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Outreach Sessions
Montreal, November 22, 2012 Toronto, November 23, 2012
Patented Medicine Prices Review BoardRegulatory Affairs and Outreach Branch
Overview
Regulatory Filing – Latest Changes Form 1 Form 2 Block 1, 2, 3
Interim Maximum Average Potential Price (MAPP)
DIP Methodology Simplified Regular
PMPRB 101
2
Regulatory Filing Latest Changes in Form 1 and Form 2 Block 1, 2, 3
3
4
Patented Medicine Privileged s.87
Prices Review Board Patent Act
Use one form per DIN
Please Specify: Original Filing - - Complete all Blocks
or Amendment to Original Filing - - Complete all Blocks and specify which Block(s) is(are) amended __________
1 NAME(S) AND USE(S) OF THE MEDICINE
Brand Name:
Generic Name:
Therapeutic use(s) of the medicine
approved by Health Canada:
Human Prescription
OR
Human O ver-the-Counter
OR
Veterinary
MEDICINE IDENTIFICATION SHEETFORM 1
(The medicine is for human use and contains a controlled substance as defined in the Controlled Drugs and Substances Act or contains a substance listed or described in Schedules C or D to the Food and Drugs Act or in Schedule F to the Food and Drug Regulations )
(The medicine is for human use and does not contain a controlled substance as defined in the Controlled Drugs and Substances Act or does not contain a substance listed or described in Schedules C or D to the Food and Drugs Act or in Schedule F to the Food and Drug Regulations )
Changes in Form 1
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Changes in Form 12 PATENTEE
Patentee Name
Patentee Address
Identity if the
patentee is: the patent holder person entit led to the benefits of a patent or to exercise any rights in relation to a patent
3 NOTICE OF COMPLIANCE (N.O.C.)
Check if Special Access Programme
Y M D applicable or
Clinical Trial Application or Investigational New Drug
4 DRUG IDENTIFICATION NUMBER (DIN)
Drug Identification Number Dosage Form Strength/Unit
First N.O.C.
6
Changes in Form 1
5 DATE OF FIRST SALE 6 PRODUCT MONOGRAPH (check only one box)
OR
Y M D
(Copy Included)
7 PATENT NUMBER OF PATENTEE'S INVENTIONS PERTAINING TO THE MEDICINE
Patent Number Date Granted Expiration Date
(Copy Included)
Product Monograph Information similar to that contained in a Product Monograph
Y M Y M D
Date of 1st
Sale
Numeric only D
7
Changes in Form 1
8 CERTIFIED BY: (in accordance with Section 7 of the Patented Medicines Regulations )
I hereby certify that the information presented is true and correct.
Signature of duly authorized person for the reporting patentee.
Name:
Title:
Organization:
Date:
Tel. Number: Fax Number :
E-mail:
Please send completed Form 1 to [email protected]
( ) ( )
8
Changes in Form 2, Block 1, 2, 3
Patented Medicine Privileged s.87
Prices Review Board INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patent Act
Cover Sheet : Block 1, 2, 3
Please Specify Original Filing
or Amendment to Original Filing
BLOCK 1 : ORIGINAL FILING
REPORTING PERIOD
NAMES OF THE MEDICINE
Brand name of the medicine
Generic name of the medicine
Y YD
Complete Block 1 and 3
FORM 2
FROM
Complete Block 2 and 3
Period to which the information applies (only one reporting period per Form):
TO
M DM
9
Changes in Form 2, Block 1, 2, 3
REPORTING PERIOD
BLOCK(s) and DIN(s) or ASSIGNED NUMBER(s)THAT ARE AMENDED
TOFROMFROM
Block 5
For each Block, list DIN(S) or Assigned Number(s) that is (are) amended.Write one DIN per cell.
BLOCK 2 : AMENDMENT TO AN ORIGINAL FILING
Check Block(s) that is(are) amended :
Block 4
Period to which the information applies (only one reporting period per Form):
Y M D Y M D
10
Changes in Form 2, Block 1, 2, 3
*Please see section 79(1) of the Patent Act for the definition of a "patentee". Note that a patentee is any person entitledto the benefits of a patent or to exercise any rights in relation to a patent. This includes patent holders, licensees or others.
in accordance with Section 7 of the Patented Medicines RegulationsI hereby certify that the information presented is true and correct.
