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. For non-commercial research studies ETCs are the responsibility of the NHS. 

As of October 1st 2018, the way Excess Treatment Costs (ETCs) are being paid is changing. Under the new system the 15 NIHR Local Clinical Research Networks (LCRNs) will help manage the ETC process on behalf of their local Clinical Commissioning Groups (CCGs) and in collaboration with NHS England’s Specialised Commissioning function. This will create a single point of access for all proposals for which ETCs may be applicable and is designed to make the process much simpler for researchers to navigate. 

As part of a pilot to test these changes researchers applying for HRA approval for clinical research studies taking place in England will need to complete a new form known as a Schedule of Events Cost Attribution Template (SoECAT). The SoECAT is a spreadsheet template that calculates the different activities and costs associated with clinical research in a standardised way. Further information about the new system and a preview of the SoECAT can be found on the NIHR website.  

Sign off by AcoRD specialists
The SoECAT will need to be signed off by an NIHR AcoRD specialist, who will confirm that the attribution is accurate before submission to the HRA. Sign off will be a prerequisite for the study to be eligible for the NIHR Clinical Research Network Portfolio and to access the support portfolio adoption provides. Local AcoRD Specialists work with researchers to signpost them to resources and training to understand the principles of AcoRD, provide specialist advice and support for activity attribution and support the resolution of attribution queries.

If you are applying for funding for a clinical research project that requires HRA approval, you should engage with AcoRD specialists as early as possible and provide as much notice as possible that support will be required. Visit the NIHR website to see how to access this support.

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 application. You can submit the completed and signed off SoECAT to Alex Thomas by email (thomasal@bhf.org.uk) alongside your online Clinical Study Grant full submission.