Marketing Reseach Costing by osz55288

VIEWS: 0 PAGES: 22

More Info
									           PRIORITY
     MEDICINES FOR
    EUROPE AND THE
              WORLD for the
    A report prepared by WHO
      Netherlands Government
                 by
          Warren Kaplan
           Richard Laing
                and

      Saloni Tanna      Marjolein Willemen
      Eduardo Sabaté    Monique Renevier
      Joyce Wilson      Lisa Greenough
1     Ann Wilberforce   Kathy Hurst
      Objectives of Priority
       Medicines Project
• Provide a methodology for identifying
  pharmaceutical “gaps” from a public health
  perspective, for Europe and the World .

• Provide a public-health based pharmaceutical
  R&D agenda for use by the EU in the 7th
  Framework Programme,

“Good public policy should spend public funds
      on areas of greatest public needs”
2
    Generating a Preliminary List of
          Diseases and Gaps

 Burden of disease ranking                          Cochrane database of
       EU10, EU25                                    systematic revie ws
The world (including EU25)                             Clinical efficacy




Projections                 PRELIMINARY LIST                           Social
and trends              OF PRIORITY DISEASES AND                      solidarity
                                  GAPS



          IN DEPTH REVIEWS OF PRELIMINARY LIST OF DISEASES AND GAPS




                              FINAL REPORT
3
                                                               Pharmaceutical "Gap"
                                               Treatment of ACUTE Stroke (Outcome: Survival at end of treatment or follow-up, unless noted otherwise)

                                    1.8
                                          Various excitatory nerve
                                          amino acid antagonists                                                            Antiplatelet
                                                                                          Fibrinogen                                                    Streptokinase
                                    1.6                                                                                     therapies
                                                                     Ion channel          depleting agents                                              urokinase
                                                                     ,modulators                                                           Glycerol     ( 7 days)

                                    1.4



                                    1.2
Relative Risk (<1 favors placebo)




                                     1


                                                                            NMDA                             Gangliosides
                                    0.8                                     antagonists


                                    0.6



                                    0.4



                                    0.2



                                     0


4
                                                                   Example of an absent
                                                                    pharmaceutical gap
                                                       Secondary prevention of occlusive event (Stroke/MI) with antiplatelet therapy

                                     2.5
                                                                                                                                                               Picotamide



                                      2
                                                                                                                                                  Suloctidil
Relative risk (<1 favours placebo)




                                                                                                                                    Ticlopidine
                                     1.5
                                                       Prior MI                                       Aspirin any
                                               Prior
                                                                                                        dose
                                                MI                Prior stroke       All trials                 Dipyridamole


                                      1
                                                                                                                         Sulfinpyrazole



                                     0.5




                                      0
                                           5
                                                 .        .            .         .        .       .       .          .         .          .           .             .
           "Commonality of
              interest"
           EUROPE                           THE WORLD
     10%   8%   6%    4%    2%    0    2%     4%   6%   8%   10%
                     Antimicrobial Resistance
??                                                                 ??
                       Pandemic Influenza
??                                                                 ??
                Ischaemic Heart Disease

                       Diabetes Mellitus

                             Cancer*

                              Acute Stroke**

                                   HIV/AIDS

                                   Tuberculosis
                            Neglected Diseases***

                                 Malaria

                      Alzheimer and other dementias

                             Osteoarthritis
                               COPD

                           Alcohol use disorders
                        Unipolar depression
 6
                            Maternal hemorrhage
     Special Needs for Women,
      Children, and the Elderly
• All groups neglected in drug development
• Complicated by different physiology &
  metabolism
• Recent improvements in situation of women and
  children
• Considerable gaps remain for the elderly who
  use the most medicines



7
    Promoting Innovation and
       Removing Barriers
• Public Private Partnerships may be a vehicle
  to address market failure
• Pricing issues are critical to the future of the
  European pharmaceutical industry. Propose
  investigating differential pricing based on GNI
  per capita and efficacy measures. Reseach
  prospective price setting.
• EMEA, FDA, Rawlins and Industry have all
  proposed similar measures to remove barriers
• Comparative trials provide critical information
  on head to head comparisons. Use of European
  databases may facilitate such studies
8
                        Differential Pricing: Indicative prices in
                       US$/annum of highly active antiretrovira
                       (HAART) and a new hypothetical regime
                             in countries of variable wealth

                       30000
                                                                                                                                                                                             United Kingdom

                                                                                                                                                                                            France
                       25000
                                                                                                                                                                                        Italy

                                                                                                                                                                        Spain
                       20000
Indicative price $US




                       15000
                                                                                                                                                   Slovenia

                                                                                                                                   Czech Republic
                       10000



                       5000                                                                                                           Latvia
                                                                                        Russian Fed.
                                                                               Kazakhstan
                                                                     Philippines
                               Mali               India          Georgia
                          0




                                                                                                                                                                                                         23225
                                                                                                                                                                                                                 26076
                                                                                                                                                                       12620
                                                                                                                                                                                15627
                                                                                                                                                                                         19831
                                                                                                                                                                                                 22783
                                                                                  1214


                                                                                                1959
                                                                                                       2125




                                                                                                                            2566




                                                                                                                                                 4921


                                                                                                                                                               10881
                                            441
                                                   487




                                                                            993


                                                                                         1637




                                                                                                              2401
                                                                                                                     2557


                                                                                                                                   3477
                                                                                                                                          3744


                                                                                                                                                        6199
                               267




                                                          607
                                                                763
                                                                      855
                                      294




                                200                 500                     1000                2000                 2500                               5000                   15000 20000 25000

                                                                                         Per capita GNI $US

9
                                                                 Indicative price existing treatment                                      Indicative price new drug
             Barriers to Innovation:
                   Background
• Cost and duration of medicines development have
  increased
     – Many projects in early development stages, but not enough of
       this potential innovation is being translated into market
       approvals.

