Analyzing Drug Shortages and Pricing: Lessons from Canada

Podium presentation given by Étienne Gaudette at ISPOR 2024, May 7, 2024

Étienne Gaudette, Mina Tadrous, Shirin Rizzardo and Kevin Pothier

Conflict of interest statement and disclaimer

S. Rizzardo, K.R. Pothier and myself are employees of the Patented Medicine Prices Review Board (PMPRB), an independent quasi-judicial agency of the Federal Government of Canada. The views expressed today are mine alone and do not represent official views of the PMPRB and the Government of Canada.

M. Tadrous has received consulting fees from Health Canada, CADTH and Green Shield Canada.

The results shown in this presentation are preliminary and conclusions may differ in future versions and publications.

Introduction

Context

Objectives

Hypothesis to test

Methods

Data and approach

Data

Approach

Results

Unadjusted shortage rates vs. foreign-to-Canadian price ratio (FTC)

Figure - Text version
Foreign-to-Canadian price ratio (FTC) Number (N) Unadjusted shortage rate
Less than 0.5 4,296 29%
0.5 to 0.7 2,162 28%
0.7 to 0.9 2,038 24%
0.9 to 1.1 1,377 21%
1.1 to 1.3 688 30%
1.3 to 1.5 429 34%
More than 1.5 1,233 36%

Foreign-to-Canadian price ratio (FTC) less than 1 means the Canadian price is higher than foreign prices.

Foreign-to-Canadian price ratio (FTC) more than 1 means that the Canadian price is lower than foreign prices.

Sample characteristics by foreign-to-Canadian price ratio (FTC)

 

FTC < 0.9
(high Canadian prices)
N=8,495

0.9 ≤ FTC ≤1.1
(aligned prices)
N=1,377

FTC > 1 .1
(low Canadian prices)
N=2,350

Generic, %

52%

46%

74%

Canadian manufacturers selling the ingredient, n (SD)

8.7 (6.4)

6.4 (6.4)

9.0 (6.2)

Canadian market size, USD Millions (SD)

10.3 (33.0)

12.6 (33.8)

8.1 (23.2)

Countries with sales, n (SD)

5.1 (3.4)

6.2 (3.4)

4.4 (2.9)

Adjusted odds ratios and significance tests

  N % in shortage OR 95% CI
FTC bin
< 0.5 4,296 29% 1.06 0.90 1.25
0.5 - 0.7 2,161 28% 1.13 0.95 1.35
0.7 - 0.9 2,038 24% 1.16 0.96 1.39
0.9 - 1.1 1,377 21% 1 [Reference]
1.1 - 1.3 688 30% 1.24 0.98 1.56
1.3 - 1.5 429 34% 1.26 0.97 1.64
> 1.5** 1,233 36% 1.32 1.09 1.60
Generic status
Brand 5,292 11% 1 [Reference]
Generic 6,805 41% 3.419 3.02 3.88
Year
2017 2,193 24% 1 [Reference]
2018 2,156 30% 1.38 1.19 1.60
2019 2,049 28% 1.26 1.09 1.47
2020 1,987 32% 1.61 1.39 1.87
2021 1,922 25% 1.12 0.96 1.31
2022 1,915 29% 1.46 1.25 1.70
Market size
Less than USD 125K 1,902 22% 1 [Reference]
USD 125K - 825K 2,750 20% 1.07 0.92 1.25
USD 825K - 4.25M 3,471 28% 1.60 1.39 1.84
More than USD 4.25M 4,099 36% 2.59 2.26 2.97
PMPRB11 countries with sales
1 2,660 40% 1 [Reference]
2-5 4,024 32% 0.86 0.77 0.96
6+ 5,538 20% 0.66 0.59 0.74
Single-source generic in Canada
No 11,896 28% 1 [Reference]
Yes 326 19% 3.022 1.04 8.79
Manufacturers
1 2,332 8% 0.28 0.10 0.78
2-5 4,541 36% 0.96 0.85 1.08
6-10 2,884 25% 1.13 1.01 1.27
11+ 2,465 36% 1 [Reference]
Int'l generic availability
No 2,097 6% 1.26 0.46 3.45
Yes 10,125 33% 1 [Reference]
12 therapeutic classes (ATC1) omitted from the table
  Chi-square p

**FTC bin

12.6

0.0495

Generic status

370.1

<.0001

Therapeutic class (ATC1)

126.9

<.0001

Year

52.1

<.0001

Market size

287.5

<.0001

Countries with sales

49.7

<.0001

Single source status

4.1

0.042

Manufacturers

13.3

0.004

Int'l generic status

0.2

0.652

Predicted probability of shortage vs FTC: case studies

Figure - Text version
  Metformin  (Leading manufacturer, 500mg tab) Sofosbuvir:velpatasvir (Originator, 400mg+100mg tab)
Foreign-to-Canadian price ratio (FTC) 95% Confidence interval lower limit Point estimate 95% Confidence interval upper limit 95% Confidence interval lower limit Point estimate 95% Confidence interval upper limit
Less than 0.5 44% 49% 54% 5% 7% 9%
0.5 to 0.7 45% 50% 56% 6% 7% 9%
0.7 to 0.9 45% 51% 57% 6% 7% 10%
0.9 to 1.1 41% 47% 53% 5% 6% 9%
1.1 to 1.3 46% 53% 59% 6% 8% 11%
1.3 to 1.5 46% 53% 60% 6% 8% 11%
More than 1.5 48% 54% 60% 6% 8% 11%
 

Foreign-to-Canadian price ratio (FTC) less than 1 means the Canadian price is higher than foreign prices.

Foreign-to-Canadian price ratio (FTC) more than 1 means that the Canadian price is lower than foreign prices.

Only patented medicines (no intl. generics available)

  N % in shortage OR 95% CI  
FTC bin
< 0.8** 881 9% 1.75 1.09 2.82
0.8 - 1.2 903 3% 1 [Reference]
> 1.2** 192 4% 1.09 0.48 2.46
Year
2017 356 4% 1 [Reference]
2018 338 6% 1.95 0.94 4.06
2019 324 6% 2.06 0.99 4.29
2020 325 7% 2.25 1.09 4.64
2021 319 6% 1.92 0.91 4.07
2022 314 5% 1.55 0.71 3.38
Market size
Less than USD 125K 237 6% 1 [Reference]
USD 125K - 825K 388 6% 0.91 0.45 1.83
USD 825K - 4.25M 542 6% 1.24 0.64 2.44
More than USD 4.25M 809 5% 1.09 0.55 2.15
PMPRB11 countries with sales
1 141 19% 1 [Reference]
2-5 403 9% 0.41 0.23 0.73
6+ 1,432 3% 0.17 0.10 0.29
6 therapeutic classes (ATC1) omitted from the table
  Chi-square p

**FTC bin

5.9

0.053

Therapeutic class (ATC1)

26.7

0.000

Year

5.9

0.318

Countries with sales

39.9

<.0001

Int'l generic status

1.2

0.748

Discussion

Appendix: Data retention and analytic sample

Figure - Text version
  • 33,386
    Canadian OS Rx-year observations in IQVIA MIDAS data
    • 31,956
      Obs. for which a Drug Identification Number (DIN) was identified
      • 12,256
        Obs. with multilateral price comparisons
      • 19,700
        Obs. without price comparisons
    • 1,430
      Obs. with no DIN identified

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