What 3-letter acronym causes the most confusion? ETCs of course! By Dr Andy Clempson, Senior Research Policy Manager, AMRC Published: 24 October 2018 Since we published our last blog on Changes to the way Excess Treatment Costs are paid, there has been plenty of interest! Our Senior Research Policy Manager, Andy, has put together a list of the most common questions we’ve been asked in case this helps you with your preparations. What is an Excess Treatment Cost (ETC)? Clinical research often involves giving patients new treatments or changing the way that care is delivered. Sometimes the treatment costs (the patient care costs) are higher in research than in routine care – and are therefore known as an ‘excess’. For instance, a patient taking part in research may be given a new drug to compare how well it works against the standard drug given to the non-research patients. If the cost of the new drug is more than the one usually prescribed, it’s an ‘excess’ as it would not occur in standard care. These excess costs are collectively known as the Excess Treatment Costs (ETC) in a study. For non-commercial research studies, these costs are the responsibility of the NHS (or in some cases other commissioners) and are currently funded through normal arrangements for commissioning patient care. For a full explanation of the different costs, please see the AcoRD guidance. It’s also worth pointing out that research doesn’t always result in extra costs. Often, research looks at reducing the amount of treatment a patient receives or changing the way in which treatment is delivered which may be cheaper than standard care. For instance research may indicate that having three rounds of treatment is just as effective as having four. The savings of administering ‘less’ treatment – with no negative consequences on patient outcomes – are termed Excess Treatment Savings (ETS). In order for the true picture of cost for research in the NHS to be understood, ETCs and ETSs need to calculated. What is the new system for paying ETCs? We have outlined the new system for paying ETCs in our recent blog. 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. Further information regarding the new system, including a route-map outlining the system, can be found on the dedicated webpage. Why do we need a new system for paying ETCs? Research has been held up for many months or years because of difficulties arranging for ETCs to be agreed and paid. This has caused real problems in the setting up of clinical research, thereby impacting the speed of patient access to research. The new system is aimed at making it simpler and less bureaucratic for ETCs to be paid, which should be better for everyone involved. What is a SoECAT The ‘Schedule of Events Cost Attribution Tool’ (SoECAT) is a template that captures and calculates the different activities and costs associated with the clinical research in a standardised way. You can find the latest version of this on the NIHR website. This MS Excel sheet, based on the existing HRA Schedule of Events, has numerous tabs designed to allocate costs according to the specific activities undertaken in a research study. Funders should request that all full applications are submitted with a completed SoECAT. This form should help funders make a better assessment of the costs. The SoECAT is also mandatory for HRA approval and entry onto the NIHR portfolio. What do the AcoRD Specialists do? 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. Under the new system being tested, the SoECAT needs to be signed off by an AcoRD Specialist who will confirm that the attribution is accurate. A ‘roadmap’ for researchers to help outline how to access this support is available on the NIHR website. Funders should encourage their researchers to engage with AcoRD specialists as early as possible and provide as much notice as possible that support will be required. This is necessary to ensure that researchers are able to submit their full application and completed, signed-off SoECAT prior to a funder’s application deadline. Why is there a test period for 6 months? This new system of paying ETCs represents a significant shift from the old arrangements. There are many unknowns, including how much total ETCs are, how much these are offset by ETSs and how higher-value ETC studies can be assessed for certainty that this research represents value for money to the NHS. Because it is difficult to plan for every eventuality, the current arrangements are being tested over 6-months to see how well the new system works before a full roll out in April 2019. It may be that changes are necessary during this time and that some further refinement after the pilot is required as more information becomes available. What if there problems during the testing period – who do we contact? First and foremost, any problems or difficulties researchers have filling in the SoECAT should be discussed with the Local AcoRD Specialist for the study through the regional contacts. Where AMRC funders themselves wish to raise concerns, please contact Dr Andy Clempson at AMRC. Which research grant applications require a SoECAT? This applies to all full-stage clinical research applications that will be undertaken in England. It does not apply to outline applications. Clinical research that is not thought to involve ETCs will still need to provide a SoECAT signed off by an AcoRD Specialist at funder submission to ensure HRA approval and NIHR portfolio status is achieved. Does it apply to new applications, or all existing studies? Under the new system, the payment of ETCs for all research studies is being managed by LCRNs on behalf of the local CCGs. Therefore all studies where CCGs are the responsible commissioner will move onto this new system. However this does not mean that all on-going studies must now complete a SoECAT. Only new full applications will be required to do this. It is however possible that some applications outside of this cohort may also be required to complete a SoECAT once research funding is agreed if these studies have ETCs. Existing studies that already have funding agreed do not need a completed SoECAT unless specifically requested. NHS England and DHSC are in the process of gathering data on these CCG funded on-going studies to understand how much the ETCs are to ensure that payments are made under the new arrangements. These on-going studies do not need to be re-costed if the ETCs have already been agreed. The new system will apply to new studies covering specialised services (funded by NHS England) from 1st October only, as for these studies there is not an intention to revisit funding agreed for studies already underway. What about studies taking placed in the devolved administrations? The new system of paying ETCs is for English commissioning organisations only as the health budgets that include clinical research are devolved. While work is on-going to ensure a UK wide approach can be delivered for researchers based on the collective use of the SoECAT, in the meantime, studies taking place in the devolved administrations should follow the ETC payment procedures in that country. Is there any guidance we should give our committee / reviewers on what is an acceptable level of ETC? As part of the AcoRD agreement funders have always been required to undertake a value for money assessment as part of peer review. This has not changed under the new arrangements. Peer reviewers should compare the cost of research to the costs attributed to support and treatment. Studies that have high cost ETCs or support costs are unlikely to be adopted by NHS trusts or commissioners, and so may not represent good value for money. This should form part of the assessment of the quality of the proposal. When your committee agrees to award a grant, they may wish to add other conditions of award or recommend amendments to ensure the costs are good value for money both to the funder and the NHS. At that point funders can ask researchers to resubmit with revised costs. What happens if the ETC is high? Where the total (study-level) ETCs are higher than £1m, or where the average ETCs are higher than £20K per patient across all patients recruited to a study, there will be an further review to ensure this research represents value to the NHS. This will take place after the funder has undertaken peer review and has issued an ‘intent to fund’ or grant award letter. At this stage, a review by DHSC, Specialised Commissioning and NHS E via the relevant clinical leads or chairs of specialities in the disease area will look over the proposal. The criteria under which they will assess the study are likely to involve: whether the level of ETC is proportional to the future patient benefit and likelihood of adoption into future patient care, the quality of the study design, the importance of the clinical area and alignment with NHS E and DHSC’s understanding of the treatment regime or patient cohort that might be best prioritised for further study, whether the findings are likely to be of use in future clinical commissioning policy determination and whether opportunities have been taken to explore the use of best value products. This final stage is unlikely to outright decline the payment of ETCs. Instead the more likely outcome could be that the ETCs are approved or ETCs will be paid if the study is amended. Where can I find the latest information? There is a single, dedicated webpage which provides the latest updates and information regarding the new arrangements for ETCs.