Spring Intro 2023

23/03/2023

F ocus of HTA differs across countries

A T

B E

C H

D E

F I

F R

N L

N O

S E

U K

Criteria

Therapeutic benefit

X X X X X X X X X X X X X X X X X X X X

Patient benefit

Cost-effectiveness

X X

X

X X X X

Budget impact

X

X X X X

X X

Pharmaceutical/innovative characteristics

X X

X X

Availability of therapeutic alternatives

X

X

X X

Equity considerations

X X X

Public health impact

X

R&D

X

Country

Clinical Effectiveness

QOL

Cost Effectiveness

Cost/QALY

Budget impact

US

Very Important

Informative

Important

Informative

Important

FRA

Very Important

Informative

Informative

Informative

Very Important

GER

Very Important

Important

Important

Informative

Important

UK

Very Important

Important

Very Important

Mandatory

Important

ITA

Very Important

Informative

Informative

Informative

Very Important

SPA

Very Important

Very Important

Important

Important

Very Important

The Organisation for Professionals in Regulatory Affairs

9

Regulatory ● Overall Benefit Risk Assessment HTA differs from Regulatory

– Does the product work for the target condition? – Is the product safe in the target population? – Can it be manufactured consistently according to GMP HTA ● Relative Effectiveness & safety – What is the added value of this new product?

– Does it work better than what is currently used for the same target condition? – Is the product safer than what is currently used for the same target population? ● Quality of Life – Does the product improve the quality of life of the patients? ● Value for money & affordability – Is it a good investment? – Can we afford it? – Does it bring advantages to the healthcare system?

The Organisation for Professionals in Regulatory Affairs

10

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