Attributing the costs of health &

social care 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

– Soon to be agreed by Scotland and Wales

• Draft documents shared with stakeholders

across UK in advance of publication

• DH taken on board issues and concerns

– Working Group established to look at key

issues around implementation

Implementation 2

• AcoRD published on the DH website in

May 2012

• Applies to new grant applications

submitted after 1 October 2012

• AcoRD will not be applied

retrospectively to studies funded before

1 October 2012

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

• 3 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

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 the R&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.”

2 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

• Examples of Research Costs are

contained in Annex A

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

the patient 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

The attribution process

Step 1

Step 2

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’

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

The activity is a

Treatment Cost

The activity is a

Service

Support Cost

Yes

No Yes

No

Is the funder an

AMRC member?

Attribute Research

activities between Part

A and Part B

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 PCTs 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, 18 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, split to be confirmed

• If funder not AMRC funder to meet the costs of Part B activities

Pharmacy Costs

• Work ongoing to identify the attribution of

specific activities within pharmacy

• But, attribution steps 1and 2 still apply

Costs of repackaging - FAQ 19

• Q19. I know that the cost of dispensing the intervention medicine for a study is a NHS Treatment Cost, but the drug has to be repackaged locally at each recruitment site specifically for the trial. Is the repackaging a NHS Treatment Cost even though it would not need to repackage the drug once the study ended even if we continued to dispense the drug to patients?

• A. The repackaging of an intervention drug is a research activity where it is performed centrally either by a single NHS organisation or by a non-NHS supplier for use by all recruitment centres. However, where a NHS organisation repackages a drug locally for its own use, the activity is a NHS Support activity.

Common problems

• 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?

• Not remembering that Network support applies to research taking place in the NHS or in a NHS service provider

• Not minimising costs by efficient study design

• Not seeking 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

• Assuming that funding for NHS costs works in the same way as funding for research costs