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

• Fellowship financial support via an educational grant from the Ontario Drug Policy Research Network

Presenter Disclosures

• 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

• 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?

• 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?

• 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?

What drugs did we include?

2211 Indications Identified

1505 Duplicate entries476 First NOC Date pre-2003120 Non-oncologic Indications22 Discontinued Drugs

88 Indications Included

Baseline Characteristics of Distinct Drugs Reviewed

Provincial Agreement in Funding Decisions

Brennan-Prediger

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

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

• 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:

• 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

Interaction Effect:

Effect of pCODR on reduction of time to funding is not uniformly affecting all provinces (p=0.01)

• 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

Reduction in days, based on quantileCh

ange

in D

ays

Quantiles of Time to Decision Making

Incr

ease

Redu

ction

|

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

• Lack of complete data sets

• Lack of dates

• Unknown rationale for discordance

• Lack of access to drug costs

Limitations

• 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

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

???Contact: Amirrtha Srikanthan, MD

amirrtha.srikanthan@bccancer.bc.ca

Thank you!