Recommendation for NHSScotland

Conventional antibiotic therapies may be insufficient for a small and diverse group of patients with difficult to treat bacterial infections. This population is characterised by one or more of the following:
  • antibiotic resistance
  • antibiotic sensitivity but clinical recalcitrance
  • high risk of death or significant complications if surgical intervention is used to manage        their infection
  • patient specific factors that preclude the use of conventional antibiotics.

Bacteriophage therapy may, at the discretion of the responsible clinician, be appropriate management for patients with difficult to treat bacterial infections. A bacteriophage laboratory is being trialled within NHS Tayside. Bacteriophage therapy is not currently licensed by the Medicines and Healthcare Products Regulatory Agency and use must comply with their guidance on the supply of unlicensed medicinal products, available here.

Published evidence on bacteriophage therapy primarily consists of a heterogeneous collection of small single arm cohort studies, small case series and individual case studies. The majority of patients in these studies received bacteriophage therapy in combination with conventional antibiotic therapies. This means that there is a limited evidence base regarding the clinical effectiveness and safety of bacteriophage therapy.

The use of bacteriophage therapy is supported by a small number of randomised controlled trials suggesting that bacteriophage therapy may be effective for patients with difficult to treat bacterial infections.

Exploratory SHTG economic modelling and analysis suggest that the addition of bacteriophage therapy to standard of care is likely to be a cost effective use of resources within a subpopulation of patients with treatment-refractory diabetic foot infection at high risk of lower extremity amputation.

Use of bacteriophage in Scotland must be accompanied by the collection of data to monitor the clinical effectiveness and safety of bacteriophage therapy for specific clinical indications, in order to inform ongoing decision making on the provision of bacteriophage therapy in Scotland.

NHSScotland is required to consider Scottish Health Technologies Group (SHTG) advice.

What were we asked to look at?  

SHTG was asked to evaluate the clinical effectiveness, cost effectiveness, safety and patient experience of bacteriophage therapy in patients whose clinical needs are not met by antibiotics (for example, where bacteria have developed resistance to multiple antibiotics). 

Why is this important 

The incidence of antimicrobial tolerant and resistant bacterial infections is increasing worldwide, contributing to the strain on healthcare services due to longer hospital stays, rising medical costs and increased mortality. During 2016, it was estimated that multi-drug resistant bacterial infections alone caused 700,000 deaths globally each year; if current practices continue this figure is expected to rise to 10 million deaths by 2050. Bacteriophage therapy represents an option to address this problem in the near future.