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Ask Us A Question? Email: [email protected] Call: US: +1.855.380.4850 EU: +44-20-7392-4161 | www.DecisionResourcesGroup.com EXECUTIVE BRIEFING 1 TECHNOLOGICAL INNOVATION IN THE UK NATIONAL HEALTH SERVICE OVERCOMING BARRIERS TO SUCCESSFUL IMPLEMENTATION By K Nather 1 , A Eccleston 2 , N Hicks 3 , R Livermore 1 FALL 2018 The UK National Health Service (NHS) is regarded as one of the best and most equitable healthcare systems in the world and was ranked 1st out of 11 developed nations on the overall healthcare performance ranking by the Commonwealth Fund in 2017 (1). However, despite the successes of the NHS, there are important areas where the NHS lags behind other developed countries, including healthcare outcomes and the uptake of innovative technologies. In the Richards report (2010), which compared the uptake of key best-practice drugs (i.e. new and old drugs considered best practice at the time) in 14 developed countries, the UK ranked 8th overall (2). While the UK was highly ranked for the uptake of drugs for acute myocardial infarction (MI), respiratory distress syndrome (RDS) and statins, its ranking was low in 7 out of 16 areas of clinical unmet need, such as cancer, dementia, hepatitis C, multiple sclerosis, rheumatoid arthritis and antipsychotics. These results indicate that the NHS is often slow to adopt innovative new drugs and other technologies. 1 DRG Abacus, 6 Talisman Business Centre, Talisman Road, Bicester, UK, OX26 6HR 2 DRG Abacus, The Lexicon – Mount St, Manchester, UK, M2 5NT 3 COBIC, 5-9 Eden Street, Kingston upon Thames, Surrey KT1 1BQ

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Ask Us A Question? Email: [email protected] Call: US: +1.855.380.4850 EU: +44-20-7392-4161 | www.DecisionResourcesGroup.com

EXECUTIVE BRIEFING

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TECHNOLOGICAL INNOVATION IN THE UK NATIONAL HEALTH SERVICE OVERCOMING BARRIERS TO SUCCESSFUL IMPLEMENTATION

By K Nather1, A Eccleston2, N Hicks3, R Livermore1

FALL 2018

The UK National Health Service (NHS) is regarded as one of the best and most equitable healthcare systems in the world and was ranked 1st out of 11 developed nations on the overall healthcare performance ranking by the Commonwealth Fund in 2017 (1). However, despite the successes of the NHS, there are important areas where the NHS lags behind other developed countries, including healthcare outcomes and the uptake of innovative technologies. In the Richards report (2010), which compared the uptake of key best-practice drugs (i.e. new and old drugs considered best practice at the time) in 14 developed countries, the UK ranked 8th overall (2). While the UK was highly ranked for the uptake of drugs for acute myocardial infarction (MI), respiratory distress syndrome (RDS) and statins, its ranking was low in 7 out of 16 areas of clinical unmet need, such as cancer, dementia, hepatitis C, multiple sclerosis, rheumatoid arthritis and antipsychotics. These results indicate that the NHS is often slow to adopt innovative new drugs and other technologies.

1DRG Abacus, 6 Talisman Business Centre, Talisman Road, Bicester, UK, OX26 6HR2DRG Abacus, The Lexicon – Mount St, Manchester, UK, M2 5NT3COBIC, 5-9 Eden Street, Kingston upon Thames, Surrey KT1 1BQ

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Overcoming barriers to successful implementation

Similarly, slow uptake of innovation is evident for medical devices, digital integration and healthcare services. In a 2008 report, the King’s Fund assessed the uptake of technologies in the NHS and highlighted that the adoption of new technologies already widespread in other sectors (e.g. the financial and travel sector) is relatively slow in the NHS (3). This remains the case a decade later. For example, while over 60% of people in the UK used online banking to manage their finances in 2017 (4), the NHS is only just beginning to provide online general practitioner (GP) services and to roll out online consultations for patients (5). It has been suggested that it can take on average 17 years for a technological innovation to be adopted at scale in the NHS (6). But if innovative new drugs, services and other technologies can help improve clinical outcomes, why is the NHS so slow to adopt them?