• For some diseases, there remains an inadequate
  understanding of basic science, and potential
  targets for medicines development have not been
  identified.



10
              Recent Publications

• Four papers published almost simultaneously,
  plus commentary on Priority Medicines website
     – EMEA: Discussion Paper: The European Medicines
       Agency Road Map to 2010: Preparing the Ground for the
       Future
     – FDA: " Challenge and Opportunity on the Critical Path to
       New Medical Products"
     – Perspectives – "Cutting the Cost of Drug Development?"
       M.D. Rawlins
     – Sue Middleton: GSK Commentary on "Barriers to
       Innovation"

11
             Barriers to Innovation:
              Suggested Solutions
• All authors agreed that every aspect of the regulatory process
  should be re-examined and that the evidence base for
  regulatory practices should be critically analysed using modern
  methodologies.
• Preclinical studies
     – Many old tests and methods
     – New analytic tools needed
     – Validation of old methods required
• Clinical Studies
     – Regulatory authorities are risk averse so the RCT has become the
       gold standard
     – Other approaches even using historical controls may be possible
       and desirable


12
            Neglected Areas:
     Post marketing Surveillance and
                Patients

• All papers neglect Phase IV studies as a part of
  the innovation process. Great opportunities for
  Europe from use of electronic data bases for
  Phase IV studies on both efficacy and safety
• Apart from the industry paper, none of the three
  other papers mention any role for patients in this
  review. They are referred to as beneficiaries of
  the process but never as contributors to the
  decision-making.

13
     Role of Patients remains
              unclear
• Patients have speeded innovation e.g.
  AIDS and Orphan diseases
• Valuable role in treatment guideline
  development emerging e.g. NICE
• Patients play important role in ethical &
  hospital committees e.g. IRB & DTCs
• Will now be part of CSM in UK
• Future role likely to be important and
  growing
14
          A "barriers to innovation"
              Research Agenda
• Bottlenecks and barriers in the current medicines development
  process are to be identified and solutions elaborated to
  overcome them.
   – Range of stakeholders required: academia, clinicians, patient
     organizations, large and small industry, regulatory and ethics
     specialists
   – Every requirement within the medicines development process
     whether clinical or preclinical should be questioned for its
     regulatory relevance, costing, and predictive value.
   – The involvement of the EMEA and the various European national
     regulatory agencies and their scientists is critical to this initiative.
   – 6th Framework already has issued a call closing November 16th


15
     PRIORITY MEDICINES FOR
     EUROPE AND THE WORLD

     Comparative Clinical Trials
           Chapter 8.4
             Warren Kaplan

16
     Comparative Trials: Background
•    For most medications at launch, we know little about whether or not a
     given medication is better value for the money than alternatives.
      – This knowledge gap exists because most drug regulatory authorities do not
        examine "value for money"


•    For most medications at launch, clinical trials are not designed to look
     at whether or not a given medication is better than another drug.

•    Typically, efficacy is measured versus a control which is often, but not
     invariably, a placebo lacking any active ingredient.
      – Many registration authorities do require comparative benefit studies


•    To estimate comparative benefit between two medicines, large (time
     consuming and expensive) trials are needed since there are often
     small differences between treatment outcomes when comparing the
     interventions.
17
            Comparative Trials:
      Who should pay for them and who
             conducts them?
• Industry? Government? Or…
• Private insurers and the government could set aside some
  fraction of their annual medicines spending to endow an
  organization to provide an independent source of reputable
  research into comparative effectiveness and cost.
     – Electronic prescription and medical databases to conduct Phase IV
       and/or pharmacoepidemiologic studies in place of controlled,
       comparative clinical trials.
     – EU has a great comparative advantage over the USA as this kind of
       electronic linkage of prescribers and medical records is still fragmented
       in the USA
     – Phase IV studies could add a randomization step ("randomized
       epidemiology")


18
            Comparative Trials/
          Comparative Effectiveness
• Europe 2005: "An information society for all",
  available at

     http://europa.eu.int/information_society/eeurope/2002/news_lib
     rary/documents/eeurope2005/eeurope2005_en.pdf.


• This Action plan on "electronic health" should be
  used as a way of creating post-marketing
  studies to better understand comparative
  effectiveness and cost-effectiveness.


19
      General Conclusions
• Commonality of interest exists for chronic diseases
  between Europe and the World
• Priorities can be set based on evidence, trends and
  projections and social solidarity
• Pharmaceutical gaps exist as a result of biological
  challenges and market failure
• Highest priorities are antibacterial resistance, influenza,
  smoking and neglected diseases
• Pricing issues and barriers to innovation strongly affect
  the European industry
• The EU needs to find a way to support translational
  research for market failure pharmaceutical gaps
20
        Regulatory Conclusions

• Common view as to how regulatory obstacles
  serve as a barrier to innovation
• Different solutions proposed by different
  stakeholders. All should be considered
• Striking lack of attention to Phase 4 activities.
  Vioxx and FDA hearings may change everything
• Strong interest in routine use of large (even
  complete) patient data bases
• A researchable topic!
21
         Priority Medicines
               Project
     For further questions, please contact:

               laingr@who.int
             wak22@comcast.net
               +41-22-791-4533

 http://mednet3.who.int/prioritymeds/report/index.htm

22

								
To top