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    Medicin der virker

    Martin S. KnudsenSenior Consultant

    IMS Health Economics and Outcomes Research

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    2

    Emner

    Hvordan er lgemiddel markedet i Danmark set i forhold tilEuropa og det globale marked

    Er udgifterne hje, hvorfor stiger de

    Hvad betyder lgemidler for national konomien Afspejler priserne behandlingseffekten, er der muligheder I

    value based pricing

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    3

    2011 sales and growth

    Japan

    Size: U.S.$95-100bn

    Growth: 5-7 %

    US

    Size: U.S.$320-330bn

    Growth: 3-5 %

    Top 5 Europe

    Size: U.S.$135-145bn

    Growth: 1-3 %

    Pharmerging Markets

    Size: U.S.$170-180bn

    Growth: 15-17 %

    Rest of World

    Size: U.S.$145-155bn

    Growth: 3-5 %

    Global Market

    Size: $880-890bn

    Growth: 5-7 %

    2011 Sales and growthSource: IMS Health, Market Prognosis, Sep 2010

    China Venezuela Egypt

    Brazi l Poland Thai land

    Russia Argentina Romania

    India Indonesia Pakistan

    Mexico S. Africa Vietnam

    Turkey Ukraine

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    Global Pharma growth to remain in single digitsA trillion dollar market by 2014 energised by emerging markets

    0

    200

    400

    600

    800

    1000

    1200

    2010 (

    ) 2011 (

    ) 2012 (

    ) 201 (

    ) 2014(

    )

    ALUE

    ALESUS$

    N

    0%

    5%

    10%

    15%

    20%

    25%

    0%

    ALUEG

    W

    %(

    onst

    US$)

    Global USAEU5 Ja an

    ier 1 Pharmerging

    ier 2 Pharmerging

    ier Pharmerging

    Source: IMS Health Market Prognosis September 2010; Tier 1 = China; Tier 2 = Brazil, Russia, India; Tier 3 = Venezuela, Poland, Argentina,Turkey, Mexico, Vietnam, S. Africa, Thailand, Indonesia, Romania, Egypt, Pakistan, Ukraine

    Global Sales and Market Growth Pharmaco challenges

    Global Pharma Market Dynamics & Current Economic Environment

    US/EU / apan no longer dominateglobal growth

    ower GDP growth and tax revenues

    will impact healthcarebudgets/promote more aggressivecost containment

    New product launches are notreplacing revenues lost to genericcompetition, especially in primarycare

    Emerging markets present the mostattractive areas for growth

    Increased pricing & reimbursementpressures

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    2001 Rank 2006 Rank 2011 Rank

    1 United States 1 United States 1 United States2 apan 2 apan 2 apan3 France 3 France 3 China4 Germany 4 Germany 4 Germany

    Italy Italy France United Kingdom Canada Italy7 Canada 7 Spain 7 Brazil

    Spain United Kingdom Canada9 China 9 China 9 Spain10 Brazil 10 Brazil 10 United Kingdom11 Mexico 11 Mexico 11 Russia12 Australia 12 Australia 12 India13 South Korea 13 South Korea 13 South Korea14 India 14 Russia 14 Australia

    1

    Netherlands 1

    India 1

    Mexico1 Russia 1 Turkey 1 Turkey17 Poland 17 Netherlands 17 Venezuela1 Belgium 1 Poland 1 Poland19 Portugal 19 Belgium 19 Greece20 Switzerland 20 Greece 20 Belgium

    Leading pharmerging markets projected to climb inthe 2011 global market ranking

    Source: IMS Health Market Prognosis, Sep 2010. Market size ranking in constant US

    Chinaexpected toenter 2011

    as #3 market

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    Den samlede udgift til lgemidler i DK stiger, isr isygehussektoren

