Goeree, RA

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decision-making, from the moment of ﬁrst application until the
ﬁnal decision made by the Ministry.
Results: As a result of the workshops the detailed process of
making reimbursement decisions has been speciﬁed and the cri-
teria for reimbursement and pricing are being deﬁned. Bill regu-
lating the reimbursement system in Poland is being prepared and
will be implemented into polish legal system in January 2009.
The Bill regulates the tasks of HTA Agency, its Consultative
Council, which makes recommendations, and MoH in the
process. It names the health priorities taken into account while
giving recommendations, lists all the documents and analyses
required in the reimbursement application.
A separate Regulation will be prepared with the template of
the reimbursement application and description of properly write
analyses based on polish HTA guideline.
The process of including (or excluding) drug to the reimburse-
ment list is divided on the steps taking place in different institu-
tions. The separate tracks are set for innovative drugs and for
generics. The specialized institutions are responsible for each
step: clinical effectiveness, safety and cost effectiveness is assessed
in AHTAPol, formal and legal requirements in MoH, price nego-
tiations by special Negotiations Committee and ﬁnal recommen-
dations to Minister is made by Reimbursement Committee which
advice the Minister of Health.
The documents prepared in each step of the process will be
transparent and available for all stakeholders except price nego-
tiations which are conﬁdential and results are known only to the
Ministry and the company involved.
The whole process described above will result in a clear and
transparent system of drug reimbursement in Poland, which will
be implemented into the Polish legal system in 2009. That was
big and important project, which improved cooperation between
policy makers and industry, between international HTA experts
and between Poland, France, the EC and other Member States.
Lessons Learned: For creating a new or improving existing reim-
bursement decision making process experience of other countries
is indispensible. Changes in the process should be transparent,
understandable for all stakeholders and if possible consulted
with all parties involved; policy makers, EC, industry, health
professionals and patients associations.
CASE2
DOTECHNOLOGY EVALUATIONS BASED ON EVIDENCE
FROM CONDITIONAL FUNDING LEADTO AN INCREASE IN
POLICY FORMATION?: FINDINGS FROM,AND IMPLICATIONS
OF, ONTARIO’S EVIDENCE-BASED HTA PROCESS
Goeree RA
Ontario Health Technology Advisory Committee (OHTAC),
Hamilton, ON, Canada
Organization: Ontario Health Technology Advisory Committee
(OHTAC); Ontario Ministry of Health and Long Term Care,
Canada.
Problem or Issue Addressed: There have been numerous concerns
and criticisms that results from Health Technology Assessment
(HTA) reports or economic evaluations are infrequently used in
health care decision making and subsequent policy formation. It
is apparent that favorable and good quality clinical and eco-
nomic evidence is not a sufﬁcient condition for policy develop-
ment. It has been hypothesized that Conditionally Funded
Field Evaluations (CFFEs)/Conditional funding with Evidence
Development (CED) may provide decision makers with the
information needed to better inform policy recommendations
and development.
Goals: To compare, in a large health care system, policy devel-
opment and uptake for technologies based on information
collected from local/geographic-speciﬁc clinical and cost-
effectiveness studies showing how a technology works in a ‘real
world’ setting to policy uptake for technologies based on tradi-
tional HTA evidence collection and synthesis techniques.
Outcomes items used in the decision: The Ontario Ministry of
Health and Long Term Care (MOHLTC) has embarked on a
relatively new initiative for publicly ﬁnanced health care deci-
sion making for new devices and medical technologies that is
embedded in an evidence-based framework. All requests for
new public funding are funneled through an independent multi-
disciplinary decision making body (Ontario Health Technology
Advisory Committee). OHTAC may either request that the
MOHLTC conduct an internal review of the available evidence
surrounding the technology (i.e. traditional literature review
and syntheses techniques) or that a CFEE/CED be conducted
due to insufﬁcient information and high decision uncertainty.
This uncertainty can arise from conﬂicting, poor quality, or
insufﬁcient evidence or simply due to concerns about general-
izability of the technology to the Ontario setting. Based on
whether the technology followed the traditional approach for
evidence generation or the CFEE/CED approach, the rates of
subsequent policy development and uptake over the last 5 years
have been compared.
Implementation Strategy: Since its inception in 2003 OHTAC has
reviewed and made policy recommendations for over 100 tech-
nologies. Of the technologies that have resulted in recommenda-
tions for funding, 5 of these were based on completed CFFE/
CED.
Results: The policy uptake rate for technologies based on favor-
able reviews from the traditional review and synthesis approach
has been low (less than 20%) while the policy uptake rate for
technologies based on CFFE/CED has been 100%.
Lessons Learned: Reducing decision uncertainty through CFFE/
CED appears to provide policy makers with the stronger eviden-
tiary base needed for reimbursement and policy decision making.
Decision makers in other jurisdictions can learn from the expe-
riences to date from the OHTAC. We have started to help initiate
CFFE/CED programs in other provinces. Bottom of Form.
CASE3
A CHANGE IN REIMBURSEMENT STRATEGY IN ICELAND:
AIMING ATVALUE-BASED PRICING
Hauksdottir R1, Björnsdottir I2, Kanavos P3
1Icelandic Medicine Pricing and Reimbursement Committee, Reykjavik,
Iceland, 2Bifröst University, Borgarnes, Iceland, 3London School of
Economics, London, United Kingdom
Organization: Icelandic Medicine Pricing and Reimbursement
Committee.
Problem or Issue Addressed: Feasibility of value-based pricing for
pharmaceuticals in Iceland.
Goals: To explore the feasibility of implementing value-based
pricing of patented pharmaceuticals in Iceland, and in case of it
being feasible, to ﬁnd a suitable model.
Outcomes items used in the decision: Literature searched for
value-based pricing models in developed countries, a model
chosen for further exploration and facilitators and hindrances in
the chosen model mapped before implementation. The chosen
model was the Swedish one, based on a few facts:
• Sweden is geographically quite close to Iceland.
• The culture of the two nations and health care system is in
many ways quite similar.
• There seems to be a general agreement on the Swedish
approach being the most rational of the value-based pricing
approaches in use currently in Europe.
Abstracts A349


CASE2 DOTECHNOLOGY EVALUATIONS BASED ON EVIDENCE FROM CONDITIONAL FUNDING LEAD TO AN INCREASE IN POLICY FORMATION?: FINDINGS FROM, AND IMPLICATIONS OF, ONTARIO'S EVIDENCE-BASED HTA PROCESS 

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CASE2 DOTECHNOLOGY EVALUATIONS BASED ON EVIDENCE FROM CONDITIONAL FUNDING LEAD TO AN INCREASE IN POLICY FORMATION?: FINDINGS FROM, AND IMPLICATIONS OF, ONTARIO'S EVIDENCE-BASED HTA PROCESS

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