Signature of duly authorized person for the reporting patentee
Name:
Title:
Organization:
Date:
Tel. Number: Fax Number :
E-mail:
Please send completed Form 2 including the cover sheet, Block 4 and Block 5 to:
Patentee Name
Patentee Address
( ) ( )
BLOCK 3 : PATENTEE * AND CERTIFYING SIGNATURE
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Interim Maximum Average Potential Price (MAPP)
12
Interim MAPP
Compendium of Policies, Guidelines and Procedures, Schedule 5, Section 1.3
1.3 When the new patented drug product is sold in fewer than five countries at the time it is first sold in Canada, the median international price will be calculated on an interim basis. At the end of three years or when the same patented drug product with the same strength and dosage form is sold in at least five countries, whichever occurs first, Board Staff will re-determine the median international price. Whenever this occurs, the drug product’s Non-Excessive Average Price will be the lower of:
(a) The re-determined median international price, and(b) The Non-Excessive Average Price derived from the ordinary
application of the CPI-Adjustment Methodology (see Schedule 9).
SubstantialImprovement
Higher of: - Top of TCC
- MIPC
Level of Therapeutic Improvement
MIPC in Introductory Price Tests
Breakthrough MIPC
Introductory Price Tests
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If no comparator is identified
Or if price ofcomparator is excessive
Or if cannot derive dosageregimen
Or If no public price is found
MIPC
Moderate Improvement
Higher of: - Mid point (Top of TCC and MIPC) - Top TCC
Slight/No Improvement
Top of TCC
Lower of: - Bottom of TCC - MIPC
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Interim MAPP: Example 1 (MIPC)
Drug product A introduced in March 2010
Pivotal test establishing the MAPP at introduction : Median International Price Comparison (MIPC) test
In 2010, Drug product A is sold in Italy ($10) and in the US ($20)
Interim MIPC = Interim MAPP (2010) = $15
15
Interim MAPP: Example 1 (MIPC)
Scenario 1: Three years (2013) In 2011, 2012 and 2013, drug A still sold in only 2 countries MIPC = $15 Post-Interim MAPP is set by MIPC
2013 N-NEAP (based on CPI-Adjustment Methodology) = $14
Impact on future requests for DIP application: IBP remains at $15
Post-Interim MAPP (2013) = $15 Final 2013 N-NEAP = $14
16
Interim MAPP: Example 1 (MIPC)Scenario 2: Five countries (lower PI-MAPP)
In 2012, Drug product A is now sold in 5 countries: Italy ($10), France ($10), Germany ($10), Switzerland ($10), US ($20) MIPC = $10
Post-Interim MAPP is set by MIPC
N-NEAP (based on CPI-Adjustment Methodology) in 2012 is $13
If 2012 N-ATP > Final 2012 N-NEAP, Company is given one year to adjust N-ATP to be ≤ 2013 N-NEAP (2012 N-NEAP + CPI)
Impact on future requests for DIP application: IBP reset in 2012 to $10
Post-Interim MAPP (2012) = $10 Final 2012 N-NEAP = $10
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Interim MAPP: Example 1 (MIPC)
Scenario 3 : Five countries (higher PI-MAPP)
In 2012, Drug product A is now sold in 5 countries: Italy ($10), France ($17), Germany ($17), Switzerland ($17), US ($20) MIPC = $17
Post-Interim MAPP is set by MIPC N-NEAP (based on CPI-Adjustment Methodology) in 2012 is $13
Impact on future requests for DIP application: IBP remains at $15
Post Interim MAPP (2012) = $17Final 2012 N-NEAP = $13
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Interim MAPP: Example 2 (Higher of TCC and MIPC)
Drug product A introduced in March 2010
Level of therapeutic improvement : Substantial Improvement
Test establishing the MAPP at introduction : Higher of top of Therapeutic Class Comparison (TCC) test and the MIPC test
In 2010, top of TCC = $10 A is sold in Italy ($10) and in the US ($20) Interim MIPC = $15
In this case, the Interim MAPP is set by the Interim MIPC
Interim MAPP (2010) = $15
