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