This leaflet outlines upcoming changes to the availability of immunoglobulin products — both intravenous (IV) and subcutaneous (SC) — and how these changes may affect you.

These changes take effect in 2025, and your prescribing team will manage the transition on your behalf.

Why are these changes happening?

Every three to four years, the list of immunoglobulin products available for use within the NHS is updated. Pharmaceutical companies must submit applications and meet specific approval criteria before their products can be included in the new framework. The latest immunoglobulin framework comes into effect in April 2025.

To be included, all immunoglobulin products must meet strict criteria, including:

  • Compliance with rigorous safety and manufacturing standards
  • Competitive pricing per gram
  • Reliable supply availability

Not all products meet these criteria, so some will not be included in the new framework. The immunoglobulin product you are currently using is among those being discontinued under the new framework. This means you will need to switch to an alternative product. However, this withdrawal is not due to any safety concerns.

Which products are affected?

Both IV and SC products are affected. The products not included in the new framework include:

  • IV: privigen, iqymune, flebogamma, intratect 5%, gammaplex and octagam.
  • SC: subgam and hizentra (including pre-filled syringes).

How will my product change be managed?

Your prescribing team will transition you to one of the approved products over the coming months. If you have previously not tolerated a particular product, an alternative will be provided.

Patients receiving IV infusions at Barnet Hospital, Chase Farm Hospital, North Middlesex University Hospital, and Royal Free Hospital

Your new product will be administered in the same way as your current one, but at a slightly slower rate initially to ensure it is well tolerated.

Patients receiving IV and SC infusions at home

For most patients, your new product will be supplied by sciensus. You will need to confirm with your specialist nursing team whether it is well tolerated. Some home therapy patients may be asked, or can request, to have a supervised test dose at the royal free hospital. As hizentra is the only medication available as a pre-filled syringes patients currently using these will need to attend the royal free for additional training.

Should I be concerned about changing products?

Most IV and SC immunoglobulin products are well tolerated by patients. Your prescribing team will closely monitor your transition to ensure your new product is suitable for you.

All products on the current and new framework are manufactured to the same standard and will keep you well to the same degree as each other. Occasionally individuals may tolerate one product better than another which is why changes are only made when necessary.

UK plasma in immunoglobulin production

In addition to the new framework, UK plasma is now being used in immunoglobulin manufacturing. Since 1999, plasma from UK donors had not been used due to a theoretical risk of vCJD transmission. However, UK plasma collection resumed in 2021. From 2025, it will be used to produce a new IV product called gamten.

Patients currently receiving octagam will be switched to gamten. It is essentially the same product, manufactured by octapharma on behalf of the NHS. Within the next year, UK-sourced plasma will be used in approximately 35% of all immunoglobulin available in the UK. This means the NHS will be less reliant on immunoglobulin with plasma sourced primarily from America.