Michelle Boudreau, Executive Director 4 th Annual Market Access Summit November 21, 2012 Toronto Patented Medicines Prices Review Board (PMPRB): Regulatory Issues and Trends
Dec 24, 2015
Michelle Boudreau, Executive Director4th Annual Market Access SummitNovember 21, 2012 Toronto
Patented Medicines Prices Review Board (PMPRB): Regulatory Issues and Trends
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Outline________________________________________________ Canadian market and market trends Role of PMPRB and Overview of Price Regulation Regime Revised Guidelines - Major Changes Regulatory Stats & Guidelines Monitoring and Evaluation Plan Update on Hearings -Anticipated Developments Looking Forward Annex
Pharmaceutical Trends Data Changes and Clarifications to Guidelines Since 2010
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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
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Market trends - share of total prescriptions* by segment, 2005/06 to 2010/11________________________________________________
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Market trends - Canada Compared to the World________________________________________________ Growth in drug sales outpacing comparator countries
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After introduction, monitor Average Transaction Price (ATP) relative to Non-Excessive Average Price (NEAP), subject to CPI based limit
Average Ratio of 2011 Price to Introductory Price, by Year of Introduction
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
Ra
tio
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Canada Compared to 21 EU Members - 2010
IMS Health Data, 2010
Czech RepublicEstonia
SlovakiaSlovenia
ItalyPortugal
PolandHungaryFinlandGreece
United KingdomNetherlands
FranceSpain
AustriaBelgium
LuxembourgSwedenIreland
DenmarkCanada
Germany
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 BILATERAL FOREIGN-TO-CANADIAN PRICE RATIOS
0.93
1.000.98
0.890.87
0.60-0.70
0.70-0.80
0.84
Average Price Ratio for 21 EU Members 0.79
1.06
Based on top 300 selling oral solids in Canada
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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
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
PMPRB Price Regulation Regime________________________________________________ Jurisdiction:
Drug products patented and sold in Canada Instruments:
Patent Act (s. 79–103) Patented Medicines Regulations Compendium of Policies, Guidelines and Procedures
Price approval not required before sale PMPRB establishes a price ceiling, but DOES NOT set selling
price of drug product Regular price reviews to monitor compliance with Guidelines
combined with enforcement mechanisms (investigations, Voluntary Compliance Undertakings, hearings, orders)
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PMPRB Price Regulation Regime _______________________________________________ Factors to be considered by Board:
Price of medicine sold in Canada Prices of other medicines in same therapeutic class sold in Canada Prices of medicines sold in comparator countries Changes in CPI
Reference based 7 comparator countries: FR, DE, IT, SE, CH, UK, US
Open and transparent price regulation Hearings are public VCUs publicly disclosed MAPP publicly available* BUT, pricing data filed is confidential (s. 87)
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PMPRB Price TestsBlend of Therapeutic Improvement and International Reference Pricing_________________________________________________
Recognize incremental pharmaceutical innovation At introduction, price premium aligned with degree of therapeutic
improvement: Four new 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
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
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Investigation Criteria and Outcome________________________________________________ Investigation into the price of a patented medicine commenced when a complaint
is filed or any of the following criteria are met: New Drug Products
– 5% above the maximum average potential price (MAPP); or – Cumulative excess revenues are $50,000 or more; or
Existing Drug Products – Cumulative excess revenues are $50,000 or more over the life of the
patent Patentee given opportunity to make further written submissions to Board Staff to
substantiate the price If price within the Guidelines
Investigation closed If price outside the Guidelines
Patentee given an opportunity to submit a Voluntary Compliance Undertaking (VCU); or
Board Staff refers the matter to the Chairperson
Revised Guidelines - January 2010
________________________________________________
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Guideline Changes
Rationale for Change
Observations
Overall Implementation
Ongoing monitoring, evaluation, and resolution of issues Proactive outreach and education
Overall Restructuring of Price Tests
Price premium to reflect therapeutic value
Board Staff proactive in publishing clarification via NEWSletter (see Annex for summary) Board Staff continue to monitor issues
New Levels of Therapeutic Improvement
Recognizing incremental therapeutic innovation
Successfully applied by HDAP members
DIP Methodology Avoid creating disincentives for offering benefits
Evidence requirements clarified to ensure feasible and easily applied
Any Market Ensuring that no sub-national market is paying excessive prices
Applies only to drugs sold after January 2010
Guidelines Monitoring and Evaluation Plan (GMEP) -2010____________________________________________
GMEP monitors and evaluates the application and impact of major changes to the Guidelines on an ongoing basis
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Major Change Observation
New Level of Therapeutic Improvement
19% of new drug products classified as “moderate improvement”
Overall Restructuring of Price Tests
15% of new drug products classified as “moderate improvement” priced at premium (above old Guidelines ceiling)
Any Market Applied at intro and when investigation triggered<2% overall cases where market specific price higher than national average transaction price
DIP Methodology Since pilot, 60 DINs successful DIP application:• 46 Simple • 14 Regular
Regulatory Statistics
Of the 109 New Drug Products introduced in 2011: 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 2009, average of 86 new patented drug products/year
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2011 2010
New Drug Products Introduced
109 68
Number of Investigations
69 87
Regulatory Statistics: Voluntary Compliance Undertakings and Board Orders – 2008-2012 ________________________________________________
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Year # VCUs # Board Orders
Paymentsof Excess Revenues
2008 6 1 $25.5M
2009 10 1 $37.3M
2010 12 3 $13.2M
2011 9 1 $0.9M
2012(September 2012)
7 2 $14.7M
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Update on Hearings________________________________________________ Matters before the Board
Tactuo – Oct 1, 2012 - Notice of Hearing issued Ongoing
Apotex Inc. (Failure to File) Apo-Salvent CFC
Matters before the Federal Court – Judicial Review ratiopharm Inc.; ratio-Salbutamol HFA; Copaxone Redetermination Sandoz Inc.
