Pgi2 the Budget Impact of Tegaserod on a Managed Care Organization Formulary

Ma, Bloom; Barghout, Victoria; Kahler, KH; Bentkover, Judith D.; Kurth, H.; Im, Gralnek; Spiegel, B.

doi:10.1016/s1098-3015(10)62991-9

Cited by 2 publications

(5 citation statements)

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“…Of the 17 analyses in which the new drug would not change the mortality or disease progression rates within the model time horizon, 12 used a simple cost-calculator model structure [30][31][32][33][34][35][36][37][38][39][40][41] and five used formal decision-analytic model structures [42][43][44][45][46]. The cost-calculator approach can be appropriate for chronic conditions when the mortality and/or disease progression rates remain constant, and this approach generally has the advantage of being simpler and more transparent for the user.…”

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

“…One decisionanalytic model did include both multiple incident cohorts and the prevalent population for the 3-year model time horizon [46]. The fifth decision-analytic model [43] Although these studies focused on chronic conditions, the time horizon assumed was 1 year in seven of the 12 cost-calculator models [31,32,34,37,38,40,41] and only 6 months in one of the cost-calculator models using data from a database analysis [30], implicitly making the assumption that the budget impact would be the same for subsequent periods. In the other four cost-calculator models [33,35,36,39] and the five decision-analytic models [42][43][44][45][46], time horizons varied from 2 to 7 years.…”

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

“…In these studies, the drug for which the budget impact was estimated took treatment share from all drugs (six studies) [33,35,36,42,45,46] or one drug (four studies) [31,38,40,43]. In one study, the drug was added to current therapy [39], and the treatment shares before and after introduction of a new drug were taken from a database analysis in two studies [30,32]. Two of the studies that took treatment shares from all drugs assumed equi-proportionate contributions of the current drugs to the treatment share for the new drug [36,42].…”

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

“…In the other two studies, changes in clinical outcomes would most likely occur beyond the model time horizon (for chronic hepatitis C [34] and glaucoma lipid therapy [37]). The other 14 studies, including the five decision-analytic models, did include changes in diseaserelated costs either in the base case or in scenario analysis [30,32,33,35,36,[38][39][40][41][42][43][44][45][46]. In one cost-calculator model for Lennox-Gastaut syndrome [35], the patients' disease was assumed to remain uncontrolled after discontinuation, with lower treatment costs but higher disease-related costs.…”

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

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A Methodological Review of US Budget-Impact Models for New Drugs

Mauskopf

Earnshaw

2016

PharmacoEconomics

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A budget-impact analysis is required by many jurisdictions when adding a new drug to the formulary. However, previous reviews have indicated that adherence to methodological guidelines is variable. In this methodological review, we assess the extent to which US budgetimpact analyses for new drugs use recommended practices. We describe recommended practice for seven key elements in the design of a budget-impact analysis. Targeted literature searches for US studies reporting estimates of the budget impact of a new drug were performed and we prepared a summary of how each study addressed the seven key elements. The primary finding from this review is that recommended practice is not followed in many budgetimpact analyses. For example, we found that growth in the treated population size and/or changes in disease-related costs expected during the model time horizon for more effective treatments was not included in several analyses for chronic conditions. In addition, all drug-related costs were not captured in the majority of the models. Finally, for most studies, one-way sensitivity and scenario analyses were very limited, and the ranges used in one-way sensitivity analyses were frequently arbitrary percentages rather than being data driven. The conclusions from our review are that changes in population size, disease severity mix, and/or disease-related costs should be properly accounted for to avoid over-or underestimating the budget impact. Since each budget holder might have different perspectives and different values for many of the input parameters, it is also critical for published budget-impact analyses to include extensive sensitivity and scenario analyses based on realistic input values. Key Points for Decision MakersPublished budget-impact analyses do not always estimate changes in the treated population size and related changes in the disease-related costs of drugs for chronic conditions that reduce mortality rates or slow disease progression, which may result in overor underestimates of the budget impact of a new drug.Treatment switching or discontinuation may not be appropriately included in many published budgetimpact analyses.Sensitivity and scenario analyses presented in published budget-impact analyses are typically too limited to allow a budget holder to assess the likely budget impact for their health plan.

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Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

Section: Constant Mortality or Disease Progression Ratesmentioning

confidence: 99%

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A Methodological Review of US Budget-Impact Models for New Drugs

Mauskopf

Earnshaw

2016

PharmacoEconomics

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“…27,28,55 While not a typical concern in the design of clinical trials, we mentioned drug prices in this context, as the initiation of tegaserod therapy increased overall outpatient costs by more than 30%, raising the fraction of medication-related expenses from 39% to 68%. 58 Facing such cost concerns, modeling studies for this and other agents concluded that the increased expenses were offset by an improved quality of life and less frequent work absenteeism. [59][60][61] However, these conclusions were based upon trials without active intervention in the control group, which is unlikely to occur in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

Bielefeldt

Levinthal

Nusrat

2015

J Neurogastroenterol Motil

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Background/AimsThe marketing of newer agents for treatment of constipation and irritable bowel syndrome with constipation (IBS-C) emphasize improvements in abdominal pain. However, it is not clear whether this observation reflects a unique visceral analgesic effect of these agents or is a general feature of effective laxation. We sought to determine the relationship between improvements in bowel frequency and decreases in abdominal pain in clinical trials of patients with constipation or IBS-C. MethodsWe searched "PubMed" and "Embase" databanks for clinical trials in patients with constipation or IBS-C, targeting publications that provided detailed data on bowel movement frequency and pain intensity before and after an intervention. We abstracted the results and performed meta-analytic and meta-regression analyses. Results Twenty

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Pgi2 the Budget Impact of Tegaserod on a Managed Care Organization Formulary

Cited by 2 publications

References 0 publications

A Methodological Review of US Budget-Impact Models for New Drugs

A Methodological Review of US Budget-Impact Models for New Drugs

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

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