CBI Patient Assistance and Access Program Conference

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  • inVentiv Health, Inc. is a leading, global provider of results-driven clinical, consulting and commercial services to the biopharmaceutical and healthcare industries
  • inVentiv Health's client roster consists of more than 350 leading pharmaceutical, biotech, and life sciences companies. 
  • inVentiv Health's client roster consists of more than 350 leading pharmaceutical, biotech, and life sciences companies. 
  • inVentiv Health welcomes Campbell Alliance, a leader in global management consulting, to the inVentiv Health family.  
  • inVentiv Health also expects to welcome i3 Research, a global contract research organization, in mid-2011. 
  • InVentiv Health is also proud to announce the launch of inVentiv Patient Access Solutions, a customizable suite of integrated patient-centric access and reimbursement solutions
  • powered by the best minds from inVentiv Health’s Clinical, Consulting, and Commercial divisions. 
  • The heart of Patient Access Solutions, formerly known as The Franklin Group, is a leader in the design and management of customized reimbursement and patient assistance contact center programs.    While our award-winning contact center takes over two million calls and manages hundreds of thousands of reimbursement cases each year, we treat each patient and provider as if they were our only priority. 
  • The end goal of Patient Access Solutions is to provide a faster and more streamlined experience for patients and providers while collecting and analyzing useful data to power our client’s brand value propositions.
  • CBI Patient Assistance and Access Program Conference

