Corinne Emery1, Julie Gourmelen2, Francis Fagnani3, Florence Suzan4, Gaëlle Desamericq5, Patrice Fardellone6. 1. Cemka, Bourg-la-Reine, France. 2. UMS 011, Institut National de la Santé et Recherche Médicale, Villejuif, France. 3. Cemka, Bourg-la-Reine, France. Francis.fagnani@cemka.fr. 4. Value, Access and Policy Department, Amgen France S.A, Neuilly-sur-Seine Cedex, France. 5. Epidemiology Department, Amgen Europe, Boulogne Billancourt, France. 6. Department of Rheumatology, CHU Amiens, Amiens, France.
Abstract
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.
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 denosumabwomen'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.
Entities:
Keywords:
Appropriateness of use; Database; Denosumab; France; Postmenopausal osteoporosis; Rheumatology
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