Question to the Department of Health and Social Care:

To ask Her Majesty's Government what changes they have made to the commissioning eligibility criteria for immunoglobulin use since the identification of a shortage of immunoglobulin; and (1) when, and (2) how, these will be implemented.

In 2021, NHS England and NHS Improvement updated the clinical commissioning criteria for the use of therapeutic immunoglobin. This update was independent of any shortages in the supply of immunoglobin. The criteria were amended to reflect the conditions where therapeutic immunoglobin treatment is now routinely commissioned and those where this treatment would no longer be routinely commissioned. This follows a clinical evidence review; advice from the Immunoglobin Expert Working Group; engagement with patients and clinicians; and the development of updated clinical policies for particular specialities. NHS England and NHS Improvement’s revised criteria was issued to National Health Service providers on 9 December 2021 for immediate implementation.

Tables showing a list of new indications where therapeutic immunoglobin treatment is now routinely commissioned and where the treatment will be no longer routinely commissioned are attached, due to the size of the data. The indications removed from the 2021 commissioning criteria due to limited clinical evidence for the efficacy of the treatment will be subject to further stakeholder testing in 2022 to determine future commissioning policy in these areas. In the interim these indications remain commissioned indications until the stakeholder testing has been completed.