The dictionary defines innovation as the development of a new method, idea or product. In the real world, this can be seen as problem solving and finding solutions to existing problems. In healthcare, medical innovations can be new diagnostic tools and procedures, new medical devices and drugs, better workflow processes or new digital services. Historically, the NHS has successfully adopted technical innovations such as computerised tomography (CT) and magnetic resonance imaging (MRI) scanners in the 1970s and 1980s. However, in recent years major barriers to the adoption and spread of innovation have become apparent within the institution (7). For innovations such as hip replacements and cataract surgery, it took the NHS more than 20 years to build the capacity to meet the need for these demonstrably effective interventions. During this time, some patients had to wait more than two years for their operations. Similarly, in a 2018 briefing, the Nuffield Trust highlighted that, after maintaining the same operational model for outpatient services for over 20 years, outpatient services were finally slowly transformed locally to make the services more efficient and valuable to patients, and to reduce costs and unnecessary outpatient services (8). These changes include a greater dialogue between primary and secondary care clinicians to establish collab-oration and make treatment decisions, the engagement of a wider clinical team in the care of patients with the

establishment of virtual clinics and improved triage, and a greater flexibility in the scheduling of follow-up appointments by giving patients more control over their disease and determining when a follow-up appointment is necessary. These changes ultimately free up resources and allow consultants to attend to the most complex cases in their care (8). So what determines whether the NHS adopts an innovation quickly and fully, slowly and partially, or not at all?

NHS OTHER SECTORS

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Overcoming barriers to successful implementation

In the 2011 Innovation, Health and Wealth report by the Department of Health, six main barriers to innovation in the NHS were identified (Figure 1) (9). Seven years later, the independent report from the King’s Fund on behalf of the Academic Health Science Network (AHSN) on the spread and adoption of innovation in the NHS makes it clear that many of these barriers still exist (7).

The fragmented nature of the NHS remains one of the main barriers for the adoption and spread of innovation that must be overcome by the NHS and innovators. The King’s Fund report highlighted that local leaders are often unwilling to pursue or invest in innovations that are

perceived to be outside their responsibilities (a “that’s not our job” mentality), hindering the rapid adoption of innovation across services (7). Operational silos within the institutions of the NHS mean that there is often no single potential adopter for an innovation, but instead various individual organisations such as clinical commis-sioning groups (CCGs), hospital trusts, and GP surgeries, all of which have their individual targets, incentives, and financial budgets. This fragmentation makes it difficult for innovators to seek out and make contact with potential customers, and requires a significant investment of time and resources to educate potential adopters about the value of the innovation (7, 10).

BARRIERS TO IMPLEMENTATION OF INNOVATIVE TECHNOLOGIES IN THE UK NHS01

Fig 1. Barriers to innovation in the NHS

BARRIERS TO INNOVATION IN THE NHS

Poor access to evidence, data and metrics

Insufficient recognition and celebration of innovation and innovators

Financial levers do not reward innovators and can act as disincentive to adoption and diffusion

Commissioners lack the tools and capability to drive innovation

Leadership culture to support innovation is inconsistent or lacking

Lack of effective and systematic innovation architecture

Adapted from Department of Health, 2011 (9)

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Overcoming barriers to successful implementation

Currently, less than 0.1% of the available resources in the NHS are set aside for the adoption and spread of innovation, with the majority of funds invested in research and development (7). The fragmented nature of the NHS means that the financial environment is unreceptive to innovation, not only because of the lack of purchasing power and financial incentives for innovations and innovators, but also annual budget systems that focus on short-term cash-releasing savings that do not allow for long-term investments (11). This is exacerbated by the top-down culture and hierarchical management structures of the NHS, where commissioners and providers are expected to meet clearly defined financial and quality targets. This often results in institutional short-sighted-ness, with investments being made only to improve the organisation’s financial position or relevant measures of quality in the short term, rather than in long-term improvements in patient services (7). Gaining financial support becomes even more problematic for innovators when investment across multiple services and sectors is required, or where the cost is borne by one part of the service (e.g. primary care) but benefits fall to another part of the service (e.g. secondary care).

Next to the barriers imposed by the system itself, behavioural and cultural factors can impose significant barriers to the adoption of innovation. Innovations with a strong evidence base can be approved for use in the NHS, but may not be adopted by the target groups. This may in part be simply due to the innovation not having been tested in the local NHS (12). Additionally, it has been highlighted that adoption by individual clinicians may only occur when the evidence is perceived as useful and in response to a previously identified need; when no such need has been identified, presenting evidence of something that works better than existing methods may be perceived as undermining professional judgement (12). Too often innovations are seen as additional services rather than alternatives, with the de-commissioning of old or the low value services occurring with great difficulty across this NHS; this means innovations and new services are competing for a very small or non-existent growth budget.

