assessing the value proposition and promoting the adoption of new and novel medical technologies

Assessing the value proposition and promoting the adoption of new and novel medical technologies

Mark Campbell

Associate Director

Medical Technologies Evaluation Programme (MTEP)

CE 2012: EU Medical Device Regulatory

Revision Conference

Birmingham, 20 September 2012

Content

• General update on NICE• Development and operation of the NICE medtech

programmes• Assessing value• Published and in-development guidance

http://review2011-2012.nice.org.uk/

A short history of NICE

QOF

Public health

Interventional Procedures

Clinical guidelines

Quality standards

NHS Evidence accreditation

decisions

Medical devices

DiagnosticsPublications

NHS Chief Executive Report on Innovation - December 2011

Innovation, health and wealth:promoting uptake of NICE guidance

• Support for adoption of NICE guidance• Compliance regime and uptake metrics• End to local duplication of NICE evaluation• Support for the NICE scientific advice programme• Targeted effort to implement dementia and

oesophageal Doppler monitoring guidance• Immediate transfer of DH Innovative

Technology Adoption and Procurement Programme(iTAPP) to NICE

“...Through its medtech progammes, which use world-leading methodologies, NICE is at the forefront of helping decision-makers derive maximum value for the NHS;and we look forward to continuing to develop these with clinicians, policy-makers and industry..”

Professor Sir Michael RawlinsChairman, NICE

http://jrsm.rsmjournals.com/content/105/suppl_1.toc

Regulation or evaluation ?Regulation Evaluation, leading to NICE

guidance

Required in order to place product on market

Not required to promote and sell product but guidance is sought by, and credible with, NHS clinicians and managers

Location-specific (UK, EU) Audience for guidance is NHS in England but very active international interest

Fundamental quality, safety and efficacy are evaluated

MTEP evaluates the value proposition (often using data from studies of safety/efficacy) including claimed benefits compared with standard care

(unless device is part of new or novel Interventional Procedure)

No assessment of resource impact Focussed on system benefits using appropriate economic methods

Medical Technologies Evaluation Programme (MTEP) bespoke design (1)

Appl Health Econ Health Policy 2012; 10 (5): 295-297

Characteristic Programme design and operational features

Different regulatory environment Can accept technologies early in life cycle

The relatively sparse evidence base for medical technologies by comparison with, for example, pharmaceuticals

All forms of evidence (published and unpublishedand with no design or quality threshold)are considered.Further evidence generation facilitated by NICE for promising technologies with guidance recommendations for further research

Medical technologies evolve at a rapid pace Short timelines. 10 weeks from notification to selection, 38 weeks from selection to guidance development

Medical technology products are usually promoted to the NHS with specific claimed benefits when used in place of or addition to standard care

The sponsor’s case for adoption drives the initial assessment and, if selected, evaluation of the product to simulate NHS decision-making. Clear and explicit value propositions are required from the sponsor before a decision is taken to evaluate

Medtech products are often claimed to be resource-releasing and more convenient.

System benefits are given equal prominence topatient benefits and sustainability benefits areidentified and actively considered.

Characteristic Programme design and operational features

The medical technology industry is large and diverse with a high rate of output of innovative products

Innovators (usually a commercial sponsor, i.e. Manufacturer or distributor) notify their products directly to NICE so that as wide a range of productss as possible can be considered.

Improving the efficiency of health services is a top policy priority

Medical Technologies Guidance specificallyexamine products which are plausibly resource releasing and the primary economic methodology used is cost-consequences analysis which gives an estimate of the saving per patient if the case for adoption is supported by the evidence

Innovative products may be slowly and/or unevenly adopted

Products which are novel but not new canbe notified and may be evaluated if there isevidence that they have plausible claimed benefitsand are not being routinely adopted.

Technical considerations (safety, compatibility, procurement, maintenance, calibration, training, upgrades) can significant influence clinical utility

Access to world-leading technical expertise to commission bespoke studies to answer specific questions which are relevant to the assessment clinical or cost utility

Medical Technologies Evaluation Programme (MTEP) bespoke design (2)

NICE medtech programmes (MTEP, DAP) at-a-glance

Selection and routing

Evaluation (MTG, DG or other)

Research facilitation

Scope – products to be evaluated

• Medical devices as defined in EU directives: – 93/42/EEC (concerning medical devices)– 98/79/EC (concerning in vitro diagnostic medical devices) – 90/385/EEC (concerning active implantable medical devices),

as amended

• …..including medical devices used for the purpose of diagnosis…and medical software

• Genetic tests within the scope of 98/79/EC provided they have a medical purpose

