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TRANSCRIPT
Biosimilars in Canada: Current Environment and Future
Opportunity
Elena Lungu, Manager Patented Medicine Prices Review Board, Government of Canada
presentation inCADTH, April 2019
2
Biologics* share of the pharmaceutical sales, OECD, 2018
26.2%
0%
5%
10%
15%
20%
25%
30%
35%
ESP
NZL
USA IR
EC
AN BEL
POR
SWE
AUS
FIN
SLK
GER SL
VSW
IFR
AAU
TU
KN
OR
LUX
HU
NIT
ATU
RC
ZE JAP
NLD
POL
EST
GR
EKO
RM
EX CH
I
OECD Median: 19.1%
Data source: MIDAS™ Database, prescription retail and hospital markets, 2018, IQVIA. All rights reserved.*Includes biologics patented in Canada as of 2017.
Biologics – an important segment of the Canadian pharmaceutical market
3
Canada has the second highest per capita spending on biologics
$381
$141$137$128$124$111$110$106$101 $92 $88 $83 $81 $77 $73 $69 $61 $59 $56 $56 $52 $44
$26 $22 $19 $18 $15 $11 $11 $2 $1
USA
CAN SW
IBE
LIR
LD
EU FIN
AUT
SWE
FRA
NO
RAU
SES
PIT
ASV
NG
BR JPN
SVK
NZL
LUX
PRT
HU
NC
ZEN
LDG
RC
KOR
POL
TUR
EST
CH
IM
EX
Data source: MIDAS™ Database, prescription retail and hospital markets, 2018, IQVIA. All rights reserved.*Includes biologics patented in Canada as of 2017.
Spending per capita, patented biologics*, OECD, 2018
OECD Median: $69
4
Canada has the second highest prices for biologics
2.14
1.00 0.98 0.95 0.91 0.88 0.87 0.86 0.86 0.85 0.85 0.84 0.83 0.83 0.83 0.80 0.77 0.77 0.76 0.75 0.72 0.69 0.68 0.67 0.66 0.66 0.65 0.64 0.620.54
0.34
USA
CAN
SWI
DEU
FIN
NZL
AUS
LUX
MEX
IRL
SWE
JPN
ESP
ITA
NLD
HUN
CHI
NOR
BEL
GBR
PRT
FRA
EST
AUS
CZE
GRC
POL
SVK
SVN
KOR
TUR
Data source: MIDAS™ Database, prescription retail and hospital markets, 2018, IQVIA. All rights reserved.*Includes biologics patented in Canada as of 2017.
OECD Median: 0.78
Average foreign-to-Canadian price ratios, patented biologics*, OECD, 2018
5
Biologics sales are on the rise, despite biosimilar availability in high-sales areas
Data source: MIDAS™ Database, prescription retail and hospital markets, 2018, IQVIA. All rights reserved.*Includes biologics patented in Canada as of 2017.
Trends in patented biologics* sales, Canada, 2009-2018
$2.0B $2.3B $2.7B$3.2B
$3.8B$4.4B
$4.9B$5.4B
$6.0B$6.7B
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Growth2017‐2018 11.3%5‐year CAGR 11.3%10‐year CAGR 14.6%
Biologics share of pharmaceutical sales
24.6%23.4%22.2%21.2%19.6%16.8%
26.2%
6
Biosimilar availability: Canada lags behind Europe
6
Data source: MIDAS™ Database, prescription retail and hospital markets, 2017-2018, IQVIA. All rights reserved.*Includes biologics patented in Canada as of 2017.
7
Biosimilar uptake: Canada lags behind Europe
Biologic medicineSales in Canada,
2017(million)
Infliximab $1,092
Etanercept $316
Insulin glargine $274
Rituximab $256
Filgrastim* $128
Epoetin alfa* $102
Enoxaparin sodium $61
Somatropin $39
Follitropin alfa* $20
*Acute biologicsData source: MIDAS™ Database, prescription retail and hospital markets, 2017, IQVIA. All rights reserved
Biosimilar uptake, Q4-2017 (share of units)
4.0%
3.1%
2.6%
43.5%
22.6%
0% 20% 40% 60% 80% 100%
MedianOECD
MedianPMPRB7
Canada
8
21% 21% 23% 22%
25% 25% 27% 25%
26% 22% 18%15%
5% 9% 10%12%
23% 23% 22%
6%5.5%
16%
0%
100%
FY2011 FY2013 FY2015 FY2017
645 702 847 995
780 8321,026 1,128
797 725666
674156 294364
541728 757
837 262252710
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
FY2011 FY2013 FY2015 FY2017
Xeljanz
Inflectra(infliximab)Remicade(infliximab)Rituxan
Etanercept
Humira
Other biologicDMARDs
Less than half of new infliximab patients were initiated on the biosimilar in 2017
Number of new patients on select DMARDs Distribution of new patients by select DMARDs
Data source: National Prescription Drug Utilization Information System Database, Canadian Institute for Health Information.
