1. Highlights from ExLPharmas 2nd Annual Patient Assistance Programs
January 25-26, 2010
Washington, D.C.

2. Health Care Reform and Compliance Considerations:Assessing the Current Regulatory Landscape and Impact of Proposed Legislative Changes on Industry PAPs and Co-Pay Assistance Foundations
September 27, 2010
3. Manufacturer Patient Support Programs:Common Features
4. Health Care Reform
?
5. Health Care Reform: Common Themes
Expand PHS 340B Pricing
Fill the Donut Hole
Universal Coverage
Public Option
6. 340B Expansion Implications
Proposed bills would expand categories of safety net providers eligible for 340B pricing, and would likely lower PHS prices due to Medicaid rebate formula changes
Manufacturers might review IPAPs for covered entities and overall PAP budgets
7. Donut Hole Closure Implications
Proposed bills would establish minimum Part D rebates to narrow the donut hole
Assistance could be deferred under expenditure-based eligibility criteria of outside-the-benefit programs
Manufacturers may review overall PAP budgets
Potential shift to independent foundations?
8. Expanded Coverage Implications
Proposed bills would expand insurance coverage
Existence of coverage as disqualifier for existing PAPs?
Subsidies as federal health care program trigger?
9. Public Option Implications
House bill contained public option for insurance to compete with private plans
Government option plan as federal health care program?
10. Assisting with a Growing Uninsured Population
11. Top Changes to Manufacturer-Sponsored Patient Assistance Programs
Multi-pronged approach to address the needs of the underinsured
Addition of New Criteria for Assistance
Increased need for support services to help patients navigate new coverage options and address barriers to access
12. Manufacturer sponsored copay assistance programs
Modify existing patient assistance programs
Donations to copay assistance charities
Multi-pronged approach to address the needs of the underinsured
13. Limited to non-federally funded, some state exclusions apply
Product(s) specific offering
Provides financial assistance to patients with copay or deductible obligations
Allows for multiple options for assistance
Implement manufacturer sponsored copay assistance programs
Manufacturer Sponsored Copay Assistance Programs
Fastest growing segment in assistance programs
14. How do manufacturers determine if their current assistance offerings are meeting existing needs
Conduct payer, geographic and product-specific analyses
Update program processes to better track and monitor data
Number or percent of underinsured patients requestingassistance

Insurance profiles

15. Financial hardship or affordability profiles (Affordability ~ income as it relates to insurance status and/or medical spend)Number or percent of underinsured patients qualifying for assistance

Reason for denial

16. Insurance profilesNumber of denied patients requesting exceptions, reasons for request, outcomes
There will be an ongoing need to monitor patient need and utilization as the number of underinsured patients continues to rise
17. Evaluate donations to copay assistance charities
Financial assistance with patient obligations such as copays, deductibles, or premiums (very limited)
Assistance can be made available from a variety of charities
Charity funding is based on disease-specific funds
Available to both federally funded and privately funded insured patients
Manufacturers can control the amount of funding they contribute
18. Addition of New Criteria for Assistance
Informed by routine and ongoing surveillance, benchmarking, and analysis of key market influences
Guided by development of overall strategic PAP plan and governance approach
PAP criteria adjusted to reflect market changes and ensure appropriate assistance continues
19. New Criteria for Assistance
Financial Criteria
Insurance Criteria
Residency Criteria

Hardship Conditions

20. Other adjustment factors 21. FPL adjustments 22. Medicare Part D 23. Other federally-funded 24. Privately Insured 25. Uninsured 26. Citizenship 27. Documentation requirements