Matter decided by the Supreme Court of Canada in 2011 Celgene Corporation (sale of Thalomid under Special Access Programme)
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Anticipated Developments___________________________________________________________________
Judicial Review
Expected Guidance on..
Copaxone and ratio-Salbutamol
• how to weigh ss 85(1) factors• the interpretation of the calculation of the ATP pursuant to ss 4(4) of the Patented
Medicines Regulations and the obligation of a patentee to file “product specific” information
• “sufficiency of reasons”
ratio-Salbutamol, ratiopharm and Sandoz
• whether the Board can regulate the price of patented medicines sold by generic pharmaceutical companies or has the Board engaged in pure price regulation
• the scope of “patentee” as per 79(1) of the Patent Act:• the Board’s jurisdiction with respect to the first “sale” and the supply chain• Interpretation of licencing/supply agreements negotiated at arm’s length• whether the corporate relationship between a parent company and its affiliate can
allow the Board to conclude that the affiliate is a “patentee” in the absence of a written agreement
• defining the scope of “patent pertain” as per s 79(1) of the Patent Act
Timing of Judicial Reviews__________________________________________ Copaxone Redetermination
Awaiting Hearing Date most likely in winter ratio-Salbutamol and ratiopharm to be heard together
Applicant and Respondent Records filed Request for Hearing Date to be filed Anticipated that it will be heard in late winter/early spring
Sandoz Applicant and Respondent to file respective Records Request for Hearing Date to be filed Anticipated that it will be heard in late spring/early summer
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Looking Forward________________________________________________ Ongoing engagement and outreach with stakeholders Continued focus on consumer protection while not creating
disincentives to innovation/approaches that benefit consumers/payers
Board adopted two priorities for 2012/13: alternate dispute resolution (“ADR”) to further enhance compliance reducing regulatory burden
PMPRB response to recently conducted program evaluation Continuing engagement with int’l organizations/regulators Commitment to Guidelines that are responsive to a changing
environment
Thank you.Merci.
www.pmprb-cepmb.gc.ca
Twitter: @PMPRB_CEPMB
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Annex - A
Pharmaceutical Trends Data
Market trends - Canadian Public Drug Plan* Spending on Rx Drugs, Rates of Growth and Annual Totals, 2005/06 to 2010/11
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* Does not include all drug plans. The totals include drug cost, retail/wholesale mark-ups as well as dispensing fees.
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Canada Compared to a Number of OECD Countries2010
S.Korea Ita
ly UK
Australi
a
France
Spain
Austria
Belgium
Swed
en
Switz
erlan
d
Denmark CAN
German
y
Mexico
Japan USA
0.00
0.50
1.00
1.50
2.00
2.50
Avg. Bilateral Foreign-to-Canadian Price Ratios: Top 300 selling oral solids in Canada
IMS Health Data, 2010
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Annex -B
Changes/Clarifications to Guidelines Since 2010
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Changes/Clarifications to Guidelines since 2010________________________________________________
Issue Change/Clarification When Change Made
Triggering Investigation
Eliminated 5% investigation trigger at national level for existing patented drug products
May 2012
Offset Excess Revenues
Replaced 3-year period to offset de minimus excess revenue with a VCU with requirement to offset in a timely manner
May 2012
Any Market
Clarified that Any Market Price Review would not be applied retroactively
April 2012
DIP Methodology
Pilot administration of the DIP methodology with streamlined processes developed with a working group
Recommendations of DIP working group accepted
April 2011 / February 2012
Existing drug products subsequently sold by another patentee
Patented DINs acquired and sold by persons other than the initial patentee are bound to the Guidelines, and continue to be treated as an existing drug product (no change from earlier Guidelines)
January 2011
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Changes/Clarifications to Guidelines since 2010 (cont’d)________________________________________________
Issue Change/Clarification When Change Made
Offset of Excess Revenue
Clarified that prices of existing patented drug products are reviewed on an annual basis. Therefore, for Jan-June period:
1) Existing drug products will not be initially identified as “Does Not Trigger”
2) Board Staff will not calculate any offset
October 2010
Policy on Use of Non-Patented Comparator Drug Products in Price Tests
price of relevant non-patented drug products included in the price tests, unless Board Staff conclude the price of the medicine is excessive, based on absence of competition or other market conditions
October 2010
International Therapeutic Class Comparison Test (ITCC)
Missing text inserted and description of ITCC test updated
April 2010