    Samlet omstning af lgemidler i DK, rets priser

    0

    2.000

    4.000

    6.000

    8.000

    10.000

    12.000

    14.000

    16.000

    2005 2006 2007 2008 2009

    Mio.kr

    Sygehus sektor Primr sektor

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    men gennemsnits prisen falderLgemiddelpriser DK 2005-2010, indeks 2005-12=100

    50

    60

    70

    80

    90

    100

    110

    2005

    -12

    2006

    -03

    2006

    -06

    2006

    -09

    2006

    -12

    2007

    -03

    2007

    -06

    2007

    -09

    2007

    -12

    2008

    -03

    2008

    -06

    2008

    -09

    2008

    -12

    2009

    -03

    2009

    -06

    2009

    -09

    2009

    -12

    2010

    -03

    2010

    -06

    2010

    -09

    2010

    -12

    Indeks,2

    005-12=100

    DDD-baseret indeks Receptpligt. lgemidler m. tilskudsstatus AIP

    DDD-baseret indeks Alle lgemidler undt. lib. sortiment AIP

    Alle lgemidler

    Recept

    Kilde; Lgemiddelstyrelsen

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    !

    Netto eksport af lgemidler Schweiz er strst,Danmark er nummer i Europa

    " # # $ " # # % " # # & ' ( ( ( ' ( ( ' ' ( ( $ ' ( ( % ' ( ( &

    - $

    &

    $

    ' (

    " %

    " '

    (

    IRELAND

    S) ITZER-LAND

    UNITEDKINGDOM

    S)

    EDEN

    GERMANY

    FRANCE

    DENMARK

    BELGIUM

    AUSTRIA

    Trade balance (2010)(Billion

    Source: EuroStat. *Trade balance calculations are made by subtracting revenues spent on importing from revenues made from exporting.EFPIA, The Pharmaceutical industry in figures, 2010 edition

    Trade balance*(Billion , MAT

    Trade of Medical and Pharmaceutical Products

    100

    SLOVENIA

    DENMARK

    S 0 EDEN

    BELGIUM

    FRANCE

    UK

    IRELAND

    GERMANY

    S 0 ITZERLAND

    1 1 1 20

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    99

    Outside the UK/US which are first and fast there is a range ofuptake times across market but on average Denmarks marketis opened quickly

