- Change in formulary status improves patients' access to Actonel -
TORONTO, June 4 /CNW/ - ACTONEL(R) (risedronate sodium tablets), a drug
indicated for the treatment and prevention of osteoporosis, has been moved
from Limited Use to General Benefit status on the Ontario Drug Benefit
Formulary (ODBF). This means osteoporosis patients covered by the Ontario Drug
Benefit plan will now have unrestricted access to Actonel. In the past, unless
patients (seniors with no private coverage or those on fixed incomes) met
restrictive criteria, they might have needed to pay out-of-pocket for Actonel,
despite it being recommended by Osteoporosis Canada's clinical practice
guidelines(1) as a first line treatment for osteoporosis.
Osteoporosis affects as many as 530,000 Ontarians, resulting in more than
57,000 osteoporosis-related fractures, 68,000 emergency department visits,
62,000 hospitalizations and 14,000 deaths each and every year. The resulting
cost to the health care system is as high as $500-million in hospitalization
and long-term care.(2)
"Fracture prevention is the goal of osteoporosis management, and having
access to a first line therapy such as Actonel, with proven fracture
prevention as early as six months is good news for Ontario osteoporosis
patients," says Dr. Rick Adachi, Professor in the Department of Medicine at
McMaster University and rheumatologist at St. Joseph's Healthcare, Hamilton.
In clinical trials, Actonel has been found to reduce the risk of
vertebral(3),(4) and nonvertebral fractures(3), including those at the hip.(5)
In analyses of the clinical trial data, fracture protection with Actonel was
seen as early as six months(6),(7) and the findings of the recently published
RisedronatE and ALendronate (REAL) cohort study,(8) a large retrospective
study that measured fracture incidence in over 33,000 postmenopausal women
receiving one of the two most popular osteoporosis drugs, were consistent with
"This General Benefit listing is great news for physicians and patients.
It is consistent with the Ontario Ministry of Health's Osteoporosis Strategy
and provides better access to effective first line therapies recommended by
evidence-based guidelines" says Dr. Famida Jiwa, Acting President & CEO of
Osteoporosis Canada. "Improving access to effective therapies allows
physicians to prescribe therapy that meets the unique needs of patients
without being restricted by drug plan status. This is an important step in
reducing the burden of osteoporosis, both on patients and on the healthcare
The Osteoporosis Action Plan: An Osteoporosis Strategy for Ontario (a
report of the Osteoporosis Action Plan committee submitted to the Ontario
Ministry of Health and Long-Term Care), states that if more people with
osteoporosis had better access to effective therapies, Ontario would be able
to reduce the number of fractures and increase the quality of life for
thousands.(9) The Transparent Drug System for Patients Act (Bill 102) calls
for the elimination of the Ontario Drug Benefit (ODB) plan's Limited Use
listings, which provides only restricted access to therapies like Actonel.
Reforming the drug system is part of the government's effort to improve access
to therapies needed by Ontario patients to live healthier, longer lives.
"All patients should have access to the medicine their doctor thinks best
suits their individual needs," says Roza Taca, osteoporosis patient. "When I
was diagnosed with osteoporosis five years ago, my doctor essentially had only
one choice of treatment that was covered by the government plan. This new
listing means doctors have more choices, and that means patients get better
Osteoporosis is a skeletal disorder characterized by compromised bone
strength predisposing a person to an increased risk of fracture. Bone strength
reflects the integration of two main features; bone density and bone
quality.(10) Osteoporosis Canada reports approximately 1.4 million Canadians
suffer from osteoporosis. It affects one in four women over the age of 50.(11)
Osteoporosis has important public health and clinical consequences because it
leads to fractures that commonly occur at the spine, wrist or hip. Fractures
can result in increased pain, disability, and mortality.
A 50-year old woman has a 40 per cent chance of developing hip, vertebra
or wrist fractures during her lifetime.(12) The lifetime risk of hip fracture
is greater (one in six) than the one in nine lifetime risk of developing
breast cancer.(13) Patients are at highest risk for subsequent fracture in the
first few months following a vertebral fracture.(14) One in four women who
have a new vertebral fracture will fracture again within one year.(15)
ACTONEL (risedronate sodium) is indicated for the treatment and
prevention of osteoporosis in post-menopausal women (PMO) for the treatment of
osteoporosis in men to improve bone mineral density, for Paget's disease, and
for the treatment and prevention of glucocorticoid-induced osteoporosis (GIO)
in men and women. Musculoskeletal pain, rarely severe, has been reported as a
common adverse event in patients who received ACTONEL for all indications. In
PMO and GIO studies with ACTONEL, the most commonly reported adverse reactions
were abdominal pain, dyspepsia and nausea. In patients with Paget's disease,
diarrhea and headache were also commonly reported.(16)
Please refer to Product Monographs for full dosing instructions,
contraindications and warnings and precautions.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by P&G Pharmaceuticals and
Aventis, part of the sanofi-aventis Group, in May 1997 to promote bone health
and disease awareness through numerous activities to support physicians and
patients around the globe.
