Attributing the costs of health & social care Research & Development – Understanding AcoRD

Attributing the costs of health & socialcare Research & Development– Understanding AcoRD Trudi Simmons Senior Manager – Research Finance & Programmes Trudi.simmons@dh.gsi.gov.uk

Intoduction • Reasons for change • Implementation • Basic principles behind the guidance • The attribution process • Common problems in attributing costs • Question and answer session

Reasons for change Primary reasons are: • Improving the consistency of cost attribution; and • Encouraging more consistent funding of the costs of research

Implementation 1 • AcoRD agreed by England, Scotland, Wales & NI • Draft documents shared with stakeholders across UK in advance of publication • DH taken on board issues and concerns • Working Group looking at key issues around implementation

AcoRD published on the DH website in May 2012. Now on the Gov website at https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research Applies to new grant applications submitted after 1 October 2012 AcoRD will not be applied retrospectively to studies funded before 1 October 2012 Implementation 2

Principles of AcoRD • Based on original principles set out in HSG(97)32 • Uses the same three cost categories and definitions as HSG(97)32 • Focuses on why an activity takes place rather than where or by whom • Focuses on the Primary Purpose of an activity

Main difference between AcoRD and ARCO DH will meet some research costs for charity-funded research taking place in the NHS, where the research grant funder is a member of the AMRC

Format of Guidance Three sections • Main section that covers the background, principles and attribution process • Annex A provides an Exemplar list of activities and where they should be attributed • Annex B provides a set of Frequently Asked Questions (FAQs)

Annexes A and B • The Exemplar lists and FAQs will be updated on a periodic basis in response to issues raised by users • Must use most up-to-date FAQs • Revised versions of Annexes A and B published in April 2013.

Exemplar Lists • Split into 3 sections – Research, Support and Treatment • Research Section has 2 parts • Part A costs met by all grant funders • Part B costs met by grant funders except where the funder is a member of the AMRC when DH will meet the cost.

The Categories of Costs Three types of costs: • Research costs • Treatment costs • NHS Service Support Costs

Research Costs • Research Costs are the costs of theR&D itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions • Research Costs are met by grant funders through the award of a research grant except for PART B costs if funder is an AMRC member • DH will meet PART B costs mainly via Research Capability funding (RCF) and Networks

Treatment Costs • NHS Treatment Costs are the patient care costs which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped • NHS Treatment Costs are met through the normal commissioning process (very exceptionally DH may make a contribution)

Excess Treatment Costs(ETCs) • ETCs are the difference between the cost of usual care and the cost of the treatment provided as part of the study • Sometimes there are treatment savings rather than excess treatment costs

NHS Service Support Costs • NHS Service Support Costs are the additional patient care costs associated with the research, which would end once the R&D activity in question had stopped,even if the patient care involved continued to be provided • NHS Service Support Costs are met from the R&D budget by the Health Departments of the United Kingdom

Attribution Process • Concept of NHS patient care services and the premise that the NHS bears the cost of caring for its patients even when they are involved in a research study • NHS patient care service is defined as “a service provided by, or on behalf of, the NHS where that service treats, or contributes to, the care needs of a patient.”

Two step approach – step 1 • Identify the core R&D activities the are being undertaken to answer the research question and which end when the research ends. These activities do not contribute to a NHS patient care service. • These are Research Costs – See Annex A for examples

Step 2 – NHS Patient Care Service Activities Activity that is part of NHS Services must be split between: • NHS Treatment Costs • NHS Support Costs

Treatment or Support Activity • An activity is a NHS Treatment activity If it is integral to the provision of a treatment regime, whether this is standard or experimental • An activity is a NHS Service Support activity if thepatient care activity is primarily undertaken to facilitate research or is driven by the NHS duty of care to a patient, eg to ensure the safety of a patient participating in research

In the context of this study is the activity a ‘service provided by, or on behalf of, the NHS where that service treats or contributes to the care needs of a patient’ Yes No The activity is a patient care cost. Is the activity integral to the provision of a treatment (or diagnostic) regime? The activity is a Research Cost because it is not directly contributing to patient care Attribute Research activities between Part A and Part B No Yes The activity is a Treatment Cost The activity is a Service Support Cost The attribution process • Step 1 • Step 2 Is the funder an AMRC member?

Treatment Costs • NHS Treatment Costs are the patient care costs which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped • For the purposes of the attribution process it can be assumed that an experimental intervention/service being tested will continue after the end of the study

Treatment Costs cont’d • As a rule of thumb most interventions that are being tested or compared as part of a study will be treatment costs even if they are experimental, unlicensed for the condition, not NICE approved, or there are no plans to continue with the intervention after the study has ended because the CCGs won’t fund • But placebo or sham treatments are research costs

Examples of NHS Support Activities • The processing of the patient record to identify patients who may be suitable to approach to ask if they wish to participate in a research project; • Obtaining informed consent; • Additional investigations, assessments and tests where the results are required by the patient’s care team to ensure patient safety and where arrangements are in place to feed the results back to the clinician

Funding Part B Research activities • If funder is an AMRC member DH will meet PART B costs • Activities numbered 16 via Research Capability funding (RCF) • Activities numbered 15 and 17 via Networks • Activity number 14, Local trial and coordination, through combination of Networks and RCF • Non-AMRC funders to meet all the costs of Part B activities

Pharmacy Costs • Work is nearly complete to identify the attribution of specific activities within pharmacy • But, attribution steps 1and 2 still apply

Common issues • Attributing the costs of R&D is complex • No one size fits all • Need to understand the detail of the study • Why is the activity taking place? • What usually happens to a patient? • What would happen to the patient if they had the same treatment outside of a research study? • Remembering that Network support applies to research taking place in the NHS or in a NHS service provider • Minimise costs through efficient study design • Seek appropriate advice before grant submission

Common attribution mistakes • Not referring back to the definitions of the 3 types of costs • Attributing treatment costs as Support or Research costs • Assuming because an activity takes place in the NHS it must be a NHS cost – not true • Trying to use the commercial costing template for a non-commercial study – a non-commercial attribution template is being developed • Assuming that funding for NHS costs works in the same way as funding for research costs

Attributing the costs of health & social care Research & Development – Understanding AcoRD