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Around 200,000 osteoporosis patients may now be eligible to access FOSAMAX™ Case on the PBS
PBS criteria expanded to include osteoporosis with a Bone Mineral Density T score of -2.5 or lower
MSD, Sydney, 6 February, 2012: MSD has announced that patients aged 70 years or older with a Bone Mineral Density (BMD) T-score of -2.5 or lower and no prior osteoporotic fracture, are now able to access osteoporosis treatment on the PBS.
FOSAMAX (alendronate sodium), FOSAMAX PLUS® (alendronate sodium/colecalciferol), FOSAMAX PLUS D-CAL® (alendronate sodium/colecalciferol + calcium carbonate), and other alendronate formulations in the bisphosphonate class are now the only treatments listed on the PBS for osteoporotic patients aged 70 years or older with a BMD T-score of -2.5 or lower and no prior osteoporotic fracture. The previous criteria required patients have a BMD T-score of -3 or lower before being eligible to access this treatment on the PBS.
This new criteria will provide reimbursed treatment options to a group of patients with osteoporosis who have previously had to pay on private prescription or wait for the disease to worsen before being eligible for reimbursement.
According to new findings from the Geelong Osteoporosis Study, recently published in the Medical Journal of Australia, osteoporosis is estimated to be present in 12.9% of Australian men (1 in 8) and 42.5% of Australian women (2 in 5) aged over 70 years.
"This expanded PBS listing means that a potential additional 200,0003 older Australians (above the age of 70 years) may now be eligible for PBS reimbursed osteoporosis therapy when they are diagnosed with osteoporosis before they fracture. It means we can take a stronger, more logical, position on osteoporosis prevention and treatment." explained Professor Eisman.
Osteoporosis occurs when bones lose their density and become weak making them more likely to fracture. In most cases, osteoporosis causes no symptoms until a fracture occurs. Sometimes a fracture is silent. Once a fracture occurs, the chances of subsequent fractures increases dramatically. According to Osteoporosis Australia, it is estimated that every 5-6 minutes, someone is admitted to an Australian hospital with an osteoporotic fracture. This is expected to rise to every 3 - 4 minutes by the year 2021, as the population ages and the number of osteoporotic fractures increase. Adequate calcium is important for strong bones either from the diet (mainly dairy foods) or supplements if dietary calcium is inadequate. Getting adequate vitamin D intake from sunshine or supplements, reducing alcohol and stopping smoking also help. Regular weight-bearing exercises such as walking, Tai Chi and gentle weights can also improve bone health.
All medicines have adverse effects. Those most commonly associated with alendronate include oesophageal, gastrointestinal and musculoskeletal related events, headache and dizziness. Rare adverse effects include skin related reactions, blurred vision and localised jaw osteonecrosis (generally associated with tooth extraction). Calcium carbonate has been associated with constipation, flatulence, nausea and abdominal pain. Patients should refer to the Consumer Medicine Information or seek advice from their doctor to determine the best course of treatment to manage their condition.
IMPORTANT INFORMATION ABOUT FOSAMAX®, FOSAMAX PLUS®, FOSAMAX PLUS D-CAL®
Indications: FOSAMAX is indicated for the treatment of osteoporosis, including for the prevention of osteoporosis in postmenopausal women with low bone mass. For a full list of other indications please see PI. FOSAMAX formulations containing Vitamin D or a supply of calcium are only indicated in patients requiring Vitamin D and/or calcium supplementation.
One FOSAMAX (70mg) or FOSAMAX PLUS (70mg/140 micrograms) once weekly tablet should be taken first thing in the morning, with a glass of water, at least 30 minutes before food or any other medication on the same day each week. For the BoneCal (500mg elemental calcium) component of FOSAMAX PLUS D-CAL, on the remaining days of the week one or two calcium tablets should be taken as directed. This regimen should be repeated each week.
These medicines should not be taken if a person has allergies to any of the components, if unable to stand or sit upright for at least 30 minutes, if a person has low or high blood calcium levels, kidney stones, calcium in the urine or certain disorders of the oesophagus.
Precautions: Consult a doctor if you have dental or jaw-bone problems or are planning to have a course of dental surgery whilst taking FOSAMAX / FOSAMAX PLUS/ FOSAMAX PLUS D-cal. Severe oesophageal ulceration has been reported with alendronate. Discontinue FOSAMAX / FOSAMAX PLUS / FOSAMAX PLUS D-Cal if dysphagia, odynophagia or retrosternal pain develops. Active upper GI disorders; severe renal impairment; bone/joint and/or muscle pain, pregnancy (category B3); lactation; children. FOSAMAX PLUS / FOSAMAX PLUS D-Cal should not be used as sole treatment for osteoporotic patients with a vitamin D deficiency.
Side effects Most of the following are the more common side effects of FOSAMAX / FOSAMAX PLUS/ FOSAMAX PLUS D-Cal. For the most part, these have been mild: stomach pain, gas in the stomach or bowel, wind, an uncomfortable feeling in the stomach or belching after eating, also called dyspepsia, or heartburn; feeling sick (nausea), vomiting, constipation, diarrhoea, headache, aching muscles, joints and/or bones, which rarely can be severe, flu-like symptoms typically at the start of treatment, such as aching muscles, generally feeling unwell and rarely fever; swelling of joints; dizziness or spinning sensation; unusual tiredness or weakness; swelling of hands, ankles or feet; hair loss; changed sense of taste, may affect your ability to drive or operate machinery.
The following side effects are rare and, very rarely, may be serious: skin rash or redness of the skin, sometimes made worse by sunlight, itchiness, mouth ulcers, blurred vision, pain or redness in the eye, symptoms of low blood calcium levels, new or unusual pain in your hip or thigh; symptoms of a kidney stone such as severe, lower back or abdominal pain or difficulty in passing urine.
The following side effects are rare and may be serious: Jaw-bone or dental problems (including toothache). Jaw-bone problems may include infection, and delayed healing after a tooth extraction or other work that involves drilling into the jaw-bone. Long-term bisphosphonate therapy has been associated with atypical stress fractures of the proximal femur but no causal relationship has been established.
For a copy of the Consumer Medicine Information,
please visit:www.msd-australia.com.au/products
PBS Information: Authority required (STREAMLINED).
Refer to the PBS Schedule for full authority information.
Merck Sharp & Dohme (Australia) Pty Limited, 66 Waterloo Rd, North Ryde NSW 2113 Australia. Copyright ® 2011 Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc., Whitehouse Station, N.J. USA. All rights reserved. OSTE-1017139-0012. First issued February 2012.
References
* FOSAMAX (alendronate sodium), FOSAMAX PLUS® (alendronate sodium/colecalciferol), FOSAMAX PLUS D-CAL®(alendronate sodium/colecalciferol + calcium carbonate),
1 Schedule of Pharmaceutical Benefits. www.pbs.gov.au
2 Henry MJ, Pasco JA, Nicholson GC and Kotowicz MA. Prevalence of osteoporosis in Australian men and
women: Geelong Osteoporosis Study. MJA 195(6);2011 Sep 19:321-322.
3 Data on file MSD