The future of Amgen’s Prolia looks bright in the UK after cost regulators for the National Health Service took a step towards approving the drug as a treatment for osteoporosis in postmenopausal women.
The National Institute for Health and Clinical Excellence has published draft guidance in which it recommends that patients are given Prolia (denosumab) for the primary and secondary prevention of osteoporosis when treatment with currently available oral bisphosphonates is unsuitable.
“Our independent Appraisal Committee felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available to prevent a first fracture in women at increased risk and also at preventing further fractures in women who have already experienced one,” explained Dr Carole Longson, Health Technology Evaluation Centre Director at NICE.
Furthermore, given its relatively low cost – Prolia is administered as a single injection twice a year, with each dose costing £183 – the therapy fell well within the limits of the Institute’s cost-effectiveness threshold.
Prolia was approved by the European Commission in May this year on the back of strong clinical data from a suite of six Phase III trials, which showed that a 60mg subcutaneous injection every six months cut the incidence of fractures and, importantly, also increased bone mineral density. In one study, the drug reduced the relative risk of new vertebral (spine) fractures by 68%, non-vertebral fractures by 20% and hip fractures by 40%, demonstrating its potential benefits to patients.
A first-in-class, fully human monoclonal antibody designed to regulate osteoclast activity and thereby reduce bone breakdown and boost bone mass and strength, Prolia will compete against bisphosphonates such as Novartis’ Reclast/Zometa (zoledronic acid) and Merck & Co’s Fosamax (alendronate), some of which are now widely available genercially. It will also up against Warner Chilcott’s Actonel (risedronate) and GSK/Roche’s Boniva/Bonviva (ibandronic acid).
However, as Amgen points out, compliance with oral bisphosphonate therapy is poor because of complex dosing regimens and side effects, with 42% of patients discontinuing therapy within the first year, and so Prolia’s ease of administration could have a significant impact on improving osteoporosis treatment outcomes.
NICE’s appraisal of Prolia is now open for consultation until July 9, and a second meeting has been scheduled for July 27.
