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Hoffmann Krueger Consulting Ltd.,                                     Hoffmann Krueger Consulting Ltd., c/o SFM
P.O. Box 33582, Ras Al Khaimah,                                       Rue Adrien-Lachenal 20
United Arab Emirates              Hoffmann & Krueger Copyright 2013   1207 Geneva, Switzerland
1
•

•




                                        2
    Hoffmann & Krueger Copyright 2013
•


                           R         E     A         C         T
•




    R   ethink    E      valuate           A     ccelerate         C    hange       T      ransform
    The patient       Your current           The Growth                Your Model       Your Strategy
    Connection        Tactics

                                                                                                        3
                               Hoffmann & Krueger Copyright 2013
•




      Ability to deliver
     value-added data,
      analysis, report,
    advices in oncology




                                                   4
               Hoffmann & Krueger Copyright 2013
Treatment
                                                                                                                             algorithms

                                              Patients cohorts


                     Epidemiology                                                                        Pricing
                                                                                                                     Oncology
                                                                                                                      product
                                                                                                                     Forecast
                                                                         R&D


                                      Genetic type
         Generics
                                                                                                     Market Access
                                                     Patent                                                             New product
                                  Start-up                                                                                Launch
                                                                         Oncology
Big pharma          Companies                                            strategies
                      sizes                                                                            Biosimilars




      Biosimilars
                                Spin-off
                                                         Generics                                  Life Cycle
                                                                                                  Management


                                                                                                                                      5
                                                              Hoffmann & Krueger Copyright 2013
Hoffmann & Krueger




                                                6
            Hoffmann & Krueger Copyright 2013
7
8
•




                                        9
    Hoffmann & Krueger Copyright 2013
Sample of analysis made for our client : “Impact of referencing in oncology European prices”

 •


                                                                                        ASMR IV-V: No formal EU price referencing; national price
                                                                                         benchmarks decisive, but lowest EU-4 price can serve as a price
                                                                                         cap if it is below the reference of the national comparator chosen.

       No influence from other
        countries
                                                                                                                No influence from other
                                                                                                                 countries




 References to FR and ITA (key countries), UK,
  GER, but also to smaller price-controlled
  countries like BE or AUT if it helps payers
 Past practice: parity to lowest available EU
  reference price or minus ~5% to 10%                                                               References mainly FR and SP (key countries), but
                                                                                                     also UK, GER, and western Europe countries
                                                                                                    Unlikely to accept prices higher than in EU-4 (FR,
                                                                                                     GER, SP, UK)
                                                                                                    AIFA may ask for a report of any price changes in
                                                                                                     other EU countries.
                                                                                                                                                  10
                                                   Hoffmann & Krueger Copyright 2013
•




             Hoffmann Krueger Consulting Ltd., c/o SFM
             Rue Adrien-Lachenal 20
             1207 Geneva, Switzerland
             Contact.uae@hoffmann-krueger.com




                                                         11
    Hoffmann & Krueger Copyright 2013
12
http://www.iarc.fr/index.html                                                   http://www.rki.de/


IARC is studying cancer incidence, mortality, and survival in                   The Robert Koch Institute collaborates with the German
numerous countries and is thus playing a leading role in cancer                 Association of Population-Based Cancer Registries to publish
registration worldwide. IARC's founding members were Germany,                   national cancer statistics for Germany. The coverage of
France, Italy, the United Kingdom, and the United States, IARC's                Germany by the registries is nearly 100% complete. This data
membership has grown to 20 countries (founding states plus                      represents the most robust and complete data source available
Australia, Belgium, Canada, Denmark, Finland, India, Ireland,                   for Germany.
Japan, Norway, the Netherlands, Republic of Korea, Russian
Federation, Spain, Sweden, and Switzerland).




http://www.eurocare.it/                                                          http://www.ecosante.fr/DEPAFRA/3034.html

EUROCARE project (European cancer registries study on                            FRANCIM is a network of cancer registries in France
cancer patients' survival and care) is an international
collaborative study on the survival of cancer patients in
Europe. It currently involves 67 population-based cancer
registries operating in 22 European countries,



