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.
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.
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 Regional Research Delivery Network (RRDNs) 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 RRDN for the study (usually the RRDN 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. Further 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.
ETC Payments
In order to calculate the ETC payments 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 seeETC 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 are made in England through the NIHR RRDNs to the organisations identified in the Payment Model that has been agreed with the study Sponsor, following discussions with the NIHR RDNCC.
For all queries relating to the ETC arrangements, contact: etc.helpdesk@nihr.ac.uk
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 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.
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
For all queries relating to the ETC arrangements, contact: etc.helpdesk@nihr.ac.uk
For further information regarding the High Cost Threshold process, contact highcostetcs@dhsc.gov.uk