About P&G (NYSE: PG)
Three billion times a day, P&G brands touch the lives of people around
the world. The company has one of the strongest portfolios of trusted,
quality, leadership brands, including Pampers(R), Tide(R), Always(R),
Pantene(R), Mach3(R). Bounty(R), Pringles(R), Swiffer(R), Folgers(R),
Charmin(R), Downy(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R),
Olay(R), Clairol Nice 'n Easy(R), Herbal Essences(R), Head & Shoulders(R),
Gillette(R), and Braun. The P&G community consists of almost 140,000 employees
working in over 80 countries worldwide. P&G is the leading consumer products
company in Canada with over $2.7 billion in annual sales. Please visit
www.pgcanada.ca for the latest news and in-depth information about P&G and its
brands. P&G Pharmaceuticals is a division of P&G Health Care with products
such as Actonel(R), Didrocal(R), Asacol(R), MacroBID(R), and Dantrium(R).
Sanofi-aventis is the world's third-largest pharmaceutical company,
ranking number one in Europe. Backed by a world-class R&D organization,
sanofi-aventis is developing leading positions in seven major therapeutic
areas: cardiovascular, thrombosis, oncology, metabolic diseases, central
nervous system, internal medicine, and vaccines. The sanofi-aventis Group is
listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). In Canada,
sanofi-aventis Canada Inc. employs over 1,140 people and has its headquarters
in Laval, Quebec.
(1) Canadian Medical Association Journal. 2002 clinical practice
guidelines for the diagnosis and management of osteoporosis in Canada.
CMAJ 2002;167(10 suppl):S1-S34. Published at www.cmaj.ca on Nov. 12,
2002. Revised on Aug. 26, 2004.
(2) Osteoporosis Action Plan: An Osteoporosis Strategy for Ontario,
February 2003. Stats for 2003 to 2007, p.2
(3) Harris ST, Watts NB, Genant HK et al. Effects of risedronate
treatment on vertebral and nonvertebral fractures in women with
postmenopausal osteoporosis. JAMA 1999;282(14):1344-52.
(4) Reginster J-Y et al. Randomized trial of the effects risedronate on
vertebral fractures in women with established postmenopausal
osteoporosis. Osteop Int 2000;11:83-91.
(5) McClung McClung, M.R., Geusens, P., Miller, P.D., Zippel, H., Bensen,
W.G., Roux, C., et al. Effect of risedronate on the risk of hip fracture
in elderly women. N Engl J Med. 2001;344:333-40.
(6) Harrington JT, Ste-Marie LG, Brandi ML, et al. Risedronate rapidly
reduces the risk for nonvertebral fractures in women with postmenopausal
osteoporosis. Calcif Tissue Int 2004;74:129-135.
(7) Roux C, Seeman E, Eastell R, Adachi J, Jackson RD, Felsenberg D,
Songcharoen S, Rizzoli R, Di Munno O, Horlait S, Valent D, Watts NB.
Efficacy of risedronate on clinical vertebral fractures within six
months. Curr Med Res Opinion 2004; 20(4): 433-439.
(8) Silverman SL, Watts NB, Delmas PD, Lange JL, Lindsay R. Effectiveness
of bisphosphonates on nonvertebral and hip fractures in the first year of
therapy: the risedronate and alendronate (REAL) cohort study. Osteoporos
Int 2007; 18(1): 25-34.
(9) Osteoporosis Action Plan: An Osteoporosis Strategy for Ontario,
February 2003, p.3
(10) Osteoporosis prevention, diagnosis and therapy. NIH consensus
(11) Hanley DA, Josse RG. Prevention and management of osteoporosis:
consensus statements from the Scientific Advisory Board of the
Osteoporosis Society of Canada: 1. Introduction. CMAJ 1996;155:921-3.
(12) Melton LJ III, Chrischilles EA, Cooper C, Lane AW, Riggs BL.
Perspective: how many women have osteoporosis? J Bone Miner Res
(13 )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.
(14) Johnell O, Oden A, Caulin F, Kanis JA. Acute and long-term increase
in fracture risk after hospitalization for vertebral fracture. Osteoporos
(15) Lindsay R, Burge RT, Strauss DM. One year outcomes and costs
following a vertebral fracture. Osteoporos Int. 2005; 16:78-85.
(16) Procter & Gamble Pharmaceuticals Canada Inc. ACTONEL Product
Monograph, Toronto, December 6th, 2006.
For further information:
For further information: Julie Holroyde, Hill and Knowlton Canada, Tel:
(416) 413-4625, Email: firstname.lastname@example.org; For medical
inquiries please call 1-800-565-0814