In October 2018, following extensive consultation with stakeholders, a new process for the management of excess treatment costs (ETC) for non-commercial research in the NHS was introduced by NHS England, NIHR Clinical Research Network Coordinating Centre (CRNCC), Department of Health and Social care (DHSC), and Health Research Authority (HRA). This was a result of continued feedback from stakeholders about their frustration of a system they saw as fragmented. The previous system for managing ETCs led to researchers having to negotiate ETCs, often with multiple commissioners, with variable arrangements leading to variable responses to requests to support ETCs. This also led to lack of consistency, clarity, and transparency, often contributing to delays in study set-up times.
In a little over a year of partnership working, a national system has been implemented to address the biggest issues reported by stakeholders: triaging over 100 studies and moving from a system with local variation towards a system that provides consistency of process. In the first six months alone, 146 studies were transitioned into the new system, where CCGs were the responsible commissioner, of which 584 organisations received additional CCG ETC payments over and above the annual thresholds. Great strides have been made in a relatively short time, which has brought:
- 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.
- Elimination of the need for researchers and providers to negotiate with commissioners.
- Increased transparency of process and access.
- Reduction in the administrative burden for providers.
There is also no need for researchers to agree ETCs with individual participating sites. Provider sites know exactly the level of ETCs that they are expected to fund from the annual threshold – and once they have met this threshold, what additional funding they can expect to receive. For studies falling into Specialised Commissioning, 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 HRA Schedule of Events has been adapted to provide information about study costs. The new Schedule of Events Cost Attribution Template (SoECAT) uses the best elements of the Activity Capture and Attribution Template that was trialled previously to capture the different costs associated with clinical research and attribute them, according to AcoRD principles. It enables the generation of an average ETC per patient value for a study.
A transparent system for the assessment of studies with high cost ETCs has also been created and implemented.
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. To date, the focus and priority has been around making changes that would have a positive impact on the most studies. Building on feedback and learning from the first six months of operation, further refinements to ensure the system works well for even more studies are currently in development:
- Comprehensive ETC guidance early in the new year 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.
- New SoECAT guidance will be published 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. These individuals have already received training to help them deal with such queries.
- The aim is to 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.
- Further improvements will be made to the SoECAT forms to will make it easier to complete.
- Additional improvements to the current tools and systems used for entering study information for ETCs will be made.
Instilling clarity and predictability into the ETC system has been an ongoing theme in the first year, as feedback and lessons have been gathered, processed, and acted upon. A system has been put in place where data can be collected and improvements made – based on more robust evidence, something which has not been possible to achieve previously. However, it is recognised that there are medium and longer-term refinements needed. In the upcoming months and years, further refinements will continue to be made to the ETC process.
These improvements show an ETC system that is growing from strength to strength – an outcome that not only benefits funders, researchers, providers, and the R&D community, but ultimately benefits the thousands of patients that have participated in research studies up and down the country. A key priority will be to continue to listen to and act on feedback to make ETCs work for everybody.