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Interim MAPP: Example 2 (Higher of TCC and MIPC)
Scenario 1 : Three years (2013)
Drug product A still sold in only 2 countries. MIPC =$15
Post-Interim MAPP is set by MIPC
N-NEAP (based on CPI-Adjustment Methodology) = $14
Impact on future requests for DIP application: IBP remains at $15
Post-Interim MAPP (2013) = $15 Final 2013 N-NEAP = $14
20
Interim MAPP: Example 2 (Higher of TCC and MIPC)Scenario 2 : Five countries (lower PI-MAPP)
In 2012, Drug product A now sold in 5 countries: Italy ($10), France ($9), Germany ($9), Switzerland ($9), US ($20) MIPC = $9
Post-Interim MAPP is set by TCC ($10)
N-NEAP (based on CPI-Adjustment Methodology) in 2012 is $13
If 2012 N-ATP > Final 2012 N-NEAP ($10) Company will be given one year to adjust N-ATP to be ≤ 2013 N-NEAP (2012 N-NEAP + CPI)
Impact on future requests for DIP application: IBP reset in 2012 to $10
Post-Interim MAPP (2012) = $10 Final 2012 N-NEAP = $10
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Interim MAPP: Example 2 (Higher of TCC and MIPC)
Scenario 3 : Five countries (higher PI-MAPP)
In 2012, Drug product A now sold in 5 countries: Italy ($10), France ($17), Germany ($17), Switzerland ($17), US ($20) MIPC = $17
Post-Interim MAPP is set by MIPC
N-NEAP (based on CPI-Adjustment Methodology) in 2012 is $13
Impact on future requests for DIP application: IBP remains at $15
Post-Interim MAPP (2012) = $17 Final 2012 N-NEAP = $13
22
Interim MAPP: Example 3 (Higher of TCC and Mid Point) Drug product A introduced in March 2010
Level of therapeutic improvement : Moderate Improvement
Test establishing the MAPP at introduction : Higher of top of TCC test and Mid Point (Average of top of TCC and MIPC)
In 2010, Top of TCC = $10 Drug product A is sold in Italy ($10) and the US ($20) Interim MIPC = $15 Mid Point = $12.50 Interim MAPP is set by Mid Point
Interim MAPP (2010) = $12.50
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Interim MAPP: Example 3 (Higher of TCC and Mid Point)Scenario 1: Three years (2013)
Drug product A is still only sold in 2 countries MIPC =$15
Mid Point = $12.50
Post-Interim MAPP is set by Mid Point
N-NEAP (based on CPI-Adjustment Methodology) in 2013 is $13
If 2013 N-ATP > Final 2013 N-NEAP ($12.50) Company will be given one year to adjust N-ATP to be ≤ 2014 N-NEAP (2013 N-NEAP + CPI)
Impact on future requests for DIP application: IBP remains at $12.50
Post-Interim MAPP (2013) = $12.50 Final 2013 N-NEAP = $12.50
24
Interim MAPP: Example 3 (Higher of TCC and Mid Point)Scenario 2: Five countries (lower PI-MAPP)
In 2012, Drug product A now sold in 5 countries: Italy ($10), France ($9), Germany ($9), Switzerland ($9), US ($20) MIPC = $9 Mid Point = $9.50
Post-Interim MAPP is set by TCC ($10)
N-NEAP (based on CPI-Adjustment Methodology) in 2012 is $13
If 2012 N-ATP > Final 2012 N-NEAP ($10) Company will be given one year to adjust N-ATP to be ≤ 2013 N-NEAP (2012 N-NEAP + CPI)
Impact on future requests for DIP application: IBP reset in 2012 to $10
Post-Interim MAPP (2012) = $10 Final 2012 N-NEAP = $10
25
Interim MAPP: Example 3 (Higher of TCC and Mid Point)
Scenario 3: Five countries (higher PI-MAPP)
In 2012, Drug product A now sold in 5 countries: Italy ($10), France ($17), Germany ($17), Switzerland ($17), US ($20) MIPC = $17 Mid Point = $13.50 Post-Interim MAPP is set by the Mid Point
N-NEAP (based on CPI-Adjustment Methodology) in 2012 is $13
Impact on future requests for DIP application: IBP remains at $12.50
Post-Interim MAPP (2012) = $13.50 Final 2012 N-NEAP = $13
Interim MAPP – Meaning and implications
- A MAPP based on any test that includes a MIPC test is interim when the MIPC is based on data from less than 5 countries.
- A post interim MAPP is calculated 3 years after intro or when the drug product is sold in five countries, whichever comes first.
