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Transcript of D4 iain smith
New Drug Approval on Prince Edward Island
Iain Smith and Amanda BurkeCADTH 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 Background Identifying potential drugs Creating two “short lists” Process for combining and ranking
Description of Delphi Technique Future Improvements
o n w a r d
upward
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PEI Demographics 146,000 Islanders 15% population >
65 in 2010* > 25% 2031
*https://www.cihi.ca/en/gsearch/aging%2Bpopulation 4
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 PEIPublic Drug Funding
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 making8 Public representation8 Multi-disciplinary8 Finance8 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 identified12
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 16
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
GuidanceProfessional Experience and Expertise Political
Judgment
Values
Resources
Pragmatics and Contingencies
Lobbyists and Special Interest Groups
Habits and Tradition
Scientific Evidence
Source: Lomas et al, 2005 (Davies 2005)
Wisdom of the CrowdCriteria DescriptionDiversity of opinion
Each person should have private information even if it's just an eccentric interpretation of the known facts.
Independence People's opinions aren't determined by the opinions of those around them.
Decentralization People are able to specialize and draw on local knowledge.
Aggregation 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 patient-perceived 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