Cost-benefit analysis of first-generation antihistamines in the treatment of allergic rhinitis.

BACKGROUND: The majority of individuals with allergic rhinitis in the US take first-generation antihistamines (FGAs). Although FGAs have been proven effective in alleviating allergic rhinitis symptoms, they have been associated with an increased risk of motor vehicle, aviation and occupational injuries and deaths, reduced productivity and impaired learning. OBJECTIVE: The objective of this analysis was to quantify the total costs and benefits of FGA use in the US from the societal perspective. METHODS: We used a decision-analytic model to quantify the annual societal costs and benefits of treatment with FGAs compared with the hypothetical alternative of no treatment for the population of individuals with allergic rhinitis and taking FGAs in the US in 2001. The benefit associated with FGA use was estimated using the willingness-to-pay framework and projected to the US population using published estimates of the prevalence of allergic rhinitis. The costs of FGA-associated sedation included lost productivity and the direct and indirect cost of unintentional injuries (including motor vehicle, occupational, public and home injuries and fatalities). The incidence of injuries and fatalities associated with FGA use was estimated using the risk of injury attributable to the sedentary effects of FGAs in the allergic rhinitis population. To evaluate uncertainty in the model assumptions, a probabilistic sensitivity analysis was conducted using Bayesian second-order Monte Carlo simulation. Costs and benefits are expressed in 2001 US dollars, using a 3% discount rate. RESULTS: Based on current utilisation, the total societal benefit (95% credible interval) associated with the use of FGAs for the treatment of allergic rhinitis was US 7.7 billion dollars (US 1.3 billion dollars to US 21 billion dollars). The societal cost of purchasing FGAs was only US 697 million dollars. However, the societal cost of FGA-associated sedation was US 11.3 billion dollars (US 2.4 billion dollars to US 50.8 billion dollars). The annual societal net benefit of FGA use for the treatment of allergic rhinitis in the US was -US4.2 billion dollars (-US 36 billion dollars to +US 0.296 billion dollars). The net benefit was negative in 97% of the 10,000 Monte Carlo simulations. CONCLUSIONS: The societal benefits of FGA use in alleviating the symptoms of allergic rhinitis are significant. However, based on the assumptions, probability distributions and parameter estimate ranges used in the current model, it is very likely that the costs associated with sedation exceed the benefits of FGA use in the US. The cost of FGA-associated sedation is comparable to estimates of the cost of all medical care expenditures on respiratory conditions in the US (US 12.1 billion dollars to US 31.3 billion dollars) [1996 values] and provides compelling evidence of the economic burden of sedation associated with FGA use.

Transitioning the second-generation antihistamines to over-the-counter status: a cost-effectiveness analysis.

BACKGROUND: A U.S. Food and Drug Administration advisory committee deemed the second-generation antihistamines (SGA) safe for over-the-counter use against the preliminary opposition of the manufacturers. As a result, loratadine is now available over-the-counter. First-generation antihistamines (FGA) are associated with an increased risk of unintentional injuries, fatalities, and reduced productivity. Access to SGA over-the-counter could result in decreased use of FGA, thereby reducing deleterious outcomes. The societal impact of transitioning this class of medications from prescription to over-the-counter status has important policy implications. OBJECTIVE: To examine the cost-effectiveness of transitioning SGA to over-the-counter status from a societal perspective. RESEARCH DESIGN: A simulation model of the decision to transition SGA to over-the-counter status was compared with retaining prescription-only status for a hypothetical cohort of individuals with allergic rhinitis in the United States. Estimates of costs and effectiveness were obtained from the medical literature and national surveys. Sensitivity analysis was performed using a second-order Monte Carlo simulation. MAIN OUTCOME MEASURES: Discounted, quality-adjusted life-years saved as a result of amelioration of allergic rhinitis symptoms and avoidance of motor vehicle, occupational, public and home injuries and fatalities; discounted direct and indirect costs. RESULTS: Availability of SGA over-the-counter was associated with annual savings of 4 billion dollars (2.4-5.3 billion dollars) or 100 dollars (64-137 dollars) per allergic rhinitis sufferer and 135,061 time-discounted quality-adjusted life years (84,913-191,802). The sensitivity analysis provides evidence in support of these results. CONCLUSION: Making SGA available over-the-counter is both cost-saving and more effective for society, largely as a result of reduced adverse outcomes associated with FGA-induced sedation. Further study is needed to determine the differential impact on specific vulnerable populations.

Current approaches to the prevention and treatment of postmenopausal osteoporosis.

Current approaches to the prevention, detection, treatment, and monitoring of postmenopausal osteoporosis are discussed. In the United States, 44 million men and women ages 50 years or older have low bone mass or osteoporosis. The most devastating consequence of this disease is fractures. The assessment of osteoporosis risk includes determining risk factors, conducting laboratory and physical examinations, and measuring bone density and bone-turnover markers. Once risk has been established, nonpharmacologic strategies, such as exercise, appropriate dietary habits, and discontinuing tobacco and alcohol use, are helpful. Fall prevention and adequate intake of calcium and vitamin D are critical. When pharmacologic therapy is warranted, bisphosphonates have shown the greatest benefit in preventing bone loss and lowering fracture rates. Selective estrogen-receptor modulators and calcitonin are also options for prevention or treatment of osteoporosis. Estrogen should not be used for the sole purpose of osteoporosis prevention; however, short-term use is acceptable for women with vasomotor symptoms or in whom the benefits outweigh the risks. Parathyroid hormone may offer another treatment alternative. A variety of pharmacologic options are available for patients with osteoporosis in whom lifestyle modifications have proven insufficient. Bisphosphonates are the mainstay of drug therapy.

Lack of diagnosis and treatment of osteoporosis in men and women after hip fracture.

STUDY OBJECTIVE: To determine whether men and women admitted to a university teaching hospital for a low-trauma hip fracture were diagnosed, evaluated, or treated for osteoporosis during admission or for up to 1 year after admission. DESIGN: Retrospective chart review. SETTING: University of Colorado Hospital, Denver, Colorado. PATIENTS: One hundred eighteen patients admitted with a low-trauma hip fracture from January 1993-December 1998. MEASUREMENTS AND MAIN RESULTS: Demographics, medical and social history, prescribed drugs, clinical outcomes, and information regarding the diagnosis, evaluation, and treatment of osteoporosis were abstracted from inpatient medical records for the index hip fracture. Similar data for the first year after the index hip fracture were abstracted from outpatient medical records of patients who had follow-up visits within the hospital system. Mean +/- SD age at the time of fracture was 70 +/- 15 years; 43 patients were men and 75 were women. Eighteen percent of patients had experienced a previous hip fracture, 4% had a history of vertebral fracture, and 6% reported a previous wrist fracture. The diagnosis of osteoporosis was noted in the charts of 14% of the patients at discharge and 26% of patients at follow-up. Only 4% of patients during hospitalization and 9% during follow-up received any evaluative tests for osteoporosis, including bone densitometry. Subsequent fractures occurred in 12.5% of patients. Documented treatment of osteoporosis was uncommon, with approximately 75% of patients receiving no therapy for osteoporosis on discharge or during follow-up. Women were more likely than men to receive a diagnosis of osteoporosis, bone mineral density testing, and osteoporosis drug therapy. CONCLUSION: In patients with hip fractures, osteoporosis is commonly not diagnosed or treated appropriately