However, as a recent report from the Health Foundation outlined, adoption of innovation is only half the story (23). There are also significant shortfalls in the NHS in spreading innovations across the healthcare network and making them work everywhere. The report highlights that

spreading an innovation from one location to another is not a simple process, and results for an innovation can vary by location. While successful uptake of an innovation is largely due to overcoming system and cultural barriers, the successful spread of an innovation requires the adaptation and implementation of the innovation in the context of the healthcare setting. In other words, the innovation needs to be placed in the context of a larger healthcare system, considering a full range of factors for its success, such as underlying behaviours and cultural factors, skills and techniques, and organisa-tional structures. However, too often innovations face the “replicability problem” with little successful spread of innovations across the healthcare systems (23).

Many innovations consequently have a limited impact in a very small subset of institutions within the NHS health network. In order for innovation to succeed in the NHS, innovators and adopters need access to appropriate funding, and barriers to access, reimbursement and implementation need to be removed.

NHS FUNDS

<0.1% ADOPTION AND SPREAD OF INNOVATION

>99% RESEARCH AND DEVELOPMENT

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Overcoming barriers to successful implementation

The traditional routes for adoption of new and existing technological innovations in the NHS are via the National Institute for Health and Care Excellence (NICE) single technology appraisals (STA), multiple technology appraisals (MTA), Diagnostics Assessment Programmes (DAP) or Medical Technologies Evaluation Programme (MTEP), which all require the preparation of lengthy documents on the clinical and cost effectiveness of the innovation, followed by a detailed process of evaluation of the technology.

In response to the Innovation, Health and Wealth report, NHS England launched a series of policy reforms, including the establishment of 15 academic health science networks (AHSN) across the country with a main objective of identifying, adopting and spreading best practice across the NHS. As part of the AHSN framework, several different programmes aim to assist in driving innovation from early stages in development

to adaptation, implementation, and successful spread and uptake (Figure 2). These include, for example, the Small Business Research Initiatives (SBRI) for early stage innovations, the NHS Innovation Accelerator (NIA) for innovations ready for diffusion in the NHS and the Innovation and Technology Tariff (ITT) and Innovation and Technology Payment (ITP) to promote the spread of innovations. The ITT went live in April 2017, followed by the ITP in April 2018 and include nine innovations that are available to health and care providers on different cost models until 2019 (Box 1). In addition, the digital tool DrDoctor received funding support to help cut missed hospital appointments. In addition to the financial support available from the AHSN specifically for innovations in healthcare, other government agencies offer funding schemes to support and drive innovations across the UK (Box 2).

ROUTES FOR INNOVATION IN THE NHS

Innovations available to healthcare providers under a zero cost model:• Non-Injectable Arterial Connector (ITT)

• PneuXTM (ITT)

• myCOPD (ITT)

• HeartFlow® (ITP)

• Endocuff Vision® (ITP)

• SecurAcath (ITP)

The innovation available at a 30% discount to designated sites:• Ethicon Plus Antibacterial Sutures (ITP)

The innovation being reimbursed on the number of uses:• EpiScissors-60® (ITT)

The innovation provided at the same cost as current procedures:• Urolift® (ITT)

Innovations available via the ITT and ITP programme

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Box 1.

Small business research initiatives (SBRI) healthcare

• Supports early stage development of products towards implementation

• Accelerates the development of new technologies meeting the current needs of the NHS

Small business research initiatives (SBRI) healthcare

• Supports early stage development of products towards implementation

• Accelerates the development of new technologies meeting the current needs of the NHS

EVALUATION

SUCCESS

?

++

NHS Innovation Accelerator (NIA)

• Aims to accelerate the uptake of proven, high impact, low-cost innovations ready for diffusion across the NHS

• Delivered in partnership with the AHSN across England

• Provides support and mentorship to accepted fellows

ADOPTION

NHS Innovation Accelerator (ITT)

• Cuts the barriers for uptake and spread of innovations across the NHS

• Guarantees reimbursement of approved innovations for one year

UPTAKE AND SPREAD

Innovation and Technology Payment (ITP)

• Builds on the existing ITT to support innovation by removing financial and procurement barriers

• Guarantees reimbursement of innovations for one year

• Applicable to innovations that can be diffused quickly and at low cost

UPTAKE AND SPREAD

INNOVATION ACCELERATOR PROGRAMMES SUPPORTED BY THE AHSNs

Fig 2.

