Martin Bradley summarises the updated NHS England commissioning criteria for IVIg, and discusses the formation of new sub-regional panels
As this journal has previously highlighted, continuity of intravenous immunoglobulin (IVIg) supply is a long-standing issue for the NHS. There have been several significant supply problems with immunoglobulin in 2018/191,2 and usage has also been increasing.
There have been several significant supply problems with immunoglobulin in 2018/19 …
The Department of Health Clinical Guidelines for Immunoglobulin Use were published in 2008 to support demand management,3 aiming to protect access to immunoglobulin for those with the most severe and life threatening conditions in times of short supply. These guidelines were updated in 2011 and a colour coding system to triage indications was introduced:4
- red indications—conditions which have the highest priority for use
- blue indications—diseases for which there is a reasonable evidence base but where alternative treatments are available and usage should be modified in a national shortage
- grey indications—conditions for which the evidence base is weak, needing consideration on a case by case basis.4
Local hospital trust immunoglobulin assessment panels have reviewed and monitored usage of immunoglobulin and made decisions about the appropriateness of treatment. As a pass-through cost, immunoglobulin has been charged to NHS England when used in accordance with these guidelines, with some grey indications being routinely funded if approved by the local panel, and other grey indications requiring an Individual Funding Request to NHS England for consideration of funding.
Establishment of sub-regional immunoglobulin assessment panels
In 2016, a questionnaire on immunoglobulin assessment panel function identified considerable variation in the establishment, role, and function of immunoglobulin assessment panels across England.2 This, as well as the continuing supply issues, has led NHS England to instigate the formation of sub-regional immunoglobulin assessment panels (SRIAPs), to move to effective overall clinical stewardship of limited supplies, and to more effectively manage individual patient access (including eligibility, indications, dose, and duration). SRIAPs are intended to manage supplies within the allocation of available immunoglobulin. This is a shift from the current approach where immunoglobulin assessment panels have focused primarily on individual patient need and clinical indication, as opposed to overall prioritisation of supplies.
Across England, 20 sub-regional panels are in the process of being established (six in the South, four in London, six in the North, and four in the Midlands).2 The intention is that the SRIAP hub level will lead to more robust decision-making and improved oversight of the use of immunoglobulin in both new and existing patients than currently is the case with single trust panels. Cost savings are expected from this increased oversight (e.g. from dose, indication, and course length optimisation). These savings will accrue predominantly with the commissioner, and a 5% reduction in growth is expected.2
Who will sit on the SRIAP?
Each SRIAP is intended to include a secretary, clinical chair, neurologist, haematologist, immunologist, and specialist pharmacist or nurse.2 Specialised commissioners and commissioning representatives will also be on the panel, and it is intended to cover all the providers in the local area who use immunoglobulin. Each provider will be expected to designate a consultant and a pharmacist as demand management leads for their organisation, and be part of the core membership of the SRIAP. Paediatric, transplantation, intensive care, rheumatology, obstetric medicine, and infectious disease specialists may also be appropriate members of the SRIAP to support the core members, as immunoglobulin is also used in these specialities.5
How will the SRIAPs operate?
The purpose of the SRIAPs is to bring together expert clinicians and commissioners to form a decision-making team for effective immunoglobulin stewardship over a defined geographical area.5 Organisations will still need to have processes in place for urgent authorisation (e.g. Trust panel), and it is likely that local panel usage data will need to feed in to, and be scrutinised by, the relevant SRIAP. The SRIAPs would need to provide oversight and assurance as to the functioning of local panels or other local approval methods, and to ensure that providers report immunoglobulin usage on the national database.
The purpose of the SRIAPs is to bring together expert clinicians and commissioners to form a decision-making team
The SRIAPs will also be available to provide expert advice to local clinicians and Trust level immunoglobulin panels, and could potentially act as the local panel for organisations that do not currently have robust panels in place.5 Indications that currently require Individual Funding Requests will continue to do so at present, though when SRIAPs are fully operational, NHS England may use them to review requests for not routinely commissioned indications. Moving forward, the panels’ function may be modified as they become established and integrated into the framework of IVIg commissioning, provision, and review.
New IVIg guidance from NHS England
In tandem with the establishment of SRIAPs, the Department of Health Guidance for the use of immunoglobulin is being updated in stages. In January 2019, NHS England released updated commissioning criteria for immunoglobulin in immunology, haematology, neurology and infectious diseases.6 NHS England focused on these indications as these specialities have accounted for the bulk of immunoglobulin usage. Specifically, the old red and blue indications in these specialities have been updated. Though there is little change in terms of criteria for use, the new guidance provides greater detail around the role, dose and place of immunoglobulin in the treatment pathway for individual indications alongside possible alternative treatment options. The new dosing recommendations are based on a combination of available evidence and expert opinion. The update also states that immunoglobulin should now be dosed according to ideal body weight-adjusted dosing. Previously, dosing has not been addressed in immunoglobulin guidance, and there has likely been significant variation in bodyweight dosing across providers as well as specialities.⁶
The intention is that the current colour coding system will eventually be phased out from the guidelines and indications will only be divided into ‘routinely commissioned’ or ‘not routinely commissioned’ according to the strength of evidence. The colour coding scheme, however, will still apply if the demand management scheme requires implementation in times of short supply. The new guidelines also detail some indications as requiring local panel approval prior to use.⁶
The second phase of the update to the guidelines will review the use of immunoglobulin in current ‘red’ and ‘blue’ indications in other specialities, and a third phase will review ‘grey’ indications. NHS England will continue to commission these indications as per the criteria in the 2011 guidelines whilst the review is ongoing.⁶
- Topping K. Immunoglobulin: volatile market leads to huge NHS challenge. Specialised Commissioning 2018; 2 (4): 31–32. Available at: www.specialised-commissioning.co.uk/articles/immunoglobulin-volatile-market-leads-to-huge-nhs-challenge/
- NHS England, NHS Improvement. 2019/20 PSS CQUIN scheme—indicator template. NHS England, 2019. Available at: www.england.nhs.uk/wp-content/uploads/2019/03/PSS9-Immunoglobulin-flat-final-PSS-CQUIN-Indicator-1920.pdf
- Provan D, Nokes T, Agrawal S et al. Clinical guidelines for immunoglobulin use—second edition. Department of Health, 2008. Available at: assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/216672/dh_130393.pdf
- Wimperis J, Lunn M, Jones A et al. Clinical guidelines for immunoglobulin use—second edition update. Department of Health, 2011. Available at: assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/216671/dh_131107.pdf
- Immunoglobulin Sub-Regional Assessment Panel terms of reference. NHS England, 2019.
- Updated commissioning criteria for the use of therapeutic immunoglobulin (Ig) in neurology, haematology, neurology and infectious diseases in England January 2019. NHS England, 2019. Available at: igd.mdsas.com/wp-content/uploads/Ig-PWG-Guidance-for-the-use-of-Ig-V1.3-12022019.pdf