GVS advice concerning romosozumab (Evenity®) for the treatment of severe osteoporosis

Zorginstituut Nederland has completed its assessment whether romosozumab (Evenity®) is interchangeable with a product that is included in the Medicine Reimbursement System (GVS). Based on the criteria for interchangeability, it can be concluded that romosozumab (Evenity®) is interchangeable with teriparatide, which is included in GVS cluster 0H05AAAP V. The Zorginstituut's advice is to include romosozumab (Evenity®) in cluster 0H05AAAP V on List 1A of the GVS.

Registered indication

Romosozumab (Evenity®) is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Romosozumab is available as a pre-filled syringe; each pre-filled syringe contains 105 mg romosozumab in 1.17 ml solution (90 mg/ml). The recommended dose is 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once monthly for 12 months.

Assessment

The Zorginstituuthas concluded that romosozumab has added therapeutic value in comparison with alendronate (oral), and that the therapeutic value is comparable with that of teriparatide (subcutaneous) in patients with postmenopausal osteoporosis and a very high risk of fracture. 

Review of interchangeability

Based on the criteria for interchangeability, it can be concluded that romosozumab (Evenity®) is interchangeable with teriparatide, which is included in GVS cluster 0H05AAAP V. 

Zorginstituut's advice

Based on the above, the Zorginstituut advises the Minister for Medical Care to include romosozumab (Evenity®) in cluster 0H05AAAP V on List 1A of the GVS. 6.9 mg/day can be applied as the standard dose. 

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.