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Faecal microbiota transplant for recurrent Clostridioides difficile infection

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4 Committee discussion

Clinical-effectiveness overview

C. difficileFMT is an effective treatment for recurrent infection for people who have had 2 or more previous episodes

4.1 The randomised controlled trial (RCT) evidence showed that faecal microbiota transplant (FMT) was significantly better at resolving a recurrent Clostridioides difficile infection than vancomycin in 4 RCTs, and better than fidaxomicin in 1 RCT. Only 1 RCT found no statistical difference in the efficacy of FMT compared with antibiotics. The committee acknowledged that there are limitations to the evidence base. However, it said that there is an unmet need in this population and FMT is likely to be an effective alternative to continued antibiotic use. It also acknowledged that FMT is already being used in the NHS for recurrent C. difficile infections and is recommended in NICE's guideline on antimicrobial prescribing for C. difficile infection. Therefore, the committee agreed that FMT should be recommended to treat a recurrent episode of C. difficile infection if people have had 2 or more previous episodes.

C. difficileThe use of FMT for refractory infections is uncertain because the definition of refractory is not clear

4.2 The external assessment centre (EAC) did not identify in-scope RCTs comparing FMT with antibiotics for refractory C. difficile infections. The clinical experts said that there is no consensus on the definition of refractory C. difficile infections, meaning that there is less available evidence. The committee acknowledged that FMT could benefit this population, but there was too much uncertainty in the definition of refractory infections to make a recommendation in this population.

FMT via enema is likely to be less effective but is a clinically appropriate option in some cases

4.3 The clinical evidence showed that FMT given via enema had less efficacy than that of the other administration routes evaluated. Clinical experts said that FMT is usually done by NGT or colonoscopy, depending on patient preference and suitability of the procedure. However, they said that it was important to have the option of enema available for people who could not have other routes of administration. The committee acknowledged that, although enema was a less effective route of administration, it should be available as an option for people who cannot have FMT by another route.

There is no evidence in scope comparing FMT via oral capsules and antibiotics

4.4 The EAC did not identify any RCTs comparing FMT given in oral capsules with antibiotics in people with a second recurrence of C. difficile infection. As a result, no evidence was presented for the clinical efficacy of oral capsules. However, the EAC did identify 2 studies for its economic evaluation (1 RCT and 1 systematic review and meta-analysis), which showed that oral capsules were as effective as FMT via colonoscopy. It also said 2 ongoing RCTs are comparing the oral capsules with antibiotic treatment. Clinical experts said that, if oral capsules were more widely available, they would be preferred because of safety and patient acceptability, especially because newer capsules containing lyophilised FMT material can be given in fewer pills than older versions. The committee acknowledged that, although the comparative evidence presented was limited, oral capsules are a promising option for FMT treatment.

Safety

A strict donor screening programme should be followed

4.5 The joint British Society of Gastroenterology and Healthcare Infection Society guidelines say that donor screening should be done for all potential stool donors. This includes a questionnaire and personal interview, to establish risk factors for transmissible diseases and factors that could affect the gut microbiome. Blood and stool screening for transmissible disease must also be done. Clinical experts said that only a small proportion of donors pass screening, and they are generally young and healthy adults. The committee acknowledged that there is still a risk of disease transmission because screening tests are not 100% sensitive. However, it acknowledged that the strict donor screen programme used currently makes FMT relatively safe. The committee also acknowledged that NICE's interventional procedures guidance on FMT for recurrent C. difficile infection has reviewed the safety of FMT.

Other patient benefits or issues

C. difficilePeople with a recurrent infection need to be informed about FMT

4.6 Patient experts said that recurrent C. difficile infections reduce quality of life. Pain and diarrhoea symptoms mean people can need help with day to day living and may not be able to work so lose income. Diarrhoea symptoms can also affect people's dignity, especially when it leads to incontinence or when the person is in a hospital or nursing home. The patient experts said patients and clinicians need to be made more aware that FMT is a treatment option for recurrent C. difficile infection.

Donor diet may need to be considered when offering FMT

4.7 The committee acknowledged that FMT may not be appropriate for some people with an anaphylactic food allergy. It also recognised that the diet and alcohol consumption of potential donors may be a barrier to having FMT for people from some faith groups or people with dietary preferences. The clinical experts said they had not experienced problems relating to religious beliefs but acknowledged that this is a valid consideration.

Cost modelling overview

FMT is cost saving compared with antibiotics in the EAC's original economic model

4.8 The base case showed that FMT is likely to be cost saving by at least £3,300 per person, compared with antibiotics. The committee acknowledged that the clinical evidence was very heterogeneous. But the cost savings were robust enough to recommend FMT for recurrent C. difficile infections for people who have had 2 or more previous episodes.

FMT remains cost saving in all scenarios in the EAC's original scenario analyses

4.9 FMT remained cost saving in all 5 scenarios presented by the EAC (see section 3.13). Clinical experts said that a short course of antibiotics is used before most FMT treatments and that the length of stay for treatment with FMT or antibiotics is likely to be short. So the committee felt that the 2 scenarios analyses done by the EAC that assumed a 1‑day hospital stay and pre-antibiotic treatment for all FMT rounds best reflected the care pathway for FMT, and reduced uncertainties in the modelling. Overall, the committee acknowledged that FMT remained cost saving in all scenarios but requested a new base case analysis to include these assumptions.

FMT remains cost saving compared with antibiotic treatment in the EAC's updated economic model

4.10 The updated base case found that FMT remained cost saving by at least £1,500 compared with antibiotic treatment. The lowest cost savings were for FMT given via enema, because it is a less effective administration route. FMT via colonoscopy, NDT and oral capsule saved between £3,691 (FMT via colonoscopy compared with VTP) and £11,274 (FMT via oral capsule compared with vancomycin). The updated probabilistic sensitivity analysis showed FMT was estimated to be cost saving 80% (FMT via enema compared with VTP) to 100% of the time (FMT via oral capsule compared with all antibiotics, and FMT via NDT compared with vancomycin or fidaxomicin) compared with antibiotic treatment. The EAC also updated scenarios 2, 3 and 4 of the original model (see section 3.13). FMT was found to remain cost saving in almost all scenarios. The only scenario in which FMT was cost incurring was for FMT via enema compared with VTP, and VTP was given as the repeat treatment for everyone in the persistent C. difficile infection state. In this scenario FMT was cost incurring by £518. But overall the committee concluded that FMT was highly likely to be cost saving compared with antibiotic treatment.