Amgen’s Prolia has been recommended again by the National Institute for Health and Clinical Excellence for use on the National Health Service for fracture prevention in osteoporosis patients.

Echoing recommendations made earlier this year, the cost regulator has published final draft guidance endorsing Prolia (denosumab) as an option for postmenopausal women who are at increased risk of osteoporotic fractures but cannot take the oral bisphosphonates alendronate, and either Procter & Gamble’s Actonel (risedronate) or etidronat.

Specifically, the Institute has agreed funding for the drug when used for primary prevention of fractures in patients who have a number of specific independent clinical risk factors and are unable to take oral biphosphonates, as well as for secondary prevention in those who can’t take the said treatments.

Prolia is a first-in-class monoclonal antibody monoclonal antibody that works by reducing osteoclast activity and thereby bone breakdown. The treatment is administered as a single subcutaneous injection twice yearly, which, as NICE’s Appraisal Committee noted, could help to boost treatment compliance particularly for those patients who have problems swallowing or taking oral biphosphonates.


Amgen’s submission to NICE was centred on results of the FREEDOM study, which demonstrated the drug’s fracture reducing capabilities; the 36-month incidence of new radiographically diagnosed vertebral fractures was 2.3% in women taking Prolia versus 7.2% in those given a ghost pill.

Also working in Prolia’s favour is its reasonable price tag - the therapy will set the NHS back around £366 per patient per year, and so falls well within the bounds of the Institute’s cost threshold.

“Our independent Appraisal Committee felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available for women who can’t have oral bisphosphonates,” said Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, explaining the decision.

The consultation period is open until September 29, and final guidance is expected later this year, NICE said.