Update on immunoglobulin supply situation

This information (dated 11th August 2021) from Immunodeficiency UK is to bring you up to date concerning the availability of immunoglobulin (IG) products in the UK. The information we are providing is based on our current knowledge of the situation.  We will continue to update you with information as we receive it.

Immunodeficiency UK understands that the IG situation will add to the high levels of anxiety that you may already be experiencing due to the COVID-19 pandemic. 

Background

COVID-19 pandemic has led to reduced plasma donations worldwide. Companies are reporting an approximate 20% drop in plasma donations in 2020 as compared to the previous year.  It takes between 6-9 months for plasma to be converted into immunoglobulin (IG) products so the global reduction in plasma donation is now impacting on the supply of IG in all countries.

Recent communications from the NHS (August 2021) have indicated that there will be up to a 14% decrease in supply of IG for at least the next six months.  Some immunoglobulin products are impacted more than others, and this means that you may have to be switched to other IG products, which are in more abundant supply, so that you can continue receiving your treatment.

Clinicians, pharmacists and Immunoglobulin Assessment Panels have been provided with guidance, endorsed by the body representing medical professionals, the UK Primary Immunodeficiency Network (UKPIN), on how to manage the short fall.

The guidance is centred around four keys principles: ensure no adverse clinical outcomes; ensure that product is well tolerated; ensure treating centre capacity to safely manage switch process and ensure that patients are able to comply and consent to change. It will be up to individual Trusts to decide on how to best manage the situation and the NHS will be working hard with suppliers and hospitals to ease the impact of the reduction in IG supply as much as it can. 

Switching immunoglobulin products

Switching, where needed, will be made following your consent and in discussion with your clinical team, who will support you throughout the process. It is our understanding that you will be given an NHS patient information leaflet describing why this is happening and what this means for you. Immunodeficiency UK unfortunately cannot signpost you to the NHS leaflet yet, but our own leaflet on switching may be helpful to you.

Learning from the past

In 2018, many patients had to switch products due to an immunoglobulin shortage caused by different reasons but the lessons remain the same. In our survey, at that time, we found that

  • 98% of respondents agreed that an immunoglobulin management system should ensure a secure, stable supply of a range of IG products for patients
  • 94% of respondents indicated that patients should have access to a wide range of IG products so that their treatment can be individualised
  • 94% of respondents indicated that patient choice was an important aspect of providing IG therapy to patients.

Here are some quotes from patients:

'I feel lucky that decisions about method of delivery and immunoglobulin product have involved me and my preferences. Regular, lifelong immunoglobulin therapy is a big part of a person's life and having it in a way that best fits their life and having a product that they feel comfortable and safe receiving are very important for overall health and well-being'.

'It is & should be respected for/as being life saving treatment. PID patients already have so much to cope with, without the huge anxiety of whether their particular treatment is/will continue to be available to them.'

Looking ahead

Companies have responded to the plasma shortage by opening new plasma donor centres in the USA, Canada, and some European countries to increase supply, but due to the long pipeline of manufacture, safety testing and batch release, it will take about one year to impact on global IG availability.

Immunodeficiency UK sincerely hopes that now plasma collection has restarted in the UK that a plasma fractionator will be appointed as soon as possible so the UK can become more self-sufficient and more resilient in providing IG therapies to its citizens. Our patient community deserves and needs stable and secure access to as wide a number of immunoglobulin products as possible.

National guidelines concerning the provision of immunoglobulin

Scotland www.nppeag.scot.nhs.uk/guidelines/

England 
NHSE_Commissioning_Criteria_for_the_use_of_Ig_V1.4_November_2019.pdf (mdsas.com)

Clinical guidelines for immunoglobulin use (second edition update)

Wales

Wales has taken a different approach from the demand management programme in England. The All Wales Immunoglobulin Strategy Group makes decisions.  Immunoglobulin products are managed via the Welsh Blood Service and local blood banks.

Northern Ireland

In Northern Ireland immunoglobulin is available as per the Department of Health, Social Services and Public Safety (DHSSPS) guidelines using an evidence-based prescribing process adopted from England's Department of Health guidance.

Posted 11th August 2021