Patented Medicine Prices Review Board
Regulatory Affairs and Outreach Branch
Outreach Sessions
Montreal, November 22, 2012
Toronto, November 23, 2012
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
Changes in Form 1
FORM 1
MEDICINE IDENTIFICATION SHEET
Pate n te d Me di ci n e
Pri ce s Re vi e w Board
Pri vi l e ge d s.87
Patent Act
Use one form per DIN
P lease Specify:
or
Original Filing - - Complet e all Blocks
Amendment t o Original Filing - - Complet e all Blocks and specify which Block(s) is(are) amended __________
1 NAME(S ) AND US E(S ) OF THE MEDICINE
Brand Name:
Generic Name:
T herapeut ic use(s) of t he medicine
approved by Healt h Canada:
Hu man Pre scri pti on
(The m e dic ine is fo r hum a n us e a nd c o nta ins a c o ntro lle d s ubs ta nc e a s de fine d in the
C o ntro lle d Drugs and S ubs tanc e s A c t o r c o nta ins a s ubs ta nc e lis te d o r de s c ribe d in
S c he dule s C o r D to the Fo o d and Drugs A c t o r in S c he dule F to the Fo o d and Drug
R e gulatio ns )
OR
Hu man O ve r-th e -C ou n te r
OR
Ve te ri n ary
4
(The m e dic ine is fo r hum a n us e a nd do e s no t c o nta in a c o ntro lle d s ubs ta nc e a s de fine d in the
C o ntro lle d Drugs and S ubs tanc e s A c t o r do e s no t c o nta in a s ubs ta nc e lis te d o r de s c ribe d in
S c he dule s C o r D to the Fo o d and Drugs A c t o r in S c he dule F to the Fo o d and Drug
R e gulatio ns )
Changes in Form 1
2 PATENTEE
Patentee Name
Patentee Address
Identity if the
the patent holder
patentee is:
person entitled to the benefits of a patent or to exercise any rights in relation to a patent
3 NOTICE OF COMPLIANCE (N.O.C.)
First N.O.C.
Y
M
D
Check if
Special Access Programme
applicable
or
Clinical T rial Application or Investigational New Drug
4 DRUG IDENTIFICATION NUMBER (DIN)
Drug Identification Number
5
Dosage Form
Strength/Unit
Changes in Form 1
5 DATE OF FIRS T S ALE
6 PRODUCT MONOGRAPH (check only one box)
Product Monograph OR
Date of 1st Sale
Y
M
D
Information similar to that
contained in a Product
Monograph
(Copy Included)
(Copy Included)
7 PATENT NUMBER OF PATENTEE'S INVENTIONS PERTAINING TO THE MEDICINE
Patent Number
Numeric only
6
Date Granted
Y
M
Expiration Date
D
Y
M
D
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:
T itle:
Organization:
Date:
T el. Number: (
)
Fax Number : (
E-mail:
Please send completed Form 1 to compliance@pmprb-cepmb.gc.ca
7
)
Changes in Form 2, Block 1, 2, 3
FORM 2
INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE
Patented Medicine
Prices Review Board
Privileged s.87
Patent Act
Cover Sheet : Block 1, 2, 3
Please Specify
or
Original Filing
Complete Block 1 and 3
Amendment to Original Filing
Complete Block 2 and 3
BLOCK 1 : ORIGINAL FILING
REPORTING PERIOD
Period to which the information
applies (only one reporting period per
Form):
NAMES OF THE MEDICINE
Brand name of the medicine
Generic name of the medicine
8
FROM
Y
TO
M
D
Y
M
D
Changes in Form 2, Block 1, 2, 3
BLOCK 2 : AMENDMENT TO AN ORIGINAL FILING
REPORTING PERIOD
Period to which the information
applies (only one reporting period per
Form):
FROM
Y
TO
M
D
Y
M
BLOCK(s) and DIN(s) or ASSIGNED NUMBER(s)THAT ARE AMENDED
Check Block(s) that
is(are) amended :
Block 4
Block 5
9
For each Block, list DIN(S) or Assigned Number(s) that is (are) amended.
Write one DIN per cell.
D
Changes in Form 2, Block 1, 2, 3
BLOCK 3 : PATENTEE * AND CERTIFYING SIGNATURE
Patentee Name
Patentee Address
*Please see section 79(1) of the Patent Act for the definition of a "patentee". Note that a patentee is any person entitled
to 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 Regulations
I hereby certify that the information presented is true and correct.
Signature of duly authorized person for the reporting patentee
Name:
T itle:
Organization:
Date:
T el. Number: (
)
Fax Number : (
E-mail:
Please send completed Form 2 including the cover sheet, Block 4 and Block 5 to:
compliance@pmprb-cepmb.gc.ca
10
)
Interim Maximum Average Potential Price (MAPP)
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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).
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MIPC in Introductory Price Tests
Level of Therapeutic
Improvement
Breakthrough
Substantial
Improvement
Moderate
Improvement
Introductory Price Tests
MIPC
Higher of:
- Top of TCC
- MIPC
Higher of:
- Mid point (Top of
TCC and MIPC)
- Top TCC
Top of TCC
Slight/No
Improvement
Lower of:
- Bottom of TCC
- MIPC
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If no comparator
is identified
Or if price of
comparator is
excessive
Or if cannot
derive dosage
regimen
Or If no public
price is found
MIPC
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
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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
Post-Interim MAPP (2013) = $15
Final 2013 N-NEAP = $14
 Impact on future requests for DIP application: IBP remains at $15
15
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
Post-Interim MAPP (2012) = $10
Final 2012 N-NEAP = $10
 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
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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
Post Interim MAPP (2012) = $17
Final 2012 N-NEAP = $13
 Impact on future requests for DIP application: IBP remains at $15
17
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
Post-Interim MAPP (2013) = $15
Final 2013 N-NEAP = $14
 Impact on future requests for DIP application: IBP remains at $15
19
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
Post-Interim MAPP (2012) = $10
Final 2012 N-NEAP = $10
 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
20
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
Post-Interim MAPP (2012) = $17
Final 2012 N-NEAP = $13
 Impact on future requests for DIP application: IBP remains at $15
21
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)
Mid Point = $12.50
Interim MAPP is set by Mid Point
Interim MAPP (2010) = $12.50
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Interim MIPC = $15
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
Post-Interim MAPP (2013) = $12.50
Final 2013 N-NEAP = $12.50
 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
23
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
Post-Interim MAPP (2012) = $10
Final 2012 N-NEAP = $10
 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
24
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
Post-Interim MAPP (2012) = $13.50
Final 2012 N-NEAP = $13
 Impact on future requests for DIP application: IBP remains at $12.50
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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
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DIP Methodology
27
Simplified DIP Methodology: Reminders
28

