TORONTO, April 4 /CNW/ - On April 4, 2011, the Canadian Expert Drug
Advisory Committee (CEDAC) through the Common Drug Review (CDR)
recommended that provincial drug plans approve funding for Prolia®
(denosumab), but with some restrictions. Denosumab is a targeted
therapy in a new class of osteoporosis medications for postmenopausal
women with osteoporosis at high risk for fracture.
"While this recommendation is a positive step forward for some patients,
these restrictions are quite limiting and mean that a significant
number of postmenopausal women with osteoporosis at high risk for
fracture may be left without access to this new treatment, including
many women for whom existing therapies are either contraindicated,
ineffective or not tolerated," said Dr. Famida Jiwa, President & CEO,
Osteoporosis Canada. "Based on these recommendations, Osteoporosis
Canada urges provinces to provide broader access to denosumab.
Provinces should ensure that this new treatment is accessible to women
with osteoporosis that can benefit from treatment for this debilitating
According to the criteria set out by the CDR, denosumab is recommended
for women with postmenopausal osteoporosis who would otherwise be
eligible for jurisdictional funding for oral bisphosphonates, but for
whom bisphosphonates are contraindicated due to hypersensitivity or
abnormalities of the esophagus (e.g., esophageal stricture or
achalasia), and have at least two of the following: older than 75 years; a prior
fragility fracture; bone mineral density (BMD) T-score of ≤-2.5.1 Currently, the most commonly prescribed drugs for this disease are
bisphosphonates. Denosumab offers a new effective alternative that is
in a completely different class of medications called RANK ligand
Provincial drug plans are not obliged to adhere to the CDR's
recommendations as each provincial authority has the right to make
listing and coverage decisions based on local priorities and resources.
Quebec, for example, has demonstrated leadership by being the first
province to list denosumab on public and private drug plans. Even so,
patient access to osteoporosis therapies in Canada is limited and
varies across the country. In addition, the CDR recommendation is not
aligned with Osteoporosis Canada's evidence-based 2010 Clinical
Practice Guidelines for the Diagnosis and Management of Osteoporosis in
"The 2010 Clinical Practice Guidelines issued by Osteoporosis Canada
recommended denosumab as a first-line therapy for the treatment of
osteoporosis in postmenopausal women at high risk for fracture," said
Dr. Bill Leslie, Chair, Scientific Advisory Council, Osteoporosis
Canada. "The CDR recognized in its recommendation that denosumab is
clinically effective in reducing the incidence of new hip and vertebral
fractures, and is cost-effective in women at high risk of fracture.
However, the restrictions on the recommendation will mean that few
women at risk will have access to this effective treatment option."
Osteoporosis could strike you or someone you love. It is a silent
disease that affects nearly two million Canadians. The risk of a major
osteoporotic fracture in Canada is among the highest in the world. Yet,
despite the high prevalence of fractures, they are often not
appropriately assessed or treated, leaving osteoporosis undiagnosed and
undertreated. Broken bones are associated with devastating health
consequences including pain, decreased quality of life, loss of
independence, and even death. Preventing new fractures for those who
have already had an osteoporotic fracture is Osteoporosis Canada's top
priority. In 2010, Osteoporosis Canada issued new Clinical Practice
Guidelines for the Diagnosis and Management of Osteoporosis in Canada that help
physicians and patients better identify the risk of fracture, resulting
in better fracture prevention and better management of osteoporosis
Additional osteoporosis statistics:
Almost 2 million Canadians are living with osteoporosis.
Over 90% of hip fractures in Canada occur in those over age 60.
In the first year after a vertebral or hip fracture there is at least a
doubling in the risk of death.
Each year in Canada there are about 30,000 hip fractures - many more
Canadians suffer osteoporotic fractures affecting the spine, wrist,
shoulder, and pelvis.
A 50-year-old woman has a 40% chance of developing hip, vertebral or
wrist fractures during her lifetime.3
Over one-quarter of hip fractures in Canada occur in men.
The 1 in 6 lifetime risk of hip fracture is greater than the 1 in 9
lifetime risk of developing breast cancer.4
1 in 4 women who have a new vertebral fracture will fracture again
within one year.5
"Osteoporotic fractures can be prevented," said Larry Funnell, Chair,
Canadian Osteoporosis Patient Network (COPN). "Patients with
osteoporosis deserve to have choices and the right to access the
medications they need."
About Osteoporosis Canada
Osteoporosis Canada, a registered charity, is the only national
organization serving people who have or are at risk for osteoporosis.
In keeping with our vision of a Canada without osteoporotic fractures,
the organization works to educate, empower and support individuals and
communities in the risk-reduction and treatment of osteoporosis by
providing medically accurate information to patients, health
professionals and the public. For more information, visit www.osteoporosis.ca.
1 Prolia® Submission Status. Canadian Agency for Drugs and Technology in
Health, Common Drug Review. Accessed at http://www.cadth.ca/index.php/en/cdr/search?status=all&order_field=brand_name&keywords=Prolia.
2 Papaioannou A et al. Clinical practice guidelines for the diagnosis and
management of osteoporosis in Canada. CMAJ. 2010; 1-10.
3 Melton LJ III, Chrischilles EA, Cooper C, Lane AW, Riggs BL.
Perspective: how many women have osteoporosis? J Bone Miner Res. 1992; 7:1005-10.
4 Cummings SR, Black DM, Rubin SM. Lifetime risks of hip, colles', or
vertebral fracture and coronary heart disease among white
postmenopausal women. Arch Intern Med. 1989; 149:2445-8.
5 Lindsay R, Burge RT, Strauss DM. One year outcomes and costs following
a vertebral fracture. Osteoporosis Int. 2005; 16:78-85.
SOURCE Osteoporosis Canada
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