Fecal Transplant is Cost Effective for Treating Recurrent C difficile

SAN DIEGO – Fecal microbiota transplantation by colonoscopy is cost-effective when used as the initial treatment for recurrent Clostridium difficile infection, new data show.

A team led by Dr. Gauree Konijeti, a gastroenterology fellow at Massachusetts General Hospital in Boston, constructed decision analytic models of various treatment strategies in a hypothetical cohort of patients with a first, mild to moderate recurrence of C. difficile infection.

Relative to vancomycin, fecal microbiota transplantation (FMT) delivered by colonoscopy had an incremental cost-effectiveness ratio (ICER) of about $38,000 per quality-adjusted life-year gained, placing it well within the conventional willingness-to-pay threshold of $50,000, she reported at the annual meeting of the American College of Gastroenterology.

Additionally, FMT colonoscopy was more effective and less costly than both metronidazole (Flagyl) and fidaxomicin (Dificid).

However, FMT using other modes of delivery – either enema or duodenal infusion through esophagogastroduodenoscopy – was not cost-effective because of its relatively lower cure rates.

"A strategy consisting of first-line treatment with FMT colonoscopy for an initial recurrence of C. difficile appeared cost-effective at conventional willingness-to-pay thresholds," Dr. Konijeti commented.

"Guidelines should consider earlier use of FMT in the treatment of C. difficile infection, and future studies should incorporate FMT for comparative effectiveness," she recommended.

A session attendee asked, "What are your thoughts on the future of noncolonoscopic delivery methods?"

"One is if we can increase the infusion cure rates for enema and duodenal infusion, or even nasogastric infusion, those would be cost-effective. Right now they are on the order of 81%, compared to colonoscopic delivery, which is closer to the 93%-95% range," Dr. Konijeti replied.

"The other thought is that there has been a study of a fecal transplant pill that was recently presented at ID Week, where they used fresh donor feces from related donors and encapsulated a concentrated form of bacteria into these pills, and then gave about 20 pills to patients in a case series. They showed about a 100% efficacy rate, with only one recurrence in the setting of antibiotics," she said. "So I think we are in an era where we have the opportunity to deliver FMT via a variety of strategies, but we need to find more standardized ways of doing it and then optimize the efficacy."

Giving some background to the research, Dr. Konijeti noted that C. difficile infection has become increasingly challenging to manage. Emergence of the 027 strain has led to lower cure rates and higher rates of resistance. Today, up to one-third of patients have a recurrence after an initial infection, and up to two-thirds of that group go on to have yet more recurrences.

"FMT has emerged as a highly effective therapy because of high cure rates and low rates of recurrence," she commented.

The investigators studied four competing treatment strategies – vancomycin, metronidazole, fidaxomicin, and FMT – for treatment of a first, mild to moderate recurrence of C. difficile infection in a hypothetical cohort of patients having a median age of 65 years.

The models used various subsequent treatments in the event of a second and third recurrence, and the time horizon was 6 months. A key assumption was that payers would be willing to pay up to $50,000 per quality-adjusted life-year gained.

Base-case results showed that FMT colonoscopy was the most cost-effective strategy relative to vancomycin, with an ICER of $38,382 per quality-adjusted life-year gained, and was much more effective than both metronidazole and fidaxomicin.

However, in sensitivity analyses, FMT delivered by duodenal infusion or enema was not superior to other strategies.

Additional analyses tinkering with various model components showed that FMT colonoscopy was the most cost-effective strategy as long as its cure rate exceeded 93.8%, its cost was less than $2,324, or the probability of a post-treatment recurrence was less than 10%.

When the investigators explored thresholds for other treatment strategies, they found vancomycin would be the most cost-effective if its post-treatment recurrence rate were less than 33.9% (vs. 35.5% in the base case); fidaxomicin if its cost dropped to less than $1,539 (vs. $2,800 in the base case); and FMT by duodenal infusion or enema if the cure rate with one-time infusion hit 89.4% and 88.8%, respectively (vs. 81.3% and 81.5%).

Finally, when analyses assumed that FMT was not available, vancomycin was the most cost-effective strategy.

