OBJECTIVES: Antimicrobial resistance is a global threat. Phage Therapy Medicinal Products (PTMPs) can help address this crisis by providing an effective treatment against resistant bacteria, but a clear regulatory and market access framework is lacking. PTMPs can be prêt-à-porter (pre-formulated ‘fixed drugs’ with marketing authorisation [MA]) or sur-mesure (personalised magistral preparations). The aim is to determine if current HTA processes are suitable to deal with both types.

METHODS: Methods guidance by HAS (France), G-BA (Germany), NICE (UK) and national policy documents were reviewed. Information was extracted on HTA processes and funding pathways. Eligibility to these were mapped to PTMP characteristics to determine fitness for purpose. Two analogues (larval debridement therapy [LDT], faecal microbiota transplant [FMT]) were analysed regarding HTA and funding.

RESULTS: Each of the HTA bodies (HTABs) implemented antimicrobial-specific processes. G-BA exempts from HTA a product qualifying as a “Reserve Antibiotic”. HAS published bespoke evidence requirements for “last resort” antibiotics. NICE is piloting a new antimicrobial-specific process.

The analogue review shows deviations between regulatory and funding positions. In all three countries, LDT and FMT are available. From a regulatory perspective both are ‘drugs’, yet only LDT is marketed as a drug (BioBag^®), while FMT is available as a procedure.

NICE assessed FMT (as a ‘Medical Technology’) but not LDT. Both are available on the NHS. HAS and G-BA assessed LDT but not FMT. LDT is routinely funded in Germany but not in France, following a negative HAS recommendation. In both Germany and France, FMT is only funded on a named-patient basis.

CONCLUSIONS: Existing HTA frameworks focus on antibiotics, excluding other innovative antimicrobials. HTABs only assess drugs with MA, thus are not prepared to assess sur-mesure PTMPs. A clear regulatory and access pathway should be established at European level to facilitate adoption of PTMPs and sustained national funding pathways for sur-mesure PTMPs created.