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