pharmacare 2020 conference vancouver, feb 26-27, 2013 michelle boudreau executive director, pmprb
DESCRIPTION
Pharmacare 2020 Conference Vancouver, Feb 26-27, 2013 Michelle Boudreau Executive Director, PMPRB. Outline ________________________________________________. Policy objectives in practice How does it really work: an imperfect alignment? Concluding remarks. - PowerPoint PPT PresentationTRANSCRIPT
Pharmacare 2020 ConferenceVancouver, Feb 26-27, 2013
Michelle BoudreauExecutive Director, PMPRB
2
Outline________________________________________________
Policy objectives in practice
How does it really work: an imperfect alignment?
Concluding remarks
Policy Objectives in Practice - key quotes and court pronouncements______________________________________________
“…changes (to Bill C-22) will also ensure consumer protection by creating a drug prices review board to monitor drug prices. . .”
The Honourable Harvie Andre made this comment upon introducing Bill C-22 for second reading on November 20, 1986.
The protection of consumer interests was one of the “Five Pillars” of public policy addressed by amendments to the Patent Act creating the PMPRB.
3
Policy objectives in practice- key quotes and court pronouncements______________________________________________“…The Board’s interpretation of its mandate under the relevant provisions was consistent with its consumer protection purpose and should not be disturbed.”
Supreme Court of Canada’s decision in the Celgene/Thalomid matter, January 2011
4
5
How does it really work - price tests ________________________________________________ Blend of therapeutic improvement & international referencing Recognize incremental pharmaceutical innovation
At introduction, price premium aligned with therapeutic improvement: Four levels of therapeutic improvement:
1) Breakthrough – Median of International Price Comparison (MIPC)2) Substantial Improvement – Higher of top of Therapeutic Class Comparison
(TCC) and the MIPC3) Moderate Improvement – Higher of mid-point between top of TCC test and the
MIP, and top of TCC (primary & secondary factors apply here)4) Slight/No Improvement – Top of TCC
After introduction, monitor Average Transaction Price (ATP) subject to CPI based price increases and cannot be greater than highest international price (HIP)
How does it really work - price tests________________________________________________
Price tests are applied in accordance with therapeutic improvement
Based on specific circumstances, price ceilings at intro may be set differently For example, in 2011, within the “slight or no improvement
category” (70% of new drugs) the highest international price comparison (HIPC) test sets the
Maximum Average Potential Price (MAPP) 30% of the time because the TCC was higher than HIPC, or a TCC could not be conducted
the TCC sets the MAPP 40% of the time
6
7
How does it really work - MAPP compared with public price________________________________________________
* Brand price sets the MAPP – brand price $0.65
Drug Cat Intro- MIP
Intro - HIPC
Pivotal Test
MAPP IntroBench Price (ATP)
Publicly available price
Brand-X SNI 1.15 2.95 TCC 2.45 0.68 0.69
Brand-Y SNI 1.40 1.85 TCC 1.52 1.50 1.50
Generic-A SNI 0.85 1.50 TCC* 0.65 0.42 0.33
Average Ratio of 2011 Price to Introductory Price, by Year of Introduction________________________________________________
8
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100.85
0.90
0.95
1.00
1.05
1.10
1.01
1.06
0.94
1.01
1.06
1.02
0.97
1.03
0.98
1.06
0.99
0.93
1.00
0.93
0.99
1.04
Source: PMPRB
Rat
io
9
Concluding remarks________________________________________________ Recognizing innovation and ensuring a non-excessive price = a delicate
balance
Very dynamic market with many factors at play
Consumer protection vis-à-vis drug pricing remains an important policy objective
Transparency in pricing around the globe makes comparisons increasingly challenging as a price regulator
Affordable access and sustainability is a concern shared by consumers, regulators and payers
Thank you.Merci.
www.pmprb-cepmb.gc.ca
Twitter: @PMPRB_CEPMB
10
11
Annex – additional information and statistics
12
Market trends - Canada Compared to the World ________________________________________________ In 2005 and 2011, Canadian drug sales accounted for 2.4% and
2.6%, respectively, of the global market
Small, but significant market
13
Market trends - Canada Compared to the World________________________________________________ Growth in drug sales outpacing comparator countries
14
Market trends - Canada Compared to the World________________________________________________ Canadian prices comparatively higher than a number of OECD
countries
S.Korea Ita
ly UK
Australia
France
Spain
Austria
Belgium
Sweden
Switzerland
Denmark CA
N
Germany
Mexico
Japan US
A0.00
0.50
1.00
1.50
2.00
2.50Avg Bilateral Foreign-to-Canadian Price Ratios: Top 300 selling oral solids in Canada
IMS Health Data, 2010
Market trends - Canadian Public Drug Plan* Spending on Rx Drugs, Rates of Growth and Annual Totals, 2005/06 to 2010/11
15
* NPDUIS, all public drug plans, including NIHB, are included with the exception of Newfoundland; Yukon; NWT’s and Quebec. Its important to keep in mind that there may be some provincial plans, like disease specific plans, that are not included even if the province is included. The totals include drug cost, retail/wholesale mark-ups as well as dispensing fees.
16
PMPRB Price Tests - How Does it Really Work?________________________________________________ Of the 109 New Drug Products introduced in 2011:
12% under investigation
69% were of slight or no improvement
25% of moderate improvement
5% of substantial improvement 1% breakthrough
17
Reference pricing at introduction and for existing drugs based on 7 comparator countries - France, Germany, Italy, Sweden, Switzerland, UK, and US Policy changes in these countries could impact prices in Canada
Over last three years, Germany has most often been the highest referenced price for PMPRB price tests, followed by US Recent cost containment measures by reference countries may lead to lower prices
in Canada (e.g., Germany)
PMPRB Price Tests - International Referencing________________________________________________
Frequency in setting Highest International Price Comparison test at introduction
France Germany Italy Sweden Switzerland UK USA0246810121416
Regulatory Statistics High level of compliance - On average, 93-95% overall compliance
Between 2000 and 2009, average of 86 new patented drug products/year Of the 109 new drug products introduced in 2011:
79% within Guidelines 13% under investigation 8% outside of Guidelines but do not trigger an investigation
18
2011 2010New Drug Products Introduced
109 68
Number of Investigations
69 87