Note: This article was originally posted on April 30. It was updated May 7.

Avalere Health conducted a retrospective cohort study of more than 268,000 Medicare recipients diagnosed with Clostridioides difficile (C. diff) and recurrent C. diff infections (CDI) from January 2010 through December 2016. The purpose was to evaluate healthcare resource utilization and all-cause, direct medical costs associated with this debilitating and occasionally deadly infection. We found that 1 in 3 patients with C. diff experienced a recurrence within 12 months, and more than half of the patients with at least 1 recurrence experienced 2 or more recurrences after the first episode. Patients with recurrent C. diff. spent 18 days in the hospital on average compared to 13 days for those with no recurrence. Recurrent CDI was also associated with higher overall healthcare costs and higher out-of-pocket costs for patients.

CDI impacts more than 475,000 Americans annually, affecting the nation’s frail elderly where its impact can be devastating. Patients typically present with watery diarrhea (up to 10 times/day) as the hallmark clinical symptom associated with CDI. Other common symptoms include abdominal cramping and pain, fever, nausea, loss of appetite, and dehydration. Recurrent CDI (rCDI) is common, and with each rCDI episode, patients with pre-existing co-morbidities possess an inherent risk of exacerbating their illness and potentially increasing disease severity. In fact, there are approximately 9,000 CDI-related deaths in US nursing homes each year, and CDI/rCDI is the 17th leading cause of death in people 65 and older.

Avalere, in collaboration with Ferring Pharmaceuticals, evaluated the healthcare burden that encompasses costs of CDI and rCDI in a sample of 268,762 Medicare beneficiaries aged 65 and older with an index CDI diagnosis between January 2010 and December 2016. Each CDI episode was followed by a 14-day claim-free period after the end of treatment. rCDI was defined as another episode within 8 weeks following the claim-free period. Patients were observed for 12 months prior and 12 months after their indexed diagnosis.

Patients with CDI were slightly older when compared with the national Medicare population (78.3 vs. 75.4). The majority were women (69% vs. 59.1%). A high percentage had been prescribed antibiotics (83%) and gastric acid suppressing agents (50%) during the 12-months prior to CDI, and the proportion of patients with transplants was 4 times higher for the 3+ rCDI cohort compared to other cohorts.

Our study confirmed literature findings related to the risk of rCDI. rCDI was identified to be greater in patients with a prior recurrence, and the length of hospitalization was higher in patients with rCDI. vs. those with no rCDI. Among the 268,762 patients with CDI diagnosis, 35% experienced a recurrence. The rate of subsequent recurrences increased to 59.1% in patients with 1 recurrence and 58.4% in patients with 2 recurrences. Length of stay per hospitalization was 13.4 days in patients with a history of CDI and increased to 17.9 days for those with 1 recurrence. Patients with 1 recurrent episode also experienced a higher rate of emergency department visits than those without recurrent disease (54.6% vs. 50.2%) and higher utilization of post-acute care services (74.6% vs. 69.9%).

Significantly, during the 12-month follow-up period, hospital admission rates increased in parallel with the number of recurrences; 12.8% of patients with CDI experienced 4 or more hospitalizations within 12 months, compared to 20%, 22%, and 25% of patients with 1, 2, and 3 or more recurrences, respectively.

Total all-cause, direct medical costs per patient over 12 months were highest in those with 3 or more recurrent episodes vs. patients without rCDI, primarily driven by hospitalizations. Inpatient costs were $22,722 per patient without a rCDI episode vs. $31,614 per patient with 3+ recurrences. Similarly, per-patient physician services costs were, $11,756 vs. $15,941 respectively; per-patient outpatient costs were, $7,749 vs. $10,861respectively; and per-patient prescription drug costs were $5,643 vs. $8,842, respectively. An increasing portion of total costs including Medicare paid plus patient paid amounts was borne by patients themselves.

In conclusion, continued efforts and interventions aimed at reducing recurrent episodes of C. diff are essential to manage the economic and patient burden of this disease. Patients, family, healthcare providers, and health systems must be aware of this debilitating infection, understand the associated cost and burden, and take action to alleviate recurrences of C. diff infections.

Disclosures

The study was funded by Ferring Pharmaceuticals Inc. (Parsippany, NJ), with study contributions from Sudhir Unni, PhD, Takara A. Scott, PhD, Mena Boules, MD and Winnie Nelson, PharmD. Drs. Teigland and Parente of Avalere provided consulting services to Ferring Pharmaceuticals Inc.