CADTH is a not-for-profit organization funded by Health Canada and provincial/territorial governments. It conducts health technology assessments of drugs and devices, employs 190 staff in Ottawa and Toronto, and is involved globally in health technology assessment. CADTH provides decision-makers with objective evidence on clinical and cost effectiveness to promote optimal use of health technologies and build domestic assessment capacity. While quality-adjusted life years are important, health technology assessment considers additional societal perspectives. Adaptive licensing and pathways prospectively plan iterative evidence gathering and regulatory/coverage adaptations to balance early access and assessment of uncertainties using real-world data across sectors.

1. About CADTH
• Private, not-for-profit corporation. Funded by Health
Canada, Provinces and Territories.
• Conducts health technology assessments (HTA) on drugs
and medical devices.
• 190 employees, Ottawa and Toronto offices. Advisory and
expert committees, numerous contractors.
• Active involvement in the global HTA community.

2. Our Mandate
• Provide decision-makers with objective evidence about the
clinical effectiveness and cost-effectiveness of health
technologies.
• Produce advice, recommendations, and tools that promote
the optimal use of health technologies.
• Build capacity for HTA in Canada.

3. HTA - Is it All About the QALY?
• Short answer is “no”
• It is an important consideration in making
recommendations as implementing funding decisions
• Help inform decisions for comparable therapies
• Do we need to include a more societal perspective in these
analyses? If so, how?
3

4. Value Based Frameworks
• A number of frameworks have been developed to help
address “value” from a number of different perspectives
e.g., ASCO, ESMO, National Comprehensive Cancer
Network, Drug Abacus, Institute for Clinical and Economic
Review
• The potential benefit of the frameworks is the ability to
compare the value of one drug versus another, however, it
is unclear if there is sufficient rigour in the frameworks to
make these comparisons
• Is driver to develop these frameworks the price of drugs?
4

5. Adaptive Licensing*
• Prospectively planned, flexible approach to regulation of
drugs and biologics
• Iterative phases of evidence gathering to reduce
uncertainties followed by regulatory evaluation and license
adaptation
• Attempts to balance access with need to assess information
• Assumes early approval and coverage
5
*
Eichler,
H.G.
et
al.
Adap5ve
licensing:
taking
the
next
step
in
the
evolu5on
of
drug
approval.
Clin.
Pharmacol.
Ther.
91:426-­‐37
(2012)

6. Adaptive Pathways
Regulatory
HTA
Payer
6
Helps to address a number of different factors:
• Unmet need – consider other inputs into the decision
framework
• Timeline of diagnosis should not be a driver of unmet
need
• Consider other factors such as burden of illness / loss
of health
hFp://onlinelibrary.wiley.com/enhanced/doi/10.1002/cpt.59

7. Adaptive Pathways
• HTA: moving from a one-off decision to an ongoing process
• Collectively: need to reduce uncertainty through evidence
generation plans and specific timelines
• E.g., post authorization studies for safety and efficacy
studies should include evidence generation
• Use of real world data
• Ability to implement across the health care sector
• Recognition of pharma industry investment
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