Recurrence Escalates Financial Burden of CDI

Clostridioides difficile infection (CDI) continues to be a costly challenge, compounded by high rates of recurrence.

“One of the things that I think people don’t appreciate is that unless you treat the infection appropriately at the outset, then the infections are going to keep coming back,” Glenn Tillotson, PhD, FIDSA, FCCP, senior consultant with GST Micro, told Contagion.

The chance of a recurrent infection increases with each subsequent recurrence, with those infected with an initial case of C diff having about a 25% chance of reinfection and those reinfected having a 50% chance of a third infection, he said. Rates of complications such as sepsis, surgery, and mortality also climb with reinfection.

The costs to the health care system accumulate, not only for treatment but also from reimbursement penalties related to readmission rates for hospital-acquired infections.

“It pays to get it right the first time or as near as you can,” Tillotson said.

Doing so can be difficult. Improving access to drugs, infection prevention and new therapies could help tackle the problem.

Access to approved treatment

Limited access to recommended drugs continues to be a challenge, despite guidelines from the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) calling for their use.

A study of Medicare Advantage/Part D enrollment and formulary data found that oral vancomycin and fidaxomicin were broadly accessible to only 14.4% and 1.1% of enrollees, respectively, despite being in the formulary for 100% and 84.1%.

“So, although the guidelines say these are the two drugs to use, the Medicare population really struggles to get hold of them,” Tillotson said. “And if you think about the population that suffers with C diff, it’s the older people.”

He said increasing awareness of the recurrent nature of CDI and the importance of managing the disease early could improve access to recommended drugs, which could benefit health care systems financially in the long run. Improving access to recommended drugs could reduce recurrence, allowing health care systems to meet targets set by the Centers for Medicare & Medicaid Services for reducing hospital acquired infections, thereby avoiding being penalized by the CMS reimbursement system.

Value-based incentive programs

In October 2016, CMS included CDI rates in value-based incentive programs (VBIPs) aimed at preventing hospital-acquired infections.

A study of more than 24 million admissions at 265 US hospitals found that the implementation of VBIPs was associated with a sustained decrease in rates of hospital-onset CDI. Recurrent and community-onset cases were excluded.

More research is needed to understand the specific factors that contributed to those declines, but the study authors noted that improvements in diagnostic and antimicrobial stewardship may have played a role along with improvements in infection control practices.

“By managing it effectively and reducing the recurrence, they have a much lower likelihood of being penalized by the CMS reimbursement system,” Tillotson said.

Getting it right the first time

Diagnostic stewardship is an important component to controlling the financial burden of CDI, Tillotson said, noting a need for a wise approach to testing that considers all factors, such as whether a patient is on laxatives, before ordering a C diff test.

“Some of those are positive when in fact the patient didn’t clinically have an infection,” he said.

Once a patient is diagnosed with C diff, recognizing the risk factors for recurrence—including recent antibiotic use, whether the patient is over 65, use of acid suppressants and recent exposure to a health care setting— can help inform appropriate treatment.

That involves “a combination of understanding what underlies recurrence and an appreciation of the spiraling cost that can occur and that those costs are not just affecting this year’s bottom line, but they can affect next year’s bottom line because reimbursement penalties will kick in,” Tillotson said.

Case managers working with pharmacists also can play a role by working to ensure that patients have access to the appropriate drugs and complete the course once they leave the hospital.

A recent small study published in Clinical Infectious Diseases highlighted the importance of advance planning and multidisciplinary collaboration.

It included 15 patients who were discharged with fidaxomicin, finding that 80% had copayments of $35 or less, 27% required prior authorization, and the 30-day CDI recurrence was 7%.

The study authors noted that formulary coverage of fidaxomicin improved in the three months after the guidelines were updated and that decisions to omit or restrict fidaxomicin based on concerns about insurance coverage may not be warranted.

New therapies

“It’s a challenging infection in many different ways,” Tillotson said. “One of the things that is beginning to emerge are new therapies that can play a role in reducing these recurrences and therefore hopefully will reduce the impact on the hospital’s bottom line.”

Fecal microbiome transplant is a promising emerging therapy that could help reduce recurrence by restoring the protective microbiota that is destroyed by antibiotics.

“I’m a believer that if you can restore that balance, it will help so many different things, not just C diff but other medical conditions,” Tillotson said.

Vaccines also have been explored, but so far they have been unsuccessful.

“Do we have to live with this forever? I think at the moment we probably do,” Tillotson said. “But if we can go some way to reducing the recurrence rate by using appropriate therapies sooner and using drugs like fidaxomicin in first line, then I think we’ve got a chance of at least moderating the disease. We’ll never eliminate it, but if we can at least moderate it, I think that would be great.”