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On the Cost-effectiveness of the Use of Probiotics in Inflammatory Bowel Disease

Samnaliev, Mihail*; Lightdale, Jenifer R.

Journal of Pediatric Gastroenterology and Nutrition: November 2011 - Volume 53 - Issue 5 - p 473
doi: 10.1097/MPG.0b013e31822ada65
Invited Commentaries

*Clinical Research Program

Division of Gastroenterology and Nutrition, Children's Hospital Boston, Boston, MA.

Address correspondence and reprint requests to Jenifer R. Lightdale, MD, MPH, Division of Gastroenterology and Nutrition, Children's Hospital Boston, 300 Longwood Ave, Boston, MA 02115 (e-mail:

Received 19 June, 2011

Accepted 21 June, 2011

The authors report no conflicts of interest.

See “Cost-effectiveness Analysis of Adjunct VSL#3 Therapy Versus Standard Medical Therapy in Pediatric Ulcerative Colitis” by Park et al on page 489.

In this issue of JPGN, Park et al (1) estimate the cost-effectiveness of the probiotic VSL#3 when used as a supplement to standard treatment for pediatric ulcerative colitis (UC). Presently, probiotics are not covered by insurance and present a significant out-of-pocket expense to patients. Park et al find that among children with severe UC, the addition of VSL#3 to standard medical regimens is associated with a small gain in quality-adjusted life-years (QALYs), yet costs more than $50,000/QALY. In turn, the authors conclude that the use of VSL#3 as adjunct therapy for UC may be cost-ineffective.

Cost-effectiveness analysis (CEA) typically is conducted from a societal perspective and is generally considered useful in informing decision makers about the relative value of alternative treatments. CEA is used by governments in many countries to determine which health care interventions to fund from available budgets (2). It can also be used by health plan officials to optimize the value of plan coverage to include cost-effective interventions on a list of reimbursable treatments and exclude cost-ineffective ones. Finally, CEA results can be used by physicians to inform them whether and what treatments to prescribe to patients.

From a societal perspective, the findings of Park et al suggest that adjunct VSL#3 therapy does not provide sufficient additional benefits over the lifetimes of children with UC to justify its added costs. The implication of these findings is that health plans may continue not to reimburse VSL#3 expenses, and in turn, treatment with this probiotic may remain available only to patients who are able and willing to pay for it out of pocket. Their findings also make a strong economic case for advising physicians to prescribe standard treatment alone. The goal of maximizing public health can be better achieved by prescribing alternative therapies, including surgery, with greater benefits per additional dollar, instead of VSL#3. At the same time, their study may not change the prescribing patterns of many physicians who do not make clinical decisions based on treatment costs, and rely instead on research that has demonstrated the efficacy of VSL#3 probiotics (3). The latter approach must be reconciled with the fact that health care resources are scarce and cross-sector tradeoffs are inevitable.

Cost-effectiveness analysis is not without controversy (4,5) and its use is objectionable to some on ethical and methodological grounds. In addition, the conclusion from Park et al that VSL#3 is cost-ineffective may have been different if they had used higher thresholds of costs per QALY (ie, >$80,000), as is not uncommon in the literature. Nevertheless, their study expands our knowledge of the economics of using probiotics in inflammatory bowel disease and demonstrates the practical value of CEA as an evaluation tool for new health care interventions. Such analyses may prove increasingly useful as pressure grows to fund and provide only the most valuable treatments, cut costs, and reverse the unsustainable growth in health care spending in the United States.

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1. Park K, Perez F, Tsai R, et al. Cost-effectiveness analysis of adjunct VSL#3 therapy versus standard medical therapy in pediatric ulcerative colitis. J Pediatr Gastroenterol Nutr 2011;53:489–96.
2. Drummond MF, Schulper M, Torrance GW, et al. Methods for the Economic Evaluation of Health Care Programs. New York:Oxford University Press; 2005.
3. Tursi A, Brandimarte G, Papa A, et al. Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study. Am J Gastroenterol 2010; 105:2218–2227.
4. AcademyHealth. Research Insights: Incorporating Costs into Comparative Effectiveness Research. http:// /files/publications/ResearchInsightsCER.pdf. Accessed September 16, 2011.
5. Neumann P. What next for QALYs? JAMA 2011; 305:1806–1807.
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