    2

    3 2 2

    4 2 2

    5 2 2

    6 2 2

    7 2 2 2

    7 3 2 2

    7 4 2 2

    elgium

    Slov

    akia

    Austria ta

    lyrance

    unga

    rySp

    ain

    echrepu

    blic

    Slov

    eniareece

    ston

    iaolan

    d

    ortugal

    Swit

    erland

    ethe

    rlands

    Swed

    en

    inland

    orway

    reland

    Den

    mark

    ermany UK US

    Delay

    8

    day

    s9

    @ aA imum/ @ inimum Average

    Range of timedelays betweenmarketing

    authorisation andmarket accesshospital and

    retail combined

    All new medicineswith marketingauthorisation from

    anuary 3 to3 December

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    1010

    Protected NLP GenericsTotal

    Share% / Dose Share% / Dose Share% / Dose

    POL 0% 0.91 9% 0.26 91% 0.16 0.17

    DNK 14% 1.10 2% 0.31 84% 0.03 0.18

    FIN 9% 0.92 21% 0.23 70% 0.08 0.18

    SWE 15% 1.14 2% 0.23 83% 0.03 0.20

    DEU 7% 1.12 27% 0.17 66% 0.13 0.21

    NOR 3% 1.10 24% 0.48 74% 0.10 0.22

    CZE 3% 0.91 28% 0.25 69% 0.20 0.24

    GBR 29% 0.80 1% 0.45 69% 0.05 0.28

    AUT 18% 0.93 13% 0.36 69% 0.24 0.38

    HUN 11% 0.58 15% 0.38 74% 0.36 0.39

    NLD 39% 0.93 4% 0.24 57% 0.04 0.40

    PRT 24% 0.68 9% 0.44 67% 0.33 0.43

    FRA 44% 0.69 19% 0.25 37% 0.26 0.44

    ESP 5% 1.09 43% 0.78 52% 0.18 0.48

    ITA 51% 0.75 26% 0.29 23% 0.21 0.51

    BEL 38% 1.06 22% 0.26 40% 0.16 0.52

    CHE 46% 1.12 10% 0.64 44% 0.44 0.78

    GRC 44% 1.00 8% 0.77 47% 0.84 0.91

    IRL 76% 1.13 14% 0.77 11% 0.70 1.04

    Source: IMS Health Monthly MIDAS, Q3/10. Market share in volume (SUB and price in Euros at MNF level.

    Original Brands Statiner

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    Health Technology Assessment (HTA) anvendt plgemidler

    "Health Technology Assessment" svarer nogenlunde til detdanske koncept for Medicinsk Teknologi Vurdering (MTV)

    Anvendes som betegnelse for en systematisk evaluering aflgemidler som bde omfatter kliniske data og konomi

    Er i varierende grad et krav til godkendelse af markedsadgang og/eller tilskudsstatus i en del lande

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    Influences price & access

    Influences access only

    Limited influence on price/ access

    FR

    IT

    AU

    DN HUIR

    CH

    SWPL PO

    UK DE

    Part ofP&R

    process

    HTA isseparateprocess

    Part ofP&R

    process

    Organizationally, HTAs have beenset up with a wide range of levelsof influence and incorporationinto the P&MA process

    HTA bodies can be part of the

    P&R process or separate These HTA bodies can

    influence two factors

    - Price and Access

    - Access only

    The range of influence varies

    widely by countries- In countries, HTA bodies

    exist but have limitedinfluence

    CZ GR

    EST

    LI

    LV

    BEL

    SK

    TUSL RO

    NO

    BUL

    NE

    FI

    SP

    Most EU27 countries report that a formal HTAprocess exists in their market at the national level

    Source: IMS Consulting research among a number of P&R authority officials and industry affiliates in 200 C

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    Value based pricing en international tendens?

    Udfordring

    Priser for patentbeskyttede produkter afspejler ikke behandlingens vrdi

    forskel paa priser for produkter med ensartet effekt Usikkerhed om langsigtede konsekvenser begrnser adgang til nye produkter Behov for fleksible priser naar produkter anvendes til forskellige indikationer Priskontrol/reduktion hmmer investerings lysten (UK)

    Lsning (?)= Value based pricing

    Maximal pris betinget af behandlings effekt

    Risk sharing hvis behandlingen ikke virker betales der tilbage

    Status

    Anvendes bl.a i Sverige og flere europiske lande

    I UK planlgger man at erstatte det nuvende PPRS system med et system baseretpaa value based pricing i 2013

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    Value based pricing - eksempler

    Sverige

    Duodopa blev tilskudsberettiget i 2003 med tidsbegrnsningunder forudstning af at yderligere dokumentation kunne pviseen omkostnings effektivitet p et rimeligt niveau. Frst I 200 fikDuodopa en endelig accept.

    UK

    Det overvejes at graduere standarden for, hvad der er omkost-ningseffektivt, s man belnner ny medicin paa srlige omrder

    stort behandlingsbehov (unmet need)

    Innovativ medicin, signifikant bedre effect

    Bredere samfundsmssige gevinster

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    1 D

    Sammenfatning

    Danske medicinudgifter er i international sammenhng ikkemarkant hje.

    Danmark har forholdvis hj beskftigelse i en medicinalindustri, som bidrager positivt til betalingsbalancen.

    Ny medicin lanceres relativt hurtigt og Danmark har et hjtoptag af ny medicin.

    Bortfaldet af patenter har medvirket til faldende priser.

    Udgifterne er de seneste r drevet op af ny sygehusmedicin.

    Value based pricing kan mske levere en ramme forintroduktion af ny medicin.

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    1 E

    Tak for opmrksomheden!