Supply of Immunoglobulin products in England

Dear UKPIPS member,

We are writing to you to advise you of some recent changes that NHS England (NHSE) has made to the supply of Immunoglobulin products in England.

We were made aware in December of last year that NHSE had spent much of 2024 tendering for a new framework contract for Immunoglobulin products and has signed a new Contract. We were told that their aim in doing this was to arrange supply of a new product that uses plasma donated in the UK as its source, and to improve stability and continuity of immunoglobulin product availability.

Since then, we have been working hard to clarify what this means for patients and clinicians so that we can communicate to our community and feed back to NHSE any concerns or questions that arise.

NHSE has issued statement on the process and their view of the implications. However, there remains uncertainty around how patients can remain on products that have not been awarded in this contract (particularly pre-filled syringes but also withdrawn products which are prescribed to fulfil a clinical requirement). The NHS has changed their emphasis from “clinical need” to “under rare circumstances”, and we are trying to get an answer on what “rare circumstances” means – both for the patient, but also for clinicians (in terms of requesting that a patient stay on their non-awarded product).

The text of the NHSE statement is as follows:

2025 Changes in Immunoglobulin Product Supply in England

In 2025, there will be several changes to the supply of Immunoglobulin (Ig) products in England, aimed at increasing self-sufficiency and ensuring more reliable product availability. These changes will apply to all conditions that require the use of Immunoglobulins.

New Immunoglobulin Framework (April 2025)
In April 2025, a new Framework for the supply of immunoglobulin will be launched, comprising three main suppliers to cover the demand for immunoglobulin products. A Framework is a public contract awarded following a fair and transparent competitive tendering process, and it sets out the provisions under which NHS Trusts can enter into contracts for the supply of goods. This framework, which will be in effect until at least December 2027, (with the option to be extended for a further 15 months), streamlines and strengthens the supply chain in the best interests of patients.
Introduction of New Brand: Gamten 10% IVIg (Q1 2025)
Alongside the new Framework, a new Immunoglobulin product for the UK, Gamten 10% IVIg, will be introduced in early 2025. This product is manufactured using the same process as Octagam 10%, but using plasma donated within the UK. Using domestically sourced plasma to manufacture plasma derived medicinal products will improve the resilience of the NHS supply chain and enable the health service to better withstand global disruption. This contract will be in effect until at least January 2030, (with the option to be extended for a further 24 months).

The suppliers and brands that have / have not been awarded are included at the end of this post.

Changes to Product Supply: Patient Impact and Brand Switching

The new Framework and awarded products will require some patients to switch to a different treatment brand.

Existing patients on long-term Ig on any of the products that have not been awarded on the new framework (shown in the table below) will need to be switched to an alternative IVIg or SCIg preparation as appropriate.

The need to switch Ig preparations is well-recognised and previous switches have been undertaken safely, with no systemic adverse effects.

There are no functionally significant differences in any product and patients and clinicians should be reassured accordingly.

The NHS is working with all relevant healthcare professionals and providers, including nurses, clinicians, pharmacists, and homecare delivery companies to ensure a safe and timely implementation.

Implementation

Where a patient is identified for switching from their current brand, they will be contacted by a member of their clinical team. Patients’ treatment frequency and dosing will remain in line with national clinical guidelines and patients will be monitored to ensure product is well tolerated with no adverse clinical outcomes. It is expected that patients treated with intravenous immunoglobulin will be switched by no later than September 2025, and patients on subcutaneous immunoglobulin will be switched by no later than December 2025. Patients identified for switching will be contacted by their clinical team from January 2025 onwards. Where possible, patients will be switched at their next scheduled appointment to minimise the need for additional visits.

It is natural that you may feel some concern around these changes. UKPIPS will continue to engage with NHSE to ensure that relevant concerns are considered and responded to, so we encourage you to discuss this with your clinician team and get in touch with us over any unanswered questions – we can be reached via telephone, email or the website (see the footer on this letter) and if you use Facebook you can visit the private discussion group.

Naturally, as the situation develops, we at UKPIPS will do our best to keep you informed.

Yours Sincerely,

UKPIPS.

Improving the lives of people with

Primary Immune Deficiency

Supply of Immunoglobulin products in England