Excess treatment costs

On 30 November 2017, NHS England and National Institute for Health Research (NIHR) published a joint statement that committed to 12 actions to support and apply research in the NHS. The first of these actions is to “manage Excess Treatment Costs better” as part of our commitments to simplify NHS research processes.

A public consultation on proposals for managing ETCs better was also launched on 30 November 2017. NHS England and partners published our response to the consultation on 4th May 2018 which outlined our plans for implementation of the new management model. View the consultation and response.

A pilot period for the new model began on 1st October 2018.  All information on the new model is hosted on the NIHR dedicated web page. This page is the current single point of information and updates.

Excess Treatment Costs – One Year On

In October 2018, following extensive consultation with stakeholders, a new national system for the management of excess treatment costs (ETC) for non-commercial research in the NHS was introduced by NHS England and NHS Improvement, NIHR Clinical Research Network Coordinating Centre (CRNCC), Department of Health and Social care (DHSC), and Health Research Authority (HRA).

In a little over a year of partnership working, a national system has been implemented to address the biggest issues reported by stakeholders. We have:

  • Triaged over 100 studies.
  • Moved a system with local variation towards a system that provides consistency of process
  • In the first six months, transitioned 146 studies where CCGs are the responsible commissioner in to the new system
  • Enabled 584 organisations to receive additional CCG ETC payments after thresholds.

This has brought about several benefits

  • A legal framework to enable CRNCC and Local Clinical Research Networks (LCRN) to manage the ETCs system.
  • The creation of a single point of access to ETC management via the LCRN.
  • A national pooled budget for CCG allocations managed by CRNCC on behalf of the CCGs.
  • A single national system for ETCs where specialised commissioning is the responsible commissioner.
  • The elimination of local variation in ETC funding arrangements for CCG commissioned studies.
  • Removal of the need for researchers and providers to negotiate with commissioners.
  • Increased transparency on the assessment of studies with high cost ETCs.
  • Reduction in the administrative burden for providers.
  • For specialised commissioning studies additional financial assurance has been created with support where necessary, and direct payments of ETCs over and above those funded within existing contracts are now provided.
  • To promote consistency of costing methodology, the new Schedule of Events Cost Attribution Template (SoECAT) captures the different costs associated with clinical research to enable the generation of an average ETC per patient value for a study.

Together these improvements have brought a level of clarity, transparency and predictability to the system that previously did not exist nationwide, but there is more to be done as we listen to feedback from our stakeholders.

Next steps

  • Publish comprehensive ETC guidance early in 2020 that brings together all the various guidance issued so far into one place. This guidance will also set out the eligibility criteria for receiving automatic ETC funding and further clarity on the thresholds for ETCs. The guidance will outline the high cost threshold process and include process maps to provide additional clarity to stakeholders who want or need to understand the process.
  • Publish SoECAT guidance that explains how a SoECAT is used and when it needs to be completed as well as guidance on completing a SoECAT.
  • For specialised commissioning studies, guidance will be published, simplifying the process for researchers to find relevant regional specialised commissioning teams and confirm ETC arrangements for studies funded pre-1 October 2018. This guidance will include details of named individuals within Regional Specialised Commissioning teams who will be responsible for handling pre- 1 October 2018 study queries.
  • Work towards making payments directly to the organisations incurring the ETCs, improving the management of studies that do not fit easily into the new system such as cluster studies.
  • Make it easier to complete the SoECAT.
  • Improve the current tools and systems used for entering study information for ETCs.

Find out more about the great strides that have been made in a relatively short time, and how we will continue to listen to and act on feedback to make ETCs work for everybody.