RESEARCH - Alendronate may not be cost-effective in women with osteopenia

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Alendronate may not be cost-effective in women with osteopenia

Rheumawire

May 2, 2005

Gandey

Minneapolis, MN - New research shows that alendronate is not cost-effective

in treating postmenopausal women with low bone mass. The findings suggest

that drug therapy may not be advisable for women with femoral-neck T-scores

better than -2.5 and no history of clinical fractures or other

bone-mineral-density-independent risk factors for fractures [1]. " These

results are probably generalizable to risedronate and raloxifene, " comment

the investigators, led by Dr Schousboe (Park Nicollet Clinic,

Minneapolis, MN). But they argue they likely do not apply to estrogen

replacement therapywhich is often less expensive than alendronate.

Schousboe and colleagues point out that current treatment guidelines

recommend drug therapy to prevent fractures for some postmenopausal women

who have low bone mass or osteopenia but who do not have osteoporosis or a

history of fractures. In the present study, published in the May 3, 2005

issue of the ls of Internal Medicine, the research team sought to

estimate the societal costs and health benefits of this recommendation. They

chose to look at alendronate specifically because it is among the most

commonly prescribed antiresorptive agents.

In an accompanying editorial, Dr McClung (Oregon Osteoporosis

Center, Portland) says that while Schousboe and colleagues clearly

demonstrate that alendronate therapy in postmenopausal women selected solely

on the basis of low bone density is not cost-effective, some women are at

clinically significant fracture risk where therapy may be justified [2]. He

cites the elderly, those beginning glucocorticoid therapy, or those

discontinuing estrogen therapy as examples of women who are expected to

experience rapid short-term bone loss who may be candidates for therapy even

if they do not have osteoporosis.

McClung argues that the diagnostic category of osteopenia does not serve the

clinical community well. " It is time to abandon the diagnosis of osteopenia

based on bone-mineral-density values and give the term back to radiologists

to describe decreased bone mineralization on radiographs. " He adds that

while bone-density measurement remains an important tool in assessing

skeletal health, the determinants of fracture are much more complex and

interesting than simply the T-score. " The objective of using osteoporosis

drugs is to prevent fractures. This can be accomplished only by treating

patients who are likely to have a fracture, not by simply treating

T-scores. "

Cost-effectiveness may be even less favorable if drug compliance declines

In the Schousboe study, the investigators collected data from

population-based studies of age-specific fracture rates and costs as well as

estimates of disutility after fractures and from the Fracture Intervention

Trial of alendronate vs placebo to prevent fractures. They looked at

postmenopausal women aged 55 to 75 years of age with femoral-neck T-scores

between -1.5 and -2.4. They used a Markov cost-utility model that contained

8 health states and compared 5 years of treatment with alendronate with no

drug therapy. The health states they used were no fracture, post-distal

forearm fracture, post-clinical vertebral fracture, post-radiographic

vertebral fracture, post-hip fracture, post-other fractures, post-hip and

vertebral fracture, and death.

The group found that for women with no additional fracture risk factors, the

cost per quality-adjusted life-year gained ranged from $70 000 to $332 000,

depending on age and femoral-neck bone density. " Alendronate is not

cost-effective in osteopenic postmenopausal women who have not had any

clinical fractures, unless substantial risk from additional

bone-mineral-density-independent fracture risk factors is present, " the

researchers write. " Moreover, the cost-effectiveness may be less favorable

if drug adherence decreases substantially over time, which 1 study of

once-weekly alendronate therapy has documented [3]. "

Conclusions could be reconsidered if drug prices lowered, for example

The authors say these conclusions should be reassessed if the cost of drugs

is significantly lowered, if drug therapy is shown to reduce the risk of

nonvertebral fractures, or if fracture-reduction benefit persists longer

than 10 years after a 5-year treatment course.

Schousboe and colleagues point out that their results are generalizable only

to the postmenopausal white female population of the US. In his accompanying

editorial, McClung notes that despite the study's limitations, the results

are consistent with the cost-effectiveness analysis reported by the National

Osteoporosis Foundation. He adds, " The analyses appropriately included the

costs of all fragility fractures, not just hip fractures, and addressed the

sensitivity of the cost-effectiveness threshold to treatment adherence and

drug costs. "

McClung explains that while cost-effectiveness is an important consideration

for health payers and policy makers, it is a concept that rarely resonates

with patients, who usually make decisions about treatment on the basis of

perception of benefit. " Many are willing to pay for treatments that will

protect them from medical consequences, if the risk associated with

treatment is minimal, " he writes. " What is often missing from the discussion

with patients about osteoporosis treatment is an appreciation of their

actual risk for fracture. "

McClung points out that patients respond to discussions of risk reduction

more readily than they do to issues of cost. He notes that fracture risk

depends not only on the bone-density value but on other independent risk

factors such as age, previous fracture, and the tendency to fall.

Sources

a. Schousboe J, Nyman JA, Kane RL, et al. Cost-effectiveness

of alendronate therapy for osteopenic postmenopausal women. Ann Intern Med

2005; 142:734-741.

b. McClung MR. Osteopenia: To treat or not to treat? Ann

Intern Med 2005; 142:796-797.

c. Ettinger M, Gallagher R, Amonkar M, et al. Medication

persistence is improved with less frequent dosing of bisphosphonates, but

remains inadequate. Arthritis Rheum 2004; 50:S513.

Not an MD

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Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org