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					                                   Dr Joanna Lis
President-Elect Polish Society of Pfarmacoeconomics
                        Expenditure                                                                     Expenditure as % GDP
                  [Exch. rate, million US$]
300,000                                                    15.0%



250,000
                                                           12.0%




                                                                                                                                                                                                              8.7%
200,000




                                                                                                                                                                                                    8.2%
                                                                                                                                                                                          8.0%
                                                                                                                                                                                7.7%
                                                           9.0%




                                                                                                                                                                       7.4%
                                                                                                                                                               6.7%
                                                                                                                                   6.1%
                                                                                                                                             6.1%
                                                                                                                                                       6.1%
150,000




                                                                                                          5.8%
                                                                                                                          5.8%
                                                                               5.2%
                                                                                               5.2%
                                                           6.0%




                                                                    4.6%
100,000

                                                           3.0%
 50,000


                                                           0.0%
     0




                                                                                                                                  Finland
                                                                                                                                            Ireland


                                                                                                                                                              Italy




                                                                                                                                                                                                             France
                                                                            Slovak Republic




                                                                                                                                                      Spain
                                                                                                        Czech Republic
                                                                   Poland


                                                                                              Hungary




                                                                                                                                                                               Austria
                                                                                                                         Greece




                                                                                                                                                                                         Germany
                                                                                                                                                                                                   Denmark
                                                                                                                                                                      Sweden
      Source: OECD Health Data 2009: data from 2007 year
                          Expenditure                                                            Expenditure as % GDP
                    [Exch. rate, million US$]




                                                                                                                                                                1.9%
 40,000                                                              2.0%

                                                                     1.8%
 35,000




                                                                                                                                                         1.5%
                                                                     1.6%




                                                                                                                                                  1.4%
 30,000




                                                                                                                                           1.3%
                                                                     1.4%




                                                                                                                             1.2%

                                                                                                                                    1.2%
 25,000
                                                                     1.2%




                                                                                                                      1.0%
                                                                                                               0.9%
 20,000                                                              1.0%




                                                                                                        0.8%
                                                                                                 0.7%
                                                                     0.8%




                                                                                   0.6%

                                                                                          0.6%
 15,000




                                                                            0.5%
                                                                     0.6%
 10,000
                                                                     0.4%
  5,000
                                                                     0.2%

     0                                                               0.0%




* expenditure on pharmaceuticals and other medical non-durables comprises pharmaceuticals such as medicinal preparations,
branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals and oral contraceptives.

    Source: OECD Health Data 2009, data from 2007 year
                                            Respiratory system;        Musculo-skeletal system;
                                                   1,42%                        3,99%
                                                                                              Nervous system;
                                          n/a ;        VARIA; 1,55%                               16,02%
              Alimentary tract and       7,92%

                  metabolism ;
                    15,52%                                                                                      Respiratory system
                                                                                                                      14,28%


                                                                                                                 Antiparasitic products,
       Blood and blood forming                                                                                insecticides and repellents;
               organs;
                                                                                                                         0,08%
                5,02%

                                                                                                      Antiinfectives for systemic
                                                                                                                  use;
                      Cardiovascular                                                                             7,35%
                                                                                                   Antineoplastic and
                      system; 14,68%                                                          immunomodulating agents;
                                                                                                         6,27%
                                                    ;
                                    Dermatologicals Genito-urinary system and Systemic hormonal
                                        0,71%            sex hormones ; preparations, excluding sex
                                                               3,98%         hormones and insulins;
                                                                                    1,23%




Source: National Health Found, Report 2008
                                                                                                                                           ◦ corelation between
                                                                                                                                             level of health care
                                       Wydatki na ochronę zdrowia 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z cukrzycą        expenditure vs quality
                                           900                                                                                               of diabetics health care
RANKING SYSTEMÓW OPIEKI NAD PACJENTAMI Z




