PID UK's statement on the provision of IG replacement therapy

Here PID UK sets out its position on NHS England’s Guidance on switching immunoglobulin (IG) products for existing patients on long-term treatment and treatments for new and short-term patients (dated October 2017).

Fundamentally this policy promotes switching patients from one product to another based on the price of an IG product and will restrict the number of products that will be made available to PID patients living in England.

While PID UK is mindful of the financial constraints on the NHS, we believe this policy is not in the best interests of PID patients reliant on immunoglobulin as a lifelong therapy and is flawed and ill conceived for the following reasons:

  1. The decision to switch should be made only on the principle of clinical appropriateness. This is the long-held principle of professional bodies, such as UK PIN, and patient groups. Any deviation from this fundamental principle undermines the role of clinicians in individualising best care for patients and sets a precedent for the future provision of immunoglobulin to patients.
  2. The price of IG products should not be used as an indicator to switch. Over time, the cost of individual products rises and falls, so the cheapest product today may be tomorrow’s most expensive.  If cost is the main driver for switching, then switching will become the norm every time a new tender is agreed.  PID UK believes that ‘clinical management by tender’ is a totally unacceptable approach to the management of people with lifelong chronic illness.  
  3. The policy restricts the number of products available to patients, thereby reducing patient choice. Restricting the number of IG products available means that supply would be dependent on only a few providers and should a problem such as a batch contamination or problems with the manufacturing processes occur, then there could be IG product shortages for patients. This contradicts the NHS’s demand management system for immunoglobulin, which was set up to ensure plurality of supply so that these risks could be mitigated. 
  4. The safety aspects of switching products derived from one donor pool to another have not been adequately addressed, and again contradict best clinical judgement for people reliant on lifelong therapy. One of the key weaknesses of the policy is not aligning intravenous and subcutaneous products from the same manufacturer/donor pool. This is key in best managing patients should they need to switch from one route of delivery to another.

As a Patient and Public Voice member of the Immunology and Allergy Clinical Reference Group, PID UK has expressed the points above and has sought reassurance. However, NHS England has been unable to adequately address the concerns and, in consultation with the PID UK patient representative panel, PID UK has taken the decision not to co-produce or endorse NHS England’s patient information leaflet on switching IG products.

Supporting patients through this process

Patients living in England who receive IG therapy may be affected by this policy and you may have already been approached to switch products. We understand that the situation may be very worrying for you, so PID UK has developed its own independent information on switching, which can be found here. This information includes a list of questions you should ask your doctor when he/she approaches you to switch.

Posted 29th November 2017