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The Cost Effectiveness of Levalbuterol Versus Racemic Albuterol
Campion Quinn, MD, FACP, MHA
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Shellie K. Schoening, MBA, PharmD, RPh

The Cost Effectiveness of Levalbuterol Versus Racemic Albuterol

Campion Quinn, MD, FACP, MHA

The lower mean number of treatments with levalbuterol versus racemic albuterol (19.0 vs 30.8; P <.001) was partly due to protocol-mandated differences in the dosing schedules. (A published letter challenged the study on this basis and also for using average wholesale prices, which may be different from what hospitals actually pay. The study investigators responded that the need for more frequent dosing with racemic albuterol than with levalbuterol to achieve an adequate clinical response was the very point of the study, and that average wholesale prices are standard in cost analyses.15) However, the protocol did not account for the fact that the mean duration of β2-agonist treatment was 29% shorter with levalbuterol than with racemic albuterol (5.5 vs 3.9 days), or that patients receiving levalbuterol versus racemic albuterol required fewer adjunctive treatments with ipratropium (mean 9.4 vs 23.2; P <.001) and had a lower 30-day rehospitalization rate (mean 5.7% vs 16.4%; P = .01). This difference was noted mainly in the subset of patients with COPD, and other factors may have affected the risk of readmission. Overall costs for delivering nebulized medications were significantly lower with levalbuterol than with racemic albuterol (for all patients $61 vs $112, P <.001; among asthma patients, $44 vs $99, P <.005). Total hospital costs were numerically lower (for all patients $2756 vs $3225, P = .11; among asthma patients, $1856 vs $2503). Regression analysis controlling for baseline FEV1, diagnosis, and ipratropium use showed that levalbuterol was associated with a 0.9-day shorter stay (P = .015), a 67% lower rate of rehospitalization (P = .056), and total cost savings of $556 per patient (P = .013).

The Economics of Asthma Care

Assessing the costs of asthma and its treatment, and the cost effectiveness of specific therapies, is a daunting task. A review by Sculpher and Price16 outlines several of the difficulties, starting with the fact that looking at total direct and indirect costs does not address the disproportionate share of costs incurred by patients with severe asthma or the unnecessary costs attributable to suboptimal management. Moreover, published reports employ such a variety of methods, outcome measures, and definitions that their findings are difficult to compile and compare. Finally, most cost-effectiveness data emerge from short-term studies of clinical efficacy, safety, and tolerability, and such findings are not necessarily predictive of long-term outcomes.

In an attempt to sort out the numerous variables that must be considered in all clinical-economic evaluations of drugs, Eisenberg and colleagues17 proposed a 3-dimensional model: (1) type of analysis (cost identification, cost effectiveness, cost benefit); (2) point of view (patient, clinician, insurer, society); and (3) types of outcome measures (direct and indirect costs, morbidity and mortality, intangible or unquantifiable results). For example, quantifiable clinical outcomes are usually of most interest to physicians, less readily quantifiable outcomes such as quality of life reflect the patient's point of view, while cost-effectiveness analyses aimed at obtaining the best clinical outcome at the lowest cost are of greatest concern to managed care, insurers, and government.

Applying this model to asthma, the economic comparison of levalbuterol versus racemic albuterol involves cost-effectiveness analysis from the point of view of the clinician and the insurer, with the focus on direct medical costs. Yet further definition is necessary; for example, pharmacy services may focus only on drug acquisition costs, but the overall cost to the medical facility and insurer may be more strongly affected by such clinical outcomes as needed for hospitalization. In the previously cited pediatric study,13 the number needed to treat (with levalbuterol instead of racemic albuterol) to avert a hospitalization was only 10.6 patients; the incremental cost of levalbuterol for such a small number of patients is minuscule compared with the cost of a single hospitalization.

Most studies that reflect the interests of the clinical audience have focused on objective measures of efficacy, such as FEV1. However, efficacy in the ideal setting of a well-designed clinical trial is not the same as effectiveness in the real-world setting of actual clinical practice. For example, how should a worsening FEV1 be interpreted in clinical practice? Assuming adequate adherence to treatment, it may be difficult to determine whether the patient's condition is becoming more severe or the drug is losing its effectiveness. With the latter possibility, loss of effectiveness may be an intrinsic problem with the drug or the result of something else happening in that patient, such as a drug interaction that induces increased metabolism of the asthma medication.

