PPTX - Patented Medicine Prices Review Board
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Transcript PPTX - Patented Medicine Prices Review Board
Canada’s Patented Medicine Prices
Review Board
Michelle Boudreau
Executive Director
Pharma Pricing and Market Access Outlook
London, United Kingdom
March 19-22, 2013
Outline
________________________________________________
Overview of the PMPRB
How the PMPRB really works.
Canada Compared to the World
Common Challenges
Looking Forward
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Overview of the PMPRB
________________________________________________
Established in 1987 as consumer protection pillar via
amendments to Patent Act
The PMPRB is an independent quasi-judicial body with a dual
mandate:
Regulatory: To ensure that prices charged by patentees for patented
medicines sold in Canada are not excessive
Reporting: To report on pharmaceutical trends of all medicines and on R&D
spending by pharmaceutical patentees
Jurisdiction
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Regulate prices patentees charge (i.e. factory-gate price) for patented drug
products sold in Canada, to wholesalers, hospitals or pharmacies, for human
and veterinary use
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)
2)
3)
4)
Breakthrough – Median of International Price Comparison (MIPC)
Substantial Improvement – Higher of top of Therapeutic Class Comparison
(TCC) and the MIPC
Moderate Improvement – Higher of mid-point between top of TCC test and the
MIP, and top of TCC (primary & secondary factors apply here)
Slight/No Improvement – Top of TCC
After introduction, PMPRB monitors average prices, CPI
increase permitted but at no time can price be higher than
highest international price (HIP)
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How does it really work – PMPRB ceiling price
compared with public price
________________________________________________
Drug
Pivotal Test
PMPRB ceiling
price
Patentee
Publicly
introductory
available
price
price
(average)
Brand-X
TCC
2.45
0.68
0.69
Brand-Y
TCC
1.52
1.50
1.50
Generic-A
TCC*
0.65
0.42
0.33
* Brand price sets the MAPP – brand price $0.65
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Regulatory Statistics
Approximately 1,200 patented drug products under PMPRB jurisdiction
2011: 109 New Drug Products introduced :
79% within Guidelines;
9% outside of Guidelines but do not trigger an investigation
12% under investigation
69% were of slight or no improvement; 25% of moderate improvement;
5% of substantial improvement and 1% breakthrough
Between 2000 and 2010, average of 84 new patented drug products/year
High level of compliance: average rate is approximately 95%
Since 1993:
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90 VCUs
26 public hearings
$137 million collected through VCUs and Board Orders
PMPRB Price Tests - International Referencing
________________________________________________
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 3 years, Germany has most often been the highest
referenced price for PMPRB price tests (“HIPC”), followed by US
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Recent cost containment measures by reference countries, like Germany, may
therefore lead to lower prices in Canada
Canada Compared to the World
________________________________________________
Canadian prices comparatively higher than a number of OECD
countries
2.50
Avg Bilateral Foreign-to-Canadian Price Ratios: Top 300 selling oral solids in Canada
2.00
1.50
1.00
0.50
0.00
IMS Health Data, 2010
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Canada Compared to the World (cont’d)
________________________________________________
Growth in drug sales outpacing comparator countries
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Canada Compared to 21 EU Members - 2010
AVERAGE BILATERAL FOREIGN-TO-CANADIAN PRICE RATIOS
1.06
Germany
Canada
Denmark
Ireland
Sweden
Luxembourg
Belgium
Austria
Spain
France
Netherlands
United Kingdom
Greece
Finland
Hungary
Poland
Portugal
Italy
Slovenia
Slovakia
Estonia
Czech Republic
0.93
1.00
0.98
0.89
0.87
0.84
0.80-0.70
0.70-0.60
0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00 1.05
Average Price Ratio for 21 EU Members 0.79
Based on top 300 selling oral solids in Canada
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IMS Health Data, 2010
Common Challenges
________________________________________________
Transparency in pricing around the globe makes comparisons
increasingly challenging as a price regulator
Next wave of new drugs (e.g., biologics) are costly
Recognizing innovation and ensuring a non-excessive price =
a delicate balance
Very dynamic market with many factors at play
Affordable access and sustainability is a concern shared by
consumers, regulators and payers
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Looking Forward
________________________________________________
Canadian-EU Comprehensive Trade Agreement (CETA)
If proposal implemented, longer period of PMPRB regulation over
patented drugs; but could also cause a re-evaluation of the balance between
intellectual/industrial policies and health care/drug costs
Critical jurisprudential decisions within approx. 1 year
Priorities of last fiscal year: reducing regulatory burden and
increasing compliance
September 2013, Board will set priorities for fiscal year 13-14
Ongoing engagement and outreach with stakeholders
Continued engagement with international organizations
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Thank you.
Merci.
[email protected]
PMPRB Website:
www.pmprb-cepmb.gc.ca
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