                                                                                                                                       13
                                                      Hoffmann & Krueger Copyright 2013
Journal of medical oncology
International Journal of Cancer
British Journal of Cancer
Journal of Thoracic Oncology
European Journal of Cancer
Oncogene
Clinical Cancer Research
New England Journal of Medecine




                                         14
     Hoffmann & Krueger Copyright 2013
1.Role of Hoffmann& Krueger Consulting Ltd.                                                                 3. Disclosure of Interests

Hoffmann&Krueger Consulting Limited will carry out the services set out in the Engagement proposal          It is possible that Hoffmann&Krueger Consulting Ltd and/or one of its associates and/or one of
and will not be obliged to provide any other advice or services unless it expressly agrees to do so.        Their respective officers, employees, representatives or agents or another client of the
                                                                                                            Hoffmann&Krueger Consulting Ltd may have interests, relationships and/or arrangements that
Any advice rendered by Hoffmann&Krueger Consulting Ltd, unless otherwise agreed by us, is solely for
                                                                                                            give rise to conflicts or interests which are otherwise material in relation to the Engagement
the benefit of the Client and must be kept confidential. This advice may not be relied on by the Client
other than for the purposes of the Engagement and may not be disclosed to any third party or                ("Other Interests"). So far as Hoffmann&Krueger Consulting Ltd is aware without having made
announced publicly unless there is a legal or regulatory obligation to disclose or announce it or           enquiry of any of its clients, no other client of Hoffmann&Krueger Consulting Ltd has, as at the
otherwise agreed by Hoffmann&Krueger Consulting Ltd. Such advice may not be used or relied on by            date of the project agreement, any Other Interests and Hoffmann&Krueger Consulting Ltd agrees
any third party without Hoffmann&Krueger Consulting Ltd's prior written consent.                            to notify the Client if it becomes aware during the Engagement of any of its clients having any
                                                                                                            Other Interests provided that Hoffmann&Krueger Consulting Ltd shall not be required to disclose
2. Authority and Information                                                                                details of the names of any such clients or any other details concerning such clients to the Client
                                                                                                            pursuant to this Clause 3
Hoffmann&Krueger Consulting Ltd is entitled to assume that its instructions in relation to the
Engagement have been properly authorised by the Client if they are given by a director or senior
                                                                                                            The employees of the Hoffmann&Krueger Consulting Ltd assigned to the Engagement may be
executive of the Client or by any of the persons referred to in the proposal. Hoffmann&Krueger
Consulting Ltd is authorised by the Client to carry out such steps as it considers necessary to complete    unaware of, and in any event are required to disregard, any Other Interests and the Client agrees
the Engagement including acting through agents.                                                             that Hoffmann&Krueger Consulting Ltd may act for it despite Other Interests and that any profit
                                                                                                            or remuneration from such interests may be retained by Hoffmann&Krueger Ltd.
The Client understands and agrees that Hoffmann&Krueger Consulting Ltd in performing its
Engagement, will use and rely upon information provided by the Client as well as publicly available         The Client agrees that Hoffmann&Krueger Consulting Ltd does not have a duty to disclose any
information and that Hoffmann&Krueger Consulting Ltd does not assume responsibility for independent         matter which comes to its notice in the course of their business if doing so would constitute a
verification of any information, whether publicly available or otherwise furnished to it by the Client.     breach of duty owed to other persons.
Accordingly, Hoffmann&Krueger Consulting Ltd shall be entitled to assume and rely upon the accuracy,        Hoffmann&Krueger Consulting Ltd will remain bound by any Confidentiality Agreement entered
fairness and completeness of all such information.
                                                                                                            into between the parties.
All reports and data is the property of the client but all documents, questionnaires, cards etc. on which
the data is recorded shall be the property of the Company. Copies of any or all of this material in an
anonymous form can be made available to clients on request on payment of additional fees. If wider
circulation of results is intended, Hoffmann&Krueger Consulting Ltd name may not be quoted in
connection with the study until the exact form of any communication has been agreed by
Hoffmann&Krueger Consulting Ltd. The Client undertakes to inform Hoffmann&Krueger Consulting Ltd
of any intended wider publication prior to release and to offer identification of Hoffmann&Krueger
Consulting Ltd as the supplier of the work to be published.




