The National Institute for Health and Clinical Excellence says it has had to terminate one of its appraisals for Amgen’s Prolia, after the company “decided not to submit any evidence of the drug’s clinical and cost-effectiveness”.

The indication in question is the use of Prolia (denosumab) for the treatment of therapy-induced bone loss in patients with non-metastatic prostate cancer. Amgen’s decision means NICE “cannot evaluate whether denosumab is useful for this indication [and] is unable to recommend the drug in this context". Carole Longson, health technology evaluation centre Director at NICE, said the Institute is “committed to producing timely guidance to the NHS but relies on the manufacturer to submit evidence so that we can appraise the treatment. Unfortunately in this case, the manufacturer decided not to”.

She added 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”. Dr Longson concluded by saying that “of course, if the manufacturer decides to submit the evidence in the future, NICE will then take the opportunity to review our advice to the NHS.”

Also, a NICE appraisal of Prolia for the treatment for therapy-induced bone loss in non-metastatic breast cancer, has been removed from the Institute’s work programme, because the drug has not received a separate marketing authorisation for this indication. Amgen has told NICE that the European Committee for Medicinal Products for Human Use believes the aforementioned indication is part of the broader indication for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, for which an appraisal is currently ongoing.

Last month NICE published draft guidance in which it recommended that patients are given Prolia for the primary and secondary prevention of osteoporosis when treatment with currently available oral bisphosphonates is unsuitable. The drug is also being reviewed for bone metastases treatment in cancer.