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                                                                                                                      ISPOR 13th Annual European Congress
                   Invited Issue Panel Session
              Reimbursement Issues In Cancer Drugs:
             Do We Have To Pay For All Cancer Drugs?
                                                                                                               Optimising the managed entry of new
                                                                                                                      cancer drugs in Europe

                                                                                                                                Prepared by Brian Godman



                                Brian Godman
         Laboratory of Regulatory Policies, Mario Negri Institute, Milan, Italy,
               Division of Clinical Pharmacology, Karolinska Institute
                       Huddinge Hospital, Stockholm, Sweden
             University of Liverpool Management School, Liverpool, UK                                    2   ISPOR Prague




                                                                                                         Resource pressures growing with the continued
                                                                                                         launch of new expensive drugs

    1. Introduction                                                                                       New expensive drugs account for over 50% of in-patient drug
                                                                                                           budget in Marseilles hospitals - growing at over 20% per year

                                                                                                          New biological drugs with acquisition prices over $50,000 to
                                                                                                           $100,000/ patient/ year are adding to resource pressures
                                                                                                           across Europe, some with only marginal health gain
    2.
    2 Ongoing developments across Europe
                                                                                                          The pressures will intensify with the next generation of cancer
                                                                                                           drugs estimated by one UK expert to cost up to £50billion a
                                                                                                           year within 4 years - raising UK basic tax by 15%

                                                                                                          New models are required to continue funding new innovative
                                                                                                           cancer drugs within an ageing population in Europe. These are
    3. Conclusions                                                                                         evolving


3   ISPOR Prague                                                                                         4   ISPOR Prague
                                                                                                                                               Ref: Lee 2008, Sikora 2008, Sermet, Andrieu, Godman et al 2010




The cost of new cancer drugs has been a concern
in Sweden. This is being addressed

                                                                                                               Drug         Total cost and estimated increase in survival
                                                                                                                               $80352
                                                                                                             Cetuximab
                                                                                                                               1.2 months (NSCLC)
                                                                                                                               $90816
                                                                                                         Bevacizumab           1.5
                                                                                                                                1 5 months (Metastatic breast cancer – not
                                                                                                                                statistically significant)

                                                                                                                               $15752
                                                                                                              Erlotinib
                                                                                                                               10 days (pancreatic cancer)

                                                                                                                               $34373
                                                                                                             Sorafenib
                                                                                                                               2.7 months (renal cell carcinoma)
5   ISPOR Prague                                             Ref: Specialist drug project, Godman 2009   6   ISPOR Prague
                                                                                                                                                                                    Ref: Fojo and Grady 2009




                                                                                                                                                                                                                1
                                                                                                                               Developments are ongoing across Europe to
                                                                                                                               help fund new cancer drugs
                                                                                                                               Ongoing developments include:
     1. Introduction
                                                                                                                                Releasing resources through encouraging use of generics at
                                                                                                                                 lower prices

                                                                                                                                OECI (Organisation of European Cancer Institutes) and OECI/
                                                                                                                                 Piperska initiatives
     2.
     2 Ongoing developments across
        Europe                                                                                                                  New models for optimising the managed entry of new drugs
                                                                                                                                 including horizon scanning, forecasting, critical drug evaluation
                                                                                                                                 and follow-up activities

                                                                                                                                Defining ‘risk sharing schemes’ and suggesting where most
                                                                                                                                 beneficial from a ‘payer’ perspective
     3. Conclusions

7    ISPOR Prague                                                                                                              8    ISPOR Prague




Supply and demand side reforms are improving
efficiency – room for improvement in some

     % change for the statins in Europe - 2007 vs. 2001

                500                                                                                                            Planned activities include:
            E
                                                                                           IE                                   Development of targeted approaches through improved science
            x   400
            p                                                                                                                    and potential biomarkers. Initiative started in Sweden in 2009
            e   300                                                                                                              and being progressed including:
            n                                                                                                                      Potential EU/ pharmaceutical company funding
            d   200                                                                                                                accreditation of cancer centres
                                                              PT
            i
            t   100         TR
                                                                                                                                Instigation of European Academy of Cancer Sciences – just
            u                    FR                                 UK                                                           starting Vision and Mission
            r       0
                            ES                                                                                                  The Piperska group lending support as part of its drive to
            e           0                     200                  400                   600                   800
                              DE         SE
                ‐100                                                                                                             improve the managed entry of new medicines (greatest
                                                              Utilisation
                                                                                                                                 challenge to comprehensive and equitable healthcare)
9    ISPOR Prague                                                                                                              10   ISPOR Prague
                                                                                            Ref: Godman, Shrank et al 2010




Proposed models to optimize managed entry                                                                                      Improved forecasting helping to create budgets
start with Horizon Scanning pre launch                                                                                         for new cancer drugs – Stockholm, Sweden


