Excess Treatment Costs

NHS Treatment Costs are the patient care costs that would continue to be incurred if the treatment being researched continued to be provided after the research study has stopped. Excess Treatment Costs (ETCs) occur when the costs of a drug or treatment are higher in a research study than in routine care.

The Department of Health and Social Care (DHSC) is responsible for funding ETCs associated with research into services that are either locally commissioned by Integrated Care Boards (ICBs) or that are nationally commissioned services, including the NHS England commissioning function.

The system is managed on behalf of DHSC by the NIHR RDNCC (RDN Coordinating Centre). The AcoRD guidance sets out the principles for attributing the costs of health and social care research, including how to determine what is an NHS Treatment Cost.

Excess Treatment Costs and the SoECAT form

ETCs must be accurately identified as part of the research funding application. The Schedule of Events Cost Attribution Template (SoECAT) is an online form that attributes the different activities and costs associated with clinical research in a standardised way in line with the AcoRD guidance. The SoECAT calculates an average per patient ETC value for the study. This process also helps identify the commissioner responsible for the payment of any ETCs in the study.

Please note that the SoECAT form should be used only for attribution of cost type (Research Part A, Research Part B, Support Costs or Excess Treatment Costs), but is not a costing tool, and should not be used to calculate the amount of funding requested for Research Part A costs.

Sign off by an AcoRD specialist

As part of your funding application to BHF, researchers (usually the Chief Investigator or their study team) are required to complete the SoECAT. You must send your completed SoECAT to your NIHR Regional Research Delivery Network (RRDN) AcoRD specialist to be authorised. There are different ways to contact an AcoRD specialist, depending on where the Chief Investigator/lead site is based:

England: NIHR Study Support Service
Scotland: NHS Research Scotland Research and Development Contacts
Wales: [email protected]
Northern Ireland: HSC Research & Development Division

For the funding application to be valid, the AcoRD specialist must approve and sign off the final completed SoECAT, confirming that the attribution of costs is accurate, prior to you submitting the application to BHF. Sign off of the SoECAT by an AcoRD specialist is also a prerequisite for the study to be eligible for the NIHR Research Delivery Network Portfolio and to access the support portfolio adoption provides.

You should engage with an AcoRD specialist as early as possible and provide as much notice as possible that support will be required.

The minimum time required to ensure sign off by the submission date is 20 working days before the submission of a funding application.

Please allow at least 10 additional working days for authorisation of a SoECAT by an AcoRD specialist for any amendments or escalations to be resolved.

If you are submitting a full application to the BHF for a Clinical Study Grant to support a study taking place in England, you will need to submit the signed-off SoECAT to the BHF as part of your online application on the Grants Management System.

High cost threshold process in England

NHS-funded ETCs are subject to a high cost threshold, which has been introduced to allow NHS England and DHSC to review studies with high cost ETCs to ensure that the research represents good value to the NHS. The High Cost Threshold is £1 million per study and/or an average per patient ETC of £20,000.

NHS England and DHSC are keen to have early sight of studies that could potentially be above the threshold when funded. BHF will notify [email protected] and [email protected] if your application is for a study with ETCs that reach the high cost threshold.

If you are applying for support for a clinical study with high cost ETCs, If the proposal is recommended for an award by the BHF committee:

BHF will need to notify NIHR RDN ([email protected] ) and the High Cost Review team at DHSC ([email protected]) and NHS England ([email protected] ) to trigger the high cost ETC review process
BHF will award research funding ‘in principle’ pending an assessment of value to the NHS, which will be conducted prior to agreement to reimburse ETCs. The assessment of value will take up to 6 weeks for a decision to be made.
In parallel, when you receive confirmation that research funding ‘in principle’ is awarded, you must inform the lead LCRN’s AcoRD specialist for the study, as denoted on the front of the authorised SoECAT form
If funding ‘in principle’ has been awarded dependent on changes to the study design, you must inform the AcoRD specialist so that any subsequent changes to the attribution of study activities are reflected, if appropriate, in an amended and authorised SoECAT
The AcoRD specialist will inform the research team of the outcome and next steps (see additional supporting information).

Assessment of clinical alignment for high cost ETCs

For studies where ETCs mainly relate to integrated care board (ICB) commissioned services, an assessment of clinical alignment will be undertaken. Assessment is on a case by case basis by NHS England and DHSC clinical experts.

For high cost ETCs relating to specialised commissioning, an assessment of clinical alignment will be undertaken. Assessment is on a case by case basis by the relevant Regional Medical Director and the Clinical Co-Chair of the relevant programme of care.

Criteria for the assessment of clinical alignment are as follows:

Is the level of proposed ETC investment proportionate to potential future benefits to patients?
Does the study replicate research already undertaken?
Is the study an important clinical area but misaligned with NHS England and/or DHSC’s understanding of the treatment regime or patient cohort that might be best prioritised for further study?
Are there any significant concerns about the study design? For example realistic delivering to time and target, or have best value opportunities been explored?

Further information

Queries related to ETCs

For all queries relating to the ETC arrangements, contact [email protected]
For further information regarding the High Cost Threshold process, contact [email protected]