The National Institute for Health and Clinical Excellence has terminated a review of Amgen’s osteoporosis drug Prolia for National Health Service prostate cancer patients on a lack of evidence.

The Institute said it is unable to recommend Prolia (denosumab) for the treatment of therapy-induced bone loss in patients with non-metastatic prostate cancer on the NHS because it did not receive any evidence from Amgen regarding the drug’s clinical and cost-effectiveness in this setting.

Prolia - a first-in-class, fully human monoclonal antibody designed to target RANK ligand, which regulates osteoclast formation, function and survival - won its first global approval in Europe in May this year on the back of strong clinical data showing that a 60mg subcutaneous injection every six months cut the incidence of fractures and, importantly, also increased bone mineral density.

In June, NICE published draft guidance recommending the drug’s use on the NHS for the primary and secondary prevention of osteoporosis when treatment with currently available oral bisphosphonates is unsuitable. However, the cost regulator was forced to terminate its appraisal of the drug for patients with prostate cancer when no evidence to support its use was submitted.

A spokesperson for NICE confirmed to PharmaTimes UK News that, in a rather uncommon move, Amgen contacted the Institute to say it would not be submitting any evidence for the drug in this setting, though she was unable to shed any further light on the reason for the decision. Unfortunately, Amgen could not be reached for comment in time for publication.

However, Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, stressed that NHS organisations “should take into account the reasons why no evidence of denosumab’s clinical and cost-effectiveness was submitted when considering their local use of the drug,” and added that the Institute will review its advice to the NHS should Amgen decide to submit the necessary data in future.