Person:

Garber, Alan

Background & Aims The cost effectiveness of alternative approaches to the diagnosis of small-bowel Crohn's disease is unknown. This study evaluates whether computed tomographic enterography (CTE) is a cost-effective alternative to small-bowel follow-through (SBFT) and whether capsule endoscopy is a cost-effective third test in patients in whom a high suspicion of disease remains after 2 previous negative tests.

Methods A decision-analytic model was developed to compare the lifetime costs and benefits of each diagnostic strategy. Patients were considered with low (20%) and high (75%) pretest probability of small-bowel Crohn's disease. Effectiveness was measured in quality-adjusted life-years (QALYs) gained. Parameter assumptions were tested with sensitivity analyses.

Results With a moderate to high pretest probability of small-bowel Crohn's disease, and a higher likelihood of isolated jejunal disease, follow-up evaluation with CTE has an incremental cost-effectiveness ratio of less than $54,000/QALY-gained compared with SBFT. The addition of capsule endoscopy after ileocolonoscopy and negative CTE or SBFT costs greater than $500,000 per QALY-gained in all scenarios. Results were not sensitive to costs of tests or complications but were sensitive to test accuracies.

Conclusions The cost effectiveness of strategies depends critically on the pretest probability of Crohn's disease and if the terminal ileum is examined at ileocolonoscopy. CTE is a cost-effective alternative to SBFT in patients with moderate to high suspicion of small-bowel Crohn's disease. The addition of capsule endoscopy as a third test is not a cost-effective third test, even in patients with high pretest probability of disease.

Background: Warfarin reduces the risk for ischemic stroke in patients with atrial fibrillation (AF) but increases the risk for hemorrhage. Dabigatran is a fixed-dose, oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin.

Objective: To estimate the quality-adjusted survival, costs, and cost-effectiveness of dabigatran compared with adjusted-dose warfarin for preventing ischemic stroke in patients 65 years or older with nonvalvular AF.

Design: Markov decision model.

Data Sources: The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial and other published studies of anticoagulation. The cost of dabigatran was estimated on the basis of pricing in the United Kingdom.

Target Population: Patients aged 65 years or older with nonvalvular AF and risk factors for stroke ((CHADS_2) score ≥1 or equivalent) and no contraindications to anticoagulation.

Time Horizon: Lifetime.

Perspective: Societal.

Intervention: Warfarin anticoagulation (target international normalized ratio, 2.0 to 3.0); dabigatran, 110 mg twice daily (low dose); and dabigatran, 150 mg twice daily (high dose).

Outcome Measures: Quality-adjusted life-years (QALYs), costs (in 2008 U.S. dollars), and incremental cost-effectiveness ratios.

Results of Base-Case Analysis: The quality-adjusted life expectancy was 10.28 QALYs with warfarin, 10.70 QALYs with low-dose dabigatran, and 10.84 QALYs with high-dose dabigatran. Total costs were $143 193 for warfarin, $164 576 for low-dose dabigatran, and $168 398 for high-dose dabigatran. The incremental cost-effectiveness ratios compared with warfarin were $51 229 per QALY for low-dose dabigatran and $45 372 per QALY for high-dose dabigatran.

Results of Sensitivity Analysis: The model was sensitive to the cost of dabigatran but was relatively insensitive to other model inputs. The incremental cost-effectiveness ratio increased to $50 000 per QALY at a cost of $13.70 per day for high-dose dabigatran but remained less than $85 000 per QALY over the full range of model inputs evaluated. The cost-effectiveness of high-dose dabigatran improved with increasing risk for stroke and intracranial hemorrhage.

Limitation: Event rates were largely derived from a single randomized clinical trial and extrapolated to a 35-year time frame from clinical trials with approximately 2-year follow-up.

Conclusion: In patients aged 65 years or older with nonvalvular AF at increased risk for stroke ((CHADS_2) score ≥1 or equivalent), dabigatran may be a cost-effective alternative to warfarin depending on pricing in the United States.

Primary Funding Source: American Heart Association and Veterans Affairs Health Services Research & Development Service.

Background: Sodium consumption raises blood pressure, increasing the risk for heart attack and stroke. Several countries, including the United States, are considering strategies to decrease population sodium intake.

Objective: To assess the cost-effectiveness of 2 population strategies to reduce sodium intake: government collaboration with food manufacturers to voluntarily cut sodium in processed foods, modeled on the United Kingdom experience, and a sodium tax.

Design: A Markov model was constructed with 4 health states: well, acute myocardial infarction (MI), acute stroke, and history of MI or stroke.

Data Sources: Medical Panel Expenditure Survey (2006), Framingham Heart Study (1980 to 2003), Dietary Approaches to Stop Hypertension trial, and other published data.

