Originally published by our sister publication Infectious Disease Special Edition
By Meaghan Lee Callaghan
Although specific products have been shown to be effective for recurrent Clostridioides difficile infections (CDIs), issues with cost and access have prevented some hospitals from using them, according to a presentation at MAD-ID 2025, in Orlando, Fla.
Rachel Kenney, PharmD, BCIDP, a pharmacy specialist in antimicrobial stewardship at Henry Ford Hospital, in Detroit, discussed strategies to bring their benefits to the patient.
With guidelines last updated by the Infectious Diseases Society of America in 2021, preferred therapy for initial CDIs or first recurrence is fidaxomicin (Dificid, Merck), with vancomycin listed as an alternative option (Clin Infect Dis 2021;73[5]:e1029-e1044). Yet, many insurance companies would rather pay for vancomycin than fidaxomicin, Dr. Kenney said.
For two or more recurrences, the IDSA guidelines recommend several options: fidaxomicin or extended-pulsed fidaxomicin, vancomycin tapered and pulsed, vancomycin followed by rifaximin, or fecal transplantation. Both fidaxomicin and vancomycin provide sustained clinical cure rates, but those rates differ depending on the study (Lancet Infect Dis 2018;18[3]:296-307; Infect Dis Ther 2023;12[1]:95-107).
Although the new live products fecal microbiota, live-jslm (Rebyota, Ferring) and fecal microbiota spores, live-brpk (Vowst, Nestlé/Seres) were not approved by the FDA when the IDSA guidelines were published, growing research has shown low rates of CDI recurrence with the products, which led to their approval in 2022 and 2023, respectively (N Engl J Med 2022;386[3]:220-229; Drugs 2022;82[15]:1527-1538).
Access Denied
Despite their proven value, it can be difficult to get the products covered, even for fidaxomicin, which has been available for some time, and without insurance coverage; the cost can be a barrier to their use. Sometimes they are not even included on the formulary.
“So, who has had access problems with fidaxomicin? It’s like everyone, right?” Dr. Kenney questioned the attendees at MAD-ID. Many institutions find it cost-prohibitive to have a blanket strategy to treat all CDI diagnoses with fidaxomicin first-line, she explained.
But some clinicians have seen success with increasing access through treatment optimization pathways, she said. In one study, researchers were able to find success treating first occurrences and second episodes of CDI by harnessing case managers, existing payor infrastructure and medication assistance programs (Infect Dis Ther 2023;12[1]:95-107). They were able to increase fidaxomicin usage to about half of their CDI cases and display positive outcomes, with lower rates of recurrence at 30 and 90 days.
An economic analysis of the treatment optimization pathway found they could save more than $220,000 per 100 patients with CDIs by preventing 12 recurrences, increasing the number of patients with sustained response to 17, reducing readmissions by 10 more patients and avoiding 50 more readmission bed days.
“This can be done. It’s going to take some coordination, but leveraging what you have in your institutions” can be successful, Dr. Kenney said.
Other people also may be seeing these benefits, or at least evolving to match the 2021 IDSA guidelines. “There may be some evidence that the revisions to the guidelines have slowly pushed payors to paying for fidaxomicin,” Dr. Kenney continued, citing a 2022 study that found the majority of fidaxomicin copays at their institution were below $50, and many of those even lower at between $0 and $4 (Clin Infect Dis 2022;75[3]:519-521). In that study, they noted some best practices included sending the outpatient prescription one to two days before hospital discharge, requesting expedited review when prior authorization was required, leveraging meds-to-beds programs when available and having a pharmacist involved with the transition of care.
The New Kids on the Block
Dr. Kenney also shared tips for implementing the use of Vowst and Rebyota, which can have their own set of hurdles due to their nature as drug products. Although Vowst capsules are stable at room temperature, Rebyota is a suspension that has to be thawed and delivered as an enema. Dr. Kenney said in her institution, they have decided not to administer Rebyota on Mondays but instead choose days later in the week, so the product can be taken out of the ultracold freezer (also something that the facility would need) and have time to thaw and be administered properly. Because of its administration method, she said that planning needs to be done so that there is a trained nursing staff member or other healthcare worker who can administer it, and there needs to be proper accommodations for the patient: A supine-accessible bed that’s close to the restroom is preferred. Administration also has an odor, so the patient may need to be isolated from other patients.
However, Vowst capsules do not require special refrigeration or administration, but they do require bowel prep beforehand, and optimal use is timed to two to four days after antibiotic completion, which Dr. Kenney said can be especially tricky with authorizations and the legwork to get the biological product to the patients.
In both cases, Dr. Kenney recommended clinicians develop a pathway and criteria for use as well as create standardized or templated documentation to ensure medical record documentation is complete, increasing the odds that any prior authorizations are approved.
“All clinicians, all of us, have an essential role to optimize access to all three of the therapies that we emphasized today.” she said “And I encourage you to go back, if you don’t already have pathways, to guidelines or infrastructure to support these, consider it, and you can take one little kernel to go care for your patients with C. diff to mitigate those access barriers.”
Dr. Kenney reported no relevant financial disclosures.
