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The New Decade Of Healthcare:   Can We  Evolve Post-Market Platforms To Inform Coverage Decisions? FDA CMS SUMMIT • Washington, DC • December 9, 2010 Nathan White, CPC Executive Director, Reimbursement Strategy inVentiv Health
The pharmaceutical industry is embarking on a perilous journey, bracing itself for the perfect storm The inefficiencies of managing  vendor and consultant relationships The complexities of proving  value to payers  The uncertainties of healthcare reform What does the perfect storm look like
Medicare and Medicaid expansion Comparative Effectiveness Research Increasing premiums and cost sharing Insurance exchanges Access to affordable coverage Premium subsidies Doughnut hole rebates Safety Outcomes Quality
Patient Protection and Affordable Care Act Uncertainties with new Congress Future legislative changes  Expansion of coverage Cost Containment Quality and outcomes
The Value Equation:  Safety + Efficacy + Comparative Cost/Clinical Effectiveness Who’s Responsibility Is It? Industry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Let’s focus on the Patient…  Patient Reported Outcomes (PRO) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
PRO Tools & Instruments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Federal Initiatives Using PRO SOURCES:  www.nihpromis.org ;  http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/   PROMIS®: Patient Reported Outcomes Measurement System NIH-funded development of PRO tools through primary research sites & coordinating centers AHRQ DEcIDE Network Group of Principal Investigators, working through 13 Research Centers, conducts studies on outcomes, effectiveness, safety and usefulness of medical treatments
MANUFACTURER Exchange of Dialogue GOVERNMENT AFFAIRS MANAGED MARKETS BRAND Patient Focused Initiatives May Be Generating Data Valuable To Payers…   ? Exchange of Dialogue PAYER CMS FDA STRATEGIES STRATEGIES STRATEGIES MANUFACTURER PATIENT PROVIDER ,[object Object],[object Object],[object Object],… But  HOW   or  IS  it being used by decision makers?
Registries/REMS Programs TOMORROW? TODAY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reimbursement (RB) / Free Drug (PAP) Programs TOMORROW? TODAY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Adherence Programs (opt-out and specialty pharmacy) TOMORROW? TODAY ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Data Elements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],SOURCES:  www.nihpromis.org ;  http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/
Sample High Touch Adherence Program ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Specialty Pharmacy MS Adherence Rates Simplified Calculation:  Medication Possession Ration modified (MPR) = Days’ Supply : Days in Period 1,2 ,[object Object],[object Object],[object Object],54% 85% 96.7% Nat’l Avg. MS Adherence Rates Specialty Pharmacy
Final Thoughts… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
To schedule a complimentary on-site consultation with the embarx BridgeTeam,  contact : Nathan White, CPC (703) 662-1851 [email_address]

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Fda Cms Summit Panel Preso In Ventiv

  • 1. The New Decade Of Healthcare: Can We Evolve Post-Market Platforms To Inform Coverage Decisions? FDA CMS SUMMIT • Washington, DC • December 9, 2010 Nathan White, CPC Executive Director, Reimbursement Strategy inVentiv Health
  • 2. The pharmaceutical industry is embarking on a perilous journey, bracing itself for the perfect storm The inefficiencies of managing vendor and consultant relationships The complexities of proving value to payers The uncertainties of healthcare reform What does the perfect storm look like
  • 3. Medicare and Medicaid expansion Comparative Effectiveness Research Increasing premiums and cost sharing Insurance exchanges Access to affordable coverage Premium subsidies Doughnut hole rebates Safety Outcomes Quality
  • 4. Patient Protection and Affordable Care Act Uncertainties with new Congress Future legislative changes Expansion of coverage Cost Containment Quality and outcomes
  • 5.
  • 6.
  • 7.
  • 8. Federal Initiatives Using PRO SOURCES: www.nihpromis.org ; http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/ PROMIS®: Patient Reported Outcomes Measurement System NIH-funded development of PRO tools through primary research sites & coordinating centers AHRQ DEcIDE Network Group of Principal Investigators, working through 13 Research Centers, conducts studies on outcomes, effectiveness, safety and usefulness of medical treatments
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.  
  • 18. To schedule a complimentary on-site consultation with the embarx BridgeTeam, contact : Nathan White, CPC (703) 662-1851 [email_address]

Notes de l'éditeur

  1. Strattera ® (atomoxetine HCl) is indicated for the treatment of attention-deficit/hyperactivity disorder in children aged 6 and older, adolescents, and adults. See Important Safety Information, including Boxed Warning, and full Prescribing Information for Strattera, available during this presentation. For Internal Use Only. Not for Use in Detailing. Optimizing ADHD Treatment With Strattera ® “Are we there yet?”
  2. Strattera ® (atomoxetine HCl) is indicated for the treatment of attention-deficit/hyperactivity disorder in children aged 6 and older, adolescents, and adults. See Important Safety Information, including Boxed Warning, and full Prescribing Information for Strattera, available during this presentation. For Internal Use Only. Not for Use in Detailing. Optimizing ADHD Treatment With Strattera ® “Are we there yet?”