Instability in Immunoglobulin supply

2018 has been a year of instability in provision of immunoglobulin (IG) products to patients. We understand that at least 800 patients (1) have had to switch products for a number of different reasons affecting supply. This article summarises the situation and the actions PID UK are taking.

What has caused this instability?

There are many factors that have affected the provision of IG products in the UK. These include the repercussions of the decisions taken by NHS commissioners in 2017, the impact of market forces resulting in companies allocating IG products to other countries, the withdrawal of the IVIG product Kiovig by Shire and technical and regulatory issues affecting the availability of some other products.

These issues have been compounded by a worldwide plasma shortage – demand for IG and other plasma products is outstripping supply. The shortage is due to a number of factors: plasma products, including IG, are being used to treat an increasing number of different medical conditions; many more countries can now access plasma products i.e. companies have many more markets to sell their products to, and thankfully, doctors are getting better at diagnosing PID and other medical conditions. These developments have impacted on the accuracy of companies demand forecasts. Companies have responded by opening up new plasma donor centres in the USA, Canada, and some European countries but due to the long pipeline of manufacture, safety testing and batch release, it will take at least one year to impact on global IG availability.

Plasma has not been collected in the UK since the epidemic of vCJD due to BSE (mad cow disease) in the late 1980’s and early 1990’s. This means the UK is entirely dependent on plasma sourced elsewhere. Since the UK has now had the same levels of “sporadic” CJD as the rest of the world for many years, and there is no evidence of onward transmission of CJD in plasma the government will hopefully reconsider the position on the use of UK sourced products in the near future.

Should PID patients in the UK be worried by the world plasma shortage?

Regardless of where you live in the UK, PID patients should not be concerned that they will be unable to have IG therapy. In times of shortage IG supplies are prioritised for PID patients over other conditions. Mechanisms to protect PID patients include manufacturers ‘ring fencing’ IG for PID patients, and NHS systems to ensure IG healthcare needs are met ‐ Clinical guidelines for IG use (2nd Edition, 2011) and the Department of Health‐initiated National Demand Management Programme for IG (available at http://igd.mdsas.com/).

NHS staff are liaising between companies and hospitals to make sure that PID patients are getting the IG infusions they need, although this may sometimes necessitate changes in product and/or route of administration. Immunology‐nursing teams have been working extremely hard, juggling product availability to ensure minimal disruption to patients and we are very grateful for their work.

Our website has a wealth of information about IG and about our other advocacy activities concerning this matter.

What is PID UK doing to help?

1. PID UK is working with UK PIN, the National Immunology and Allergy Nurses Group and the British Society of Immunology to:

a. Make NHS England accountable for its commissioning decisions.

We are pressing for publication of a ‘lessons learned’ report concerning commissioning decisions in 2017 and an agreed action plan for future frameworks.

b. Persuade NHS England to increase the number of subcutaneous products available to patients.

Currently only one subcutaneous product is routinely commissioned. Patients should have access to as wide a range of products as possible.

c. Make the NHS provide the PID community with information on how regional Immunoglobulin Assessment Panels (IAPs) will work, reach decisions and be supported.

IAPs will help ensure that IG is available to patients that need it through better stewardship of IG prescribing. This may help close the gap between demand and supply, however PID UK wants transparency on how decisions will be made.

d. Get the NHS to publish the newly updated guidelines on IG use as soon as possible so as to guide IAPs.

2. PID UK opposed the Government’s proposed changes to include plasma products under a statutory scheme to control the cost of branded health medicines.

This scheme, if implemented, means that companies supplying IG will be asked to pay a surcharge to the Government based on sales. The repayments proposed are 9.9% in 2019 rising to 21.7% in 2021. NHS tendering for IG is already very competitive and these proposals risk further destabilising IG provision by making it unattractive for companies to supply the UK market.

3. Representatives of PID UK are working with the Plasma Protein Therapeutics Association’s taskforce to determine global priorities in plasma product supply, coordinate actions to increase donors and improve government’s awareness of the plasma market.

As part of this work the taskforce will be lobbying the UK Government to allow collection of UK plasma. However, this will not be a quick‐fix solution for the problems the UK are currently experiencing but will provide much needed security for UK PID patients in the future.

PID UK will keep you updated on developments.

(1) Data from the 2018 UK PIN Census (report to be published).

Article posted 22nd November 2018