IDEA FOR INNOVATION

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Overcoming barriers to successful implementation

Funding schemes supporting innovation in the UK

Innovate UK

Innovate UK is part of UK Research and Innova-tion which is funded by a grant-in-aid from the UK government. The main aim of Innovate UK is to bring together innovators with potential partners and investors, and to de-risk, enable and support innovation.

Innovate UK runs regular funding competi-tions which are open to any area of technology, science or engineering that can be applied to the economy.

A list of current live competitions can be found at: https://apply-for-innovation-funding.service.gov.uk/competition/search

Knowledge Transfer Network (KTN)

The Knowledge Transfer Network, a non-profit organisation and the network partner of Innovate UK, provides innovation networking and aims to link people with ideas with the right expertise, markets, and financial resources to accelerate innovation. The KTN strives to link up businesses with people who can support and provide solutions to their ventures, and introduce entrepreneurs to investors to aid the adoption of innovation. The KTN works across all aspects of technology, science and engineering, but also provides networking for other funders.

For more information see: https://ktn-uk.co.uk/

National Institute for Health Research (NIHR)

The NIHR is funded by the Department of Health and Care and aims to fund health and care research to move discoveries from bench to bedside. The NIHR works across six themes, including the funding of research, translating discoveries, training

Box 2.

of researchers and leaders, economic growth, research within the NHS, and involvement of the public in research.

As part of its funding programme, the NIHR offers a translational funding scheme “Invention for Innovation” (“i4i”) which is targeted at small to medium-sized business, universities or the NHS to advance healthcare technologies that have already demonstrated a proof-of-principle and require support for adoption and commer-cialisation of their technology. The i4i offers two funding streams, the i4i Connect, which supports small to medium-sized businesses to reach the next stage in the development pathway, and the Product Development Awards which provide financial support at any stage of the product development pathway.

For more information, visit: https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/funding-programmes/invention-for-innovation/

Additionally, the NIHR has launched funding for Applied Research Collaborations. This funding is intended for health and care research, with subsequent support for implementation of the innovation into practice. The application is open to all NHS organisations and providers within England with applications for this year closed on 20th August 2018.

For more information, visit: https://www.nihr.ac.uk/funding-and-support/funding-infrastructures/applied-research-collaborations/8597

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FROM IDEA TO INNOVATION: CASE STUDIES OF SUCCESSFUL INNOVATIONS IN THE NHS

Since the establishment of the AHSN framework, the AHSN has successfully supported numerous innovations for uptake in the NHS. One of the innovations which benefited from AHSN support at a very early stage and throughout its development is the self-management application, myCOPD (Box 3).

MyCOPD is a web-based application providing a self-management programme for patients with chronic obstructive pulmonary disease (COPD). The main aim of myCOPD is to reduce the need for hospitalisations due to flare-ups and exacerbation of the disease, and to improve treatment compliance.

In the early stages, Simon Bourne, the founder of the company my mHealth and a respiratory consultant at Portsmouth hospital, received support from the local Wessex AHSN and won an SBRI grant to develop his idea into a robust technology ready for roll-out across the wider NHS. MyCOPD was officially launched in 2015 and joined the NHS Innovation Accelerator for accelerated uptake within the NHS. In 2017, myCOPD was selected by the ITT to promote its adoption and spread across the AHSN network.

03

MyCOPD: AHSN-supported innovationseverity of the disease, compliance with medication and lifestyle changes is poor among patients. The approach

Faced with the challenges of the management of COPD, the innovative respiratory consultant Simon Bourne at Portsmouth hospital devel-oped myCOPD, a digital platform that allows the self-management of the disease. The tool consists of two main interfaces:

A patient-facing component, focusing on:

• Disease education and inhaler training

• Self-management, including a medication diary and symptom scoring

• Self-directed pulmonary rehabilitation exercises

• Facilitating lifestyle changes

• Symptom reporting to the clinician

Box 3.

