Excess Treatment Costs

Excess treatment costs: Guidance on the national management model for England

NHS England guidance published in September 2021 which:

• provides the framework for how Integrated Care Board (ICB) commissioned studies which incur ETCs are paid.
• sets out the provider types which can utilise the national payment system.
• assist researchers navigate the ETC system.

Visit the NHS England website to read Excess treatment costs: Guidance on the national management model for England.

For operational queries regarding ICB commissioned ETC studies, please visit our dedicated site

Identification of Excess Treatment Costs

ETCs must be accurately identified as part of the research funding application. This ensures that health care providers can be reimbursed by the appropriate funder. Researchers are required to complete a Schedule of Events Cost Attribution Template (SoECAT). This 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 can be found on our What is AcoRD? 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 at least 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.

Process chart for non-commercial studies that have ETCs.

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 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. Each study is 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 the 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 was agreed with the study CI and sponsor, following discussions with the NIHR CRNCC.

For all queries relating to the ETC arrangements, contact: etc.helpdesk@nihr.ac.uk.

ICB ETCs updates, for all changes to the process and updates to the ICB payment system please visit our news updates

Specialised commissioning studies

When a study is assigned the commissioner NHSE Specialised Commissioning there are two different processes to follow. This depends on when the research funding approval was received.

For studies which received research funding approval after 1 October 2018, an additional financial assurance process is undertaken. This determines the ETC per participant value that will be supported.

Once the Triage team confirms the commissioning decision, your study will be directed to the Specialised Commissioning Team. They will review the SoECAT, and will reach out to request information if required. The purpose of this step is to:

• establish which activities will be paid via standard pre-existing Specialised Commissioning contractual arrangements,
• 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 any additional per participant payment for the study is confirmed.

Studies which received research funding approval before 1 October 2018 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 is on the Specialised Commissioning ETC Frequently Asked Questions (FAQs). 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.This enables 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 patient 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. 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. 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 NHSE 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.

A flowchart of the ETC assessment process [PDF}. If you need an an accessible version of this flowchart, contact england.highcostETC@NHS.net

Non-NHS Excess Treatment Costs

Non-NHS ETCs refer to ETCs in studies of services for which the Office for Health Improvement and Disparities (OHID), 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.

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