NHS England commissioning update Mandy Matthews 14th December 2018

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

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?

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

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

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

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

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

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

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

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

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: https://www.england.nhs.uk/specialised-commissioning-document-library/routinely-commissioned-policies/ and https://www.england.nhs.uk/specialised-commissioning-document-library/policy-statements-urgent-policy-statements/ Public Health England provides advice on use of immunoglobulin at: https://www.gov.uk/government/publications/immunoglobulin-when-to-use