Clinical and Economic Outcomes After Implementation of a Fidaxomicin Treatment Optimization and Access Pathway at a US Hospital System.

INTRODUCTION: This study aimed to evaluate the clinical and economic outcomes of implementing a Clostridiodes difficile infection (CDI) Treatment Optimization and Access Pathway (treatment pathway) directing first-line use of fidaxomicin for CDI. METHODS: This was a retrospective, quasi-experimental study of adult patients with CDI using Electronic Health Record data from a single center. The primary intervention was implementation of a treatment pathway directing first-line use of fidaxomicin for patients with first/second CDI episode and at high risk of recurrence. The primary clinical outcome was CDI recurrence within 30 days of completing therapy in patients achieving clinical cure. Secondary clinical outcomes included clinical cure and sustained response evaluated at 90 days after completion of CDI treatment. Economic outcomes included costs associated with hospital stay at index admission and 30- and 90-day readmission. Differences between the pre- and post-implementation cohorts were assessed for baseline characteristics, CDI treatment utilization, clinical outcomes, and economic outcomes. The budget impact was calculated for the pre- vs. post-implementation cohorts, each normalized to 100 patients. RESULTS: Post- vs. pre-implementation, 30-day recurrence (6.4% vs. 18.0%., p = 0.001), 90-day recurrence (14.9% vs. 27.1%, p = 0.009), and 30-day (4.6% vs. 12.7%, p = 0.007) and 90-day CDI-related readmissions (8.5% vs. 18.9%, p = 0.007) were lower. The clinical cure (94.1% vs. 84.4%, p = 0.002) and 90-day sustained response rates were higher (73.3% vs. 55.9%, p < 0.001). Median total costs were also lower in the post- vs. pre-implementation cohorts at index admission ($11,934.64 vs. $14,523.27, p = 0.048), and 30-day ($7685.82 vs. $12,424.44, p = 0.102) and 90-day CDI-related readmission episodes ($8246.69 vs. $12,729.57, p = 0.042). The budget impact analyses of 100 patients post- vs. pre-implementation found saving of $222,895 overall and $9432 per CDI-readmission avoided. CONCLUSIONS: Implementation of the CDI treatment pathway was associated with better clinical outcomes and hospital cost savings. The findings help validate real-world value of fidaxomicin for CDI disease management.

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

INTRODUCTION: Fidaxomicin is as effective as vancomycin in treating Clostridioides difficile infection (CDI) but more effective at preventing recurrence. However, because fidaxomicin is more costly than vancomycin, its overall value in managing CDI is not well understood. This study assessed the budget impact of introducing fidaxomicin versus vancomycin for the treatment of adults with CDI from a hospital perspective in the US. METHODS: A cohort-based decision analytic model was developed over a 1-year horizon. A hospital with 10,000 annual hospitalizations was simulated. The model considered two adult populations: patients with no prior CDI episode and patients with one prior CDI episode. Two scenarios were assessed per population: 15% fidaxomicin/85% vancomycin use and 100% vancomycin use. Model inputs were obtained from published sources and expert opinion. Model outcomes included cost, payment, and revenue at the hospital level, per treated CDI patient, and per admitted patient. Budget impact was calculated as the difference in revenue between scenarios. One-way sensitivity analyses tested the effects of varying model inputs on the budget impact. RESULTS: In patients with no prior CDI episode, treatment with fidaxomicin resulted in potential savings over 1 year of $1105 at the hospital level, $14 per treated CDI patient, and $0.11 per admitted patient. In patients with one prior CDI episode, fidaxomicin use was associated with potential savings over 1 year of $1150 at the hospital level, $74 per treated CDI patient, and $0.12 per admitted patient. Savings were driven by a reduced rate of CDI recurrence with fidaxomicin treatment and uptake of fidaxomicin. Sensitivity analyses indicated savings when inputs were varied in most scenarios. CONCLUSION: Budgetary savings can be achieved with fidaxomicin due to reduced CDI recurrence as a result of a superior sustained clinical response. Our results support considering the broader benefits of fidaxomicin, beyond its cost, when making formulary inclusion decisions.

Clostridioides difficile infection (CDI) is a common hospital-acquired infection that affects about half a million people in the US each year. In some patients who have already had CDI, it can recur. These recurrent infections can be difficult to treat, and they place a burden on the healthcare system. CDI is usually treated with the antibiotics fidaxomicin or vancomycin. Fidaxomicin is as effective as vancomycin for treating CDI but is even more effective than vancomycin at preventing CDI recurrence. However, fidaxomicin is more expensive. In this study, we estimated the impact of replacing vancomycin with fidaxomicin for treating CDI on the budget of a typical US hospital. We estimated that treating 15% of patients with CDI using fidaxomicin in place of vancomycin would save the hospital between $1105 and $1150 in a year. This means that despite the higher cost of fidaxomicin, treating as few as 15% of patients with CDI using fidaxomicin instead of vancomycin can be cost-saving for hospitals.

Risk assessment of post-discharge mortality among recently hospitalized Medicare heart failure patients with reduced or preserved ejection fraction.

Objective: Targeted care management for hospitalized patients with acute decompensated heart failure (ADHF) with reduced or preserved ejection fraction (HFrEF/HFpEF) who are at higher risk for post-discharge mortality may mitigate this outcome. However, identification of the most appropriate population for intervention has been challenging. This study developed predictive models to assess risk of 30 day and 1 year post-discharge all-cause mortality among Medicare patients with HFrEF or HFpEF recently hospitalized with ADHF.Methods: A retrospective study was conducted using the 100% Centers for Medicare Services fee-for-service sample with complementary Part D files. Eligible patients had an ADHF-related hospitalization and ICD-9-CM diagnosis code for systolic or diastolic heart failure between 1 January 2010 and 31 December 2014. Data partitioned into training (60%), validation (20%) and test sets (20%) were used to evaluate the three model approaches: classification and regression tree, full logistic regression, and stepwise logistic regression. Performance across models was assessed by comparing the receiver operating characteristic (ROC), cumulative lift, misclassification rate, the number of input variables and the order of selection/variable importance.Results: In the HFrEF (N = 83,000) and HFpEF (N = 123,644) cohorts, 30 day all-cause mortality rates were 6.6% and 5.5%, respectively, and 1 year all-cause mortality rates were 33.6% and 29.5%. The stepwise logistic regression models performed best across both cohorts, having good discrimination (test set ROC of 0.75 for both 30 day mortality models and 0.74 for both 1 year mortality models) and the lowest number of input variables (18-34 variables).Conclusions: Post-discharge mortality risk models for recently hospitalized Medicare patients with HFrEF or HFpEF were developed and found to have good predictive ability with ROCs of greater than or equal to 0.74 and a reasonable number of input variables. Applying this risk model may help providers and health systems identify hospitalized Medicare patients with HFrEF or HFpEF who may benefit from more targeted care management.

Placement of selected new FDA-approved drugs in Medicare Part D formularies, 2009-2013.

OBJECTIVES: To assess formulary decisions by Part D plans for selected newly approved drugs. STUDY DESIGN: Retrospective cohort study. METHODS: Formulary placement and restrictions were identified for 33 drugs in 8 therapeutic classes (antihyperglycemics, anticoagulants, antiplatelets, disease-modifying agents for multiple sclerosis [MS] and rheumatoid arthritis [RA], chronic obstructive pulmonary disease [COPD] drugs, antiepileptics, and antipsychotics) in 863 Part D plans with continuous CMS contracts between 2009 and 2013. Multivariable models estimated the impact of drug characteristics and Part D plan characteristics on probability of drug adoption and, for adopters, evaluated factors associated with months to adoption and requirements for prior authorization (PA) or step therapy (ST). RESULTS: First Part D formulary placements varied from 2 to 14 months post FDA approval. On average, 56.7% of plans placed each drug within 6 months and 64.1% placed within 1 year of the National Drug Code assignment date. The most rapid adoption was for antipsychotics and antiepileptics. The slowest was for COPD drugs. More than 90% of disease-modifying agents for MS and RA were subject to PA. ST was uncommon except for antihyperglycemic agents. In adjusted analyses, enhanced benefit plans had a 4% higher probability of formulary placement (P <.01), and each additional star in the CMS star rating system increased the probability of adoption by 4% (P <.01). Overall, Medicare Advantage prescription drug plans had higher placement rates due to greater reliance on enhanced plan offerings and higher star ratings. CONCLUSIONS: We found significant heterogeneity in formulary placement and restrictions for 33 new drugs in the Part D marketplace between 2009 and 2013. Further research is necessary to determine whether this pattern applies to other drug classes.

Healthcare Costs Among Patients with Heart Failure: A Comparison of Costs between Matched Decedent and Survivor Cohorts.

