“The model does not include utility adjustments to account for the incidence of AEs. Although the incidence of cough, productive cough and dysgeusia were markedly higher for colistimethate sodium DPI than nebulised tobramycin, some AEs were less common for colistimethate sodium DPI. As a consequence, it is unclear whether the inclusion of health utility decrements associated with the incidence of AEs would improve or worsen the economic case for colistimethate sodium DPI.
Although Forest Laboratories kindly provided detailed AE data for each treatment group at each visit, the considerable gaps in the available EQ-5D evidence (…) relating to the disutility of these events precluded the inclusion of these effects within the model.
It should also be noted that the model does not include the potential impact of resistance to tobramycin. This exclusion is reasonable, as it is unclear how this phenomenon would manifest in terms of reduced treatment effect.”
AE, adverse event; DPI, dry powder inhalation
From: Appendix K, Health Economics
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