Dr. Konijeti disclosed no relevant conflicts of interest.

SAN DIEGO – Fecal microbiota transplantation by colonoscopy is cost-effective when used as the initial treatment for recurrent Clostridium difficile infection, new data show.

A team led by Dr. Gauree Konijeti, a gastroenterology fellow at Massachusetts General Hospital in Boston, constructed decision analytic models of various treatment strategies in a hypothetical cohort of patients with a first, mild to moderate recurrence of C. difficile infection.

Relative to vancomycin, fecal microbiota transplantation (FMT) delivered by colonoscopy had an incremental cost-effectiveness ratio (ICER) of about $38,000 per quality-adjusted life-year gained, placing it well within the conventional willingness-to-pay threshold of $50,000, she reported at the annual meeting of the American College of Gastroenterology.

Additionally, FMT colonoscopy was more effective and less costly than both metronidazole (Flagyl) and fidaxomicin (Dificid).

However, FMT using other modes of delivery – either enema or duodenal infusion through esophagogastroduodenoscopy – was not cost-effective because of its relatively lower cure rates.

"A strategy consisting of first-line treatment with FMT colonoscopy for an initial recurrence of C. difficile appeared cost-effective at conventional willingness-to-pay thresholds," Dr. Konijeti commented.

"Guidelines should consider earlier use of FMT in the treatment of C. difficile infection, and future studies should incorporate FMT for comparative effectiveness," she recommended.

A session attendee asked, "What are your thoughts on the future of noncolonoscopic delivery methods?"

"One is if we can increase the infusion cure rates for enema and duodenal infusion, or even nasogastric infusion, those would be cost-effective. Right now they are on the order of 81%, compared to colonoscopic delivery, which is closer to the 93%-95% range," Dr. Konijeti replied.

"The other thought is that there has been a study of a fecal transplant pill that was recently presented at ID Week, where they used fresh donor feces from related donors and encapsulated a concentrated form of bacteria into these pills, and then gave about 20 pills to patients in a case series. They showed about a 100% efficacy rate, with only one recurrence in the setting of antibiotics," she said. "So I think we are in an era where we have the opportunity to deliver FMT via a variety of strategies, but we need to find more standardized ways of doing it and then optimize the efficacy."

Giving some background to the research, Dr. Konijeti noted that C. difficile infection has become increasingly challenging to manage. Emergence of the 027 strain has led to lower cure rates and higher rates of resistance. Today, up to one-third of patients have a recurrence after an initial infection, and up to two-thirds of that group go on to have yet more recurrences.

"FMT has emerged as a highly effective therapy because of high cure rates and low rates of recurrence," she commented.

The investigators studied four competing treatment strategies – vancomycin, metronidazole, fidaxomicin, and FMT – for treatment of a first, mild to moderate recurrence of C. difficile infection in a hypothetical cohort of patients having a median age of 65 years.

The models used various subsequent treatments in the event of a second and third recurrence, and the time horizon was 6 months. A key assumption was that payers would be willing to pay up to $50,000 per quality-adjusted life-year gained.

Base-case results showed that FMT colonoscopy was the most cost-effective strategy relative to vancomycin, with an ICER of $38,382 per quality-adjusted life-year gained, and was much more effective than both metronidazole and fidaxomicin.

However, in sensitivity analyses, FMT delivered by duodenal infusion or enema was not superior to other strategies.

Additional analyses tinkering with various model components showed that FMT colonoscopy was the most cost-effective strategy as long as its cure rate exceeded 93.8%, its cost was less than $2,324, or the probability of a post-treatment recurrence was less than 10%.

When the investigators explored thresholds for other treatment strategies, they found vancomycin would be the most cost-effective if its post-treatment recurrence rate were less than 33.9% (vs. 35.5% in the base case); fidaxomicin if its cost dropped to less than $1,539 (vs. $2,800 in the base case); and FMT by duodenal infusion or enema if the cure rate with one-time infusion hit 89.4% and 88.8%, respectively (vs. 81.3% and 81.5%).

Finally, when analyses assumed that FMT was not available, vancomycin was the most cost-effective strategy.

Dr. Konijeti disclosed no relevant conflicts of interest.

