HTA: What Can Ukraine Learn from

the International Experience

Milena Izmirlieva, Senior Manager

29 October 2013

Presentation at 2013 Ukrainian Pharmaceutical Forum

© 2013 IHS 2

Agenda

• What is HTA?

• Why do HTA?

• HTA role and criteria

• HTA process

• What are the benefits of HTA?

• What are the costs of HTA?

• “Best practice” in HTA

• Does Ukraine need HTA?

© 2013 IHS 3

What is HTA?

• Health Technology Assessment (HTA):

• the systematic evaluation of the properties and effects of a health

technology, addressing the direct and intended effects of this technology, as

well as its indirect and unintended consequences, and aimed mainly at

informing decision-making regarding health technologies

• HTA aims to inform health policy and decision-making in a bid to optimise

care using the available resources, so that the most effective technologies

are promoted while taking consideration of organisational, societal and

ethical issues.

© 2013 IHS 4

Why Do HTA?

• New health technologies of proven clinical value pose a dilemma:

their application may require additional (financial and non-

financial) resources or redistribution of existing resources within

the health system.

• Is funding the given technology a good use of limited resources

compared to existing options?

• Support funding decisions!!!

© 2013 IHS 5

HTA is One Element of Decision-Making

Source: WHO, adapted from Davies, 2005

HTA is not the

decision!!!

HTA serves to help

make the decision.

It provides a bridge

between research and

a real-life situation

where multiple priorities

need to be balanced.

HTA brings rationality to

health policy decision-

making.

© 2013 IHS 6

HTA Role Depends on Various Factors

• Existence of HTA agency

• Remit of HTA agency

• Timing of HTA review

• Link between HTA and funding decision

• Other cost-containment tools in use

© 2013 IHS 7

HTA Criteria Applied by Country

Criteria Applied to

HTA for

Pharmaceuticals

Germany Denmark France Hungary Italy Netherlands Poland UK Brazil

Budget Impact √ √ √ √ √ √

Costs √ √ √ √

Cost Effectiveness √

(not

systematically

used)

√ √

(since

Oct.

2013)

√ √ √ √ √

Efficacy √ √ √ √ √ √ √

Degree of Innovation

√

√ √ √

Need √ √

√

√ √

Safety √ √ √ √ √

Relative Effectiveness √ √

√ √ √ √

Source: IHS

© 2013 IHS 8

HTA Process

• Assessment request (submission or identification of research

need); prioritisation; commissioning

• Developing the remit and scope (treatment, comparators, outcome

measures, measures of costs and length of time, stakeholders)

• Appraisal of the evidence: clinical and cost effectiveness and

financial analysis in terms of the limits agreed at the scoping stage.

• Draft recommendation (potential to appeal, submit additional data)

• Final recommendation

© 2013 IHS 9

Decision Outcome

• Full or partial funding/reimbursement recommendation

• Coverage with evidence generation

© 2013 IHS 10

HTA Recommendation Implementation

HTA

Outcome

Recommendation to

decision-making body Government or other reimbursement

body makes final decision

(France, Switzerland, Poland, Romania)

HTA

Outcome

HTA outcome is binding Payers/National Health System

( UK, Germany, Finland)

© 2013 IHS 11

Benefits of HTA

• Bring rationality to healthcare decision making

• Improve transparency

• Help decision-maker to balance different priorities

• Improve fairness

• Reflect societal expectation/ideals

• And the unexpected: protect government/insurers from litigation

(e.g., in Brazil)

© 2013 IHS 12

Costs of HTA

• HTA agencies tends to be non-profit bodies, funded by public

funds, with some contributions from the industry

• HTA agency budgets vary from EUR1 million to substantially

more than EUR10 million depending on function

• Opportunity cost: with limited resources, time spent on one

appraisal could have been used to appraise another technology

© 2013 IHS 13

“Best Practice” in HTA

• There is no agreement on best practice in terms of methodology

for conducting HTA even if the steps of the process are agreed:

• Cost-effectiveness measured in ICER per QALY is the favoured approach in

UK and certain other Anglo-Saxon countries

• Cost effectiveness or cost utility analysis based on relative effectiveness to

treatment alternatives is favoured in France and Germany

© 2013 IHS 14

Does Ukraine Need HTA?

• A decision for Ukraine to make.

• When it comes to pharmaceuticals, HTA is typically used for

originator medicines (i.e., pointless to use if you plan to reimburse

only generics).

• HTA needs to be seen in the context of the healthcare system: no

point in conducting HTA if other cost-containment tools invalidate

its effect (e.g., Bulgaria, Romania)

• If the answer is “yes”, help is at hand: e.g., EUnetHTA initiative,

NICE International.