The challenge

Chronic pulmonary obstructive disease (COPD) is a serious and progressive respiratory disease, usually due to chronic bronchitis or emphysema, resulting in decreased airflow in the lungs. COPD is one of the leading causes of death in the UK and presents a high burden to the healthcare system:

• COPD is the second most common reason for emergency hospital admissions and accounts for one in eight non-elective admissions (13)

• One in six people with COPD who are hospital-ised will die during an emergency admission; one in twelve will die within 3 months (13)

• The direct healthcare costs are estimated to be £800 million (14)

There is currently no cure for COPD, and treatment focuses on symptom management to prevent flare-ups and exacerbation of the disease. Despite the

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A clinician-facing dashboard which:

• Provides a geographical display of all myCOPD users

• Allows the remote monitoring and management of patients with COPD, based on patient-re-ported data

Early funding was secured through an SBRI grant from the local AHSN Wessex, followed by the official launch of myCOPD in 2015 and it joining the NHS Innovation Accelerator. In 2017, myCOPD was selected for the ITT programme (15).

The outcomes

MyCOPD has now been implemented in Bradford CCG and South Coast CCG, with implementation in progress across Mid and South Essex, Devon, and Ipswich and Suffolk sustainability and transfor-mation plans (16).

Key outcomes so far:

• MyCOPD is proven to correct 98% of patient inhaler errors without clinical involvement (14)

• MyCOPD has proven to reduce the time in delivering an annual review by 50% (14)

• MyCOPD has doubled the rate of recovery from acute exacerbations (14)

• MyCOPD was as good as a conventional face-to-face pulmonary rehabilitation programme in a randomised clinical trial (17)

• In a CCG with an average population of 250,000 people, myCOPD would provide a return of investment of 846% (18)

• myCOPDs pulmonary rehabilitation (PR) service costs £20 for the lifetime of the patients, compared with current NHS costs of £400–£800 for a six-week PR course (14)

enterprises (SMEs) that do not have the expertise to negotiate the complex structures of technology assessments, which requires the preparation of a detailed submission document for appraisal, including the clinical and cost effectiveness of the innovation in question, followed by a lengthy evaluation process. How this can be managed successfully with the correct strategy support is exemplified by one of DRG Abacus’ case studies on the acceptance of a novel prognostic genomic test for breast cancer in draft NICE guidance (Box 4).

In this case study, a medium-sized molecular diagnostics company was invited into the NICE Diagnostics Assessment Programme for a second generation, genomic, prognostic test to assess the risk of women diagnosed with ER+, HER2- breast cancer to develop metastases within 10 years following the initial diagnosis. Although the company had knowledge of the NICE DAP process, it had limited capacity to drive the NICE DAP submission and was in need of strategic consultancy support which DRG Abacus was able to provide.

Funding from the AHSN is awarded via a competitive process which, depending on the stage of the innovation and the requirements of the funding award, requires demonstration of the value of the innovation, a detailed breakdown of financial and planning requirements, presentation of the existing evidence base for the innovation and the expected economic impact, as well as a strategy for scaling the innovation in the NHS. Often, such awards are limited to innovations that can demonstrate a quick return on investment, rather than those that have long implementation timeframes. If a business is unsuccessful in or unsuitable for gaining financial and strategic support from the AHSN, other funding opportunities and more traditional roads to innovation exist (e.g. NICE STA, DAP); however, these may lack the strategic support that small and medium enterprises require to successfully bring an innovation to market.

Navigating the traditional routes of STAs and DAPs for adoption of new and existing technical innovations in the NHS can seem daunting for small and medium-sized

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Assessment of a prognostic genomic test for breast cancer via the NICE DAP

• Review and response to the draft scope, evidence assessment group (EAG) report and draft guidance

• Support to adapt local discount schemeinto a formal patient access scheme (PAS) proposal

• Coordination of key face-to-face meetings

• Internal strategy meetings

• NICE meetings (scoping workshop and appraisal committee meetings)

The outcomes

Following an initial draft negative recommenda-tion, the company received a positive, optimised DAP (draft) recommendation for their prognostic genomic test in an specific patient population. The new guidance is expected to be published in October 2018.

Inclusion of the genomic test in the updated guidelines is expected to:

• Provide clinicians and patients with access to a wider range of tumour profiling tests to guide adjuvant chemotherapy

• Support decision-making concerning the long-term prognosis, treatment and management of ER+,HER2- breast cancer

DRG Abacus influenced this decision by:

• Impacting on the final scope to amend the population, comparator and outcomes to better align with the evidence for the product

• Providing extensive written responses at key NICE DAP consultation steps using technical and strategic input to change a draft negative recommendation to a positive recommendation

Box 4.

