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Fda Cms Summit Panel Preso In Ventiv


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Presented at the FDA CMS Summit in Washington, Dec 2010

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Fda Cms Summit Panel Preso In Ventiv

  1. 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. 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. 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. 4. Patient Protection and Affordable Care Act Uncertainties with new Congress Future legislative changes Expansion of coverage Cost Containment Quality and outcomes
  5. 5. The Value Equation: Safety + Efficacy + Comparative Cost/Clinical Effectiveness Who’s Responsibility Is It? Industry <ul><ul><li>AHRQ </li></ul></ul><ul><ul><li>NIH </li></ul></ul><ul><ul><li>Patients and providers </li></ul></ul><ul><ul><li>Payers </li></ul></ul><ul><ul><li>(CMS & Private) </li></ul></ul><ul><ul><li>PCORI </li></ul></ul>
  6. 6. Let’s focus on the Patient… Patient Reported Outcomes (PRO) <ul><li>Helps to develop evidence of effectiveness outside an artificial controlled environment (RCT) </li></ul><ul><li>“ Self-reports” by a patient </li></ul><ul><li>Data collected through self-administered questionnaires or interviews </li></ul><ul><ul><li>Generic </li></ul></ul><ul><ul><li>Disease specific </li></ul></ul><ul><li>Attempts to assess: </li></ul><ul><ul><li>Impairments to well-being </li></ul></ul><ul><ul><li>Disabilities </li></ul></ul><ul><ul><li>Health perceptions </li></ul></ul><ul><ul><li>Quality of Life (QoL) </li></ul></ul><ul><ul><li>Other healthcare ratings </li></ul></ul>
  7. 7. PRO Tools & Instruments <ul><li>SF-36 Health Survey </li></ul><ul><li>SF-12 Health Survey </li></ul><ul><li>Sickness Impact Profile </li></ul><ul><li>EQ-5D (EuroQol) </li></ul><ul><li>Other disease specific tools: </li></ul><ul><ul><li>Adult Asthma Quality of Life Questionnaire </li></ul></ul><ul><ul><li>National Eye Institute Visual Functioning Questionnaire </li></ul></ul><ul><ul><li>Seattle Angina Questionnaire </li></ul></ul>
  8. 8. Federal Initiatives Using PRO SOURCES: ; 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. 9. 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 <ul><li>Registries/REMS </li></ul><ul><li>Reimbursement/Patient Assistance </li></ul><ul><li>Adherence </li></ul>… But HOW or IS it being used by decision makers?
  10. 10. Registries/REMS Programs TOMORROW? TODAY <ul><li>Historically, registries were marketing tools but have evolved </li></ul><ul><li>Most focused on safety in the confines of REMS </li></ul><ul><li>Results of ETASU & patient education effectiveness used principally by FDA </li></ul><ul><li>2010 Kaiser Permanente study found registries play an important role in CER </li></ul><ul><li>Does patient education have an impact on outcomes? </li></ul><ul><li>Could measurements of effectiveness of patient education be useful to payers? </li></ul><ul><li>Could PRO instruments could be adapted to measure effectiveness of education? </li></ul><ul><li>Genzyme’s Gaucher Registry is model for the future </li></ul>
  11. 11. Reimbursement (RB) / Free Drug (PAP) Programs TOMORROW? TODAY <ul><li>Focused on helping patients with reimbursement access barriers (RB) and assisting the uninsured (PAP) </li></ul><ul><li>Used primarily as marketing tools to encourage prescribing </li></ul><ul><li>Captures some data which could be valuable to managed markets teams </li></ul><ul><li>Typically doesn’t capture PRO </li></ul><ul><li>How could a PAP be evolved to collect PRO data? </li></ul><ul><li>What confounding factors would inhibit such an evolution? </li></ul><ul><li>Would patient advocates object to muddying the waters of a free drug program? </li></ul><ul><li>Could a RB/PAP be incorporated into a Phase IV study to reduce sponsor cost? </li></ul>
