National Registry of Robotically Assisted Surgery

The contract will initially be delivered for NHS-funded care in England for a period of 3 years, at a maximum total budget of up to £1,300,320 including VAT, £1,083,600 excluding VAT. Bids exceeding this limit may be rejected. There is the potential to extend this contract for up to 24 months via either a funded extension or the method stated in section 4.2 of Annex A.

All pricing submissions must be in regard to this 'core' value, and not inclusive of any extension costs or aspirational intent costs, i.e. Please only submit a cost schedule up to the maximum core value of £1,300,320 including VAT, £1,083,600 excluding VAT.

The maximum budget ‘core’ value of £1,300,320 including VAT, £1,083,600 excluding VAT excludes the potential two year extension and aspirational intent as described in section 14.4 of Annex A - Service Specification.

Please note, there is no commitment by the Authority at this stage to include any aspirational intent measures. Taking the total of this aspirational intent into account, as well as the possibility that a contract extension may be offered for an additional two years, the potential ceiling value is £10,800,808 GBP including VAT, £8,640,646.40 excluding VAT.

The registry should aim to address, where possible and as a priority, the recommendations and requirements of the NICE early evaluation assessment (EVA) and is expected to support the acquisition of relevant metrics. NICE EVA orthopaedics - www.nice.org.uk/guidance/htg743/reso… ↗

and

NICE EVA soft tissue - www.nice.org.uk/guidance/htg742 ↗

The registry will continue to evolve in line with the uptake of robotic surgery working with Medicines and Healthcare products Regulatory Agency (MHRA), NHSE, National Equipment Tracking and Information System (NETIS) and NICE to ensure evidence generation, availability of data for analysis to highlight variations in care and poor outcomes including health inequities

The aims of the national robotically assisted surgical registry are to:

•Improve patient safety by tracking short- and long-term results of robotically assisted surgery

•Capture key quality metrics aligned with the requirements of the NICE EVA recommendations (see section 9.3)

•Support the standardisation of practice

•Identify variation in surgical outcomes across hospitals

•Provide outcome evidence to inform clinical guidelines, commissioning, and regulatory decisions

•Facilitate research and innovation conducted by others in robotic surgical technologies and techniques

•Understand the current provision and the equity of access to help inform future strategic decisions.

•Make available, near real time data for authorities to evaluate the effectiveness of robotically assisted surgery compared with conventional techniques

•Maintain close alignment with relevant NICE national guidance and quality standards throughout the establishment of the registry (see section 9.1 and appendix 1)

•Provide timely and high-quality data analysis that compares providers of healthcare

•Be clinically led

•Link data where feasible and of value at an individual patient level to other relevant national datasets either from the outset or in the future, and plan for these linkages from the inception of the contract

•Use robust methodological and statistical techniques (see section 6.2.2)

•Provide outputs tailored to a variety of different audiences Provide results in a timely, accessible and meaningful manner minimising the reporting delay and providing continual access to each stakeholder for their own data

•Develop and maintain strong engagement with local clinicians, networks, commissioners, patients and their families and carers and charity and community support groups to drive improvements in services

The project requirements are*:

•A registry that captures prospective key data about robotically assisted surgery. This registry should be delivered by 2029 therefore, before the end of year three of the contract

•The provision of information to address, where possible, the evidence gaps highlighted by the NICE medical technologies advisory committee concerning promising health technologies that have the potential to address national unmet need (see: Committee discussion)

•To, during the first three years, design a self-sustaining style funding model. The funder and commissioner should be involved in all discussions with final sign-off approval. It is anticipated that at the end of the 3-year contract term the funding should switch from a publicly funded to a self-sustaining funding model. Given the pump priming publicly funded start up to this project, the expectation is that the current funders will be involved at all stages of the self-sustaining future model and be integrally involved as a primary stakeholder in the governance and oversight

•With the set up and implementation of a self-sustaining financial model, the registry should consider a mechanism to enable the flow of data to robotic manufacturers named in the NICE EVA (or other safety programmes) and who contribute to the funding of the registry when the self-sustaining model is developed. Information for manufacturers may potentially include data for product and system improvement, safety and post-market surveillance, benchmarking and performance feedback, value demonstration, collaborative research and development. The supplier should avoid providing information to manufacturers that supports commercial messaging or market advantage and be confined to information relating to service user outcomes

•That the registry’s design and governance arrangements consider the remit and existing data holdings of other similar registries and data collections, ensuring interoperability where appropriate and avoiding duplication of data collection, analytical outputs, or reporting functions

•At the conclusion of the three-year contract term, the strategic intention is for the registry to mature into a continuous, prospective data collection underpinned by a sustainable, self- funding model. This transition must not dilute or displace the required system-level oversight. HQIP and NHSE will therefore remain central and non-negotiable partners within the governance framework for the registry throughout the contract and into any subsequent phase

•The supplier will be required, to commit to this governance structure, including the roles of HQIP and NHSE, and to demonstrate how their proposed operating model will support effective accountability, assurance and long-term sustainability

•The development of this registry including data platforms and tools within this contract are initially a proof of concept and future delivery arrangements are currently unknown. If a self-funding model is agreed and developed as defined in this section (3.2), it will form part of the contractual deliverable requirements, specifically adhering to clause 20, intellectual property, of the terms and conditions. Migration to a definitive platform under future commissioning arrangements may be necessary and the future portability of a technical solution must be considered and be freely available to transition between any outgoing and incoming providers, along with all other foreground IPR rights contained within clause 20 of the terms and conditions

•There may be a clinical need to evolve and expand the metrics to capture additional metrics outside of the NICE EVA requirements. The supplier will need to closely collaborate with NICE to consider changes to metrics and mutually agreeable metric modifications.

•The registry will continue to evolve in line with the uptake of robotic surgery working with MHRA, NHSE, NETIS and NICE to ensure evidence generation, availability of data for analysis to highlight variations in care and poor outcomes including health inequities

*Please refer to section 13.2 for further potential additional requirements for this contract.