Fidaxomicin as first line: What will it cost in the USA and Canada?

Abstract

AbstractImportanceRecent changes in the Infectious Diseases and Healthcare Epidemiology Societies of America (IDSA-SHEA) guidelines for managing Clostridioides difficile infections (CDI) have placed fidaxomicin as first-line treatment for CDI.ObjectiveTo estimate the net cost of first line fidaxomicin as compared to vancomycin in the American and Canadian healthcare systems and to estimate the price points at which fidaxomicin would become cost saving.Data sourcesWe identified all randomized controlled trials comparing fidaxomicin with vancomycin through the 2021 IDSA-SHEA guideline update. Medication costs were obtained from wholesale prices (US) and the Quebec drug formulary (Canada). The average cost of a CDI recurrence was established through two systematic reviews using PubMed.Study selectionFor fidaxomicin efficacy, we included double-blind and placebo-controlled trials. For the systematic review of recurrence costs, studies were included if they were primary research articles, had a cost-analysis of CDI, included cases of recurrent CDI, and were calculated with cost parameters from American or Canadian healthcare systems. Studies were excluded if the population was solely pediatric or hospitalized.Data extraction and SynthesisFor the efficacy meta-analysis, data was pooled using a random effects model. For the costs review, literature screening was performed by 2 independent reviewers. The mean cost across identified studies was adjusted to 2021 dollars.Main Outcomes and MeasuresThe primary outcome of the meta-analysis was CDI recurrence at day 40. The primary outcome of the systematic review was the average cost of a CDI recurrence in the American and Canadian healthcare systems. The objective was to estimate the net cost per recurrence prevented and the price point below which fidaxomicin would be cost saving.ResultsAt current drug pricing, the estimated additional cost of a 10-day course of fidaxomicin compared to vancomycin in order to prevent one recurrence was $46,178USD (95%CI $36,942-$69,267) and $13,760CAD (95%CI $11,008-$20,640), respectively. The estimated mean systemic cost of a CDI recurrence was $14,506USD and $8,588CAD, respectively. When priced below $1550USD and $800CAD, fidaxomicin was likely to become cost saving.Conclusions and RelevanceThe increased drug expenditure on fidaxomicin will not be offset through recurrence prevention unless fidaxomicin price is re-negotiated.Key PointsQuestionAt what price point does new guideline recommendations for changing from vancomycin to fidaxomicin for first line C. difficile infection (CDI) therapy become cost saving?FindingsFor a 10-day course, we estimated that compared to vancomycin, treatment with fidaxomicin costs an additional $46,178USD to prevent one CDI recurrence and that treating one recurrence costs $14,506USD. The current cost of fidaxomicin is only partially offset through prevention of recurrences. Upfront therapy with fidaxomicin would be cost saving if the price were reduced below $1550USD per treatment.MeaningNew guideline updates could add billions in additional drug costs for CDI treatment.