The challenge

ER+, HER2- breast cancer is a type of breast cancer that is more likely to respond to hormone therapy than drugs targeting HER2. Although chemothera-py may be used for treatment, there is uncertainty about the value of chemotherapy in this patient population (19).

Prognostic gene expression profiling tests are used to not only identify the cancer subtype but also to predict the risk of recurrence and metastasis, and to guide the use of adjuvant chemotherapy (19).

While there was positive NICE guidance (DG10) for a competitor product routinely used within the NHS, NICE invited five manufacturers of existing and new gene expression tests to participate in an update of the current DG10 guidance.

The approach

DRG Abacus provided a dedicated team compris-ing a strategic advisor, project lead and a senior systematic review (SR) analyst with health tech-nology assessment (HTA) expertise to support the company throughout the NICE DAP process. The support covered three main themes:

• Targeted literature review

• Review of the clinical and economic evidence of the product and relevant comparators via a targeted literature review

• Findings used to support written responses to key NICE DAP consultation steps

• Strategic consultancy throughout the NICE DAP process

• Review and critique of the previous DG10 assessment

• Advice on timings, process and stakeholder engagement

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THE IMPORTANCE OF ECONOMIC MODELLING FOR SUCCESSFUL INNOVATION04

Whatever the route to implementation, demonstrating the value and impact of an innovation to the healthcare system is key to influence local or national adopters’ decision making. Economic modelling is one of the main components of communicating value to decision makers and allows for the available evidence to be synthesised to generate estimates of the clinical and cost-effective-ness in a format relevant to the decision-making process. While the demonstration of the clinical and economic benefits of an innovative medicine is imperative for any funding or NICE submission, appraisal of a technological innovation is especially challenging due to the complex nature of the healthcare system and how technological innovations can have long-term and indirect conse-quences on the way how care is delivered. This can represent a barrier to their development and adoption. As a result, modelling approaches simulating a healthcare system and the impact of change are required before adoption in practice becomes attractive.

Economic modelling for NICE

Economic modelling is required for most economic evaluations performed by NICE, including the Diagnostic Assessment Programme (DAP) and the Medical Technolo-gies Evaluation Programme (MTEP), and specifically those where (20):

• Full end-to-end studies are not available, in which case modelling is used to estimate final outcomes

• All the relevant evidence is not contained in a single trial

• Patients in studies do not match the typical patients likely to use the technology in the NHS

• Intermediate outcome measures are used

• Relevant comparators have not been used

• The long-term costs and benefits of the technology need to be extrapolated

However, there are different requirements and challenges when preparing an economic model for DAP or MTEP evaluation.

NICE Diagnostics Assessment Programme

The DAP evaluates diagnostic technologies that may improve health outcomes but whose introduction is likely to be associated with an overall increase in cost to the NHS. Consequently, the DAP requires a cost-effectiveness (specifically cost-utility) analysis for evaluation.

For diagnostic technologies, the majority of outcomes are indirect and benefits are realised downstream, e.g. as a more efficient use of resources, a reduction in treatment costs or improved patient outcomes. Consequently, models built to assess the cost-effectiveness of diagnos-tic technologies should consider not only the diagnostic process itself, but also the treatment pathway of patients. An ideal method to establish the relative effectiveness of diagnostic technologies would be with studies that randomise patients and follow them from the initial diagnostic tests through treatment and up to the final outcomes. This would result in a relatively simple model structure that summarises the data. However, these studies are typically very expensive and are rarely con-ducted. More commonly, large and complex models are required that capture the differences between diagnostic tests and the impact that this may have on the treatment pathway of patients.

Medical Technologies Evaluation Programme

The NICE MTEP methods guide specifies the model requirements for evaluation and decision-making by the assessment committee (21). The committee’s main con-siderations when making its decisions are:

• Benefit to patients – whether the medical technology has a measurable benefit to patients over currently available health and social care system technologies, measured by relevant outcome indicators

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• Benefit to the health and social care system – whether the medical technology is likely to reduce the burden on health and social care system staff or reduce resource use compared with current management

Unlike the DAP process, the MTEP does not require a cost-utility analysis; instead, cost-consequence analyses are preferred (21). These analyses consider and compare the costs, resource use and clinical benefits resulting from the technology under evaluation with those currently used.

