b7 amirrtha srikanthan revision
TRANSCRIPT
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Impact of pCODR on Cancer Drug Funding DecisionsCADTH Symposium 2016
April 11, 2016Amirrtha Srikanthan, Helen Mai, Nianda Penner, Eitan Amir,
Andreas Laupacis, Mona Sabharwal, Kelvin K.W. Chan
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• Fellowship financial support via an educational grant from the Ontario Drug Policy Research Network
Presenter Disclosures
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• Differences in structures and processes for drug review and funding of cancer drugs
• Variation in use/acceptability of pharmaco-economic information, submission requirements, who could submit
• Variation in coverage across jurisdictions
• Can it be better?
The national landscape prior to pCODR
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• 2007 – iJODR formed– An interim process– Not a formal structure – Provinces (other than ON) were observers not active
participants– No obligation to follow recommendations or timing of
work– An evaluative process
• 2011 – pCODR formed– National, formalized transparent process– Resources for rigorous evidence-based review– Reduce duplication of review of same drug
What was done?
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• Has pCODR made a difference?
• Our aims:1. Describe changes in concordance of decisions
across participating provinces2. Describe changes in time from Health Canada
Notice of Compliance (NOC) to drug funding across provinces
• Conducted a retrospective review with the support of the pCODR provincial advisory group, provincial Ministries of Health and Cancer Agencies and Health Canada
So what?
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• Included chemical entities with an original (i.e. first) NOC date from 2003 to May 31, 2014 inclusive
• Drug funding decisions and dates from 2003 – 2014 inclusive (as at December 31, 2014)
• Statistical analyses:– Agreement statistics to assess concordance– Multiple linear model to assess time to funding– Quantile regression to assess differential impact
How did we assess this?
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What drugs did we include?
2211 Indications Identified
1505 Duplicate entries476 First NOC Date pre-2003120 Non-oncologic Indications22 Discontinued Drugs
88 Indications Included
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Baseline Characteristics of Distinct Drugs Reviewed
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Provincial Agreement in Funding Decisions
Brennan-Prediger
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pre-pCODRpCODR
Type of Coefficient
Corr
elati
on C
oeffi
cien
t
Brennan-Prediger kappa:
pre-pCODR 0.54, 95% CI 0.43 – 0.65 versus post-pCODR 0.78, 95% CI 0.68 – 0.89, p-value=0.002
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• pre-pCODR: 52 indications– 14 (27%) had funded unanimously– 5 (10%) had unanimously not funded
• After pCODR: 36 indications– 19 (53%) were funded unanimously – 2 (6%) were unanimously not funded
• Proportion of unanimous decisions has increased – pre-pCODR 37% versus pCODR 60%, p=0.048
After censoring of missing data:
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• No statistically significant change in the proportion of drugs funded at a provincial level
– pre-pCODR 66% versus pCODR 73%, p-value=0.10
When taking into consideration indications still in the review process or under consideration
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Interaction Effect:
Effect of pCODR on reduction of time to funding is not uniformly affecting all provinces (p=0.01)
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• Nationwide, median number of days– 522 to 393 days, p-value<0.001
• Negative time to funding values– 50 in the pre-pCODR period – 2 in the pCODR period
• Max timelines– pre-pCODR: 1355-3602 days– pCODR: 749-1555 days
• Challenges:– Incomplete data for funding dates (80%)
Time to funding analyses
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Reduction in days, based on quantileCh
ange
in D
ays
Quantiles of Time to Decision Making
Incr
ease
Redu
ction
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Summary of Conclusions
• Standardization of review has led to:
– Increased concordance in decisions across provinces
– No change in proportion funded
– Decrease in time to funding timelines
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• Lack of complete data sets
• Lack of dates
• Unknown rationale for discordance
• Lack of access to drug costs
Limitations
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• Negative time intervals
• Prolonged time to funding intervals (>3 years)
• Ongoing inter-provincial variation
• Improved availability of data
• Collaboration (pan-Canadian Pharmaceutical Alliance)
Discussion Points
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Acknowledgements• pCODR Provincial Advisory Group• Provincial Ministries of Health and Cancer Agencies• Health Canada• ODPRN Program
• Specific Individuals– Helen Mai – Nianda Penner– Mona Sabharwal– Eitan Amir– Andreas Laupacis– Kelvin Chan