INTRODUCTION: Prior research suggests increased costs during the final months of life, yet little is known about healthcare cost differences between patients with heart failure (HF) who die or survive. METHODS: A retrospective claims study from a large US health plan [commercial and Medicare Advantage with Part D (MAPD)] was conducted. Patients were ≥18 years old with two non-inpatient or one inpatient claim(s) with HF diagnosis code(s). The earliest HF claim date during 1 January 2010-31 December 2011 was the index date. Cohort assignment was based on evidence of death within 1 year (decedents) or survival for >1 year (survivors) post-index. Per-patient-per-month (PPPM) and 1-year (variable decedent follow-up) costs (all-cause and HF-related) were calculated up to 1 year post-index. Cohorts were matched on demographic and clinical characteristics. Independent samples t tests and Pearson's chi-square tests were used to examine cohort differences. RESULTS: Among patients with HF, 8344 survivors were 1:1 matched to decedents [mean age 75 years, 50% female, 88% MAPD; mean time to decedents' death: 150 (SD 105) days]. Compared to survivors, more decedents had no pharmacy claims for HF-related outpatient pharmacotherapy within 60 days post-index (42.1% vs. 27.1%; p < 0.001). Decedents also incurred higher all-cause medical costs (PPPM: $21,400 vs. $2663; 1 year: $60,048 vs. $32,394; both p < 0.001) and higher HF-related medical costs (PPPM: $16,477 vs. $1358; 1 year: $39,052 vs. $16,519; both p < 0.001). Hospitalizations accounted for more than half of all-cause PPPM medical costs (54.6% for survivors, 84.3% for decedents). CONCLUSION: Patients with HF who died within 1 year after an index HF encounter incurred markedly higher costs within 1 year (despite the much shorter post-index period) and PPPM costs than those who survived, with the majority of costs attributable to hospitalizations for both patient cohorts. There may be opportunities for improving outcomes in HF, considering higher use of pharmacotherapy and lower costs were seen among survivors.

Health Care Costs for Patients with Heart Failure Escalate Nearly 3-Fold in Final Months of Life.

BACKGROUND: Heart failure (HF) is a severe chronic disease with growing prevalence and health care burden as well as high mortality. End-of-life cost data for patients with HF may inform disease and medication therapy management. OBJECTIVES: To (a) characterize a real-world sample of patients with HF who died; (b) estimate health care costs for 6 months and semiannually for 24 months, before death; and (c) examine associations between patient characteristics and predeath health care costs. METHODS: This was a retrospective study of commercial and Medicare Advantage with Part D (MAPD) enrollees (aged ≥ 18 years), using data from a large national health plan. Included patients had evidence of HF during January 1, 2009-December 31, 2013, based on ≥ 1 inpatient hospitalization or ≥ 2 noninpatient encounters with diagnosis code for HF and evidence of mortality during July 1, 2009-December 31, 2013. Demographic data, comorbidities, guideline-directed HF-related outpatient pharmacotherapy (HFRx), and predeath health care costs (all-cause and HF-related) were described. A generalized linear model examined associations between all-cause health care costs (months 6 and 1 previous to death) and specific patient characteristics. RESULTS: Of 48,026 identified patients, mean age was 77.9 years; 52.8% were female; 93.0% were MAPD enrolled; 92.5% had Quan-Charlson comor-bidity score ≥ 3; and about one quarter (26.0%) had no evidence of HFRx. Over the last 6 months of life, monthly all-cause total cost increased 3.2-fold for MAPD enrollees and 2.8-fold for commercial enrollees, although pharmacy cost decreased slightly (0.8-fold for both plan types). Cumulative 6-month all-cause medical cost was $37,186 for MAPD enrollees and $143,363 for commercial enrollees (68.8% and 73.2% due to hospitalization, respectively), and cumulative HF-related medical cost was $20,794 for MAPD enrollees and $78,440 for commercial enrollees (88.8% and 95.3% due to hospitaliza-tion, respectively). Over the last 24 months, semiannual all-cause total cost increased 3.2-fold for MAPD enrollees and 4.5-fold for commercial enroll-ees, although pharmacy cost increased only slightly (1.1-fold and 1.3-fold, respectively). Based on multivariable analysis, factors associated with higher risk of incurring a cost increase between month 6 and month 1 before death included older age (75-84 years: cost ratio [CR] = 1.33, P < 0.001; 226585 years: CR = 1.43, P < 0.001), comorbid coronary heart disease (CR = 1.12, P = 0.003), and no evidence of HFRx (CR = 1.48, P < 0.001). CONCLUSIONS: Patients with HF experienced ≥ 2.8-fold increase in monthly all-cause total cost over the last 6 months of life, which was driven by hospitalization. Although MAPD enrollees incurred greater cost increases, cumulative costs were higher for commercial enrollees. After multivariable adjustment, older age, comorbid coronary heart disease, and no evidence of HFRx were among factors associated with higher risk of cost increase over the last 6 months of life. Study findings provide predeath cost information that should be useful in value assessments of innovative HF interventions and highlight impact of HFRx on predeath health care costs.