Scottish Medicines Consortium Approves Bonviva(R) - Scottish Women To Have Access To New Once-monthly Treatment

Main Category: Bones / Orthopedics
Also Included In: Women's Health / Gynecology
Article Date: 14 Feb 2006 - 14:00 PDT

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Several thousand women across Scotland will now have access to a new drug called Bonviva(R) (ibandronic acid also known as ibandronate), following its approval for NHS prescription in Scotland.1,2 Bonviva is the first ever once-monthly treatment for post-menopausal osteoporosis.

Osteoporosis is a disease which causes over 230,000 fractures a year in the UK, including 120,000 spine fractures. Across the UK an alarming one in two women will suffer a fracture after the age of 50.3 This places a substantial economic burden on the NHS, with the annual cost of treating osteoporosis estimated at £1.7 billion3.

The Scottish Medicines Consortium (SMC), which advises NHS boards on the use of newly licensed drugs in Scotland, has recommended that Bonviva be made available for the treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral fractures.2 Within this guidance, the SMC highlights both Bonviva's efficacy and possible cost-saving benefits to the Scottish health service.2

The exact SMC advice is: Ibandronic acid (Bonviva) is accepted for use within NHS Scotland for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures. Ibandronic acid 150mg monthly is superior to daily ibandronic acid in terms of lumbar spine bone mineral density at 1 year. Compared with placebo, daily administration of ibandronic acid results in a relative risk reduction for vertebral fractures of 62%. Unlike some other bisphosphonates, efficacy in reducing femoral neck fractures (and other non-vertebral fractures) has not been established.

Bonviva is the first once-monthly oral treatment to be licensed for any chronic disease. Reducing dosage frequency from daily to weekly is known to have improved the likelihood of patients continuing to take their treatment. A study has already established that patients prefer the convenience of just one tablet a month, compared to weekly osteoporosis treatments.4 In studies specifically looking at how long patients remain on treatment, approximately 50% of patients on a weekly bisphosphonate have stopped taking it by the end of the first year.5,6 Studies designed to reflect real life circumstances are due to report soon on whether patients are more likely to stay on Bonviva (taken once a month) compared to Fosamax (taken once a week). David Reid, Professor of Rheumatology at the University of Aberdeen and Chairman of the NOS Medical Board, notes the significance of this. "If the improvement in adherence to treatment that we saw after weekly bisphosphonates were introduced is repeated with the introduction of a once-monthly tablet, this would be great news for patients at risk of vertebral fractures. If medicines aren't taken regularly they won't prevent fracture."

Bisphosphonates are the most commonly prescribed treatment for osteoporosis. Bisphosphonates are extremely effective at reducing fracture risk and are generally well-tolerated by patients. However, for many patients the frustration of having to take them on an empty stomach, and then remain upright and avoid eating for a while after taking the tablet, may be responsible for the current low levels of adherence.

"It is essential for patients to have access to all available drug treatments if we are to make progress in protecting women from this debilitating and life-threatening disease," said Professor David Reid. "With ever increasing numbers of patients being diagnosed with the disease, more action is needed to reduce the increasing burden of osteoporotic fractures on the NHS."

About Bonviva once monthly

Bonviva is a 150mg film coated tablet taken once a month. It is novel among bisphosphonates because it is the only monthly oral treatment for postmenopausal osteoporosis. Patients who are prescribed Bonviva can sign up for a Patient Support Programme called active!, which is designed to support long term compliance with the novel once-monthly regimen. active! is a freephone helpline staffed by nurses, who provide information on osteoporosis, and regular contact and support.

About Osteoporosis

-- The World Health Organisation defines osteoporosis as a 'a disease characterised by low bone mass and micro-architectural deterioration of bone tissue, leading to enhanced bone fragility and a consequent increase in fracture risk7

-- An estimated 3 million people in the UK suffer from osteoporosis3

-- It has also been estimated that every year in the UK, there are:3
50,000 wrist fractures
120,000 spinal fractures
70,000 hip fractures

About the Roche/GSK Collaboration

In December 2001, Roche and GSK announced that they would co-develop and co-promote ibandronic acid for the treatment of postmenopausal osteoporosis in all countries, except Japan. The Roche/GSK collaboration provides expertise and commitment to make new osteoporosis therapies available as quickly as possible.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Find out more at http://www.rocheuk.com

About GSK

GSK, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
http://www.gsk.com

All trademarks used or mentioned in this release are legally protected.

References 1 The Scottish Intercollegiate Guidelines Network (SIGN) Published Guideline 71 (2003): 'Management of Osteoporosis, a national clinical guideline'. www.sign.ac.uk

2 Scottish Medicines Consortium (SMC). Guidance for ibandronic acid (also known as ibandronate), 150mg, film-coated tablet (Bonviva") No. (228/05) http://www.scottishmedicines.org.uk

3 National Osteoporosis Society online: What is osteoporosis? http://www.nos.org.uk/osteo.asp

4 Emkey R et al. (2005) Patient preference for once monthly ibandronate versus once-weekly alendronate in a randomized, open label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Curr Med Res Opin, 21 (12): 1895 - 1903

5 Cramer JA et al. (2004) Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women. J Bone Miner Res; 19 (Suppl 1): S448 (Abstract M434)

6 Ettinger MP et al. (2004) Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum; 50 (Suppl.): S513

7 Report of World Health Organisation Study Group (1994) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. WHO Technical Series 843

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