Reason for request

Re-assessment of the IAB

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Clinical Benefit

Low

the actual benefit of QUADRAMET is low in the Marketing Authorisation indication, i.e. “relief of bone pain in patients with multiple painful osteoblastic metastases which take up technetium (99mTc)‑labelled bisphosphonates on bone scan”.


Clinical Added Value

no clinical added value

The proprietary medicinal product QUADRAMET does not provide any improvement in actual benefit (IAB V, nonexistent) in the strategy for the management of painful osteoblastic skeletal metastases of various origins (mammary, pulmonary, prostatic).