Typically, cost-consequence analyses calculate and present estimates of resource use and of clinical benefits as separate domains in the evaluation. Estimates of resource use should include costs of the technology acquisition, use and maintenance. Estimates of resource use may also include the comparative value of healthcare service use outcomes (such as length of hospital stay, or number of hospitalisations, outpatient or primary care consultations) associated with the use of the technology or its comparators (21).

Economic modelling for healthcare providersDemonstrating the local value of a service change is key to successfully creating a local purchaser base. As health-care providers are extremely cost sensitive when making decisions, due to financial budget constraints, it is vital that the economic value, in particular the cost benefits of new technologies, are captured and communicated clearly. Budget impact models compare the value of technologies and their associated resource use and costs to calculate the budget impact to a local provider over a 1–5 year time horizon. Budget impact models can be used with decision makers to present a customisable economic argument to facilitate local change.

Service impact models on the other hand allow for tasks, resources and constraints of a proposed service change to be compared with the current system. Service impact modelling enables decision makers to make confident decisions by providing sound evidence on the impact of a service change. Various modelling techniques can be used, including decision trees, Markov models and simulation modelling. While simulation modelling has the greatest data requirements, it can provide the most accurate representation of a real-world system. Simulation modelling can be conducted in Microsoft® Excel, which is

best suited for HTA evaluations, or in specialist software such as Simul8 which provides an intuitive visual mock-up of the model showing patients pass through the various stages of a treatment or a system. With the addition of timings and rules to the tasks, as well as resources and constraints which make up the system, the simulation will accurately represent the real world process and allows for changes to be tested to observe which variables deliver an optimal result for the system.

£

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CONCLUSION

The implementation of technological innovation in the NHS has traditionally been, and still remains, challenging due to systemic and cultural barriers. Although much innovation in the NHS occurs naturally within the ever evolving healthcare system, there are an increasing number of initiatives to support a systematic spread of innovation based on previously identified areas of unmet need within the NHS. Such initiatives are often short-lived and have variable success over a limited time period. Despite the formal routes of access to innovations, one of the key factors for the success of an innovation is the communication of its value and benefits to local potential purchasers. As much as this can be a technical process, one factor to the successful spread of innovation within a fragmented NHS is the promotion of innovations by clinicians themselves regionally and nationally; this can provide testimonies of the practical benefits of adopting an innovation within the clinical community.

Supporting the value and benefits of an innovation to the healthcare system in the short and long-term not only requires efficacy and safety evidence, but also a demonstration of its sustainability and economic value to the NHS by using economic modelling. While different funding schemes and NICE programmes have different requirements for the type of economic models used, budget and service impact models, as well as cost-conse-quence models are of particular interest for local decision makers and potential buyers to assess the impact and value of new innovations to the local healthcare system. Innovations have historically been slow to adopt by the NHS for the reasons described above. In addition, the recent decision of the UK to leave the European Union (EU) has created a great deal of uncertainty across the research and healthcare sector, and the pharmaceutical industry. A reduced involvement of the UK in international

research programmes, such as Horizon 2020, fewer UK patients participating in global clinical trials and fewer international research grants could contribute to slow innovation and adoption of new drugs, methodologies and research techniques in the UK healthcare system (22). While NICE decisions are deemed as very influential for future reimbursement applications in other countries, in the event of a hard Brexit, the UK may lose its status as an early launch market as the much larger EU market would be prioritised. Outside of research and develop-ment, supply chains and pharmacovigilance are major areas which will be impacted by the exit from the EU.

Successful adoption of innovation in the NHS will be key to the future sustainability of the health service. Whatever the outcome of Brexit negotiations, innovators will need to demonstrate and communicate the value of new technologies in order to promote adoption and spread.

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HOW DRG CAN HELP

Here at DRG, we seek to understand the different accelerator opportunities, the nature of the markets and the innovative products which are most likely to benefit from such opportunities. Collating the necessary data to meet all reimbursement application requirements, via more traditional routes or via new innovation accelerator pathways, can be challenging and onerous. DRG has the expertise to advice and support the submission processes, evidence generation and modelling of the economic value of innovative technologies.

DRG aim to combine talent, experience and passion to provide thought leadership on topics relevant to healthcare and the pharmaceutical industry.

For more thought-provoking views on the impact of Brexit on the UK healthcare system and pharmaceutical industry, as well as other topics, please visit our Blog.

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