The document summarizes key topics from ExLPharma's annual patient assistance programs conference, including implications of US health care reform proposals. Proposed reforms around expanding Medicaid eligibility, establishing health insurance exchanges, and closing the Medicare Part D "donut hole" could impact existing industry patient assistance programs by reducing the uninsured population and affecting cost-sharing responsibilities. Manufacturers may need to modify programs, increase support services to help patients navigate new coverage options, and coordinate more with public health programs and exchange navigators. The growing underinsured population also presents ongoing challenges requiring innovative program characteristics and operational improvements.

1. Highlights from ExLPharma’s 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

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

20. Other adjustment factors

21. FPL adjustments

22. Medicare Part D

23. Other federally-funded

24. Privately Insured

25. Uninsured

26. Citizenship

28. Strategies for Industry PAPs to Provide Medications to an Escalating Number of Patients in Need

29. Financing Options 20 Screen for existing benefits Gain coverage under existing benefits Petition for coverage via alternative benefit, if cost sharing is prohibitive Work with employers to gain exceptions Gain exceptions as needed Counsel patients on alternatives

30. What Access Programs Do Open doors for vulnerable patients Investigate patient benefits Facilitate prior authorization Assist with proactive re-certification Appeal claims and prior authorizations Identify alternative funding sources for patients Counsel patients about benefits Coverage limits Costs Access solutions 21

31. Number of Uninsured People 22 Source: Congressional Budget Office Letter to Majority Leader Reid. page 22. 12/19/09 http://www.cbo.gov/ftpdocs/108xx/doc10868/12-19-Reid_Letter_Managers_Correction_Noted.pdf

32. Patient Assistance as Part of a Company’s Access Strategy Offer assistance for patients with no insurance Must meet eligibility requirements Application by phone, fax, US mail, overnight delivery Drug is either shipped to physician to dispense to patient accessed at pharmacy with a pharmacy card mailed to patient 23

33. The Underinsured: A Growing Segment 24 Uninsured during year 45.5 (26%) Insured, not underinsured 102.3 (58%) Uninsured during year 49.5 (28%) Insured, not underinsured 110.9 (65%) Underinsured 15.6 (9%) Underinsured 25.2 (14%) 2007 Adults 19–64 (177.0 million) 2003 Adults 19–64 (172.0 million) Source: C. Schoen, S. Collins, J. Kriss, M. Doty, How Many are Underinsured? Trends Among U.S. Adults, 2003 and 2007, Health Affairs Web Exclusive, June 10, 2008. Data: 2003 and 2007 Commonwealth Fund Biennial Health Insurance Surveys.

34. Types of Assistance for the Underinsured Offer support for specific issues: Lack of insurance Premiums Deductibles High costs during the donut hole Formulary limits Coinsurance Uncovered services or equipment Challenges vary by: Coverage and cost sharing Payer mix Disease area Type of drug (oral or injectable) Drug regimen Degree of symptom relief Side effects Involvement by specialists Network limits 25

35. Ongoing Concerns Corporate commitment to patient assistance at all-time high Increased demand likely to continue Extensive need to coordinate health care and health care financing Lack of eligibility information Time-consuming screening and enrollment 26 Need user-friendly experience, quality services, coordination of services and financing

36. Evolving Program Characteristics “Self-service” Research by drug name, program or company On-line screening tools On-line applications Patient outreach and follow up Persistency and adherence support Case management Coordination of services Coordination of financing sources Distribution options – mail order, cards, etc. 27

38. Online services

39. Turnaround time and quality

40. Customer feedback

41. Complex case management

42. Data collection and analysis

43. Understand program sponsors and participants

44. Inform ongoing program management

49. Still have any questions? For additional information on ExLPharma’s Patient Assistance Programs, please visit www.exlpharma.com