Patented Medicine Prices Review Board. Regulatory Affairs and Outreach Branch . Overview. Regulatory Filing – Latest Changes. Form 1. Form 2 Block 1, 2, 3. Interim Maximum Average Potential Price (MAPP). ID: 726743
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Outreach SessionsMontreal, November 22, 2012 Toronto, November 23, 2012
Patented Medicine Prices Review Board
Regulatory Affairs and Outreach Branch
Slide2OverviewRegulatory Filing – Latest ChangesForm 1Form 2 Block 1, 2, 3Interim Maximum Average Potential Price (MAPP)DIP MethodologySimplifiedRegularPMPRB 101
2
Slide3Regulatory Filing Latest Changes in Form 1 and Form 2 Block 1, 2, 33
Slide44
Changes in Form 1
Slide55Changes in Form 1
Slide66Changes in Form 1
Slide77Changes in Form 1
Slide88Changes in Form 2, Block 1, 2, 3
Slide99Changes in Form 2, Block 1, 2, 3
Slide1010Changes in Form 2, Block 1, 2, 3
Slide1111Interim Maximum Average Potential Price (MAPP)
Slide1212
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:
The re-determined median international price, and
The Non-Excessive Average Price derived from the ordinary application of the CPI-Adjustment Methodology (see Schedule 9).
Slide13Substantial
Improvement
Higher of:
Top
of TCC
-
MIPC
Level of Therapeutic Improvement
MIPC in Introductory
Price
Tests
Breakthrough
MIPC
Introductory Price Tests
13
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
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
Slide1414
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
Slide1515
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
Slide1616
Interim MAPP: Example 1 (MIPC)
S
cenario 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
Slide1717
Interim MAPP: Example 1 (MIPC)
Scenario 3 : Five countries (higher PI-MAPP)
I
n
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) = $17
Final 2012 N-NEAP = $13
Slide1818
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
Slide1919
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
Slide2020
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
Slide2121
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
Slide2222
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
Slide2323
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
Slide2424
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
Slide2525
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
Slide26Interim MAPP – Meaning and implicationsA 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
Slide27DIP Methodology27
Slide28Simplified DIP Methodology: RemindersPatentee acquires DIN from previous patentee prior to January 1, 2010: patentee to obtain original IBP from previous patentee for DIP applicationsBenefits 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
Slide29Regular 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
29
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
Slide30Regular 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
30
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
Slide31Regular 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
Slide32PMPRB 10132
Slide33SOLD OUTPMPRB 101
Where? PMPRB office, 14
th
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
33
Slide34The different forms that need to be filedSection 82: Notification of Intent to SellForm 1Form 2Overview of Filing Session for PMPRB 101
Filing timelines
34
Reporting process
Slide35Overview of Filing Session for PMPRB 10135
Failure to File
Common filing errors
Compliance Status Reports
Where to find the forms on the PMPRB website
Slide36Overview of the Introductory Price AnalysisScientific ReviewSubmission Process for Scientific Data on New Drug ProductsHuman Drug Advisory Panel (HDAP) Scientific Review ProcessLevels of Therapeutic ImprovementSelection of ComparatorsSelection of Dosage Regimens36
Slide37Introductory Price ReviewIntroductory Price TestsMedian International Price Comparison (MIPC)Therapeutic Class Comparison (TCC)Mid-pointReasonable Relationship (RR)Highest International Price (HIPC)Criteria for Investigation at IntroductionCommunication of Results to Patentees37
Overview of the Introductory Price Analysis
Slide3838Price Review of Existing MedicinesCPI 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
Slide3939Communication with Board StaffQuery to PMPRB StaffGuidelines: 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
pmprb@pmprb-cepmb.gc.ca
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