Transcript New Drug Approval on Prince Edward Island

New Drug Approval on
Prince Edward Island
Iain Smith and Amanda Burke
CADTH Symposium, Ottawa, ON
2016-04-12
Disclosure
 We have no actual or potential conflict of
interest in relation to this topic or
presentation.
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Objectives
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Background
Identifying potential drugs
Creating two “short lists”
Process for combining and ranking
u
p
w
a
r
d
 Description of Delphi Technique
 Future Improvements
onward
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PEI Demographics
 146,000 Islanders
 15% population > 65
in 2010*
 > 25% 2031
*https://www.cihi.ca/en/gsearch/aging%2Bpopulation
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Health PEI
 Responsible for the operation and delivery
of publicly funded health services in PEI
 Created in July 2010
 “One Island Health System”
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Health PEI
Public Drug Funding
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Hospitals
2 main referral hospitals
4 community hospitals
1 inpatient psychiatric facility
Provincial Cancer Treatment
Centre
PEI Pharmacare
 29 drug programs;
currently under review
Health PEI
 Previous formulary decision-making
 PEI Pharmacare
 Hospitals
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Provincial Drugs and
Therapeutics Committee
 Established in 2012
 Streamlining of
formulary approval
processes
 Partnership with
government
 Formulary alignment
Committee Composition
• Expanding participation in
decision making
 Public representation
 Multi-disciplinary
 Finance
 Administration
National Review Process
for New Drugs
 Steps prior to provincial
decisions
 Health Canada’s
approval of a drug ≠
provincial/territorial
funding
 (+) recommendation
from expert advisory
committee ≠ funding
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PEI Status
 Substantial number of drugs or indications with
(+) CDR or pCODR /iJODR recommendation still
to be considered for PEI
 Master list of all drug submissions through the
CDR/pCODR process
 Tracks PEI status of expert advisory
committee recommendations
 Updated monthly
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Starting Point
 Omit drugs with (-) recommendations or
that have not yet been vetted thru pCPA
process
 Consider whether (-) recommendation was
due to clinical reasons or cost
 Separate approval process for drugs that
are budget neutral
 Funding status of each drug in other
provinces is identified
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Starting Point
 Focus on drugs that are covered in 5 or
more provinces
 Recommendations of Atlantic Common
Drug Review (ACDR) are also considered
 Two short lists
 Oncology Drugs
 Non-oncology Drugs
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Combining the Lists
 Both lists are provided to voting members
of PD&T Oncology and Formulary Review
Subcommittees
 Relevant links to CDR/pCODR reviews are
included where applicable
 Participants are asked to rank the drugs via
an on-line questionnaire and provide
comments/rationale
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Consensus Building
 Delphi Technique
 Written communication between groups with
relevant information/perspectives
 No face to face interaction
 Reveals issues for greater discussion in the course
of this type of decision-making
 Responses/perspectives are collected,
summarized and shared with group members
 Members then make another decision based
upon the new information
 Adds validity to a very difficult process
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Combining the Lists
 Pooled results of round 1 & comments are
shared with subcommittee members
 Participants are asked to consider the
results & re-rank the drugs
 Pooled ranking is used to create a final list
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Limitations
 Appears to lack objectivity
 Not easily described to the average person
 Perception of what constitutes an “expert” at
the local level
 “I’m not an expert, so I my opinion isn’t
relevant”
 Some “experts” feel we lack sufficient experts
 Many are uncomfortable ….
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“All important decisions must be made on the basis of insufficient data”
Challenges
 Process works best when participants share
rationale/perspectives
 Providing the appropriate information to
participants is important and remains a
challenge
 Expanding number of participants
 More perspectives, better decisions
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Combining Scientific and Colloquial
Evidence for Context-Sensitive Guidance
Professional
Experience
and Expertise
Pragmatics and
Contingencies
Lobbyists and
Special Interest
Groups
Political
Judgment
Scientific
Evidence
Habits and
Tradition
Resources
Values
Source: Lomas et al,
2005 (Davies 2005)
Wisdom of the Crowd
Criteria
Diversity of
opinion
Independence
Decentralization
Aggregation
Description
Each person should have private
information even if it's just an eccentric
interpretation of the known facts.
People's opinions aren't determined by the
opinions of those around them.
People are able to specialize and draw on
local knowledge.
Some mechanism exists for turning private
judgments into a collective decision.
- Surowiecki, James (2005). The Wisdom of Crowds.
Challenges
 Engagement of non-clinical members of
committees
 Consistent approach to estimating costs
 …or value
 A means of comparison across treatments is
needed
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Future
 Adoption of Multi-criteria Decision Analysis
 Agreed upon criteria
 EVIDEM Collaboration
 Criteria are “weighted” (facilitated by Delphi)
 Weighted criteria are scored against each
therapy under consideration
 Results are totaled and ranking is established
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EVIDEM Criteria
 Disease severity
 Unmet needs
 Comparative
safety/tolerability
 Type of preventive
and/or therapeutic
benefit
 Comparative cost
consequences
– cost of intervention
– other medical costs
– non-medical costs
 Size of affected
population
 Comparative
effectiveness
 Comparative patientperceived health / PRO
 Quality of evidence
 Expert consensus/clinical
practice guidelines?
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….to conclude
 On PEI we have a somewhat unique
situation,
 …but also challenges common to many
other groups
 A process that’s not perfect, but an
improvement
 A sense that we can do better, and
hopefully learn to live within our means