Women in the UK at risk of osteoporotic fractures benefit from NICE’s decision to provide a novel treatment on the NHS
27th October 2010: Women in the UK at risk of post-menopausal osteoporotic fractures today have access to a new targeted treatment option, Prolia® (denosumab), following final guidance published by the National Institute for Health and Clinical Excellence (NICE). The guidance recommends denosumab as a treatment option for the prevention of osteoporotic fragility fractures in postmenopausal women who are at risk and for whom oral bisphosphonates are unsuitable.1
Denosumab has been designed to mimic the natural processes that control the breakdown of bone, thereby reducing the risk of future fractures. It specifically targets the cells that actively break down bones (osteoclasts) and this mode of action results in greater bone density and reduced risk of fractures at the spine, hip and other key non-vertebral sites.2-4 Administered every six months as an easy subcutaneous injection, denosumab can be given either at a GP surgery or a hospital clinic.
Dr Alun Cooper, a GP in Crawley, said: “I am delighted that NICE has made the decision to give patients access to this convenient and effective treatment option. Denosumab is a treatment that prevents osteoporotic fractures, which could significantly reduce the financial burden of fragility fractures on the NHS as well as offering an alternative treatment option to patients for whom oral bisphosphonates are unsuitable”.
There are estimated to be 230,000 osteoporosis-related fractures every year in the UK, of which 70,000 are hip fractures.5 Over half of all patients surviving a hip fracture are no longer able to live independently and the cost of hip fractures alone to the NHS is estimated at around £2 billion a year.5,6 Despite the fact that osteoporosis treatments have been available for more than 10 years, 68% of patients in the UK are no longer taking their medication after one year.7 The NICE appraisal committee stated that denosumab would be a clinically effective alternative to existing treatment options for the prevention of osteoporotic fragility fractures in post-menopausal women.1
Amgen and GlaxoSmithKline, who are co-marketing denosumab, welcomed the NICE decision. John Kearney, General Manager at Amgen today commented: “We are delighted that the NICE appraisal of denosumab has resulted in this positive guidance. Amgen researchers were the first to discover a fundamental biochemical pathway that controls bone remodelling almost fifteen years ago and we are thrilled that this discovery has led today to patients having access on the NHS to a convenient treatment that really has been shown to be highly effective in preventing fractures caused by osteoporosis”.
Dr Pim Kon, Medical Director at GlaxoSmithKline said: “GSK is delighted at the news that denosumab has been approved for use on the NHS. Treatments like denosumab can transform the lives of osteoporosis patients for whom other treatments are unsuitable. The recognition by NICE that denosumab is cost-effective is excellent news for UK patients who now have convenient access to this treatment option”.
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Notes to Editors:
Denosumab was granted marketing authorisation on 26th May 2010. The marketing authorisation includes data from the FREEDOM trial (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) that involved 7,800 patients and showed denosumab reduces the relative risk of new vertebral (spine) fractures by 68%, non-vertebral fractures by 20% and hip fractures by 40%.2
Denosumab, a RANK Ligand inhibitor, is licensed for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.3 Its innovative mode of action, compared with existing osteoporosis treatments, has been specifically designed to inhibit the osteoclast formation, function and survival, thereby reducing the risk of future fractures.2-4
Osteoporosis is the most common disease affecting the bones and is estimated to affect more than 2 million women in the UK.8 There are approximately 230,000 osteoporotic fractures every year in the UK, 70,000 of which are hip fractures.5 The impact of hip fracture can be devastating: 20% of patients suffering hip fracture die within four months and 30% within a year.9 Over half of those who survive a hip fracture are no longer able to live independently.6 The cost of osteoporotic fractures to the NHS is estimated at £2 billion per year.5
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com/
About GlaxoSmithKline
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit http://usto-pweb-cms01/leave_amgen.jsp?site=http://www.gsk.com
For further information please contact:
Amgen:
Emma Gilbert:
+ 44 (0)1223 436713
+ 44 (0)7983 179507
GlaxoSmithKline:
Sarah Hornby:
+44 (0)20 8990 3540
+44 (0) 7825 116090
References
1. Denosumab for the prevention of osteoporotic fractures in postmenopausal women. Technology Appraisal Guidance, 27 October 2010 Available at http://usto-pweb-cms01/leave_amgen.jsp?site=http://www.nice.org.uk/guidance/ta/published/index.jsp
2. Cummings SR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med, 2009; 361:756-765
3. Prolia® Summary of Product Characteristics (SPC)
4. Kostenuik PJ. Osteoprotegerin and RANKL regulate bone resorption, density,
geometry and strength. Curr Opin Pharmacol 2005; 5: 618-625
5. Protecting fragile bones. A strategy to reduce the impact of osteoporosis and fragility fractures in England. National Osteoporosis Society
6. Osteoporosis Facts and Figures. National Osteoporosis Society. Downloaded from http://www.nos.org.uk/NetCommunity/admin/Document.Doc?id=47. Downloaded 30.11.09
7. Li, L et al. OP54 Non-persistence to anti-osteoporosis medications in the UK using the general practice research database (GPRD) Rheumatology 2010; 49: Supplement 1
8. NICE technology appraisal guidance 161
9. DOH: Effective interventions for falls and fractures, 2009
DMB-GBR-AMG-550-2010 • UK/DNB/0104b/10
Date of Preparation: October 2010