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
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) CPI
Use lower of :
annual (one year)
CPI and
% increase of Form 2 Block 5 Canada price
2008
2009
2010
$0.8284 $0.8284
$0.8391
$0.8391
$0.8533
% Bl5 increase
2.5%
1.3%
% annual CPI
2%
Form 2 Bl5 Canada
29
2005
2006
$0.8085
2007
2.1%
1.7%
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 years
Use lower of:
Cap
 % increase in Form 2 Block 5

Form 2 Bl5 Canada
30
2005
2006
2007
$0.8085
$0.8284 $0.8284
2008
2009
2010
$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.
2008
2009
2010
$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%
Form 2 Bl5 Canada
2005
2006
$0.8085
2007
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
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
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PMPRB 101
32
PMPRB 101
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 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
Overview of Filing Session for PMPRB 101
• The different forms that need to be filed
• Section 82: Notification of Intent to Sell
• Form 1
• Form 2
• Filing timelines
• Reporting process
34
Overview of Filing Session for PMPRB 101
• Failure to File
• Common filing errors
• Compliance Status Reports
• Where to find the forms on the PMPRB website
35
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



36
Levels of Therapeutic Improvement
Selection of Comparators
Selection of Dosage Regimens
Overview of the Introductory Price Analysis
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
37
PMPRB 101
Let’s Talk Numbers
Price Review of Existing Medicines
•
•
CPI Adjustment Methodology
Highest International Price Comparison
Exchange Rates
Verification of International Prices
•
Calculating ex-factory prices
Criteria for an investigation
Application forms for the DIP Methodology
38
Communication with Board Staff
 Query to PMPRB Staff






Guidelines: Ginette Tognet
Tel: (613) 954-8297
E-mail: ginette.tognet@pmprb-cepmb.gc.ca
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: beatrice.mullington@pmprb-cepmb.gc.ca
Investigation: Senior Regulatory Officer assigned to Company
Form 3: Lokanadha Cheruvu
Tel: (613) 954-9812
E-mail: lokanadha.cheruvu@pmprb-cepmb.gc.ca
Website: Carol McKinley
Tel: (613) 960-4550
E-mail: carol.mckinley@pmprb-cepmb.gc.ca
 All other questions: 1-877-861-2350
39
pmprb@pmprb-cepmb.gc.ca