The Infection-Busting Treatment Payers Don't Want to Talk About

Fecal microbiota transplantation is an inexpensive treatment for a potentially deadly infection. But FMT is not for the squeamish. It's time for payers to get on board with this antibiotic alternative, which has a 90% cure rate.

First the good news about Clostridium difficile, the deadly bacteria that can take over the gut of hospitalized patients after their natural gastrointestinal flora has been decimated by antibiotics: There's an inexpensive and highly effective treatment for it.

C. diff, which is antibiotic-resistant, causes diarrhea that contributes to the deaths of about 14,000 Americans this year, according to the federal Centers for Disease Control and Prevention. It's also a cause of costly hospital readmissions, with about a quarter of infected patients experiencing at least one relapse within a month after completing antibiotic treatment.

Related: Multiple Recurring C. Diff. Infections on the Rise

Now the bad news: The inexpensive treatment with a 90% cure rate—fecal microbiota transplantation—is not for the squeamish.

There are reports of fecal transplantation in early Chinese medicine, but the earliest documented instances of the procedure in Western medicine date back only to the 1950s. Now researchers are trying to isolate the beneficial microbiota that seek and destroy C. diff.

One Mayo Clinic researcher likens exploration of the uses of gut microbiome in disease treatment to "the beginning of the space program."

Microbiome as 'Miracle Cure'
"Our patients have failed all other therapies," Lee Jones, founder, CEO and president of Rebiotix, told me this week. The Roseville, MN-based company is developing a fecal matter suspension that can be delivered to a C. diff patient's GI tract with an enema. The shelf-stable product, RBX2660, is in the final stage of testing at the federal Food and Drug Administration.

Rebiotix decided "the most prudent action was to mimic" the real microbiota.

Although it's "a non-antibiotic product… we've had to formulate our product as a drug product," she told me. "We try to preserve as much of the natural product as possible. Fresh stool is almost always guaranteed to work."

"We don't talk with our patients, but we hear about them in our clinical data," Jones told me. "For those people, this is like a miracle cure."

Rebiotix is raising millions in capital for its microbiome business, and Jones is convinced that healthcare payers will soon rank this treatment high on their lists. "There's a great deal of value in stopping people from returning to the hospital," she told me of C. diff patients. "We do believe there will be people willing to pay."

Far from commercialization, however, Rebiotix does not yet have pricing information and has "not yet begun to investigate the reimbursement landscape," a spokesperson told me.

Nonprofit Approach
In Massachusetts, Open Biome, a nonprofit startup venture, is filling the fecal microbiota transplantation market niche one homogenized 250-milliliter bottle at a time. Each is priced at $250.

"The steps for sourcing and distributing fecal microbiota "are fairly simple," Open Biome Executive Director James Burgess told me this week. "What's a little more complicated is the donor screening."

Open Biome donors deposit four samples per week at its Cambridge facility. "We run them though a couple rounds of risk evaluation," Burgess said of the donors. The cost can rise to "several thousand dollars" for same-day fecal transplant procedures, he said.

First, donors complete a questionnaire that includes queries about recent antibiotic use and travel to countries with waterborne illnesses. A second round of screening tests donor candidates for several diseases including HIV and syphilis.

"Only about 30 percent pass through that questionnaire and round of assays," Burgess said. Once a sample is obtained, the material is homogenized and held in quarantine for 60 days in one of the startup's minus-80-degree freezers.

"That's just to make sure we haven't seen any change in the donor since the beginning of the collection window," Burgess says.

At that point, the microbiota samples are ready to be administered to patients. As the startup's website says, "With Open Biome, all that's needed to deliver FMT is a doctor and an endoscope."

Who Will Pay for FMT?
Hospitals, their patients, and some commercial insurers already see the value and are paying for the procedure.

For now, Hartford, CT-based Aetna was the only commercial payer willing to discuss FMT with me. "Aetna considers fecal bacteriotherapy medically necessary for persons with Clostridium difficile infection, with infection confirmed by a positive stool test for C. difficle toxin, that has recurred following at least one course of adequate antibiotic therapy," an Aetna spokesperson told me last week.  It covers the cost of the fecal material and the procedure to administer including clinician fees.

While the insurance carrier has established standards for C. diff treatment with vancomycin and metronidazole, "Aetna considers fecal bacteriotherapy experimental and investigational for all other indications."

Aetna appears to be among the enlightened few payers who have seen the fecal transplantation light, Burgess told me. "Most of the costs are being borne by the patients and the hospitals," he said, adding that there are reimbursement codes in place for elements of fecal transplantation delivery such as colonoscopy.

The Open Biome executive director expects other payers to see the benefits of FMT soon. "This is a really big win from the payer perspective," Burgess told me, noting a $250 bottle of fecal matter is a bargain compared to a $1,500 course of vancomycin.

But the biggest winners are C. diff patients.