Ruling on convenient twice-yearly injection will benefit women in Scotland
Monday 13th December, 2010: Women in Scotland at increased risk of postmenopausal osteoporotic fracture now have access to a new targeted treatment option, Prolia® (denosumab). The Scottish Medicines Consortium (SMC) has recommended denosumab for women with osteoporosis (bone mineral density T-score of < -2.5 and = -4.0) for whom oral bisphosphonates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions.1
Professor Stuart Ralston, Arthritis Research UK Professor of Rheumatology at the University of Edinburgh and clinical lead for the Osteoporosis Service in NHS Lothian said. “I am delighted to hear that the SMC has approved the use of denosumab for the treatment of women with postmenopausal osteoporosis in Scotland. Denosumab is a highly effective treatment which will be particularly useful in patients who are having problems taking the standard treatment which is a tablet that is given once a week. At the moment we are able to treat these patients but it involves them coming up to hospital to give them a drug that is given by an infusion (or "drip"). Denosumab will provide us with an alterative option for these patients since it can be given easily by the patient’s GP or practice nurse by a subcutaneous injection once every six months without the need for a hospital visit. It’s a valuable new addition to the fight against osteoporosis”.
Administered every six months as a convenient subcutaneous injection, denosumab significantly reduces the risk of fractures at the spine, hip and other key non-vertebral sites.2,3 It has been designed to mimic the natural processes that control the breakdown of bone and specifically targets the cells that actively break down bones (osteoclasts), resulting in greater bone density.2,3 Denosumab can be given at a hospital clinic or GP surgery.
Dr Stephen Gallacher, Consultant Physician & Endocrinologist, Southern General Hospital, Glasgow, said “I am delighted that the discovery of a biochemical pathway that controls the way bones are built and broken down has meant we are able to tackle osteoporosis at the root cause of the disease. The recommendation by the SMC is promising news for the thousands of women currently suffering with the disease”.
Osteoporosis-related fractures affect around 200,000 women in Scotland, with one in three women over the age of 50 suffering a fracture.4 Over half of all patients surviving a hip fracture are no longer able to live independently.5 Hip fractures also have a significant financial burden, with the average cost of treating a hip fracture being £13,000 in the first year and £7,000 for the subsequent year.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
Amgen and GlaxoSmithKline (GSK), who are co-marketing denosumab, welcomed the SMC recommendation. John Kearney, General Manager at Amgen today commented “Amgen is very pleased with the recommendation from the SMC. Following Amgen’s discovery of the fundamental biochemical pathway controlling bone remodelling over a decade ago, it is great to see this being used to transform the lives of women with postmenopausal osteoporosis for whom other treatments are unsuitable.”
Dr Pim Kon, Medical Director at GSK, said “Following positive NICE guidance on denosumab for patients in England and Wales, we are delighted that women in Scotland unable to tolerate other treatments for postmenopausal osteoporosis now have access to an alternative, efficacious treatment option. Furthermore, the recognition by the SMC of the cost-effectiveness of denosumab could significantly reduce the financial burden of fragility fractures.”
-ends-
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.2,3
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.9 The impact of hip fracture can be devastating: 20% of patients suffering hip fracture die within four months and 30% within a year.10 Over half of those who survive a hip fracture are no longer able to live independently.5 The cost of osteoporotic fractures is estimated at £2 billion per year.9
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 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 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. Scottish Medicines Consortium: Denosumab (Prolia®). Number 651/10. Published 13 December 2010 at http://www.scottishmedicines.org.uk/Home
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) (last date accessed 25.11.10)
4. Scottish Intercollegiate Guidelines Network. 71 Management of Osteoporosis: A national clinical guideline. Downloaded from http://www.sign.ac.uk/pdf/sign71.pdf. Downloaded 23.11.10
5. Osteoporosis Facts and Figures. National Osteoporosis Society. Downloaded from http://www.nos.org.uk/NetCommunity/admin/Document.Doc?id=47. Downloaded 23.11.10
6. Falling Short: Delivering Integrated Falls and Osteoporosis Services in England. All Party Parliamentary Osteoporosis Group, December 2004
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. Protecting fragile bones. A strategy to reduce the impact of osteoporosis and fragility fractures in England. National Osteoporosis Society
10. DOH: Effective interventions for falls and fractures, 2009
DMB-GBR-AMG-619-2010 • UK/DNB/0156/10
Date of Preparation: December 2010
