NICE halts Prolia appraisal

NICE says it has been forced to terminate a review of Amgen’s bone density drug Prolia after the US biotech firm failed to send sufficient data.

The institute was appraising Prolia (denosumab) for therapy-induced bone loss in patients with non-metastatic prostate cancer, but was unable to recommend it after Amgen decided not to submit any clinical and cost-effectiveness evidence.

Dr Carole Longson, health technology evaluation centre director at NICE, said: “NICE 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 submit evidence on whether denosumab would be a useful treatment for therapy-induced bone loss in patients with non-metastatic prostate cancer, and we have had to terminate this appraisal.”

Longson continued: “When an appraisal is terminated, we issue advice to the NHS stating that 'NICE is unable to recommend the use of the technology'. This advice sets out an explanation provided by the manufacturer as to why they did not submit evidence and will offer advice on what to do next.

“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.”

The guidance for the terminated appraisal of denosumab can be viewed here. Meanwhile,

Prolia is currently under NICE review for two other indications: osteoporotic fracture prevention and for bone metastases treatment in cancer (specifically for solid tumours and multiple myeloma).

In June, NICE gave an early thumbs up in preliminary draft guidance for Prolia’s use as a preventative treatment for osteoporotic fractures in post-menopausal women.

Second appraisal ceased

Separately, another NICE appraisal of Prolia, this time evaluating the drug as a treatment for therapy-induced bone loss in non-metastatic breast cancer, has been removed from the drugs watchdog’s work programme by the Department of Health.

This decision was taken because the drug has not received a separate marketing authorisation for this indication, which is necessary for NICE to carry out the appraisal.

Meanwhile, Amgen has informed NICE that European regulatory advisors at the CHMP believe this indication is part of its broader use as a treatment for osteoporosis in postmenopausal women, which NICE is currently appraising.

Ben Adams