Antimicrobial Therapy (Vancomycin and/or Metronidazole) Cost Comparison Analysis of Recurrent C. difficile Treated with Fecal Microbiota Transplants vs. Antimicrobial Therapy Shah S, Rascati K, Chimah C, Shukla N Health Outcomes & Pharmacy Practice Division, College of Pharmacy, The University of Texas at Austin Patient Selection Process After excluding patients with Inflammatory Bowel Disease and other Infectious Colitis’ (n=5,841) Patients older than 18 years of age (n=7,700) Patients with more than one readmission of CDI (n=7,717) Patients with primary or secondary diagnosis of CDI (n=29,010) Patients without FMT (n=5,790) Patients with FMT (n=51) Background Demographic Characteristics Discussion Clostridium difficile (CDI) is a hospital acquired gastrointestinal infection that costs the US healthcare system about $4.8 billion annually.1 Recurrent CDI (RCDI) occurs in up to 65% of first time cases within 14-56 days. The estimated number of nationwide recurrences of CDI is 83,000.2 Established treatment regimens with metronidazole and vancomycin have low resolution and high recurrence rates.3 Each episode of recurrence costs $13,000-18,000 per patient4. Fecal microbiota transplants (FMT) have demonstrated high efficacy and lower recurrence rates in treating RCDI.5 FMTs have also been projected to be cost effective treatments of RCDI as compared to established methods of treatment.6,7 Guidelines advocate the use of FMT at the third recurrence of CDI after having tried IV Vancomycin + Metronidazole for the first recurrence and pulsed Vancomycin for the second.8 Gender FMT Cohort (n=51) Eligible Controls (Pharmaco-therapy) (n=5,790) Female 24 3,577 Male 27 2,213 The uptake of FMT during readmissions related to CDI is extremely low. This study hopes to provide a real world comparison of costs and utilization associated with CDI treatment. Based on higher efficacy, FMT has the potential to reduce cost to treat RCDI. Age Mean (SD) 76.84 (15.02) 81.29 (11.72) Benefit Design Commercial 6 373 Medicare 45 5,417 Limitations Guidance for the use of FMT was introduced in 2013. CPT codes to identify FMT are based on consultation with providers and may not reflect standard CMS issued codes. Data in this study was from 2010-12 only. RCDI Patients treated with Bezlotoxumab could not be accounted for in this study as the drug was approved for prevention of recurrent CDI in 2016 . Bezlotoxumab is a monoclonal antibody against C difficile toxin B and became available for use in February, 2017. Geographic Region Midwest 22 2,078 Northeast 1 218 South 2,855 West 6 639 To compare the healthcare costs and utilization of RCDI patients treated with FMT vs. currently accepted anti-microbial therapy. The hypothesis is that treating RCDI with FMT would reduce recurrences and total healthcare costs. Objective Race White 43 4,775 Black 2 514 Other 38 Asian 17 Hispanic 61 Native American 16 Unknown 6 369 Materials & Methods This was a retrospective cohort study of adults 18 years and above using administrative claims from a large commercial insurer. Cases with first readmission related to CDI as defined by 2 subsequent claims with ICD9 code 008.45 at least 20 days apart were included in the study. Demographic characteristics were compared between both groups using T-tests for continuous variables and Chi-square tests for categorical variables. Study participants needed to be continuously enrolled for 6 months pre-index. Patients treated with FMT were identified using CPT codes: G0455, 44705, 45378, 44799, 45381, 43259 and 45383. Next Steps: Patients that met the inclusion criteria will be matched 1:1 using propensity scores with the comparison cohort that included RCDI patients treated with pulsed vancomycin and/or metronidazole and/or fidaxomicin identified by their respective J codes. Patients will be followed from the admission date of first recurrence for one year. Inpatient, outpatient and prescription costs, as well as number of readmissions, vancomycin cycles and FMTs will be calculated. Note: This is a work in progress Descriptive costs and utilization measures FMT (by colonoscopy) Pharmacotherapy (Vancomycin and/or Metronidazole) Resolution rate >90% 50% with metronidazole >80% with vancomycin at the first episode Recurrence rates (after first treatment) 2.7-5.5% 27-35% Average cost/QALY8 $3611 $3393-$4753 Conclusions Patients undergoing FMT were relatively younger as compared to patients treated with pharmacotherapy. No other demographic differences were noted in the treatment cohorts. Correspondence SANKET.SHAH@UTEXAS.EDU 512-471-8509 Dubberke,E.R., Olsen, M.A.Burden of Clostridium difficile on the Healthcare System. Clinical Infectious Diseases. 2012;55(suppl 2):S88. Lessa, F.C., Beldavs,Z.G., Farley, M.M., et al. Burden of Clostridium difficile Infection in the United States. New England Journal of Medicine. 2015;372(9):825. McFarland, L. V., Surawicz, C. M., Rubin, M., et al. (1999). Recurrent Clostridium difficile disease: epidemiology and clinical characteristics. Infection Control & Hospital Epidemiology, 20(01), 43-50. Ghantoji,S.S., Sail,K., Lairson, D.R., et al. Economic healthcare costs of Clostridium difficile infection: a systematic review. Journal of Hospital Infection. 2010;74(4):309-318. doi:10.1016/j.jhin.2009.10.016. Varier, R.U., Biltaji E., Smith,K.J., et al. Cost-Effectiveness Analysis of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection. Infection Control & Hospital Epidemiology. 2015;36(4):438-444. Konijeti, G.G., Sauk, J.J., Shrime,M.G., et al. Cost-effectiveness of Competing Strategies for Management of Recurrent Clostridium difficile Infection: A Decision Analysis. Clinical Infectious Diseases. 2014;58(11):1507. Surawicz, C.M., Brandt, L..J., Binion,D.G., et al. Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections. The American Journal of Gastroenterology. 2013;108(4):478-498. Konijeti, G.G., Sauk, J., Shrime,M.G., et al. Cost-effectiveness of Competing Strategies for Management of Recurrent Clostridium difficile Infection: A Decision Analysis. Clinical Infectious Diseases. 2014;58(11):1507. Potential savings per patient treated with FMT colonoscopy vs. Vancomycin = $17,1068