01 / 11 / 2016
Accelerated Access Review: Review of innovative medicines and medical technologies
An independently chaired report, supported by the Wellcome Trust, October 2016
Recommendations on how best to access innovation for the benefit of patients and to improve health care efficiency are contained in the final report of the Accelerated Access Review.
Confederation members’ views, gathered during two roundtable discussions, were fed in to the review team, and our recent former Chief Executive, Rob Webster, provided policy advice to the review team throughout. The review ran from late 2014 to summer of 2016.
The report outlines a vision, which focuses on three key areas:
1. Establishing streamlined mechanisms for prioritising emerging technologies and identifying strategically important innovations, including:
- enhanced horizon scanning process
- digital health technology catalyst – a competitive challenge fund which would include funding for late-stage testing in a real world environment
- ‘transformative’ designation for the 5-10 most strategically important products (medical technologies, diagnostics, pharmaceuticals or digital innovations) that have the potential to deliver significant benefits in cost or outcomes, which would enter an accelerated pathway (more on this below)
- a common set of principles describing what good partnership with patients and the public looks like along the whole innovation pathway – it is suggested local and national organisations develop their own, based on work by National Voices.
2. Working with innovators to accelerate approvals, speed up adoption and evaluate technologies efficiently using new data sources
- covering regulatory requirements, commercial arrangements, revenue and market access) for transformative innovations
- suitable for medical technologies, diagnostics and digital products, as well as medicines and emerging forms of treatment
- fund of £20-30m over five years to invest in strategically important products manufactured by SMEs and not -for-profit organisations
- use of a commissioning through evaluation pathway
- NICE’s guidance to include a bespoke incentive framework that supports diffusion across the NHS
- Measures to better align regulation, evaluation and commissioning.
- A new strategic commercial unit in NHS England, able to consider a range of flexible pricing models as part of a commercial dialogue with innovators.
Role of AHSNs:
For ‘incremental’ (rather than ‘transformative’) innovations, AHSNs to enable regional and local routes to market which operate consistently across the NHS. AHSNs should have a new mandate and align with STP footprints. They would:
- have a key role in identifying, and establishing evaluation of, suitable innovations. Evidence gathering would be structured and nationally consistent, enabling effective innovations to be badged with an ‘NHS warrant’ recognised by providers and commissioners.
- act as an innovation exchange, working with health economies to establish need and with innovators to meet needs.
- identify, test and disseminate digital technologies, particularly those that are demonstrating locally the potential to deliver efficiencies.
- play a role in the post-CE mark testing and dissemination of medical technologies, diagnostics and digital products, with a focus on determining their clinical utility, cost effectiveness and whole pathway benefits
- provide change management capacity and capability
- The NHS Test Beds programme can act as a pilot for this new, strengthened remit for AHSNs.
- An extra £10-20m funding for AHSNs from 2017 is recommended, along with greater support from NHS Improvement.
Role of leading research hospitals:
Tertiary academic hospitals that host Academic Health Science Centres (AHSCs) or Biomedical Research Centres (BRCs) should champion innovation and lead collaborations in their local health economies. As active partners in the Accelerated Access Pathway:
- championing the early adoption of these products in referring organisations and the health systems in which they work;
- acting as centres of excellence in innovation;
- capturing real-world evidence on how a product is used in a clinical setting, and supporting wider roll-out.
- An additional £4-8m funding per centre for this role is recommended.
Incentives for and recognition of professionals’ adoption of innovations:
- recognition in appraisals, through awards schemes or through pay advancement
- a network of innovation champions.
- Professional leadership bodies, including Royal Colleges, should include adherence to NICE clinical guidance as a criterion for achieving professional standards in clinical care.
- A faster route for digital products built on the Paperless 2020 simplified app assessment process. NHS England and NHS Digital should also develop a generic framework for app prescription.
- The digital infrastructure should enable the system to capture information on the use of innovations and associated outcomes. This rests on a significant improvement in digitisation across the NHS, including electronic patient records and e-prescribing.
Role of NICE:
- NICE should review its health technology assessment processes and methods to ensure they work for new types of emerging products. It should refocus its work to place more emphasis on medical technologies, diagnostics and precision medicine tools, and a funding requirement should apply for those products that improve efficiency. NICE should support uptake, for example, proposing structured incentives or tariffs to support uptake.
- NICE, NHS Improvement and NHS England should have a greater focus on disinvestment, and outdated products and services should be made less attractive in the national tariff. Right Care can support this.
- The Innovation Scorecard to be used as a single, accessible source of information on the uptake of technologies for the NHS, patients and industry.
- A 'how to' guide to support innovators, particularly SMEs, in navigating national and local paths to market.
3. Aligning national organisations to transform the NHS’ ability to adopt the right innovations rapidly
A new ‘Accelerated Access Partnership’ bringing together the main national organisations in this landscape – NIHR, MHRA, NICE, NHS England, NHS Improvement and the Department of Health, as well as patient and industry representatives. It should have strong links to the local innovation exchanges facilitated by the AHSNs. Work on this should begin immediately.The Accelerated Access Partnership’s strategic activities should include:
- horizon scanning for and prioritisation of strategically important products;
- designing the selection criteria and process for making a transformative designation; and
- articulating the healthcare system’s priorities to innovators to help them focus their investment.
Its operational activities should include:
- overseeing the Accelerated Access Pathway;
- helping innovators navigate and collaborate with the system;
- providing guidance on pathways to market; and
- enabling the use of the products the NHS wants through commercial arrangements we can afford.
The Partnership should be responsible for implementing the report’s recommendations, supported by a strong commitment from NHS England and working with NHS Improvement.
The report also emphasises the increased economic importance of the life sciences industry following the referendum vote to leave the EU. It also emphasises the strengths of the NHS as a place to adopt cost-effective innovations at scale, highlighting particularly the integrated nature of its research system and potential ability to quantify economic value across the system.