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Is HTA More similar Than Different Across the Atlantic? Comparison of Canada and Europe
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Is HTA more similar than different across the
Atlantic? Is there room for collaboration?
Ansgar Hebborn F. Hoffmann-La Roche AG, Basel, Switzerland
Ottawa, CADTH Conference, 8 April 2014
How similar is HTA between jurisdictions?
The value proposition of
multi-stakeholder HTA collaboration
Recommendations
From a distance it all looks very similar
Relative effectiveness research principles
3 Kleijnen, S. et al. Relative effectiveness assessments of pharmaceuticals, Value Health 2012
Similar, but certainly not the same
Kleijnen et al. : EUnetHTA JA WP5: Relative Effectiveness Assessment (REA) of
Pharmaceuticals. Background review 2011.
HTA objectives impact principles and conduct
Germany: HTA with sole focus on price negotiations
5
HTA submission requirements & templates
EUnetHTA analysis
George E., BDA 2014
HTA submission requirements & templates
EUnetHTA analysis
George E., BDA 2014
George E., BDA 2014
How similar is HTA between jurisdictions?
The value proposition of
multi-stakeholder HTA collaboration
Recommendations
Multi-stakeholder REA collaboration
Aligning national assessments - a realistic expectation?
HTA Country A
Ethical/legal/
social impact
Cost vs benefit and
budget impact
HTA Country B
Ethical/legal/
social impact
Cost vs benefit and
budget impact
HTA Country Z
Ethical/legal/
social impact
Cost vs benefit and
budget impact
o o o
Relative clinical
effectiveness Relative clinical
effectiveness
Relative clinical
effectiveness
Eff
icacy
Safe
ty
Qu
ality
Evidence Base Development (Manufacturer)
EMA
Methodological
Standard EMA Joint Methodological Standards
(HTA)
Joint
Regulatory
Assesment
? Alignment?
11
Multi-stakeholder REA collaboration
Key pillars of its value proposition
Faster and more consistent patient access by means of:
– a common set of “reasonable” evidentiary and
analytical standards i.e. to balance relevance, validity,
feasibility, and timeliness, based on a thorough
understanding of the “real of world” of technology
development and its challenges
– improved process efficiency: avoiding unnecessary
duplication of effort in HTA agencies and companies
How similar is HTA between jurisdictions?
The value proposition of
multi-stakeholder HTA collaboration
Recommendations
Multi-stakeholder REA collaboration
Recommendations
1. Clarify objectives, develop compelling “value proposition” for
stakeholders, understand supportive forces of collaboration
(incentives/disincentives)
2. Seek political support at home
– to secure resources required for collaboration
– to overcome legal constraints to use jointly developed assessments
down stream to ultimately realize process efficiencies
3. Focus on areas that are the least specific to the local context
– General methodological standards for REA
– Disease-specific REA guidance
– Product-specific early dialogue/scientific advice
– Joint REAs
Doing now what patients need next
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