Excess Treatment Costs
The costs of non commercial research are met by different funders depending on the type of cost. Guidance from the Department of Health and Social Care for the Attribution of Costs for Research and Development (AcoRD) sets out the principles for determining who pays for the different costs.
Treatment Costs are the care costs that would continue to be incurred if the patient care service in question continued to be provided following the end of the research study. The difference between the Treatment Costs and the costs of the existing standard treatment is referred to as the Excess Treatment Cost (ETC).
ETCs are paid for by service commissioners.
Identification of Excess Treatment Costs
ETCs must be accurately identified as part of the research funding application to ensure that health care providers can be reimbursed by the appropriate funder.
Researchers are required to complete one of the Schedule of Events Cost Attribution Template (SoECAT) forms which help calculate an average per patient ETC value for the study. The NIHR Clinical Research Network provides AcoRD specialists to support researchers, their teams and sponsors in completing this. For more information about AcoRD support, visit our study support service.
This process also helps identify the commissioner responsible for the payment of the ETCs in the study. This is dependent upon the service under study. These fall under two categories: NHS and non-NHS commissioners.
For the benefit of grant applicants and Sponsors it has been decided that, as part of SoECAT development, a second SoECAT (Template B) has been made available for use with studies which have up to 15 study arms. The availability of this extended template has been requested by the community at large and is located here as an addition due to it's increased file size. All applicants completing a SoECAT with five or fewer arms are still advised to complete Template A.
Download the Schedule of Events Cost Attribution Template A (SoECAT)
Download the Schedule of Events Cost Attribution Template B (SoECAT)
Read the supporting guidance for researchers, study teams and sponsors to complete the SoECAT
Please report any SoECAT functionality issues or improvement suggestions directly to the Health Research Authority via firstname.lastname@example.org
NHS ETCs are paid for either by NHS England as the direct commissioner, for example in Specialised Commissioning, or by NHS Clinical Commissioning Groups, depending on the service under study. ETCs are paid to the organisations that have recruited the participants. These organisations will normally be expected to hold a NHS contract to provide clinical care.
In order to calculate the payments due to each organisation, the agreed ETC per patient value is multiplied by the number of study participants recruited at that organisation. The data held on the NIHR Central Portfolio Management System are used for these calculations.
Each provider has an annual ETC threshold that must be reached before additional payments are made. When a provider has reached this threshold, ETC payments will then be made on a quarterly basis in arrears. The threshold does not apply to studies where NHS England is the responsible commissioner.
Payments for studies for which NHS Clinical Commissioning Groups are the responsible commissioner are made to recruiting organisations through the NIHR Local Clinical Research Networks. Payments for studies for which NHS England is the responsible commissioner are made to the recruiting organisations directly by NHS England via the normal contractual route.
Specialised and other direct commissioning studies
Studies linked to any nationally-commissioned services begin the process of defining values in exactly the same way as studies relating to CCG-commissioned services, using the SoECAT and supported by AcoRD specialists. Studies identified as linked to specialised or NHS England's other direct commissioning functions may be asked to complete one additional costing template to appropriately finalise payable ETCs.
Only studies which received research funding approval after 1 October 2018 are subject to the new national process – any studies funded before this date will continue to use the historic process, and will not be transitioned. For these studies using the historic process, ETC approval sits with the relevant commissioning team (e.g. local / regional specialised commissioning team(s)), as budget holders for clinical activity commissioned from local trusts and other commissioned providers. The contact details for regional / local specialised commissioning teams can be found here.
Non-NHS ETCs refer to ETCs in studies of services for which Public Health England, Local Authorities or other non-NHS bodies are the responsible commissioners.
Separate guidance is available for researchers undertaking public health research in organisations in England and who are seeking funding for ETCs.
High Cost Threshold Process
NHS-funded ETCs are subject to a High Cost Threshold which has been introduced to enable NHS England and the DHSC to review studies with high cost ETCs to ensure that the research represents good value to the NHS. The High Cost Threshold is £1M per study and/or an average per patient ETC of £20,000.
NHS England and DHSC are keen to have early sight of the pipeline of studies that could potentially be above the threshold when funded. Therefore, funders are asked to notify NHS England when an application is received for a study with ETCs that reach the High Cost Threshold.
Once a funder has confirmed the intention to fund a High Cost study, an assessment of value to the NHS will be conducted prior to agreement to reimburse ETCs. It will take up to six weeks for a decision to be made.
- For studies where the ETCs mainly relate to CCG commissioned services, an assessment of clinical alignment will be undertaken 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 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 is delivering to time and target realistic, have opportunities been taken to explore the use of the best value product (e.g. biosimilars).
For further information regarding the High Cost Threshold process please contact england.highcostETC@NHS.net
For all queries relating to the ETC arrangements, contact: email@example.com
Note that queries submitted using the previous email address (firstname.lastname@example.org) will still be actioned and there is no requirement to re-submit.
For further information regarding the High Cost Threshold process, contact england.highcostETC@NHS.net
To report any SoECAT functionality issues or improvement suggestions, contact the Health Research Authority via email@example.com