SAN DIEGO – Fecal microbiota transplantation by colonoscopy is cost-effective when used as the initial treatment for recurrent Clostridium difficile infection, new data show.

A team led by Dr. Gauree Konijeti, a gastroenterology fellow at Massachusetts General Hospital in Boston, constructed decision analytic models of various treatment strategies in a hypothetical cohort of patients with a first, mild to moderate recurrence of C. difficile infection.

Relative to vancomycin, fecal microbiota transplantation (FMT) delivered by colonoscopy had an incremental cost-effectiveness ratio (ICER) of about $38,000 per quality-adjusted life-year gained, placing it well within the conventional willingness-to-pay threshold of $50,000, she reported at the annual meeting of the American College of Gastroenterology.

Additionally, FMT colonoscopy was more effective and less costly than both metronidazole (Flagyl) and fidaxomicin (Dificid).

However, FMT using other modes of delivery – either enema or duodenal infusion through esophagogastroduodenoscopy – was not cost-effective because of its relatively lower cure rates.

"A strategy consisting of first-line treatment with FMT colonoscopy for an initial recurrence of C. difficile appeared cost-effective at conventional willingness-to-pay thresholds," Dr. Konijeti commented.

"Guidelines should consider earlier use of FMT in the treatment of C. difficile infection, and future studies should incorporate FMT for comparative effectiveness," she recommended.

A session attendee asked, "What are your thoughts on the future of noncolonoscopic delivery methods?"

"One is if we can increase the infusion cure rates for enema and duodenal infusion, or even nasogastric infusion, those would be cost-effective. Right now they are on the order of 81%, compared to colonoscopic delivery, which is closer to the 93%-95% range," Dr. Konijeti replied.

"The other thought is that there has been a study of a fecal transplant pill that was recently presented at ID Week, where they used fresh donor feces from related donors and encapsulated a concentrated form of bacteria into these pills, and then gave about 20 pills to patients in a case series. They showed about a 100% efficacy rate, with only one recurrence in the setting of antibiotics," she said. "So I think we are in an era where we have the opportunity to deliver FMT via a variety of strategies, but we need to find more standardized ways of doing it and then optimize the efficacy."

Giving some background to the research, Dr. Konijeti noted that C. difficile infection has become increasingly challenging to manage. Emergence of the 027 strain has led to lower cure rates and higher rates of resistance. Today, up to one-third of patients have a recurrence after an initial infection, and up to two-thirds of that group go on to have yet more recurrences.

"FMT has emerged as a highly effective therapy because of high cure rates and low rates of recurrence," she commented.

The investigators studied four competing treatment strategies – vancomycin, metronidazole, fidaxomicin, and FMT – for treatment of a first, mild to moderate recurrence of C. difficile infection in a hypothetical cohort of patients having a median age of 65 years.

The models used various subsequent treatments in the event of a second and third recurrence, and the time horizon was 6 months. A key assumption was that payers would be willing to pay up to $50,000 per quality-adjusted life-year gained.

Base-case results showed that FMT colonoscopy was the most cost-effective strategy relative to vancomycin, with an ICER of $38,382 per quality-adjusted life-year gained, and was much more effective than both metronidazole and fidaxomicin.

However, in sensitivity analyses, FMT delivered by duodenal infusion or enema was not superior to other strategies.

Additional analyses tinkering with various model components showed that FMT colonoscopy was the most cost-effective strategy as long as its cure rate exceeded 93.8%, its cost was less than $2,324, or the probability of a post-treatment recurrence was less than 10%.

When the investigators explored thresholds for other treatment strategies, they found vancomycin would be the most cost-effective if its post-treatment recurrence rate were less than 33.9% (vs. 35.5% in the base case); fidaxomicin if its cost dropped to less than $1,539 (vs. $2,800 in the base case); and FMT by duodenal infusion or enema if the cure rate with one-time infusion hit 89.4% and 88.8%, respectively (vs. 81.3% and 81.5%).

Finally, when analyses assumed that FMT was not available, vancomycin was the most cost-effective strategy.

Dr. Konijeti disclosed no relevant conflicts of interest.