                                                                                                                                           ◦ 0,74 (p<0,05)
                                           850                                                   UK      DAN
                                                                                         HOL            FRA
                                                                                           BEL
                                           800                                                                             NOR
                                                                                        WŁO          NIE
                                           750                                                   IRL
                                                                                                   SZWC
                                                                                                   SZWE
                                                                                                       AUS
               CUKRZYCĄ




                                                        LIT                             FIN                                 LUX
                                           700         ŁOT                       HISZ
                                                                        SLO
                                                                   WĘG MAL
                                           650                           GRE
                                                           EST
                                                                         CZE
                                           600
                                                                 SK

                                           550             POL
                                                     RUM
                                                           CYP             POR
                                           500
                                                      BŁG

                                           450
                                                 0     500        1000     1500         2000     2500        3000   3500     4000   4500
                                                                 w ydatki na ochronę zdrow ia per capita 2006 (USD, ppp)


                                           Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)
                                                                                                                                         Strong corelation between
                                                                                                                                          level of health care
                                                                                                                                          expenditure vs quality of
                                                         Wydatki na ochronę zdrowia per capita w 2006 r. (USD, ppp)
                                                         a ocena systemu opieki nad pacjentami z chorobami serca
                                                                                                                                          health care in cardiology
                                           900                                                                                           0,84 (p<0,05)
RANKING SYSTEMÓW OPIEKI NAD PACJENTAMI Z




                                           850                                                      FRA                 LUX

                                           800
                                                                                      HOL           AUS
            CHOROBAMI SERCA




                                           750                                                    SZW
                                                                       SLO           WŁO
                                                                                      FIN    UK       DAN
                                           700                                         BEL        NIE
                                                                      MAL
                                                                              HISZ           IRL
                                           650           CYP
                                                         EST SK
                                                                      CZE
                                           600                           POR
                                                                          GRE
                                                                WĘG
                                           550
                                                         LIT
                                                         POL
                                           500
                                                       ŁOT

                                           450
                                                 0     500     1000      1500        2000    2500         3000   3500   4000   4500
                                                        WYDATKI NA OCHRONĘ ZDROWIA PER CAPITA 2006 (USD, PPP)

                                                     Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)
         PRICE CONTROL                x   VOLUMEN CONTROL       =   SPENDING CONTROL

        PRICE REGULATIONSj,               CUT TING COSTS FOR
                                                                             RSS
        (freezing, lowering, …)               MARKETING


S      NATIONAL REFERENCE
U                                          PRODUCT VOLUME
             PRICING                                                  REVENUE CONTROL
P                                               CAPS
P
L   International Price Comparisons
Y
      "Cost-effectiveness pricing"                                     PROFIT CONTROL

               REBATES                                              PRODUCT RENEVUE CAPS
                  VBP


       PATIENT’S COPAYMENT                   FOLUMULARIES           PATIENT/DISEASE BUDGET


D     REGISTRATION & MARKET                POSITIVE/NEGATIVE
                                                                     PHYSICIAN RX BUDGET
E      AUTHORISATION RULES                REIMBURSEMENT LISTS
M
A                                              CONTROL              PHUSICIAN HEALTH CARE
N        INSURANCE SYSTEM
                                             PRESCRIPTION                  BUDGET
D

      GENERIC SUBSTITIUTION               TRATMENT GUIDELINES


                TAXES                       PARALLEL TRADE
   Name                                 Merits                        Advance
 Pharma      Amendment implementing EU Dir                          Consulted in
             Important: introduction of 8+2+1 RDP regime            2009
    Law
 Clinical    Assumptions of new Law ( single act) Important:        Consulted in
             - New (obligatory) insurance for each participant      Jan’10
  trials
             - 1 trials at a time by one investigator
 Registra-   New law on Regulatory Office Important:                Consulted in
             MA issued by President of Reg. Office (not MoH)        2009
   tion
 Reimbur-    New reimbursement law : expected important changes:    Not
              Individual decisions                                 Consulted
  sement
              Fixed margins and prices                             yet
              Risk-sharing agreements
              Tax on pharma activities (Garattini tax)