                    Industrial drug development

                    Phase II Phase III         Approval         Phase IV

     Time


             Horizon                  HTA                         HTA
            scanning               pre-launch                  post-launch




                                                                                                 Observational
                                                                  Structured                       studies on
                                  Forecasting                    introduction                    effectiveness,
                                                                 programmes                     safety and health
                                                                                                    economy




11   ISPOR Prague                                                                                                              12   ISPOR Prague
                                         Ref: Wettermark, Godman, Eriksson, van Ganse, Joppi, Malmstrom, Paterson et al 2010                                               Ref: Wettermark, Person, Wilking et al 2010




                                                                                                                                                                                                                         2
We recently defined risk sharing schemes from a                                             Potential risk sharing schemes for new cancer
payer perspective to reduce confusion                                                       drugs include transparency and good science

 Proposed definition                                                                       Key payer criteria for proposed risk sharing schemes

     ‘Risk sharing schemes for pharmaceuticals should be                                     The objectives and scope are explicit and transparent
     considered as agreements concluded by payers and                                        The new drug is:
     pharmaceutical companies to diminish the impact on the                                      A novel treatment with envisaged health gain
     payer’s budget of new and existing medicines brought                                        Few effective treatments currently available
     about by either the uncertainty of the value of the                                         With/ without long term safety concerns
     medicine and/ or the need to work within finite                                         Translational science suggests good effectiveness and delaying
     budgets’                                                                                 treatment may not be in key stakeholders’ interest
                                                                                             The likely health gain can be determined within a limited time
                                                                                              frame
 Using this definition, the various schemes can be subdivided                               Patient access schemes substantially lower health service costs
  into:                                                                                       having factored in all administrative costs especially processes
    Financial/financial-based models                                                         to claim refunds/ rebates
    Outcome/performance-based models



13   ISPOR Prague                                        Ref: Adamski, Godman et al 2010    14   ISPOR Prague                                             Ref: Adamski, Godman et al 2010




Concerns with patient access schemes (PAS)
include administrative burden and logistics
Logistic concerns with PAS
 Whether the system can cope with the time scales for refunds,
                                                                                                 1. Introduction
  e.g. time between monitoring disease progression and the next
  physician visit to stop therapy
 Whether the national health system is set up to receive free
  goods/ rebates from pharmaceutical companies
 Whether refunds to hospitals/ hospital trusts are passed back
  t th ‘payers’ in practice to fully realise the benefits
  to the ‘       ’i      ti t f ll      li th b      fit                                         2.
                                                                                                 2 Ongoing developments across Europe
Administrative concerns with PAS schemes
 Capacity to manage PAS schemes without funding additional
  staff
 Time taken to administer schemes
 Communication between physicians and pharmacists to ensure                                     3. Conclusions
  refunds/ rebates, e.g. every missed claim for bortezomib
  loosed GB£12000

15   ISPOR Prague                       Ref: Williamson 2010; Williamson and Thomson 2010   16   ISPOR Prague




A number of activities are in progress to                                                   Minimum improvements in survival for funding
improve funding for new cancer drugs                                                        premium priced cancer in UK hospitals

 A number of activities are ongoing to improve funding for new                             Minimum effectiveness and data quality for new cancer drugs
  cancer drugs and these will continue. This includes improved                                           Effectiveness                         Criteria
  processes to ‘manage their entry’                                                                              A       Median survival improved > 9months + improved QoL

                                                                                                                 B       Median survival improved 3 - 6 months + improved QoL

 Increasingly critical evaluation of the health gain that                                                       C          Improved QoL but no impact on overall survival

  constitutes ‘added value’ for new cancer drugs (raising the                                                    D        Minimal impact QoL and no impact on overall survival

           bar).
  clinical bar) This builds on discussions in the UK in the late                                         Data Quality                          Criteria

  1990s                                                                                                     alpha +              Meta analysis or two high quality RCTs
                                                                                                            alpha -        One high quality RCTs and supporting Phase II data
                                                                                                                beta      One poor quality RCT and/or several Phase II studies
 Future funding helped by less rhetoric and greater
  collaboration between pharmaceutical companies, diagnostic                                 Ferguson and colleagues believed only new products with A
  companies and others to improve targeting. In addition,                                     and B effectiveness criteria and alpha data quality should be
  greater involvement and transparency with payers pre-launch                                 funded at premium prices

                                                                                             This study involving key stakeholder provide direction to
                                                                                              others
17   ISPOR Prague                                                        Ref: Barker 2010   18   ISPOR Prague                                                    Ref: Ferguson et al 2000




                                                                                                                                                                                            3
19   ISPOR Prague                            20   ISPOR Prague




                     Thank You
                    godman@ marionegri.it;
                     Brian.Godman@ ki.se;
                    mail@briangodman.co.uk




21   ISPOR Prague




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