                                                                                                                                                                                                   15
                                                                                   Hoffmann & Krueger Copyright 2013
Hoffmann Krueger Consulting Ltd.,                                     Hoffmann Krueger Consulting Ltd., c/o SFM
P.O. Box 33582, Ras Al Khaimah,                                       Rue Adrien-Lachenal 20
United Arab Emirates              Hoffmann & Krueger Copyright 2013   1207 Geneva, Switzerland

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Hoffmann &Krueger Oncology Excellence

  • 1. Hoffmann Krueger Consulting Ltd., Hoffmann Krueger Consulting Ltd., c/o SFM P.O. Box 33582, Ras Al Khaimah, Rue Adrien-Lachenal 20 United Arab Emirates Hoffmann & Krueger Copyright 2013 1207 Geneva, Switzerland
  • 2. 1
  • 3. • • 2 Hoffmann & Krueger Copyright 2013
  • 4. R E A C T • R ethink E valuate A ccelerate C hange T ransform The patient Your current The Growth Your Model Your Strategy Connection Tactics 3 Hoffmann & Krueger Copyright 2013
  • 5. Ability to deliver value-added data, analysis, report, advices in oncology 4 Hoffmann & Krueger Copyright 2013
  • 6. Treatment algorithms Patients cohorts Epidemiology Pricing Oncology product Forecast R&D Genetic type Generics Market Access Patent New product Start-up Launch Oncology Big pharma Companies strategies sizes Biosimilars Biosimilars Spin-off Generics Life Cycle Management 5 Hoffmann & Krueger Copyright 2013
  • 7. Hoffmann & Krueger 6 Hoffmann & Krueger Copyright 2013
  • 8. 7
  • 9. 8
  • 10. 9 Hoffmann & Krueger Copyright 2013
  • 11. Sample of analysis made for our client : “Impact of referencing in oncology European prices” •  ASMR IV-V: No formal EU price referencing; national price benchmarks decisive, but lowest EU-4 price can serve as a price cap if it is below the reference of the national comparator chosen.  No influence from other countries  No influence from other countries  References to FR and ITA (key countries), UK, GER, but also to smaller price-controlled countries like BE or AUT if it helps payers  Past practice: parity to lowest available EU reference price or minus ~5% to 10%  References mainly FR and SP (key countries), but also UK, GER, and western Europe countries  Unlikely to accept prices higher than in EU-4 (FR, GER, SP, UK)  AIFA may ask for a report of any price changes in other EU countries. 10 Hoffmann & Krueger Copyright 2013
  • 12. Hoffmann Krueger Consulting Ltd., c/o SFM Rue Adrien-Lachenal 20 1207 Geneva, Switzerland Contact.uae@hoffmann-krueger.com 11 Hoffmann & Krueger Copyright 2013
  • 13. 12
  • 14. http://www.iarc.fr/index.html http://www.rki.de/ IARC is studying cancer incidence, mortality, and survival in The Robert Koch Institute collaborates with the German numerous countries and is thus playing a leading role in cancer Association of Population-Based Cancer Registries to publish registration worldwide. IARC's founding members were Germany, national cancer statistics for Germany. The coverage of France, Italy, the United Kingdom, and the United States, IARC's Germany by the registries is nearly 100% complete. This data membership has grown to 20 countries (founding states plus represents the most robust and complete data source available Australia, Belgium, Canada, Denmark, Finland, India, Ireland, for Germany. Japan, Norway, the Netherlands, Republic of Korea, Russian Federation, Spain, Sweden, and Switzerland). http://www.eurocare.it/ http://www.ecosante.fr/DEPAFRA/3034.html EUROCARE project (European cancer registries study on FRANCIM is a network of cancer registries in France cancer patients' survival and care) is an international collaborative study on the survival of cancer patients in Europe. It currently involves 67 population-based cancer registries operating in 22 European countries, 13 Hoffmann & Krueger Copyright 2013
  • 15. Journal of medical oncology International Journal of Cancer British Journal of Cancer Journal of Thoracic Oncology European Journal of Cancer Oncogene Clinical Cancer Research New England Journal of Medecine 14 Hoffmann & Krueger Copyright 2013