Doctors      Draft law on New types of specializations              Consulted
                                                                    Jan 2010
Clinical     New regime of clinical hospitals (erected by Medical   n/a
             Universities)
hospitals
                                                                                   10
DRAFT!
                                               Coverage with clinical evidence
                        conditional                       development
                        re imbursement
                                             Payment for treatment continuation
                                                              only

             He alth
 C ompany   o utcome
                                p ay for       Payment for treatment outcome
    MoH
                             p erformance

   risk-                                     Upfront payment refunded in case of
  sharing                                             no treatment outcome

 ag reem.
                                                  Defined market share and
                              population            overspendings’ pay-back
            Financial           based
            o utcom
                                             Defined volume and overspendings’
                                                           pay-back



                                                   Limited no of treatment
                               individual
                             patient based
                                                       Natural rebate


                                                                                   11
   A complete assessment of health technology
    comprises the following analyses:

   1) Analysis of decision problem

   2) Clinical effectiveness analysis

   3) Economic analysis

   4) Analysis of impact on health care system
Analysis of impact on health care system
 covers
 ◦ the budget impact analysis and

 ◦ the assessment of organizational consequences for
   the heath care system, and possibly the assessment
   of possible ethical and social implications
      ◦ Lantus utilization after reimbursement decision

     Future expenditures on Lantus after its reimbursement are
      calculated based on predicted use of Lantus given in international
      units (IU).
     Share of estimated consumption of Lantus within basal insulin
      market was estimated on the basis of data from European countries
      where Lantus is reimbursed.

      ◦ Lantus utilization without reimbursement decision

     Values for this forecast was obtained based on the dynamics of the
      consumption of Lantus in Poland (IMS Health data)

      ◦    Insulin dosage
     Calculator gives the opportunity to use input data on insulin dosage
      from RCTs, observational studies or market research studies


* HTA Consulting, 2010
                                       DAILY INSULIN DOSES (IU)


            Insulin           RCT                     Observational studies      Market research study


            Lantus             39                              23,1                      27,9


             NPH               37                              23,1                      28,3


        Premixed insulin      46,5                             35                        41,2


                           Proportions of use between Lantus and other insulin


            Insulin           RCT                     Observational studies      Market research study


             NPH              0,94                             1,00                      1,01


        Premixed insulin      1,19                             1,59                      1,48




HTA Consulting, 2010
   Utilization of insulin glycaemic test strips

   Comparison of use of test strips in addition to insulin therapy indicates
    differences between patients on Lantus, NPH and premixes.
   Compared to NPH/Premixes Lantus requires less strips.
    ◦ The difference is 20 less strips a month for new patients starting therapy
       and
    ◦ 13 strips a month for patients using insulin for before

   Insulin prices

   Perspective of the analysis:
   The analysis was conducted from public payer (NHF) and patient
    perspective.

   Time horizon
   The analysis was conducted in 5 years perspective.



    HTA Consulting, 2010
   Replacement (switching) of insulin (NPH and
    premixes) by Lantus

   Based on the insulin utilization from European
    countries (analysis of the structure of insulin
    market relating to replacement of NPH and
    premixes after Lantus reimbursement)
   User can choose:
    ◦ Selected country (choice between different European
      countries can be made)
    ◦ European mean calculated as arithmetic mean
    ◦ European mean calculated as mean weighted by
      population size
    ◦ European mean calculated as mean weighted by
      insulin utilization
    ◦ User prognosis – user can choose the degree of
      share between NPH and Premixes which are replaced
      by Lantus
                                                            Insulin utilization and trends used in the
   Data on consumption of different types of                          prognosis in Greece
    insulin, together with the characteristics that
    describe the dynamics of the consumption
    trends (for the sample country (Greece))

      HTA Consulting, 2010
                                         Reimbursement by payer – scenario with OADs
                            20


                            15


                            10
 Refundacja NFZ [mln PLN]




                             5

                                                                                         Lantus

                             0                                                           NPH

                                                                                         Mieszanki

                                                                                         Metformina
                             -5                                                          Glimepiryd

