What are ETCs?
About Excess Treatment Costs (ETCs)
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 (DHSC) 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.
For answers to commonly asked questions on AcoRD, see the Department of Health and Social Care's Annex B - Attributing the costs of health and social care Research & Development (AcoRD) FAQs.
Excess treatment costs: Guidance on the national management model for England
NHS England guidance published in September 2021 provides the framework for how ICB commissioned studies which incur ETCs are paid, and sets out the provider types which can utilise the national payment system. The purpose of the guidance is to assist researchers navigate the ETC system.
Visit the NHS England website to read Excess treatment costs: Guidance on the national management model for England.
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 a Schedule of Events Cost Attribution Template (SoECAT) which calculates an average per patient ETC value for the study. AcoRD Specialists at NIHR Local Clinical Research Networks (LCRNs) are available to support researchers, study teams and sponsors in completing and authorising the completed SoECAT. Further information about AcoRD attribution support can be found on our advice, guidance and tools to help plan your research study page. To get in touch with an AcoRD specialist, contact the Lead LCRN for the study (usually the LCRN where the Chief investigator/lead site is based). Please allow a minimum of 10 working days for authorisation of a SoECAT by an AcoRD Specialist.
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. Futher details of the ETC process can be found here.
SoECAT guidance
Please visit our online SoECAT guidance page for more information on completing a SoECAT.
Please report any SoECAT functionality issues or improvement suggestions directly by email to etc.helpdesk@nihr.ac.uk, including 'SoECAT functionality' within the email subject line.
NHS Excess Treatment Costs (ETCs)
NHS ETCs are paid for either by NHS England (NHSE) as the direct commissioner, for example in Specialised Commissioning, or by NHS ICBs, depending on the service under study.
ICB Commissioned Studies
In order to calculate the ETC payments for studies commissioned by NHS ICBs the agreed ETC per participant value is multiplied by the number of study participants recruited and recorded as confirmed on the NIHR Central Portfolio Management System (CPMS) at the time of the NIHR quarterly data cut deadlines. No retrospective ETC payments will be allocated to missed recruitment recorded on CPMS for any past financial years. It is then given 1 of 8 payment models which calculate and determine the organisation due to receive payment. For more information please see the ETC Process & Guidance.
Each provider in England has an annual ETC threshold that must be reached before ETC payments are made. Please see ICB ETC payment timetable for more detailed information. When a provider has reached this threshold, ETC payments will then be made. The threshold does not apply to individual studies, but to the organisation due to receive the ETCs.
Payments for studies for which NHS ICBs are the responsible commissioner are paid in England through the NIHR LCRNs to the organisations identified in the Payment Model that has been agreed with the study Sponsor, following discussions with the NIHR CRNCC.
For all queries relating to the ETC arrangements, contact: etc.helpdesk@nihr.ac.uk
ICB Excess Treatment Costs updates: for all changes to the process and updates to the ICB payment system please click on news updates.
Specialised Commissioning Studies
For studies where the responsible commissioner is NHSE Specialised Commissioning and research funding approval was received after 1 October 2018, an additional financial assurance process is undertaken to determine the ETC per participant value that will be supported.
Following Triage, the Specialised Commissioning Team will review the SoECAT and reach out to the study team directly if they require any additional information. The purpose of this additional assurance step is to establish which activities will be paid via standard pre-existing Specialised Commissioning contractual arrangements, and should therefore be charged via these usual routes, whether there are any additional activities that will not be covered, and what the costs associated with these are. Once this assurance process is complete, the ETC per participant value and additional per participant payment for the study is confirmed.
Studies which received research funding approval prior to 1 October 2018 will continue to use the historic process. For these studies ETC approval sits with the relevant regional Specialised Commissioning Teams, as budget holders for clinical activity commissioned from local trusts and other commissioned providers. Contact details for regional / local specialised commissioning teams can be found on the Specialised Commissioning ETC Frequently Asked Questions (FAQs) and further information about regional teams can be found on the NHSE website.
High Cost Threshold Process
NHS-funded ETCs are subject to a High Cost Threshold which has been introduced to enable NHSE 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 £1 million per study and/or an average per participant ETC of £20,000.
NHSE 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 england.highcostETC@nhs.net and highcostetcs@dhsc.gov.uk 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 ICB commissioned services, an assessment of clinical alignment will be undertaken on a case by case basis by NHSE 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 NHSE and/or DHSC’s understanding of the treatment regime or participant cohort that might be best prioritised for further study?
Are there any significant concerns about the study design - for being taken to explore the use of the best value product (e.g. biosimilars).
A flowchart of the ETC assessment process [PDF} (.PDF). If you require an accessible version of this flow-chart, please email: england.highcostETC@NHS.net
Further information
For all queries relating to the ETC arrangements, contact: etc.helpdesk@nihr.ac.uk
For further information regarding the High Cost Threshold process, contact england.highcostETC@NHS.net and highcostetcs@dhsc.gov.uk
For further information regarding the Specialised Commissioning process, contact: england.speccommETCs@nhs.net