Transcript The national landscape prior to pCODR

April 11, 2016
Amirrtha Srikanthan, Helen Mai, Nianda Penner, Eitan Amir,
Andreas Laupacis, Mona Sabharwal, Kelvin K.W. Chan
Presenter Disclosures
• Fellowship financial support via an educational grant from
the Ontario Drug Policy Research Network
The national landscape prior to pCODR
• 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?
What was done?
•
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
So what?
• Has pCODR made a difference?
• Our aims:
1. Describe changes in concordance of decisions across
participating provinces
2. 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
How did we assess this?
• 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
What drugs did we include?
2211 Indications
Identified
1505 Duplicate entries
476 First NOC Date pre-2003
120 Non-oncologic Indications
22 Discontinued Drugs
88 Indications
Included
Table 1: Baseline Characteristics
Characteristic
Baseline
Characteristics
of Distinct Drugs
Reviewed
Number
Total Number of Distinct Drugs (chemical entities)
51
reviewed
Total Number of indications
Submitted NOC
88
Route of Administration
Oral
44
IV
35
IM
1
Subcutaneous
8
Submission Period
Pre-pCODR
52
pCODR
36
NOC Dates
2005 or before
8
2006-2008
23
2009-2011
25
2012-2014
32
Tumour Group
Haematology
28
GI
12
Lung
12
Renal
9
Breast
8
Prostate
6
Dermatology
5
Sarcoma
4
Thyroid
1
Ovarian
1
Head and Neck
1
CNS
1
CNS, central nervous system; GI, gastrointestinal; IM, intramuscular;
IV, intravenous; NOC, notice of compliance; pCODR, pan-Canadian
Oncology Drug Review
Provincial Agreement in Funding Decisions
1
Correlation Coefficient
0.9
0.8
0.7
0.6
0.5
pre-pCODR
0.4
pCODR
0.3
0.2
0.1
0
Brennan-Prediger
Type of Coefficient
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
After censoring of missing data:
• 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
When taking into consideration indications still in the
review process or under consideration
• No statistically significant change in the proportion of drugs
funded at a provincial level
– pre-pCODR 66% versus pCODR 73%, p-value=0.10
Table 2: Change in Time to Funding Estimates (pre-pCODR versus pCODR)
Mean Reduction
in the number of
days*
pre-pCODR
(days)
pCODR (days)
Time from NOC
date to funding
270
768
497
date
NOC, notice of compliance; pCODR, pan-Canadian Oncology Drug Review
*Adjusted for province and indication
95% Confidence
Interval
p-value
89, 453
0.004
Interaction Effect:
Effect of pCODR on reduction of time to funding is not uniformly affecting
all provinces (p=0.01)
Time to funding analyses
•
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%)
Reduction | Increase
Change in Days
Reduction in days, based on quantile
Quantiles of Time to Decision Making
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
Limitations
• Lack of complete data sets
• Lack of dates
• Unknown rationale for discordance
• Lack of access to drug costs
Discussion Points
• Negative time intervals
• Prolonged time to funding intervals (>3 years)
• Ongoing inter-provincial variation
• Improved availability of data
• Collaboration (pan-Canadian Pharmaceutical Alliance)
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
Thank you!
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Contact: Amirrtha Srikanthan, MD
[email protected]