                                                                                         Paski glikemiczne

                            -10


                            -15


                            -20
                                  2010          2011       2012        2013       2014

                                                           YEAR




HTA Consulting, 2010
                                                                   Insulins usage
                            250
                            200
                            150                                                                       Lantus
Zużycie insulin [mln IU]




                            100
                             50
                                                                                                      NPH
                              0
                            -50
                           -100                                                                       Mix

                           -150
                           -200
                                                          2010   2011         2012      2013   2014
                                                                        Rok
                                                                        Reimbursement by payer – scenario without OADs
                                                         20
                                                         15
                              Refundacja NFZ [mln PLN]




                                                         10
                                                          5
                                                                                                                      Lantus
                                                          0
                                                                                                                      NPH
                                                          -5                                                          Mieszanki

                                                         -10                                                          Metformina

                                                         -15                                                          Glimepiryd

                                                                                                                      Paski glikemiczne
                                                         -20
                                                         -25
                                                                 2010            2011          2012    2013    2014

                                                                                               Rok


                           HTA Consulting, 2010
ECONOMIC

             SOCIAL

                          ETHICS


           ORGANIZATION




            NEGOTIATION
                 in
                RSS
   Individual decisions: changes to administrative procedures leading to full implementation of
    EU Transparency Directive No 105.
      Decisions are to be taken in the individual form
      Drugs reimbursement lists will be often updated and published in form of internal MoH
       order/ not as legal Act published in Official Journal.
      New bodies will be introduced: Transparency Council and Economic Committee which will
       conduct negotiations with pharmaceutical companies
   Fixe margins and prices
      Rebates will be forbidden as well as all kinds of commercial practices concerning
       decreasing of ex-factory official price.
      Pharmacy margins will be accounted from reimbursement limit/ not from the price.
    Risk-sharing agreements
      Arrangements between a payer and a pharmaceutical, device, or diagnostic manufacturer
   Tax on pharma activities („Garattini tax”)
      3% of reimbursed drugs sales paid by Pharmaceutical Companies to the state budget.
      This money are going to be spent on independent clinical trials and registers (CER)
   Others:
      Limits will be based on the cheapest drug with 15% market share level in therapeutic
       group.
      Constant cost-reevaluation under reference price system
                                                                      E
    In case of lack of head to head trials                            F
                                            E      Health Technology
    comparing directly an assessed and an                             F
    alternative technology, it is            F        Assessment
                                                                      E
    recommended to conduct an indirect
    comparison.                              F                        C




                                                 Does it Work?




                                                                 Comparative
                                                  For whom?
                                             I                        T




                                                                               Cost
   Indirect comparisons can be performed                             I
    and presented independently of direct    C                        V
    comparisons. In the case of mixed
    comparisons involving both direct and    A                        E
    indirect comparisons, the results of     C                        N
    direct comparisons alone should be                                E
    presented separately and                         Evidence Based
                                             y          Medicine
    independently from the results of the                             S
    mixed comparison.                                                 S
                                                            E
                         Health Technology
                                                            F
                           Assessment
E                                                           F
                                                            E
F
                                                            C
F
    Does it Work?

                                                            T




                                       Comparative
                    For whom?

I                                                           I




                                                     Cost
C                                                           V
                                                            E
A
                                                            N
C                                                           E
y                                                           S
                Evidence Based Medicine                     S
   Comparative Effectiveness is the conduct and
    synthesis of research comparing the benefits and
    harms of different interventions in a „real world”
    settings.
       The purpose of this research is to improve health outcomes
        by developing and disseminating evidence – based
        information to patients, clinicians and other decision
        makers, responding to their expressed needs, about which
        interventions are most effective for which patients under
        specific circumstances”


   Additional taxes for financing CER
 CHANGES IN HEALTH CARE SYSTEM
WHICH ALLOW TO GET BETTER ACCESS
    WITHIN LIMITED RESOURCES



          Let’s do together!

				
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