Target Population: U.S. adults aged 40 to 85 years.

Time Horizon: Lifetime.

Perspective: Societal.

Outcome Measures: Incremental costs (2008 U.S. dollars), quality-adjusted life-years (QALYs), and MIs and strokes averted.

Results of Base-Case Analysis: Collaboration with industry that decreases mean population sodium intake by 9.5% averts 513Â 885 strokes and 480Â 358 MIs over the lifetime of adults aged 40 to 85 years who are alive today compared with the status quo, increasing QALYs by 2.1 million and saving $32.1 billion in medical costs. A tax on sodium that decreases population sodium intake by 6% increases QALYs by 1.3 million and saves $22.4 billion over the same period.

Results of Sensitivity Analysis: Results are sensitive to the assumption that consumers have no disutility with modest reductions in sodium intake.

Limitation: Efforts to reduce population sodium intake could result in other dietary changes that are difficult to predict.

Conclusion: Strategies to reduce sodium intake on a population level in the United States are likely to substantially reduce stroke and MI incidence, which would save billions of dollars in medical expenses.

Primary Funding Source: Department of Veterans Affairs, Stanford University, and National Science Foundation.

Pandemic (H1N1) 2009 has caused 182 166 confirmed infections and 1799 deaths in more than 150 countries to date (1). Both the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have declared public health emergencies in response to global circulation of this virus, and the WHO has raised the influenza pandemic alert level from 3 to 6 (2).

As a result of the strain's novelty, most people lack innate immunity to pandemic (H1N1) (3); currently available vaccines do not protect against the virus; and the time needed to manufacture, test, and distribute a matched vaccine is several months (4–5).

In the absence of a matched vaccine, infections and deaths from pandemic (H1N1) will continue globally until a sufficient proportion of the population has developed immunity through infection and recovery, inducing “herd immunity” (population immunity that decreases the effective reproductive rate of the virus below 1, ending the pandemic by epidemiologic definitions [6]). Public health officials were planning to begin vaccination campaigns in mid-October 2009 (7); however, the National Biodefense Science Board, a group of advisors to the U.S. Department of Health and Human Services, recommended moving large-scale vaccine administration to mid-September 2009 (8). Decisions on vaccination timing and distribution are complicated: It is unclear how many individuals would require vaccination to substantially reduce transmission once vaccine is available (some scientists note that the first epidemic wave may in fact already be complete by this time [9]), and it could be expensive to manufacture and administer the vaccine and to treat its side effects.

To help guide policymakers in advising vaccine manufacturers, we developed a model of progression of the 2009 (H1N1) pandemic to determine how vaccination in October or November 2009 would affect the course of the pandemic. We compared the effectiveness and cost-effectiveness of no vaccination, vaccination in mid-October, and vaccination in mid-November.

Background Teriparatide is a promising new agent for the treatment of osteoporosis.

Methods The objective of this study was to evaluate the cost-effectiveness of teriparatide-based strategies compared with alendronate sodium for the first-line treatment of high-risk osteoporotic women. We developed a microsimulation with a societal perspective. Key data sources include the Study of Osteoporotic Fractures, the Fracture Intervention Trial, and the Fracture Prevention Trial. We evaluated postmenopausal white women with low bone density and prevalent vertebral fracture. The interventions were usual care (UC) (calcium or vitamin D supplementation) compared with 3 strategies: 5 years of alendronate therapy, 2 years of teriparatide therapy, and 2 years of teriparatide therapy followed by 5 years of alendronate therapy (sequential teriparatide/alendronate). The main outcome measure was cost per quality-adjusted life-year (QALY).

Results For the base-case analysis, the cost of alendronate treatment was $11 600 per QALY compared with UC. The cost of sequential teriparatide/alendronate therapy was $156 500 per QALY compared with alendronate. Teriparatide treatment alone was more expensive and produced a smaller increase in QALYs than alendronate. For sensitivity analysis, teriparatide alone was less cost-effective than alendronate even if its efficacy lasted 15 years after treatment cessation. Sequential teriparatide/alendronate therapy was less cost-effective than alendronate even if fractures were eliminated during the alendronate phase, although its cost-effectiveness was less than $50 000 per QALY if the price of teriparatide decreased 60%, if used in elderly women with T scores of −4.0 or less, or if 6 months of teriparatide therapy had comparable efficacy to 2 years of treatment.

Conclusions Alendronate compares favorably to interventions accepted as cost-effective. Therapy with teriparatide alone is more expensive and produces a smaller increase in QALYs than therapy with alendronate. Sequential teriparatide/alendronate therapy appear expensive but could become more cost-effective with reductions in teriparatide price, with restriction to use in exceptionally high-risk women, or if short courses of treatment have comparable efficacy to that observed in clinical trials.