Osteoporosis Medicine Decision Welcomed

Media Release

Tuesday 27 September 2005

Osteoporosis Medicine Decision Welcomed

The decision to widen taxpayer-funded access to the osteoporosis medication Fosamax® will result in significant quality of life improvements for the estimated 30% of New Zealand women over the age of 50 who have osteoporosis.

“Fosamax is the only medicine available for osteoporosis conclusively proven1,2 in clinical trials to reduce the risk of fractures at all the key osteoporosis sites – the hip, spine and wrist,” said Alister Brown, managing director of Merck Sharp & Dohme – which developed Fosamax and markets the prescription medicine in New Zealand.

“Having wider taxpayer-funded access to Fosamax has been long awaited by patients and the medical community, who I am sure will applaud this decision.”

Fosamax was approved for use in postmenopausal osteoporosis by the NZ regulatory agency MEDSAFE in September 1995. An application for subsidised access to Fosamax for patients with osteoporosis was made that same year. In February 2000, PHARMAC provided taxpayer-funded access to Fosamax for patients with two prior osteoporotic fractures and very low bone mass (three standard deviations below the mean normal value in young adults: a ‘T-Score’ of 3.0).

From 1 October 2005, wider access criteria for Fosamax will include patients with either one previous osteoporotic fracture and a bone mineral density T-Score of 2.5 or more; or a history of two significant osteoporotic fractures; or a T-Score of 3.0 or above; or one osteoporotic fracture and either the patient is elderly or densitometry scanning cannot be performed for one of a number of reasons.

“It’s good news for patients and the health sector that PHARMAC and Merck Sharp & Dohme have been able to work together to reach this agreement,“ Alister Brown said.

“Osteoporosis is a serious illness which reduces the quality of life of many New Zealanders. However, this agreement will not only improve quality of life for a large number of women with osteoporosis and a small number of men with the condition. By preventing fractures, this deal will also reduce public and private sector expenditure on fracture treatment across the health sector.”

Note: The clinical name for Fosamax is alendronate. It is packaged, sold and known to patients and the general public in New Zealand as Fosamax.

ENDS

Therapeutic Advertising Pre-Vetting System (TAPS) no. NZ9837

® Registered trademark of Merck & Co. Inc, Whitehouse Station, NJ, USA. PRESCRIPTION MEDICINE

1. Bone et al, New England Journal of Medicine, 2004, Vol. 350, 1189-99
2. Black et al, Journal Of Clinical Endocrinology & Metabolism: 2000, Vol. 85, No. 11, 4118-4124

THINGS TO KNOW BEFORE USING FOSAMAX (alendronate) 10 & 70 mg tablets:
FOSAMAX is indicated for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). FOSAMAX should not be taken by patients who have a hypersensitivity reaction, food pipe (oesophageal) abnormalities, low calcium (hypocalcaemia) and have an inability to stand/sit upright for 30mins. Precaution should be taken when administering FOSAMAX to patients with active upper gastrointestinal problems, impaired renal function and calcium or vitamin D deficiency. Common side effects are: abdominal pain, dyspepsia, food pipe (oesophageal) ulcer, difficulty swallowing (dysphagia), abdominal distension, musculoskeletal pain, constipation, diarrhoea, flatulence and headache. FOSAMAX is a prescription only medicine, fully subsidised under special authority for those who meet specified criteria. A prescription charge will apply. Consult your doctor to see if FOSAMAX is right for you, a normal doctors visit fee will usually apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist or health professional. Marketed by: Merck Sharp & Dohme (NZ) Limited, Newmarket, Auckland. For detailed prescribing information, consult the data sheet or consumer medicine information phone 0800 500 673, or refer to the Medsafe website www.medsafe.govt.nz . [MPI-FSM-2]

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