Economic Evaluation Framework for Medical

Technologies

IMSTA ANNUAL CONFERENCE

22 March 2017

Rosemary Durcan Life Sciences & Healthcare Consultant

https://ie.linkedin.com/in/rosemarydurcan

Medtech Global - 2022

• Global market to reach $529.8 billion

• CAGR 5.2%

• R&D expenditure to reach $34.0 billon

• Number of first-time PMAs and HDEs

hit a ten-year high in 2015

• While 510(k) clearances decrease 6%

to 3,064

Source: Evaluate MedTech. World Preview 2016, Outlook to 2022

Top 15

Medtech Market - 2022

• Top 10 MedTech Companies

are predicted to account for

35% of industry sales by 2020

• Medtech will still be dominated

by SME sector

• 300-400 new medtech

products per year

Top 10 35%

11- 30

25%

Rest of Market

40%

Source: Evaluate MedTech. World Preview 2016, Outlook to 2022

Medtech - Ireland • Europe’s leading medtech cluster

• Highest per capita employment of medtech employees

in Europe

• 18 of the Top 25 Global companies based here

• 29,000 employees

• €12.6 billon exports annually (9% all exports from

Ireland)

• Exporting to over 100 countries

• 400 companies - 50% indigenous

• Vascular, Neuromodulation, Ophthalmic, Orthopaedic,

Drug Delivery/ Combination Devices, Diagnostics,

Connected Health, Hospital/ Homecare Products and

Industry services/ solution providers Source: IDA Ireland, Enterprise Ireland & IMDA

Medtech R&D Ireland

Source: IDA Ireland

60% companies engaging in R&D

Investing for the Future

Scientists use graphene and toy silly

putty® to make state-of-the-art sensors

- AMBER/ TCD

• Graphene + silly putty = conduct

electricity

• Electrical resistance of the G-putty is

sensitive to deformation

• Preliminary work shows by placing G-

putty onto the chest and neck of human

can be used it to measure breathing,

pulse and even blood pressure.

• Material will find applications in a range

of medical devices

Professor Jonathan Coleman and his son, Oisin, with the amazing 'G-

putty

Innovations coming soon ..

Patient Access

• Innovative medical technologies can

improve patient outcomes and reduce

overall treatment costs

• A responsibility to get products to

patients which are of value & can be

afforded by the system

• Healthcare is moving to:

• Value Based Care - rewarding quality

and outcomes

• Not about number of patients, tests &

procedures but will be about patient

outcomes: quicker recoveries, fewer

readmissions, lower infection rates,

and fewer medical errors

Procurement without HTA

• 70% of global medtech sales go thorough a public-

procurement process & 70% of those are

determined on basis of price

• High focus on purchase price & short term savings

• Does not consider the patient or other colleagues

health care costs within the system

• Leads to less competition in the market place with

some companies going out of business

• Reduces innovation & discourages adaptation of

new technologies

• Does not address quality or total cost of patient

care

• Encourages silos in hospitals, misaligned

incentives, bureaucratic administration

Product Value

Health System

Priorities Patient Benefits

Impact on

Health System

Resources

From the buyers perspective

How do we actual measure the value?

From the funders perspective

• €13.9bn Gov Healthcare Spend

• Medtech Spend €0.5bn per year

• Patient Outcomes

Cost of Achieving those Outcomes

Health Technology Assessment

A health technology assessment (HTA) is the systematic

evaluation of the intended and unintended effects of health

technologies on the lives of patients and the health care

systems, and society such as:

• Clinical effectiveness

• Cost‐effectiveness

• Socio-economic benefits

• Ethical and legal impacts

• To inform health care policy & decision makers on

whether to reimburse and use a technology and if so,

how it is best used and who will benefit most from it.

• HTA differs according to the type of questions decision makers ask

• Systematic evaluations of the properties & effects of the technology

• Conducted by interdisciplinary groups and use a variety of scientific

methods, including statistics and health economics, and reviewing

data (clinical, economic and increasingly patient outcomes data).

• Stakeholder involvement (patients, doctors, decision makers and

technology manufacturers) is key to the success of an HTA

How are HTAs carried out?

HTAs in Ireland • National Centre for Pharmacoeconomics (NCPE)

• Health Information & Quality Authority (HIQA)

• Health Technology Assessment Unit, Limerick

• Some evaluation carried out by Procurement

Evaluation Group, Individual health

professionals, Primary Care Reimbursement

Service (PCRS), Health Sector Procurement

Agency (HBS)

• Not yet a systematic process for evaluating

clinical & cost effectiveness of medtech

• Risks innovative products not becoming

established & benefits are lost to the patient and

the economy

International HTAs

• England & Wales, NICE

• Norway - Institute of Public

Health

• Germany - GBA/IQWIG

• Scotland - Scottish Health Technologies Group

• New Zealand - Pharmac

• Australia - Medical Services Advisory Committee

• Netherlands- National Health Care Institute

Mini HTAs

• Australia, Canada, Norway,

Denmark, Sweden, Spain &

USA

Key Attributes HOW?

• Systematic System

• Clear route to Market

• Dedicated Independent Resource

• Open & Transparent Process

• Stakeholder Involvement (Health System, Patients & Industry) is key

• Horizon Scanning

• Evidence Based Assessments

• Expert input & independent advisory committees

• Full HTAs, STA & Mini HTAs

WHY?

• Provide appropriate decision making

• Improve patient safety & access to new treatments

• Rational use of resources

• Introduce new treatments

• Divest obsolete treatments

• Systematic, predictable process for introduction of new treatments

• New technologies expected to increase life expectancy, reduce the duration of disease reduce symptoms and complications, or improve quality of life

In Summary

Ireland’s is a Centre of Excellence for Medical Technologies

Adoption of Innovative Medtech is important for both the patient & sector

Evaluation of Value Based Outcomes

National HTA Framework - Systematic, transparent, independent, consistent

Stakeholder Involvement is key

IMSTA Market Access / Health

Economic Reference Group

Thank you

Rosemary Durcan

Life Sciences & Healthcare Consultant

https://ie.linkedin.com/in/rosemarydurcan