Digital health in the Accelerated Access Review DHACA Day Event

Monday 11th January 2016

The Accelerated Access Review

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Digital health products are part of the new innovative solutions to which we want to accelerate access, and so we have been engaging the digital sector to ensure that the Review is sufficiently considering issues relating to digital alongside pharma, med tech and diagnostics.

The Accelerated Access Review independently chaired by Sir Hugh Taylor aims to revolutionise the speed at which 21st century innovations in medicines, medical technologies and digital products get to NHS patients and their families.

The review so far

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Accelerated Access Review interim report

The AAR’s interim report was published on 27th

October. It sets out a vision of a lit runway for innovation that:

• accelerates access for NHS patients to the small number of new products that promise to be truly transformative, and

• supports all innovators through the regulatory, evaluation and reimbursement stages of the pathway to give their product the best chance of succeeding.

This is underpinned by a focus on:

• empowering patients by giving them the opportunity to be an active participant in decision-making, and

• harnessing and enhancing existing structures in the health system to align their goals and help deliver the aims of the review.

The review is centred on five propositions that set out this vision in more detail and describe the areas of focus for the next phase of the review:

Getting ahead of the curve

Galvanise the NHS

Putting the patient centre stage

Delivering change

Supporting all innovators

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The scope for digital health in the review is being bench-marked against the following criteria: 1) Is it an innovation for the NHS and citizens and 2) does it focus on treatment.

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Mobile health• Apps (medical apps,

prevention, CBT, med management)

• Wearables• Game-ification

Telehealth and telecare• Activity/fall

monitoring• Remote consultations

Digital medtech• Intelligent

orthopaedics• Medical imaging

Diagnosis

Chronic conditions

Wellbeing

Infrastructure

Acute care

A digitised health and care system• Clinical software e.g. e-health records• Digital services e.g. transactions, e-

prescribing• Secure data storage

Data enabled health• Health analytics• Bioinformatics• Data for decisions

• LTC monitoring

• Ingestible/implantable sensors

The work of the National Information Board (NIB) will be of relevance for the review. In particular, NIB workstream 1.2 focusing on “providing citizens with access to an endorsed set of NHS and social care apps”.

Known barriers to uptake

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Technical

Market & supply

Cultural

Structures &processes in the

healthcare system

Multiple buyers and purchasing practices

Budget silos

Clinical testing grounds

Public trust in health data and tech

Clinicalenthusiasm

Changes to ways of working

Procurement rules

Data standards

System and organisational interoperability Information

governance and data sharing

Investment in underpinning infrastructure

Unfamiliar business models

Winning business in the NHS

We regularly hear that these in particular are the key issues for app developers.

Regulatory pathways

Evaluation methods that keep pace with tech time

Lack of health informatics skills

Tendering requirement

Proposed areas for recommendation

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HORIZON SCANNING:

ROLE OF AHSNs:

DIGITAL PATHWAY:

TENDERING:

COMMISSIONING &

PAYMENT:

Developing stronger, more systematic mechanisms for horizon scanning and a more transparent decision making process for identifying and prioritising the most promising digital health solutions.

Developing the network of AHSNs to strengthen their coordination role and facilitate a network of local innovation exchanges that ensure the patient voice is heard by innovators, commissioners and providers.

Setting out a new pathway for digital products that clarifies the steps involved in getting to market.

Setting out a managed access pathway with an early promise designation for the most promising digital health solutions.

Building the work of the NIB 1.2 app assessment process into the review’s recommended pathways.

Recognising the heavy tendering data requirements which often disadvantage SMEs. Promoting the use of digital health solutions in tender specifications and other documentation

for CCGs.

Recognise the barriers to commissioning digital health and issues faced by SMEs having to sell to over 200 CCGs – no standard template for evidence requirements. Propose that NHS England works to address these.

Flexible funding models for most promising digital health solutions. Explore the use of Article IX of the drug tariff for primary care prescribing of digital.

SUPPORTING INNOVATORS: Developing ‘how to guides’ for navigating the innovation pathway Guidance for AHSNs and CCGs around commissioning and uptake of

digital health solutions.

Emerging recommendations – what could the digital pathway look like?

Ongoing dialogue to provide support at checkpoints throughout the accelerated access pathway

Early dialogue via innovation exchanges

Promising Device Designation

Marketed product available to NHS via routine commissioning with supported uptake

Business case development via provider-innovator partnerships

Regulatory approval

CE mark awarded,If appropriate

Full endorsementTemporary/ permanent funding decision

Self-evaluation

Community evaluation

Business case development via provider-

innovator partnerships

Business case developed

NIB workstream 1.2

RWD collection (clinical and economic data)

Clinical studies Uptake assessment

Business case developed

Other products

Patient-facing products (within scope of NIB

workstream 1.2)

Innovator & AHSNs Innovator & providersNotified Body Innovator & NHS (national)

Innovator AHSN with support from innovators

Innovator, NIHR, NHS

National Innovation Partnership (core members: DH, NHSE, MHRA and NICE with delivery partners across the devolved administrations)

CE mark required for devices entering the NIB

1.2 process

Managed Access

PathwayHTA

Recommended for routine commissioning

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January February March April

15 Pharma Pathway Event 19 Digital Pathway

Event 28 Med Tech & Diagnostics Pathway Event

RAND research

How to guide production

Int review

Report Writing

redrafting

Report sent to PS(LS)

26 National Voices Event

4 Engagement Site Closes

Evidence analysis Evidence Centre Report

RAND Report

How to guide

2nd Draft Report

Ext review

redrafting

Govt response production

1st Draft Report

Pre launch pitch-rolling

FinalReport

& Govt

response

Policy Development

15 EAG 7 EAG7 SSG ?1 SRG21 X-govt

PWC work PWC Report

SHT GF catch up

Recs drafting

NEXT STEPS – AAR TIMELINE

Any questions?

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CONTACTS

Tamsin Berry, Head, Accelerated Access Review Team – (Tamsin.Berry@officeforlifesciences.gsi.gov.uk) Jazz Bhogal, Incoming Head of AAR Team – (Jazz.Bhogal@dh.gsi.gov.uk) Usama Edoo, Digital Policy Lead for AAR – (Usama.Edoo@officeforlifesciences.gsi.gov.uk)