Excess Treatment Costs for Non-Commercial Research Studies in the Nhs

Making an application to Commissioners for excess treatment costs (ETCs) for non-commercial research studies in the NHS

This form is intended to support the process of applying to Clinical Commissioning Groups and/or NHS England Area Teams for ETCs. This form should be used when:

 the ETCs are incurred in primary care or  the provider Trust where the ETCs are being incurred (i.e. where the care is being delivered) cannot fund the ETCs themselves Commissioners will have their own local process for considering the funding of Excess Treatment Costs associated with non-commercial research projects. Decisions are likely to be made at a senior level and the key individuals involved could include: CCG Executive GP; Director or Assistant Directors of Finance and Contracting; Medical Director; Director with responsibility for Research and Development. Other staff may be co-opted as required e.g. Chief Pharmacist.

Information required Examples & detail Rationale for information request

Study title

Name & contact details of Chief Investigator and the Principal Investigator in the GP practice or local provider trust (as applicable)

Summary of the study design with a clear Directors don’t have time to read a full study protocol Include details on the purpose of the study. description of the intervention that will incur so need a summary of the study What is the specialty or medical condition involved? excess treatment costs

Research funding body Who is funding the research costs? If the application for This is to provide evidence that the funding body is ETCs is being made before bid submission, then which non commercial and therefore the ETC application is Developed by Rachel Illingworth, Head of Research and Evaluation, Nottingham City Clinical Commissioning Group in collaboration with the East Midlands & South Yorkshire Primary Care Research Leads Group and the NIHR Research Design Service for the East Midlands. Version 4 August 2013 funding body is it being submitted to and what is the valid submission deadline. Study approvals – summary of approvals For example: This provides information about timelines for trial set required and current progress.  Ethics approval – received up and therefore likely start date and also reassures  NHS permission – in progress the CCG/Area Team that the necessary approvals have been gained or are in progress  MHRA approval – not required e.g. trial intervention is a health promotion intervention  Or the ETC application is being made during the funding application stage so not applicable.

Trial duration, timelines, number of trusts For example: This gives the Directors information about whether involved, total number of patients recruited  600 patients recruited in 30 hospital sites across this is a national multi-centre trial or a local single England centre trial i.e. whether there are lots of other  The trial team are working to a start date of xxxx CCCs/Area Teams also making a similar decision which might lead to discussion with other  This will be a 3 year trial Commissioners to gain a consensus view.

Local impact How much is the CCG and/ or the Area Team being asked to It is important to present the information in terms of fund and over what timescale? Where are the ETCs being NHS financial years to assist with financial decision incurred? making and planning For example:  GP practices  Name of the provider trust (e.g. local mental health trust)  How many patients locally are being recruited and over what time period e.g. 30 patients to be recruited to the trial from x local Trust and costs will be incurred over 3 NHS financial years i.e. 2013/14 – 2015/16

Cost to the CCG and/or the Area Team What is the bottom line for the CCG and/or Area Team by This is critical to assist with financial decision making Developed by Rachel Illingworth, Head of Research and Evaluation, Nottingham City Clinical Commissioning Group in collaboration with the East Midlands & South Yorkshire Primary Care Research Leads Group and the NIHR Research Design Service for the East Midlands. Version 4 August 2013 financial year and planning  2013/14 – part year costs: £15 000  2014/15 – full year costs: £30 000  2015/16 – full year costs: £30 000

Breakdown of ETCs requested. What is What are the drug costs or costs of clinical staff time e.g. 0.4 The Directors want to see that the costs are included within the total cost? wte Band 6 physiotherapist for 18 months. appropriate This can be presented as per patient cost recruited, but a breakdown of how this has been calculated is required.

If the costs are being incurred by a provider Information should include a summary of discussions held at This will demonstrate that local discussions within the Trust (i.e. not in primary care) then justification the provider trust and who has been involved in the decision Provider Trust have been held with the relevant is required as to why the provider Trust can’t making. individuals e.g. Clinical Director / R&D Director / fund the ETCs. Director of Finance / Director of Contracting, Business Can the provider trust part fund the ETCs to share the costs? Development etc

Any other relevant information For example information on value for money (VFM) in relation to the study intervention.

Notes for applicants:

 R&D teams supporting commissioning organisations may require additional information eg fit with local strategic priorities. Please liaise with the relevant R&D team for advice

 Excess treatment costs are funded through the normal arrangements for commissioning patient care

 Please liaise with the relevant R&D Manager in the first instance about invoicing arrangements for approved ETCs

As from 1st April 2013:

Developed by Rachel Illingworth, Head of Research and Evaluation, Nottingham City Clinical Commissioning Group in collaboration with the East Midlands & South Yorkshire Primary Care Research Leads Group and the NIHR Research Design Service for the East Midlands. Version 4 August 2013  Clinical Commissioning Groups (CCGs) commission most services on behalf of patients in their local areas including emergency care, out of hours care, planned hospital care, maternity services, community services, and mental health and learning disabilities services. CCGs also hold the prescribing budgets for their GP member practices.

 NHS England Area Teams have direct commissioning responsibilities for GP services, dental services, community pharmacies and optometrists. 10 Area teams lead on specialised commissioning across England commissioning all specialised services. A smaller number of Area Teams carry out the direct commissioning of other services such as military and prison health.

Developed by Rachel Illingworth, Head of Research and Evaluation, Nottingham City Clinical Commissioning Group in collaboration with the East Midlands & South Yorkshire Primary Care Research Leads Group and the NIHR Research Design Service for the East Midlands. Version 4 August 2013