XGEVA (denosumab) - Oncology

Opinions on drugs - Posted on May 24 2024

Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the following indications:

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with an advanced solid tumour involving bone.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

(For more information see the MA)

Unfavourable opinion in the other indications, i.e. in the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with other advanced malignancies, including multiple myeloma, involving bone.

No clinical added value of the new XGEVA 120 mg solution for injection in pre-filled syringe form compared to the forms already available.

Clinical Benefit

Substantial	The Committee considers that the clinical benefit of XGEVA 120 mg (denosumab) solution for injection in a 1.0 mL pre-filled syringe (120 mg/mL) is substantial only in the “prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with an advanced solid tumour involving bone”.
Moderate	The Committee considers that the clinical benefit of XGEVA 120 mg (denosumab) solution for injection in a 1.0 mL pre-filled syringe (120 mg/mL) is insufficient to justify its public funding cover in the other MA situations, i.e. in the “prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with other advanced malignancies, including multiple myeloma, involving bone”.
Insufficient