The Advisory Committee on Borderline Substances (ACBS) is responsible for assessing and recommending products applying for listing in Part XV of the Drug Tariff. The ACBS periodically reviews products listed in Part XV to ensure they are still clinically effective and recently looked at the probiotics VSL#3 and Vivomixx.
The Committee concluded that the evidence did not sufficiently demonstrate that the products are clinically effective. The original studies were small and described high rates of recurrent pouchitis in the control groups than one would expect in clinical practice (as described in reviews & case series of pouchitis). The Cochrane review felt there was 'low quality evidence' of benefits. There are no new supportive studies (one unsupportive) to confirm efficacy. The ACBS & MHRA’s position has developed such that they would be likely to consider the presentation of a product to prevent a clinical condition such as pouchitis as a specific medicinal claim. As such, any product presented with such a claim may more appropriately be considered by the MHRA to fall within the definition of a medicine and would be regulated accordingly.
In reaching its conclusion, the Committee also considered NHS England’s consultation report on conditions for which over the counter items should not be routinely prescribed in primary care, which recommended that probiotics should not be routinely prescribed in primary care due to limited evidence of clinical effectiveness.
On this basis, the ACBS recommended to the Secretary of State for Health and Social Care that VSL#3 and Vivomixx be removed from Part XV of the Drug Tariff. The Secretary of State accepted the recommendation and the products have recently been removed from Part XV of the Drug Tariff.