By Dr Andy Clempson, Senior Research Policy Manager, AMRC

Published: 28 August 2018

The way in which Excess Treatment Costs (ETCs) are paid for clinical research is changing. From 1 October 2018, funders opening new grant calls should be aware that a new system will be used to manage the payment of ETCs. As part of this, researchers will be required to complete a new form known as a ‘Schedule of Events Cost Attribution Template (SoECAT)’ for clinical research. This form is designed to capture the different costs associated with clinical research and attribute them accordingly. It is very important that you and your funded researchers are aware of these changes. We explain more about the changes and what they might mean for you here.

In the past, we’ve heard from lots of funders and researchers about the challenges of getting ETCs paid. From the point-blank refusal of some parts of the NHS to pay ETCs to arguments over who pays what and how much – ETCs have been a real headache for everyone involved. In the worst cases, researchers have resorted to asking funders to pay ETCs to circumvent problems. It was clear the system wasn’t working well and time after time, research has been delayed. This is bad news for funders as it slows down research even more and worse news for patients who are waiting to be enrolled on studies.

In summer 2017, NHS England undertook a scoping exercise and consultation to gather views from across all parts of the clinical research landscape to find out about the specific problems of getting ETCs paid. They also road-tested some new ideas over how ETCs might be paid to see if they resonated. AMRC responded to this consultation - you can read our response here. NHS England and its partners NIHR, HRA and NHSI published their response to the consultation in May 2018. For those particularly interested in this space, it’s worth a read as it contains some of the details around what the new proposed system to pay ETCs is. Since then, we’ve been working with NHS England and partners to further understand how these proposals are being developed. We’re now at the stage where we have some specifics and we wanted to share these with you.

What’s it all about?

The new system will be trialled from 1 October 2018 to 1 April 2019. This means that in the long term, the details may still change and there will be a degree of learning as the trial period unfolds. The trial period is unlikely to totally problem free but the new system is designed to simplify and streamline ETC management to remove the barriers that currently exist.

There are three key changes aiming to overcome some of the longstanding issues with ETCs:

  1. Partnering with the 15 NIHR Local Clinical Research Networks (LCRNs) to help manage the ETC process on behalf of their local CCGs

The NIHR Clinical Research Network (NIHR CRN) will operate a single point of access for all proposals for which ETCs may be applicable and also directly manage ETCs on behalf of Clinical Commissioning Groups (CCGs). This should make the process much simpler for researchers to navigate.

The NIHR CRN Coordinating Centre (CRN CC) will have national operational oversight of the ETC management system. A single point of contact in each of the 15 NIHR Local Clinical Research Networks (LCRN), for services commissioned by CCGs and Specialised Commissioning will include:

    • A Lead LCRN to oversee and coordinate ETCs for each multi-site trial in England.
  • A triage process to identify and categorise ETCs into CCG commissioned services and those under specialised services to enable appropriate ETC management and payment processes.
    • A consistent approach across all LCRN regions.
    • Using the existing AcoRD Specialist capabilities already embedded in the CRN study to provide a support service available for researchers.
  1. Funding for ETCs for services commissioned by CCGs

CCGs will contribute an allocation of 5.2p per capita per annum per CCG for funding ETCs. These funds will be managed by CRN for the 6-month trial period. Data on ETCs incurred during this period will inform a review of the allocation rate for 2019/20 to make sure the contributions are appropriate.

  1. ETC Thresholds

To speed up the payment of ETCs further, NHS England and NHS Improvement will calculate an annual ETC threshold for each Trust. Thresholds will be calculated based on a total (cumulative) ETC threshold per Trust, per financial year, based on Trust income. For all non-commercial studies with ETCs, Trusts will absorb ETCs up to their threshold before being reimbursed.

During the trial period, this Trust threshold will be set at 0.01% of total provider operational income. There will also be a minimum threshold level set at £10,000. (Although please note that the minimum threshold will not apply for primary care providers).

In addition to the minimum absorption threshold, there will also be a maximum ETC threshold. These studies with very high ETCs will be subject to a scrutiny of the value of the study to the NHS. The value of this threshold and the way in which the assessment will be undertaken is still be worked up. Look out for updates soon.

What does this mean in practical terms for funders?

One of the biggest changes funders will see is the introduction of a Schedule of Events with Cost Attribution functionality within the tool - the SoECAT. In the new system, researchers will be required to complete the Schedule of Events Cost Attribution Tool, which will be available during the trial period from the NIHR dedicated webpage: This is designed to capture the different costs associated with clinical research and attribute them according to whether they are:

    • Research Costs – including Part A (that funders pay) and Part B (that the NHS pays for AMRC members),
    • Service Support Costs,
    • Treatment Costs, and
    • Excess Treatment Costs / Treatment Cost Savings.

Definitions of the different cost categories are available here. The Schedule of Events Cost Attribution Tool is really important as it standardises the way in which the different costs categories will be calculated and attributed. A guide to help researchers, study teams and sponsors to complete this during grant application and study planning will be made available and dedicated support will be available through AcoRD Specialists via the NIHR Clinical Research Network who will sign off the attribution under the new arrangements. Completion of the Schedule of Events Cost Attribution Tool will be mandatory for research eligible for the NIHR portfolio and the support this provides, which will include access to ETCs under the new arrangements.

What do funders need to do?

  1. The pilot for ETC payments starts for all new research calls that open after 1st October 2018. Any calls that opened before this date don’t need to make any specific changes unless they wish. Please note this is only for new calls – not existing calls already open.
  2. For these new calls, funders should make sure they update their guidance to applicants to tell them about these changes – in particular the need for researchers to complete the Schedule of Events Cost Attribution Tool. This should be submitted to funders alongside completed application forms. This may require technical changes to your systems. NHS England is working up a formal communications plan to spread the word to researchers, but funders also need to be aware of these changes in case your researchers seek advice from you about the new system.
  3. Funders should continue to undertake a value for money assessment of the research as part of peer review. The Schedule of Events Cost Attribution Tool may be helpful in doing this as it divides the costs into the different categories.
  4. Stay up to date with the progress on this from AMRC and NHS England as it develops. Work to set the maximal threshold is still being undertaken – so please look out for further details as they emerge. We expect funders to be consulted by NHS England if any of their studies go over the threshold. It is likely that the threshold will be set high only affecting a very small proportion of studies.

Want to find out more?

There’s a lot to digest here – please stay tuned for further information over the coming weeks. If you want to talk to us, please contact me via [email protected]