Outreach Sessions Montreal, November 22, 2012		Toronto, November 23, 2012
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Presentation on theme: "Outreach Sessions Montreal, November 22, 2012 Toronto, November 23, 2012"— Presentation transcript:

Slide1

Outreach SessionsMontreal, November 22, 2012 Toronto, November 23, 2012

Patented Medicine Prices Review Board

Regulatory Affairs and Outreach Branch

Slide2

OverviewRegulatory Filing – Latest ChangesForm 1Form 2 Block 1, 2, 3Interim Maximum Average Potential Price (MAPP)DIP MethodologySimplifiedRegularPMPRB 101

2

Slide3

Regulatory Filing Latest Changes in Form 1 and Form 2 Block 1, 2, 33

Slide4

4

Changes in Form 1

Slide5

5Changes in Form 1

Slide6

6Changes in Form 1

Slide7

7Changes in Form 1

Slide8

8Changes in Form 2, Block 1, 2, 3

Slide9

9Changes in Form 2, Block 1, 2, 3

Slide10

10Changes in Form 2, Block 1, 2, 3

Slide11

11Interim Maximum Average Potential Price (MAPP)

Slide12

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:

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).

Slide13

Substantial

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

Slide14

14

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

Slide15

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

Slide16

16

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

Slide17

17

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

Slide18

18

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

Slide19

19

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

Slide20

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

Slide21

21

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

Slide22

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

Slide23

23

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

Slide24

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

Slide25

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

Slide26

Interim 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

Slide27

DIP Methodology27

Slide28

Simplified 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

Slide29

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

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

Slide30

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

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

Slide31

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

Slide32

PMPRB 10132

Slide33

SOLD 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

Slide34

The 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

Slide35

Overview of Filing Session for PMPRB 10135

Failure to File

Common filing errors

Compliance Status Reports

Where to find the forms on the PMPRB website

Slide36

Overview 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

Slide37

Introductory 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

Slide38

38Price 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

Slide39

39Communication 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