Download New technology is cost-effective at a given price Its premium price

Zoltán Kaló
Professor of Health Economics
ISPOR 18th Annual European Congress, Milan
10 November 2015
e-mail: [email protected]
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New technology is cost-effective at a given price
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Its premium price can be justified by additional
health gain or savings in the health care budget
Caveat: the value based price is country specific
In Central and Eastern European (CEE) countries compared to
Western European (WE) countries
 savings from avoided medical events is less
 willingness to pay for one life year / QALY gain is less
 prices of new pharmaceuticals are not significantly different
due to the extensive us of external price referencing
Conclusion:
 what is just cost-effective in WE (e.g. at NICE), it is usually
not cost-effective in CEE countries
 prices of new pharmaceuticals are usually not value based
in CEE
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In most cases the new drug is not cost-effective, except
 health burden in CEE is greater than WE
 a non cost-effective drug is already reimbursed, and a new drug is not
worse and slightly cheaper (cost-minimization)
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If a drug is not cost-effective, and the critical appraisal team is not
experienced in economic modelling
 companies / market access consultants may prepare an economic
evaluation report with manipulated results, especially if
 model submission is not requested or not mandatory
 HTA reports are not publicly available
 there is no follow-up / revision of previous conclusions
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Decisions are based on potentially manipulated scientific evidence, such
systems are prone to corruption
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In most cases the new drug is not cost-effective, except
 health burden in CEE is greater than WE
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If a drug is not cost-effective, and the critical appraisal team is experienced in
economic modelling, and there is room for confidential price reduction
through managed entry agreements
 companies submit the HTA dossier with local adaption of international
models
 HTA agencies may validate the model, and calculate the true value based
price
 managed entry agreements may provide the necessary price reduction to
reach the value price
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Decision are evidence based, however some details remain confidential.
Implementation of such systems requires substantial input by HTA
professionals, especially health economists.
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Motto: "you do not need to repeat what is already done by
prestigious HTA agencies in WE"
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If the drug is just cost-effective in WE, market access is justified in
CEE countries
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Decision, however, is inappropriate
 international economic model are not adapted to lower income
countries
 transferability of cost-effectiveness evidence is limited
 especially if confidential pricing agreement is implemented in WE
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Decisions are based on inappropriate scientific evidence without
local adaptation of international evidence
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Some pharma companies, as it translates to market access
with low investment and relatively high drug prices in CEE
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Consultants, who are
 against or not experienced in conducting economic
evaluations
 do not prefer decisions based on explicit criteria
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(WE HTA agencies / research centers? importance of their
decisions or research is increased with reference by other
countries?)
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Impact on chances for full HTA implementation
 no need for training HTA professionals  academic centers
cannot develop, and consequently have limited chances to join
EU projects
 no incentives for local economic evaluation
 limited improvement in quality of local data
 trained professionals usually leave the country
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Impact on patients & opportunity cost
 patients with access to non cost-effective medicines: huge benefit
 all other patients: access limits
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Overall impact: Gap between WE and CEE is increased
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Building light HTA approach in Central and Eastern European
countries based on HTA recommendations in Western
European countries: more harm than good? YES (personal
opinion)
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Reasonable approach: national adaptation (reuse) of
international work with managed entry agreement, if
necessary. This is in line with the EUnetHTA approach
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Academic approach: compare recommendations of light
HTA vs. national adaptation of international work (n>20),
and use light HTA only if recommendations are the same
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Tradition for corruption in CEE
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Bad reputation of pharma industry due to inappropriate sales
practices
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"Market access" becomes more crucial than "Marketing & sales"
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Be careful with
 manipulation of economic models
 promoting the use of non-transferable scientific evidence
 selection of your consultans
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Sales driven evidence  Evidence driven sales