Enhanced National Contract Value Review rolls-out across October

Date: 28 September 2023

• From October, the NHS are stopping local negotiation of commercial research prices beyond the Lead NHS Organisation review for later phase studies as outlined in NHSE National Directive for commercial contract research and Devolved Administration equivalents
• NHS organisations and Life Sciences Representatives are empowered to escalate any instances of non-compliance with the UK interactive Costing Tool that generates site specific prices for each study following a Lead NHS Organisation study resource review. Please escalate these to lauren.tough@nihr.ac.uk
• You have all helped to shape the approach that helps the UK deliver globally competitive set-up timelines through the establishment of this tool and process: thank you for all your continued efforts to embed this as standard practice 

What changes will I see over October?

The change will be initiated on the 1st of October, with the release of the revised financial appendix as part of the unmodified model agreements. Mid month (17th October), changes within the interactive Costing Tool functionality and some cost calculations will be released, such as set-up fees moving from unit costs to time based activities. By the end of the month, an updated tariff, including the NHS Organisation specific multiplier (known as the Market Forces Factor) will apply to all commercial contract studies included in NCVR that have not yet signed contracts with participating sites by the end of October.

How will this impact live studies?

All changes with the iCT (including the site specific multiplier) will automatically be applied to all un-contracted content. The Local CRN and Devolved Administrations will support a pragmatic approach with Sponsors and sites with ongoing negotiations over this implementation period. From this date, further updates to the tool interface will be released to improve the user experience and streamline this part of set-up activities.

What about early phase studies and other NHS providers?

Early Phase and Advance Therapy studies have national guidance to support an NHS study resource review to support the work to bring these early phase studies into the process. A voluntary adherence scheme for primary care studies will be initiated this month with NHS providers adhering to this approach listed in the UK iCT tariff workbook.

NHS consultation on site multiplier and visibility of this impact through an NHS dashboard
Throughout the summer consultation has taken place with NHS organisations on changes required to the UK interactive Costing Tool (iCT) to achieve a position of no local negotiation beyond the Lead NHS site review for late phase studies.

What the price variation data tells us
The data collected by NHS England throughout this process implementation has highlighted the major barriers being set-up fees and outsourcing. The price variation data submitted by the 25% of organisations not able to accept the site specific prices generated by the UK iCT ahead of October does not reveal any further significant areas of adjustments needed to the existing tariff. Analysis of these insights will continue to support the continual improvement of the tool in the future.

Changes
To address the concerns raised, the changes agreed include a tiered Research & Development (R&D) set-up fee, clarification of the definitions of the cost components (e.g. indirect costs and capacity building), assessment of the NHSE inflator value utilised, removal of pass through costs (patient expenses, archiving) into financial appendix and new site multiplier incorporating outsourcing and research factors. These changes will impact each NHS organisation, independent of their current adherence position.

Dashboards will show impact of changes for NHS organisations
The impact of the proposed changes will be shared with NHS organisations in England using a dashboard in Open Data Platform (ODP) that enables direct comparison of the 23/24 tariff as it stands, and with the proposed changes from October, with support to access this via the CRN Business Intelligence and Local CRN teams. This will be shared once available. 

Testing from October as part of the National Contract Review expansion 
Implementation of changes to support no local negotiation within the UK iCT during October marks the start of testing this approach. Refinements to this methodology will continue as part of the UK iCT annual updates made in April to reflect each new financial year. Requests to change any components continue to be made through the online iCT feedback form and are overseen by the UK commercial costing reference group.

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