Fewer patients initiated on infliximab after biosimilar entry
…instead, new patients start on other originator products
9
The infliximab experience: the biosimilar uptakeWithout switching existing patients and only initiating few new patients on the biosimilars, Canada lags behind all OECD countries in terms of the infliximab biosimilar uptake
98%96%92%
89%
79%78%
64%63%60%59%56%
53%
40%37%36%30%
23%22%17%17%16%
9% 8% 7%0% 0% 0%
NO
R
POL
UK
AUT
ITA
SWE
SVN
PRT
FRA
CZE
ESP
DEU IR
L
KOR
SVK
BEL
TUR
SWI
MEX FI
N
AUS
JPN
CAN USA CH
I
HU
N
NZL
Data source: MIDAS™ Database, prescription retail and hospital markets, Q4-2018, IQVIA. All rights reserved.
OECD Median: 37%
Biosimilar uptake (share of units), infliximab, Q4-2018
10
Biosimilars are often priced higher in Canada
Data source: MIDAS™ Database, prescription retail and hospital markets, 2017, IQVIA. All rights reserved.
Biosimilar uptake, Q4 2017 (share of units) Biosimilar prices are generally higher, despite greater discounts, likely due to higher originator prices prevailing in Canada
Why biosimilar savings matter?
Cost drivers in select Canadian public drug plans
2.7% 2.1% 2.7% 3.0% 1.8% 2.9%
1.7% 2.2% 0.3% 1.3%1.0%
1.0%
4.1% 5.4%4.9%
4.1%4.4%
4.7%
-2.0%-6.0%
-3.0% -1.8% -1.0% -1.1%
-7.2%-1.5%
-3.2%-2.3%
-1.8% -1.3%
8.0%
-2.3%
2.4%
-10%
-8%
-6%
-4%
-2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
Note: Drug costs include markups.Data source: National Prescription Drug Utilization Information System Database, Canadian Institute for Health Information.
ON data isnot represented
8.5%9.7%
7.9%
16.2%
7.2%
9.5%
-0.8% 2.0%Net Change 2.5% 12.0% 2.0% 6.8%
-9.2%-7.5%
-6.2%-4.1%
-5.1%
-2.1%
2012/13 2013/14 2014/15 2015/16 2016/17 2017/18 2018/19 2019/20 2020/21
Growth rate 24.8%, CAGR 7.7%
12 Data source: MIDAS™ Database, prescription retail and hospital markets, IQVIA. All rights reserved.
Infliximab ($1,092M) Etanercept ($316M) Insulin glargine ($274M) Filgrastim ($128M)2019 2020 2019 2019
Canadian savings only a fraction of their potential
$31M $7M $6M $17M
Actual vs. potential
at average OECD
uptake $91M
$60M $26M$19M
$23M
$17M$18M
34% 26% 27% 92%
Actual vs. potential
at top OECD
uptake
$514M
$482M
$140M
$147M
$124M
$130M
$45M
$62M
6% 5% 5% 27%
Forecasted savings
Savings Unrealized Savings
13
Recent developments in Canada
Biosimilar industry association: announces the introduction of Patient Support Programs to be launched in 2019
HTA: CADTH streamlined the biosimilar review process (Feb 2018), with fewer submission requirements, shortened review period, etc.
Price negotiation: pCPA Policy on Biologics and Biosimilars (Sept 2018) aims for parallel processes with the HTA, requires price transparency and considers the implementation of tiered listing and switching
Public payers: Preferential reimbursement: generally applies to biosimilars for treatment-naïve patients (e.g., Remicade) –
those on reference biologic do not have to switch; Quebec only reimburses the lowest priced version of infliximab
Tired reimbursement: implemented by Manitoba – new patients required to try two Tier 1 products before being reimbursed for a Tier 2 product; Tier 1 biologic products have been determined to be the most cost-effective
Private payers: Preferential reimbursement: e.g., Green Shield Canada opened its biosimilar transition program to any
sponsor who wishes to take part (Dec 2018); patients that do not switch to the biosimilar pay the difference out of pocket
14
Conclusions
Canada has the second highest spending on biologics in the OECD, and pays the second highest prices
Canadian biosimilar availability and uptake lags behind Europe
Biosimilar savings have been minimal in Canada, well below international norms
Given the cost pressures, payers depend on biosimilar savings to fund new and innovative therapies
Canadian biosimilar industry, HTA, price negotiators, and payers are taking steps towards greater market penetration of biosimilars: Patient Support Programs, streamlined and transparent processes, preferential reimbursement, transitioning, and tiered reimbursement
T H A N K Y O UPatented Medicine Prices Review Board
Elena LunguManager, Policy Development Patented Medicine Prices Review Board / Government of [email protected] / Tel: 613-288-9602