Just as it is difficult to gauge the overall therapeutic worth of an asthma drug from changes in FEV1 in a short-term controlled clinical trial, it is difficult to assess a drug's cost effectiveness by looking only at direct medical expenditures recorded in that same trial. A working group from the National Heart, Lung, and Blood Institute reviewed the role of health economics in planning optimal asthma management strategies, and offered a set of recommendations for future research, including adoption of standardized definitions and outcome measures, a focus on long-term effectiveness rather than short-term efficacy, and controls for such variables as patients' age and socioeconomic status, and the duration and severity of asthma.18

Conclusion

From the evidence currently available, it appears that levalbuterol represents a clinically important advance over racemic albuterol. The advantage in clinical efficacy (ie, improved respiratory performance) is matched by an advantage in cost effectiveness, which leads to a reduction in the need for hospitalization. Long-term follow-up in the clinical practice setting may determine the degree to which these short-term advantages are maintained.

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2. Data Fact Sheet: Asthma Statistics. National Heart, Lung, and Blood Institute, National Institutes of Health; January 1999.

3. Lozano P, Sullivan SD, Smith DH, Weiss KB. The economic burden of asthma in US children: estimates from the National Medical Expenditure Survey. J Allergy Clin Immunol. 1999;104:957-963.

4. Morbidity & Mortality: 2002 Chart Book on Cardiovascular, Lung, and Blood Diseases. National Heart, Lung, and Blood Institute, National Institutes of Health, May 2002.

5. Surveillance for Asthma–United States, 1980-1999. Morbidity and Mortality Weekly Report Surveillance Summaries, Centers for Disease Control and Prevention, March 29, 2002.

6. Weiss KB, Sullivan SD. The health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol. 2001;107:3-8.

7. Hoffman BB. Catecholamines, sympathomimetic drugs, and adrenergic receptor antagonists. In: Hardman JG, Limbird LE, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001.

8. Nelson HS, Bensch G, Pleskow WW, et al. Improved bronchodilation with levalbuterol compared to racemic albuterol in patients with asthma. J Allergy Clin Immunol. 1998;102:943-952.

9. Milgrom H, Skoner DP, Bensch G, Kim KT, Claus R, Baumgartner RA, Levalbuterol Pediatric Study Group. Low-dose levalbuterol in children with asthma: safety and efficacy in comparison with placebo and racemic albuterol. J Allergy Clin Immunol. 2001;108:938-945.

10. Nowak RM, Emerman CL, Schaefer K, DiSantostefano RL, Vaickus L, Roach JM. Levalbuterol compared with racemic albuterol in the treatment of acute asthma: results of a pilot study. Am J Emerg Med. 2004;22:29-36.

11. Gawchik SM, Saccar CL, Noonan M, Reasner DS, DeGraw SS. The safety and efficacy of nebulized levalbuterol compared with racemic albuterol in the treatment of asthma in pediatric patients. J Allergy Clin Immunol. 1999;103:615-621.

12. Schreck D, Brotea C, Shah S. Comparison of racemic albuterol and levalbuterol in the treatment of acute asthma. Ann Emerg Med. 2001;38:S10. Abstract.

13. Carl JC, Myers TR, Kirshner HL, Kercsmar CM. Comparison of racemic albuterol and levalbuterol in treatment of acute asthma. J Peds. 2003;143:731-736.

14. Truitt T, Witko J, Halpern M. Levalbuterol compared to racemic albuterol: efficacy and outcomes in patients hospitalized with COPD or asthma. Chest.2003;123:128-135.

15. Hendeles L, Hartzema A. Levalbuterol is not more cost-effective than albuterol for COPD (letter). Chest. 2003;124:1176-1178.

16. Sculpher MJ, Price M. Measuring costs and consequences in economic evaluation in asthma. Resp Med.2003;97:508-520.

17. Eisenberg JM, Schulman KA, Glick H, Koffer H. Pharmacoeconomics: economic evaluation of pharmaceuticals. In: Strom BL, ed. Pharmacoepidemiology. 2nd ed. New York, NY: Wiley; 1994.

18. Sullivan S, Elixhauser A, Buist AS, Luce BR, Eisenberg J, Weiss KB. National Asthma Education and Prevention Program working group report on the cost effectiveness of asthma care. Am J Respir Crit Care Med. 1996;154(3 pt 2):S84-S95.

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