- The final N-NEAP will be the lower of the post-interim MAPP and the N-NEAP based on the CPI-Adjustment Methodology
26
DIP Methodology
27
Simplified DIP Methodology: Reminders
Patentee acquires DIN from previous patentee prior to January 1, 2010: patentee to obtain original IBP from previous patentee for DIP applications
Benefits at introduction: consider reporting transactions with and without benefits on separate lines in Form 2 Block 4
Pay attention to Form 2 Block 5 Canada price
28
2003 2004 2005 2006
Form 2 Block 5 Canada $20.00 $16.00 $16.00 $16.00
N-ATP $20.00 $12.00 $12.00 $20.00
IBP/IBP* $20.00 $16.00 $16.00 $16.00
Regular DIP Methodology: Calculation of IBP*
Block 5 Canada price increase < annual (one year) CPIUse lower of :
annual (one year) CPI and % increase of Form 2 Block 5 Canada price
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2005 2006 2007 2008 2009 2010
Form 2 Bl5 Canada $0.8085 $0.8284 $0.8284 $0.8391 $0.8391 $0.8533
% Bl5 increase 2.5% 1.3% 1.7%
% annual CPI 2% 2.1% 2.4% 0.3% 1.8%
IBP/IBP* $0.8085 $0.8101 $0.8101 $0.8206 $0.8206 $0.8346
N-ATP $0.8085 $0.7958 $0.7724 $0.7277 $0.7304 $0.8300
N-NEAP $0.8085 $0.8247 $0.8213 $0.8002 $0.7313 $0.7501
Regular DIP Methodology: Calculation of IBP*
No increase in Form 2 Block 5 Canada price for at least 3 yearsUse lower of:
Cap % increase in Form 2 Block 5
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2005 2006 2007 2008 2009 2010
Form 2 Bl5 Canada $0.8085 $0.8284 $0.8284 $0.8284 $0.8284 $0.8533
% Bl5 increase 2.5% 3%
% annual CPI 2% 2.1% 2.4% 0.3% 1.8%
Cap 3% 3.2% 3.6% 0.5% 2.7%
IBP/IBP* $0.8085 $0.8101 $0.8101 $0.8101 $0.8101 $0.8320
N-ATP $0.8085 $0.7958 $0.7724 $0.7277 $0.7304 $0.8300
N-NEAP $0.8085 $0.8247 $0.8213 $0.8002 $0.7313 $0.7501
Regular DIP Methodology: Calculation of IBP*
When Form 2 Block 5 Canada price increases every year, CPI-Adjustment Methodology considered.
2010 CPI 0.8412 X 1.045 = 0.8791 CAP 0.8606 X 1.027 = 0.8838 % Bl5 increase 0.8606 X 1.022 = 0.8795
31
2005 2006 2007 2008 2009 2010
Form 2 Bl5 Canada $0.8085 $0.8284 $0.8450 $0.8872 $0.8961 $0.9158
% Bl5 increase 2.5% 2% 2% 0.3% 2.2%
% annual CPI 2% 2.1% 2.4% 0.3% 1.8%
% Cap 3% 3.2% 3.6% 0.5% 2.7%
% CPI Adj. Factor 2% 4.2% 6.6% 4.9% 4.5%
IBP/IBP* $0.8085 $0.8247 $0.8412 $0.8580 $0.8606 $0.8791
N-ATP $0.8085 $0.7958 $0.7724 $0.7277 $0.7304 $0.8300
N-NEAP $0.8085 $0.8247 $0.8213 $0.8002 $0.7313 $0.7501
PMPRB 101
32
SOLD OUT
PMPRB 101
Where? PMPRB office, 14th floor, 333 Laurier Avenue West, Ottawa
When? December 6, 2012 from 10:00 a.m. to 3:30 p.m.
For whom? Employees from pharmaceutical companies who need to understand PMPRB basic operations such as filing,
calculation of intro prices and ongoing NEAPs
What? Introduction to PMPRB processes
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• The different forms that need to be filed• Section 82: Notification of Intent to Sell• Form 1• Form 2
Overview of Filing Session for PMPRB 101
• Filing timelines
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• Reporting process
Overview of Filing Session for PMPRB 101
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• Failure to File
• Common filing errors
• Compliance Status Reports
• Where to find the forms on the PMPRB website
Overview of the Introductory Price Analysis
Scientific Review Submission Process for Scientific Data on New Drug Products Human Drug Advisory Panel (HDAP) Scientific Review Process
Levels of Therapeutic Improvement Selection of Comparators Selection of Dosage Regimens
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Introductory Price Review Introductory Price Tests
Median International Price Comparison (MIPC) Therapeutic Class Comparison (TCC) Mid-point Reasonable Relationship (RR)
Highest International Price (HIPC) Criteria for Investigation at Introduction Communication of Results to Patentees
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Overview of the Introductory Price Analysis
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Price Review of Existing Medicines• CPI Adjustment Methodology• Highest International Price Comparison
PMPRB 101 Let’s Talk Numbers
Exchange Rates
Verification of International Prices• Calculating ex-factory prices
Criteria for an investigation
Application forms for the DIP Methodology
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Communication with Board Staff
Query to PMPRB Staff
Guidelines: Ginette Tognet Tel: (613) 954-8297 E-mail: [email protected]
Scientific and new meds: Catherine Lombardo Tel: (613) 952-7620 E-mail: catherine.lombardo@pmprb-
cepmb.gc.ca Filing Form 1 and 2: Beatrice Mullington
Tel: (613) 952-2924 E-mail: [email protected]
Investigation: Senior Regulatory Officer assigned to Company Form 3: Lokanadha Cheruvu
Tel: (613) 954-9812 E-mail: [email protected]
Website: Carol McKinley Tel: (613) 960-4550 E-mail: [email protected]
All other questions: 1-877-861-2350 [email protected]
