Budget Impact Analysis of Fidaxomicin Versus Vancomycin for the Treatment of Clostridioides difficile Infection in the United States

Jiang, Yiling; Sarpong, Eric; Sears, P.S.; Engels, N

doi:10.1007/s40121-021-00480-0

Cited by 12 publications

(6 citation statements)

References 34 publications

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“…Given the differences in healthcare systems, it is difficult to compare the per patient cost in Germany for fidaxomicin to the PMPM cost of FMBL in the US; however, both models showed that higher drug costs were offset by the reduction in medical costs associated with rCDI. A recent US model by Jiang et al [29] was developed from a hospital perspective and demonstrated a minimal budget impact of fidaxomicin in the US. In addition, two prior studies evaluated the budget impact of bezlotoxumab plus antibiotics compared to antibiotics alone in patients for the prevention of recurrence from a hospital perspective in Germany and the US, respectively [30,31].…”

Section: Discussionmentioning

confidence: 99%

Budget Impact Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) for Preventing Recurrent Clostridioides difficile Infection in the US

et al. 2023

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Introduction: Patients with Clostridioides difficile infection (CDI) often experience recurrences (rCDI), which are associated with high morbidity, mortality, and healthcare expenditures. REBYOTA TM (fecal microbiota, live-jslm [FMBL]) is a microbiota-based live biotherapeutic approved for the prevention of rCDI following antibiotic treatment for rCDI. We quantified the budget impact of FMBL during the first 3 years following introduction from a thirdparty US payer perspective. Methods: A decision-tree model was used to estimate the budget impact of one-course FMBL by comparing costs under the scenario with FMBL to the scenario without FMBL (standard of care) in patients with one or more (C 1) recurrences after a primary episode of CDI and had completed C 1 round of antibiotic treatments. Drug costs, rCDI-related medical costs, and budget impact over 1-3 years were estimated in 2022 US dollars. One-way sensitivity analyses were performed. Results: For an insurance plan with a population size of 1,000,000, 468 patients per year were estimated to have C 1 rCDI. The budget impact of one-course FMBL at $9000/course was cost-saving at an» average of -$0.0039 on a permember-per-month (PMPM) basis, an average of -$8.30 on a per-treated-member-per-month (PTMPM) basis, and a total of -$139,865 on a plan level assuming 5%, 15%, and 20% of patients receive FMBL over 1-3 years, respectively. The scenario with FMBL entry was associated with higher drug costs

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Section: Discussionmentioning

confidence: 99%

Budget Impact Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) for Preventing Recurrent Clostridioides difficile Infection in the US

et al. 2023

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“…This narrow spectrum of activity results in superiority over vancomycin with regard to recurrence/sustained clinical response up to 25 days after treatment completion (Louie et al 2011;Cornely et al 2012); however, it has been reported as inferior to vancomycin for clinical response to RT 027 infections (Louie et al 2011;Cornely et al 2012). Its high cost (USD1 767 for 10 day treatment) initially raised concerns about its benefit compared with treatment with vancomycin (USD14) or metronidazole (USD8), but multiple cost effectiveness analyses demonstrated that it is cost effective due to high cure rates and prevention of recurrent episodes, reducing re-admissions to hospital (Rajasingham et al 2020;Jiang et al 2021).…”

Section: Treatment Of Initial and Recurrent Episodes Of CDImentioning

confidence: 99%

Ridinilazole: a novel, narrow-spectrum antimicrobial agent targeting Clostridium (Clostridioides) difficile

Collins

Riley

2022

Letters in Applied Microbiology

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Clostridium (Clostridioides) difficile infection (CDI) remains an urgent threat to patients in health systems worldwide. Recurrent CDI occurs in up to 30% of cases due to sustained dysbiosis of the gut microbiota which normally protects against CDI. Associated costs of initial and recurrent episodes of CDI impose heavy financial burdens on health systems. Vancomycin and metronidazole have been the mainstay of therapy for CDI for many years; however, these agents continue to cause significant disruption to the gut microbiota and thus carry a high risk of recurrence for CDI patients. Treatment regimens are now turning towards novel narrow spectrum antimicrobial agents which target C. difficile while conserving the commensal gut microbiota, thus significantly reducing risk of recurrence. One such agent, fidaxomicin, has been in therapeutic use for several years and is now recommended as a first-line treatment for CDI, as it is superior to vancomycin in reducing risk of recurrence. Another narrow spectrum agent, ridnilazole, was recently developed and is undergoing evaluation of its potential clinical utility. This review aimed to summarize experimental reports of ridinilazole and assess its potential as a first-line agent for treatment of CDI. Reported results from in vitro assessments, and from hamster models of CDI, show potent activity against C. difficile, non-inferiority to vancomycin for clinical cure and non-susceptibility among most gut commensal bacteria. Phase I and II clinical trials have been completed with ridinilazole showing high tolerability and efficacy in treatment of CDI, and superiority over vancomycin in reducing recurrence of CDI within 30 days of treatment completion. Phase III trials are currently underway, the results of which may prove its potential to reduce recurrent CDI and lessen the heavy health and financial burden C. difficile imposes on patients and healthcare systems.

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“…In brief, antibiotic treatment is still considered as a cornerstone of CDI treatments, and there still is an unmet medical need for new antibiotics that could further reduce the recurrence rate. , Moreover, vancomycin and fidaxomicin exhibit diminished activity against the emerging hypervirulent strain of C. difficile ribotype 027. − Therefore, a new prospective agent in CDI shall not cause a significant dysbiosis and has an elevated activity against ribotype 027.…”

Section: Introductionmentioning

confidence: 99%

Identification of Micrococcin P2-Derivatives as Antibiotic Candidates against Two Gram-Positive Pathogens

Kim,

Lee,

Shyaka

et al. 2023

J. Med. Chem.

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Thiopeptides exhibit potent antimicrobial activity against Gram-positive pathogens by inhibiting bacterial protein synthesis. Micrococcins are among the structurally simpler thiopeptides, but they have not been exploited in detail. This research involved a computational simulation of micrococcin P2 (MP2) docking in parallel with the structure–activity relationship (SAR) studied. The incorporation of particular nitrogen heterocycles in the side chain of MP2 enhances the antimicrobial activity. Micrococcin analogues 6c and 6d thus proved to be more effective against impetigo and C. difficile infection (CDI), respectively, as compared to current first-line treatments. Compound 6c also showed a shorter treatment period than that of a first-line treatment for impetigo. This may be attributed to its ability to downregulate pro-inflammatory cytokines. Compound 6d had no observed recurrence for C. difficile and exerted a minimal impact on the beneficial gut microbiome. Their pharmacokinetic properties and low toxicity profile make these compounds ideal candidates for the treatment of impetigo and CDI and validate their involvement in preclinical development.

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Budget Impact Analysis of Fidaxomicin Versus Vancomycin for the Treatment of Clostridioides difficile Infection in the United States

Cited by 12 publications

References 34 publications

Budget Impact Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) for Preventing Recurrent Clostridioides difficile Infection in the US

Budget Impact Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) for Preventing Recurrent Clostridioides difficile Infection in the US

Ridinilazole: a novel, narrow-spectrum antimicrobial agent targeting Clostridium (Clostridioides) difficile

Identification of Micrococcin P2-Derivatives as Antibiotic Candidates against Two Gram-Positive Pathogens

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