denosumab use. The objectives of this study were to describe the profile of women initiated with denosumab over the 14-month period after launch and to check as far back as possible for the appropriateness of its use regarding the restrictions brought by French health authorities.

Methods: A retrospective study using a national representative claims database, i.e., the "Echantillon Généraliste des Bénéficiaires" (EGB), was performed. The population was composed of women aged ≥ 40 years old who had an initiation of a PMO treatment in 2013 or 2014. The denosumab women's profiles were compared with those of women that started any other PMO treatment (except denosumab) over the same period.

Results: In 2013 and 2014, we identified 256 women who initiated denosumab. Denosumab was primarily prescribed by specialists (75%) compared with the other PMO treatments (37.6%). Patients on denosumab were significantly older, 73.2 versus 69.1 years old, and they more frequently had a history of fractures (20.7% versus 17.4%, NS) and chronic uptake of high-dose steroids (25% versus 22.8%, NS). Of the women initiated with denosumab, 93.8% had undergone a previous PMO treatment (during the 2005-2014 period). In 92.9% of cases, it was a BP alone or in association.

Conclusion: This study suggests satisfactory compliance of prescribers concerning the restriction of the reimbursed indication of denosumab in second line after bisphosphonates with 6.2% possible inappropriate prescriptions.

Funding: Amgen.