Prolia gets early thumbs up from NICE
pharmafile | June 18, 2010 | News story | Sales and Marketing | Amgen, NICE, Prolia
Amgen’s new treatment to prevent bone fractures caused by osteoporosis has been given preliminary approval from the UK’s cost effectiveness body.
NICE says postmenopausal women who are at increased risk of osteoporotic fractures should be treated with Prolia (denosumab) if treatment with oral bisphosphonates is unsuitable.
Prolia is a new treatment for women at increased risk of osteoporotic fractures and is given by injection twice a year.
Amgen will be pleased not only with NICE’s preliminary decision, but its speed, coming just weeks after the drug was launched in the UK.
But the restricted recommendation means that Prolia should only be considered in those women who cannot take the older (and cheaper) bisphosphonates drugs.
NICE say the widely used oral bisphosphonates may be unsuitable in women unable to comply with the special instructions for the administration, (such as not being able to remain standing or sitting upright for half an hour after taking the drugs) or if they have a contraindication to, or are intolerant of, bisphosphonates.
Prolia should be an option for these women if they are judged to be at increased risk of fractures, according to the NICE draft guidance.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “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.
“We hope that older women at increased risk of osteoporotic fractures who cannot take oral bisphosphonates will be considered for this drug in order to help prevent the misery of breaking a bone.”
NICE are now opening up its preliminary decision to consultation.
Prolia is administered as a single subcutaneous injection into the thigh, abdomen or the back of the arm. The recommended dosage is 60mg once every six months. Each dose costs £183, which means that the annual cost of treatment with denosumab is £366.
Head-to-head in osteoporosis and cancer
Prolia’s main competitor is Aclasta, a similar treatment from Novartis that is administered just once a year. But Prolia has the advantage of being injectable as opposed to the infusion needed for Aclasta.
Aclasta was approved a year ago in Europe as a once-yearly treatment for treat men and postmenopausal women with osteoporosis caused by long-term use of glucocorticoids.
Analysts Datamonitor predict Prolia will achieve sales of over $850m across the seven major markets by 2019. However it adds that despite its first-in-class status, Prolia is unlikely to revolutionise the current treatment algorithm, as existing unmet needs remain.
Prolia also has potential in treating bone problems in cancer patients, which if approved, could double the drug’s revenues.
Trials have shown it to be better than Novartis’s Zometa at delaying fractures and other skeletal events in men with advanced prostate cancer.
A phase III study of 1,900 men with prostate cancer which had spread to the bone compared Prolia with Novartis’ Zometa, which is already approved to help prevent skeletal-related problems in cancer patients.
Andrew McConaghie
Related Content
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS
Walton Oaks, 21st May 2025 – Pfizer Ltd announced today that the National Institute for Health and Care …
Dual immunotherapy for bowel cancer now available under NHS
Dual immunotherapy, a combination of Opdivo (nivolumab) and Yervoy (ipilimumab), has been granted extension in …
