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)