• Other products (eg tissue engineered products), on advice from DH

The case for adoption (compared with standard care)

• Replace ongoing therapy costs with one-off intervention or device

• Deliver treatment decision or care nearer to home • Reduce unnecessary surgical interventions • Enable self-care• Reduce length of stay• Enable treatment by a lower grade or less scarce type

of staff• Improve patient dignity and treatment compliance• Reduce future hospitalisation• Speed up recovery • Etc

Eligibility and selection criteria

Eligibility Selection

Timing Patient benefit

New or novel System benefit

Suitable for evaluation Disease impact

Cost considerations

Sustainability

Plausible

promise

Ineligible or not-selected topics are returned to the sponsor with a summary of the Committee’s considerations

Routing selected topics:what’s the value proposition ?

Clinical performance Better At least equivalent

Cost Higher Less overall

Patient benefits (inc preference)

Evidenced and used to adjust value

Evidenced and anecdotal – but not used to adjust value

Appropriate evaluation method

Cost effectiveness Cost consequences

Example Drug-eluting stents (TA152)

Oesophageal doppler monitoring (MTG3)

Which programme at NICE?

Cost modelling – cost consequences analysis

Cost model - examples

Acquisition costsRunning costs eg disposables or concomitant treatment

Staffing costs

System savings (eg change in setting)

Reduced costs of improved health outcomes

Improved ease of use or patient acceptability

MTG recommendationsUsually:

• Case supported (wholly, partly or not)

• Consider using in <case for adoption> <research>

• Resource consequences

NICE medical technology guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This ‘case’ is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.

Development of further evidence

• MTEP has a research workstream as an integral part of programme

• Designed to facilitate research to address gaps in evidence which led to research recommendations in MTG or DG

• Flexible approach to research products but must be able to be completed within ~ two years

• Subject to findings and evaluation – updated guidance

Assessing value

What do decision makers need to know about new technologies?

Product value

What you need to do – constructing claims and driving value

A point-of-care diagnostic test which allows 'test and treat'

A test which confirms or excludes serious illness more quickly and/or more accurately allowing faster targeted treatment/faster discharge

A device which enables people to be more independent

A device which allows more accurate and/or more convenient monitoring (and therefore shorter or no time in hospital or fewer hospital visits)

An imaging technology which allows a reduced radiation dose and/or more accurate imaging and/or better treatment planning or monitoring

Common pitfalls and....some solutionsCommon problem Solution

Evidence doesn’t match the claim

Be clear about best possible application of product before commissioning study

Lack of clarity about the product’s position in care pathway

Talk to UK-based clinicians about how they might use the product and how it would change treatment

Unrealistic view of potential savings

Understand current treatment and availability – don’t assume a more expensive comparator is widely used

Not enough evidence to support the case for adoption

Share all possible sources of data with NICE – post-market, audit, unpublished

Getting help

General support for innovation - Technology Strategy Board/ Knowledge Transfer Networks www.innovateuk.org

Relevant evidence for health technology assessment - NICE Scientific Advicewww.nice.org.uk

Evidence generation - NIHR NOCRIwww.nocri.nihr.ac.uk

http://www.innovateuk.org/

December 2011

Published and in-development guidance

11 MTG published, 9 in development5 DG published, 7 in development

Patient and system benefits of published guidance

Topic Patient benefits System benefits

Cost saving (per patient*)

MTG 1 Sequent Please balloon catheter for restenosis.

Lower rate of restenosis and reduced need for re-treatment and major cardiac adverse events.

Fewer repeat procedures.

450

MTG 2moorLDI imager for medium-severe burns.

Better treatment planning (and less prodding !)Avoidance of unnecessary surgery.

Fewer skin grafts.

1248

MTG 3Cardio Q ODM for intraoperative fluid management.

Fewer post-op complicationsEarlier mobilisation(No increase in repeat surgery or re-admission).

Reduced length of stay.

1100

BBC News at 10: 29 March 2011

Topic Committee recommendation

Current status

MTG 4Copeptin assay for rule out of acute MI

Promise of excluding acute MI earlier than 2nd troponin (but further research required)

Recommendations for further research being scoped

MTG 5The MIST Therapy System for chronic hard-to-heal wounds

Promise of more ulcers healed more quickly (but further research required)

Evidence generation underway

MTG 6Ambulight PDT for non-melanoma skin cancer

Early promise but insufficient evidence to support case for routine adoption. NHS should take into account when considering investment.

Final guidance published

assessing the value proposition and promoting the adoption of new and novel medical technologies

Documents