  • 16. 1.Role of Hoffmann& Krueger Consulting Ltd. 3. Disclosure of Interests Hoffmann&Krueger Consulting Limited will carry out the services set out in the Engagement proposal It is possible that Hoffmann&Krueger Consulting Ltd and/or one of its associates and/or one of and will not be obliged to provide any other advice or services unless it expressly agrees to do so. Their respective officers, employees, representatives or agents or another client of the Hoffmann&Krueger Consulting Ltd may have interests, relationships and/or arrangements that Any advice rendered by Hoffmann&Krueger Consulting Ltd, unless otherwise agreed by us, is solely for give rise to conflicts or interests which are otherwise material in relation to the Engagement the benefit of the Client and must be kept confidential. This advice may not be relied on by the Client other than for the purposes of the Engagement and may not be disclosed to any third party or ("Other Interests"). So far as Hoffmann&Krueger Consulting Ltd is aware without having made announced publicly unless there is a legal or regulatory obligation to disclose or announce it or enquiry of any of its clients, no other client of Hoffmann&Krueger Consulting Ltd has, as at the otherwise agreed by Hoffmann&Krueger Consulting Ltd. Such advice may not be used or relied on by date of the project agreement, any Other Interests and Hoffmann&Krueger Consulting Ltd agrees any third party without Hoffmann&Krueger Consulting Ltd's prior written consent. to notify the Client if it becomes aware during the Engagement of any of its clients having any Other Interests provided that Hoffmann&Krueger Consulting Ltd shall not be required to disclose 2. Authority and Information details of the names of any such clients or any other details concerning such clients to the Client pursuant to this Clause 3 Hoffmann&Krueger Consulting Ltd is entitled to assume that its instructions in relation to the Engagement have been properly authorised by the Client if they are given by a director or senior The employees of the Hoffmann&Krueger Consulting Ltd assigned to the Engagement may be executive of the Client or by any of the persons referred to in the proposal. Hoffmann&Krueger Consulting Ltd is authorised by the Client to carry out such steps as it considers necessary to complete unaware of, and in any event are required to disregard, any Other Interests and the Client agrees the Engagement including acting through agents. that Hoffmann&Krueger Consulting Ltd may act for it despite Other Interests and that any profit or remuneration from such interests may be retained by Hoffmann&Krueger Ltd. The Client understands and agrees that Hoffmann&Krueger Consulting Ltd in performing its Engagement, will use and rely upon information provided by the Client as well as publicly available The Client agrees that Hoffmann&Krueger Consulting Ltd does not have a duty to disclose any information and that Hoffmann&Krueger Consulting Ltd does not assume responsibility for independent matter which comes to its notice in the course of their business if doing so would constitute a verification of any information, whether publicly available or otherwise furnished to it by the Client. breach of duty owed to other persons. Accordingly, Hoffmann&Krueger Consulting Ltd shall be entitled to assume and rely upon the accuracy, Hoffmann&Krueger Consulting Ltd will remain bound by any Confidentiality Agreement entered fairness and completeness of all such information. into between the parties. All reports and data is the property of the client but all documents, questionnaires, cards etc. on which the data is recorded shall be the property of the Company. Copies of any or all of this material in an anonymous form can be made available to clients on request on payment of additional fees. If wider circulation of results is intended, Hoffmann&Krueger Consulting Ltd name may not be quoted in connection with the study until the exact form of any communication has been agreed by Hoffmann&Krueger Consulting Ltd. The Client undertakes to inform Hoffmann&Krueger Consulting Ltd of any intended wider publication prior to release and to offer identification of Hoffmann&Krueger Consulting Ltd as the supplier of the work to be published. 15 Hoffmann & Krueger Copyright 2013
  • 17. Hoffmann Krueger Consulting Ltd., Hoffmann Krueger Consulting Ltd., c/o SFM P.O. Box 33582, Ras Al Khaimah, Rue Adrien-Lachenal 20 United Arab Emirates Hoffmann & Krueger Copyright 2013 1207 Geneva, Switzerland