    1. 1. Connect. Engage. Simplify. with inVentiv Patient Access SolutionsThe New Decade Of Healthcare: Enhancing Commercial Tools For Better ValueNathan White, CPC, Executive Director, Access and Reimbursement12th Annual Patient Assistance & Access Programs • Baltimore, MD • March 1-2, 2011
    2. 2. Connect. Engage. Simplify.with inVentiv Patient Access Solutions
    3. 3. A global provider of results-driven Clinical, Consulting and Commercialservices to the biopharmaceutical and healthcare industries
    4. 4. Client Roster 350 Leading pharmaceutical, biotech, and life sciences companies. A global provider of results-driven Clinical, Consulting and Commercialservices to the biopharmaceutical and healthcare industries
    5. 5. Client Roster 350Leading pharmaceutical, biotech, and life sciences companies.
    6. 6. A leader in global management consulting Client Roster  Brand Management Consulting 350  Business Development Consulting  Managed Markets ConsultingLeading pharmaceutical, biotech,  Trade and Distribution Consulting and life sciences companies.  Clinical Development Consulting  Medical Affairs Consulting  Sales Force Effectiveness  Market Research  Education and Training
    7. 7. A global contract research organization Clinical Trial Outsourcing Clinical Staffing Data Management Biostatistics Medical Writing and Scientific Communications Investigator Recruitment Patient Recruitment REMS Consulting and Planning
    8. 8. inVentiv Patient Access Solutions:A leading provider of a customizable patient-centric solutions Access and Education Programs Strategic Consulting (REMS, Reimbursement, Managed Markets and Health Policy) Integrated, Field-Based Clinical and Reimbursement Support Integrated Payer Communications
    9. 9. Powered by the best minds from inVentiv Health’s Clinical,Consulting and Commercial divisions.COMMERCIAL CLINICAL CONSULTING
    10. 10. The heartof inVentiv PatientAccess Solutions:guiding providersand patientsthrough the difficultprocess of securingcoverage for therapiesthat keep patients well.
    11. 11. We developstrategies thatresonate withpayers and, bydoing so, buildmarket sharefor your brand.
    12. 12. Connect. Engage. Simplify.with inVentiv Patient Access Solutions
    13. 13. The pharmaceutical industry is embarking on a perilous journey,bracing itself for the perfect storm What does the perfect storm look like The uncertainties of healthcare reform The complexities of proving value to payers The inefficiencies of managing vendor and consultant relationships
    14. 14. Increasing premiums and cost sharingMedicare and Medicaid expansion Comparative Effectiveness ResearchAccess to affordable coverage Safety Doughnut hole rebates Outcomes Quality Premium subsidies Insurance exchanges
    15. 15. Patient Protection and Affordable Care Act Uncertainties with new Congress Future legislative changes Expansion of coverage Cost Containment Quality and outcomes
    16. 16. The Value Equation:Safety + Efficacy + Comparative Cost/Clinical Effectiveness Industry AHRQ NIH PCORI Payers Patients and providers (CMS & Private) Who’s Responsibility Is It?
    17. 17. Patient Centered Outcomes Research Institute Patient Centered Outcomes Research Institute − Non-profit corporation − Not “an agency or establishment of the federal government” Assists in making informed healthcare decisions − Comparative clinical effectiveness research − Health outcomes, clinical effectiveness, and appropriateness of treatment Governed by stakeholders in AHRQ and NIH in addition to other healthcare leaders (appointed in late 2010) Methodology Committee appointed in Jan. 2010
    18. 18. SOURCES:National Pharmaceutical Council, PCORI Methodology Committee: Resource Guide, February 2011
    19. 19. Patient Centered Outcomes Research Institute Administer funds for research from: − Trust (PCORTF) − Private insurance − Appropriations and other federal Trust Funds Who can participate in PCORTF funded research? − NIH − AHRQ − Hospitals and other institutions − Commercial organizations (CRO’s) − Pharmaceutical companies Identify “national priorities” for research (similar to IOM’s priority list released Summer 2009)
    20. 20. Let’s focus on the Patient… Patient Reported Outcomes (PRO) Helps to develop evidence of effectiveness outside an artificial controlled environment (RCT) “Self-reports” by a patient Data collected through self-administered questionnaires or interviews (ex. EQ-5D or SF-36) − Generic − Disease specific Attempts to assess: − Impairments to well-being − Disabilities − Health perceptions − Quality of Life (QoL) − Other healthcare ratings
    21. 21. Federal Initiatives Using PRO AHRQ DEcIDE Network Group of Principal Investigators, working through 13 Research Centers, conducts studies on outcomes, effectiveness, safety and usefulness of medical treatments PROMIS®: Patient Reported Outcomes Measurement System NIH-funded development of PRO tools through primary research sites & coordinating centersSOURCES:www.nihpromis.org;http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/
    22. 22. Patient Focused Initiatives May Be Generating Data Valuable To Payers… • Registries/REMS • Reimbursement/Patient Assistance • Adherence MANUFACTURER PAYER STRATEGIES BRAND ? Exchange of Dialogue PROVIDER MANAGED CMS STRATEGIES MARKETS Exchange of Dialogue PATIENT FDA STRATEGIES GOVERNMENT AFFAIRS MANUFACTURER …But HOW or IS it being used by decision makers?
    23. 23. Patient Access Programs TODAY TOMORROW?  Focused on helping patients  Managed markets data could with reimbursement access be used to better guide NAM barriers (RB) and assisting the tactics underinsured  Could this program type be  Used primarily as marketing integrated into a Phase IV study initiative to reduce sponsor cost?  Captures some data which  CHALLENGE: How do we get could be valuable to managed all the stakeholders markets and brand teams (vendor, brand teams, managed markets, etc) to share the same  Typically doesn’t capture PRO vision?
    24. 24. Patient Assistance Programs TODAY TOMORROW?  Focused on assisting the  PAPs could begin to collect uninsured (PAP) adherence/compliance data (especially IPAPs)  Used primarily as corporate awareness to the public  What confounding factors would inhibit such an evolution  Captures some data which (ex. IRS, study population bias)? could be valuable to managed markets teams  Would patient advocates object to muddying the waters of  Typically doesn’t capture PRO a free drug program?
    25. 25. Adherence Programs TODAY TOMORROW?  Focused on changing patient  Would patients be willing to behavior and improving patient respond to PRO questionnaires health outcomes in an opt-out program?  Opt-out programs typically  How can manufacturers administered through 3rd party partner with payers and and use claims data to manufacturers to utilize PRO intelligently message patients more effectively?  High touch programs use a clinical case management approach
    26. 26. Registries/REMS Programs TODAY TOMORROW?  Historically, registries were  Does patient education have marketing tools but have evolved an impact on outcomes? (ad-hoc -> RiskMAP -> REMS)  Could measurements of  Most focused on safety in the effectiveness of patient education confines of REMS be useful to payers?  Results of ETASU, MedGuides  Could PRO instruments could and HCP Communications used be adapted to measure principally by FDA effectiveness of education?  2010 Kaiser Permanente study found registries play an important  Genzyme’s Gaucher Registry role in CER is model for the future
    27. 27. Thoughts from REMS Expert Jeff Fetterman…  REMS enables management of risks that otherwise would prevent commercialization of products that could help specific patient populations − Thalidomide (leprosy and certain malignancies) − Clozapine for psychoses  REMS creates interesting challenges for payers and managed markets − Possibly interferes with the care management process of the integrated health system model − Increases complexity and burden of pharmaceutical care  REMS offers intriguing opportunities for payers and managed markets − Reducing total cost of care by improving outcomes and costly adverse events − Possibly could reduce the need for payer medication management and control when access is carefully integrated with REMSJeff Fetterman is President, ParagonRx, an inVentiv Health companyParagonRx is a recognized leader in REMS consulting, design and implementation.
    28. 28. Final Thoughts… Commercial programs have an enormous potential to be integrated with evidence based medicine demonstration initiatives, both private and public − Elise Berliner, Director of Technology Assessment Program at AHRQ says that AHRQ is looking for more innovative and external partnerships to do comparative effectiveness research (manufacturers, institutions, CRO’s) Adherence and Access programs with multiple messaging mediums are key to an intelligent PRO collection strategy Payers (federal, state and private) will need to weigh in on how PRO data will be integrated into their coverage decision making practices Strategic, long-term partnerships amongst manufacturers, payers, facilities/systems, vendors, and federal agencies are critical to the success of healthcare reform
    29. 29. THANK YOU FROM INVENTIV PATIENT ACCESS SOLUTIONS!Contact:Nathan Whitenwhite@inventivhealth.com

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