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					Comparative Effectiveness Research and
       Personalized Medicine:
   Policy, Science, and Business
   Policy Considerations: CER & Industry Structure

                   October 28, 2009




                                      Comparative Effectiveness Research and Personalized Medicine:
                                                                    Policy, Science, and Business
                                                                                  October 28. 2009
Garden of Earthly Delights

                                     Complicated Landscape
          FDA      NIH
 MCOs &                  CMS/VA     •Who conducts CER research is
ACADEME                             arguably as important in the long-
                                    run as what government does with
                                    the results .
                                    •Structural significance equal to
            AHRQ
                                    the establishment of the RCT as
                                    the basis for the drug industry in
                                    the 1962 Kefauver Amendments.



                                    Anticipating PM language in the
                                    Patient-Centered Outcomes
                                    Research Act: “groups of
                                    individuals with
                                    different…quality of life
                                    preferences.”



                                  Comparative Effectiveness Research and Personalized Medicine:
                         2                                      Policy, Science, and Business
                                                                                October 28. 2009
Lucrative Landscape

        Big Government                                    Big Business

• ARRA Stimulus Funding                         • Ingenix (UnitedHealth)
   – ARHQ $300                                     – $1.8 billion dollar business
       • Four times the funding for the                • Up 26% in most recent quarter
         agency in the FY 05-07                        • UnitedHealth’s highest margin
   – NIH $400 million                                    business, 13.3% operating profit
       • Compared to $120 million for                  • More than 50 companies
         ALLHAT                                          purchased in past 10 years –
                                                         including Lewin Group
   – HHS Secretary $400 million                    – UHC “provides Ingenix and i3
                                                     access to one of the world’s
• Land-rush to get in:                               largest patient databases…. “
   – VA makes pitch:
       • “Largest research program
         embedded in an integrated health
                                                • United Biosource
         care system in the U.S., and                  • $125 million investment Oct. 8 for:
         possibly the world….”                           20% of six-year-old company
       • “VA Research benefits from an                 • “Continuous stream of evidence of
         unmatched electronic record….”                  product safety, economic value
                                                         and medical effectiveness in the
       • Running ALLHAT follow                           peri- and post-approval
                                                         environment.”

                                                       Comparative Effectiveness Research and Personalized Medicine:
                                            3                                        Policy, Science, and Business
                                                                                                     October 28. 2009
 CER/PM Growing in Shadow of FDA/REMS

                                                              Few Patients,
                                                              Tight Control
                 Patient-specific-monitoring, lab                                     Post-market controls
                         tests, registries                                            set by pre-market
                                                        PM
                                                                                      decisions
           Specialties, limited pharmacies,
                    hospitals only                  Safe Access                       FDA advisory
                                                                                      committees are
     MedGuides, Follow-up messages                                                    already asking for
                                                Enhanced
          for docs, DTC rules
                                              Communications
                                                                                      more specific
                                                                                      information on sub-
Timelines for re-review; Safety                                                       populations
      labeling authority
                                          Labeling & Assessment


                                              Mandatory Trials



                                                      More Patients,
                                                      Less Control
                                                                         Comparative Effectiveness Research and Personalized Medicine:
                                                          4                                            Policy, Science, and Business
                                                                                                                       October 28. 2009
Tried and True Marketing Tools

   Goals of Dissemination                    FDA Precedents

• IOM recommends more                 • A speaker’s bureau for
  effective use of                      Xenazine to include local
  communication and                     and national thought
  marketing principles                  leaders.
• Baucus-Conrad:                      • A slide deck for MSLs for
  “disseminate the findings of          Cimzia
  research to clinicians,             • Registry of prescribing
  patients, and the public in a         doctors and signed
  comprehensible manner                 certificates for Sabril
  and form”                           • Mandatory detailing to five
                                        specialty groups for Effient.

                                             Comparative Effectiveness Research and Personalized Medicine:
                                  5                                        Policy, Science, and Business
                                                                                           October 28. 2009
Takeaways

• CER rules will change the way drugs and other
  treatments are studied and accepted by the medical
  community and public
• Inflow of money is already building a new
  database/observational infrastructure
• FDA and industry may be taking care of a significant
  part of the dissemination challenge through REMS
  programs

•   Great opportunity – Don’t Bosch It.


                                   Comparative Effectiveness Research and Personalized Medicine:
                           6                                     Policy, Science, and Business
                                                                                 October 28. 2009

				
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