  12. 12. Adherence Programs (opt-out and specialty pharmacy) TOMORROW? TODAY <ul><li>Focused on generating additional revenues (opt-out) and improving patient health outcomes (specialty pharmacy) </li></ul><ul><li>Opt-out programs typically administered through 3 rd party and use claims data to intelligently message patients </li></ul><ul><li>Specialty pharmacy programs use a high touch, case management approach </li></ul><ul><li>Would patients be willing to respond to PRO questionnaires in an opt-out program? </li></ul><ul><li>How can specialty pharmacies partner with payers and manufacturers to utilize PRO more effectively? </li></ul>
  13. 13. Clinical Data Elements <ul><li>Disease Severity </li></ul><ul><ul><li>Rheumatoid Arthritis: Health Assessment Questionnaire (HAQ-II) </li></ul></ul><ul><ul><li>Crohn’s Disease: Harvey Bradshaw Index (HBI) </li></ul></ul><ul><ul><li>Psoriasis: % Body Surface Area (BSA) & Psoriasis Quality of Life (PQOL) </li></ul></ul><ul><ul><li>HIV/MD/Hepatitis C: Patient Health Questionnaire (PHQ 2 & 9) </li></ul></ul><ul><ul><li>Hepatitis C: Sustained virologic response (SVR) and Genotype </li></ul></ul><ul><li>Adherence & Persistency Data </li></ul><ul><ul><li>Medication Possession Ratios (MPR) </li></ul></ul><ul><ul><li>Daily Average Consumption </li></ul></ul><ul><ul><li>% Drop off at Certain Time in Therapy </li></ul></ul>SOURCES: ;
  14. 14. Sample High Touch Adherence Program <ul><li>Data points </li></ul><ul><ul><li>Prior therapies, length of prior therapies </li></ul></ul><ul><ul><li>PQOL-12, % body surface area </li></ul></ul><ul><ul><li>Reasons for discontinuation </li></ul></ul><ul><ul><li>Insurance type, Co-pay amount </li></ul></ul><ul><ul><li>Dosing changes </li></ul></ul><ul><ul><li>Prescriber specialty </li></ul></ul><ul><ul><li>% of second and third doses </li></ul></ul><ul><li>Benefits </li></ul><ul><ul><li>Used to identify trends in utilization </li></ul></ul><ul><ul><li>Used to develop strategies to develop or optimize business strategies </li></ul></ul><ul><ul><li>Plan to publish data </li></ul></ul><ul><ul><li>Plan to link data with satisfaction survey results </li></ul></ul>
  15. 15. Specialty Pharmacy MS Adherence Rates Simplified Calculation: Medication Possession Ration modified (MPR) = Days’ Supply : Days in Period 1,2 <ul><li>References  </li></ul><ul><li>Sclar DA, Chin A, Skaer TL, Okamato MP, Nakahiro RK, Gill MA. Effect of health education in promoting prescription refill compliance among patients with hypertension. Clin Ther. 1991;13:489-495 </li></ul><ul><li>Sclar DA, Skaer TL, Chin A, Okamoto MP, Gill MA. Utility of a transdermal delivery system for antihypertensive therapy. Part 2. Am J Med. 1991;91:57S-60S. </li></ul>54% 85% 96.7% Nat’l Avg. MS Adherence Rates Specialty Pharmacy
  16. 16. Final Thoughts… <ul><li>Free drug programs have a lot of potential to be integrated with evidence based medicine initiatives </li></ul><ul><li>Pharmacy-based opt-out adherence programs with multimedia (SMS/email/web) are key to an intelligent PRO collection strategy </li></ul><ul><li>More effective PRO instruments need to be developed </li></ul><ul><li>Payers (federal, state and private) will need to weigh in on how PRO data will be integrated into their coverage decision making practices </li></ul><ul><li>THE BIG QUESTION: Will practitioners alter clinical practices based on PRO/CER studies? </li></ul><ul><li>RECOMMENDATION! </li></ul><ul><li>Read the paper “Healthcare Reform’s Wild Card: The Uncertain Effectiveness of Comparative Effectiveness Research” by Richard Saver, Assoc. Professor of Law, UNC School of Law </li></ul>
  17. 18. To schedule a complimentary on-site consultation with the embarx BridgeTeam, contact : Nathan White, CPC (703) 662-1851 [email_address]