1. NHS England commissioning update
Mandy Matthews
14th December 2018

2. Use of immunoglobulin in England
NHS England is responsible commissioner for immunoglobulin
2017/18 annual spend approaching £190 million in England
Commissioned in line with national Clinical Guidelines
Significant supply issues in 2018
Patient care
Resources required to manage supplies

3. Significant risks: Availability – nationally & globally
On-going growth in use
CART-T
Market share of products and risk if a supply issue; product choice
Variation in use, e.g. indication, dose, frequency
Decision making – how robust, variation in IAPs, IFRs
Data
Impact of exit from EU?

4. Steps to manage risk:
Improved collaborative working – Commercial medicines unit, clinicians, NHS England, Public Health England, MDSAS
Immunoglobulin project working group
Review of the current Clinical Guidelines for Immunoglobulin use
Sub-regional Immunoglobulin Panels
Proposed CQUIN for 2019/20
Proposed prior approval

5. Guidelines review: Launching 1st four sections: Haematology Immunology
Infectious diseases (specific)
Neurology
Next steps:
Review use in “other” indications, including other infection-related use
Review evidence for grey indications
Stakeholder consultation; updated based on feedback – launching via hubs
Support IAPs to review existing patients
Includes reference to alternative therapies – e.g. rituximab in MG; link to policies on last slide
Advice on dosing in neurology
Guidance available on IG in ID in line with PHE recommendations – only relates to hep A, measles, polio, tetanus, varicella. Use of Ig in other infection associated conditions, e.g. staph toxic shock syndrome, c. diff – will be considered in the next phase of the review

6. Sub-regional Immunoglobulin Assessment Panels (SRIAPs):
Improve scrutiny & stewardship of immunoglobulin use
Support demand management
Manage usage within allocated volumes
Improve communication channels in times of supply issues
Compliance with NHS England commissioning guidance; review of existing patients; new patients
Support data collection
Looking at up to 20 IAPs in place across England – based on hub and spoke model. 6 in the North and in the South; 4 in London; 3 in M&E.
Resources being provided include TOR, peer support via panel chairs’ calls, data

7. Immunoglobulin CQUIN:
Provide funding to support the development of SRIAPs
Role of SRIAPs in stewardship of immunoglobulin
Ensure compliance with commissioning guidance
Support implementation of prior approval
A tool to support panels to deliver those actions detailed on previous slide

8. Prior approval:
Automated system to approve use of Ig in line with updated guidance
Approval required prior to use
Options:
MDSAS national immunoglobulin database
Blueteq
How to incorporate this into trust processes

9. Key messages: Importance of SRIAPs in managing demand
New patients to meet eligibility criteria
Review of existing patents in line with updated guidance
Alternative therapies
Data is key – usage & outcomes must be reported on the database

10. Prior Approval In your groups consider the following: Options:
MDSAS national immunoglobulin database
Blueteq
Pros and cons of each system?
Issues for providers?
What would support implementation?
Use to introduce group discussions on merits of prior approval, issues which will need to be overcome and pros/cons of each method. Record feedback on sheet on the table – 15 mins; then feedback to whole

11. Sub-regional Immunoglobulin Panels
In your groups consider:
Progress so far
Issues, concerns
Resources required to support the panel

12. Useful links: Rituximab, as a treatment option, in :
Anti-NMDAR autoimmune encephalitis
Cytopaenia complicating primary immunodeficiency
Dermatomyositis and polymyositis
Immunobullous Disease
Commissioning policies and position statements are available at: and
Public Health England provides advice on use of immunoglobulin at: