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340 b coalition presentation

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  • 1. Today’s PAP• Great PR tool for brand teams and corporate image• For individual PAPs: • Basic application and dispense model • Perceived by some advocates and patients as cumbersome• Frequently does not research coverage through other means• Does not collect many valuable data elements related to PRO and value• Provide free product but at the expense of the manufacturer• More patients eligible to enroll today than in a few years with coverage mandates
  • 2. PAP of the Future• New premium data collection vehicle (evidence development platform) • Creates internal value as well as externally to public • Patient base for late phase outcomes studies• Manufacturer is payer of last resort• Higher touch service model with compliance/persistency built in• Other services include: • assisting underinsured with co-pay and premium • selecting an insurance plan• Web enabled and secure information portal connecting patients, HCPs, pharma, vendors and nonprofits• Manufacturers expanding facility types for IPAP
  • 3. Outcomes Data: Why is it relevant?• Risk sharing agreements require ongoing outcomes data collection• Billions of dollars in federal funding over next 10 years available for comparative clinical effectiveness research through PPACA • Government/quasi-government (AHRQ, NIH, PCORI) • Private (investigator consortiums, pharma, academia, institutions)• PRO (patient reported outcomes) are becoming an increasingly valuable part of Phase III/IV studies • QoL (quality of life) • Functionality • Symptoms and impairment• Private payers increasingly basing coverage decisions on results from outcomes studies
  • 4. Federal Involvement• 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 the Directors of AHRQ and NIH in addition to other healthcare leaders• Will be at the center of outcomes research in the years to come
  • 5. What will PCORI do?• Administer funds for research from: • Trust (PCORTF) • Private insurance • Appropriations and other federal Trust Funds• Who can participate in PCORTF studies? • NIH • AHRQ • Hospitals and other institutions • Commercial organizations (CRO’s)• Identify “national priorities” for research (similar to IOM’s priority list released last summer)
  • 6. Why is this Institute important?• Administration of billions of $ in federal research contracts over the next decade• New revenue source for hospitals• Existing study population in PAPs/IPAPs patients to conduct research
  • 7. What next?• Engage in partnership conversations with: • Contract research organizations • PAP/IPAP vendors • Hospitals and IPAP facilities• Retain consultants who understand federal contracting requirements• Begin to involve your research departments (especially staff health economists)

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