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Highlights from ExL Pharma’s 2nd Annual Patient Assistance Programs

  1. 1. Highlights from ExLPharma’s 2nd Annual Patient Assistance Programs<br />January 25-26, 2010<br />Washington, D.C.<br />
  2. 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<br />September 27, 2010<br />
  3. 3. Manufacturer Patient Support Programs: Common Features<br />
  4. 4. Health Care Reform<br />?<br />
  5. 5. Health Care Reform: Common Themes<br />“Expand PHS 340B Pricing”<br />“Fill the Donut Hole”<br />“Universal Coverage”<br />“Public Option”<br />
  6. 6. 340B Expansion Implications<br />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<br />Manufacturers might review IPAPs for covered entities and overall PAP budgets<br />
  7. 7. Donut Hole Closure Implications<br />Proposed bills would establish minimum Part D rebates to “narrow” the donut hole<br />Assistance could be deferred under expenditure-based eligibility criteria of “outside-the-benefit” programs<br />Manufacturers may review overall PAP budgets<br />Potential shift to independent foundations?<br />
  8. 8. Expanded Coverage Implications<br />Proposed bills would expand insurance coverage<br />Existence of coverage as disqualifier for existing PAPs?<br />Subsidies as federal health care program trigger?<br />
  9. 9. “Public Option” Implications<br />House bill contained “public option” for insurance to compete with private plans<br />“Government option” plan as federal health care program?<br />
  10. 10. Assisting with a Growing Uninsured Population<br />
  11. 11. Top Changes to Manufacturer-Sponsored Patient Assistance Programs<br />Multi-pronged approach to address the needs of the underinsured <br />Addition of New Criteria for Assistance<br />Increased need for support services to help patients navigate new coverage options and address barriers to access<br />
  12. 12. Manufacturer sponsored “copay” assistance programs<br />Modify existing patient assistance programs<br />Donations to “copay” assistance charities<br />Multi-pronged approach to address the needs of the underinsured <br />
  13. 13. Limited to non-federally funded, some state exclusions apply<br />Product(s) specific offering<br />Provides financial assistance to patients with copay or deductible obligations<br />Allows for multiple options for assistance<br />Implement manufacturer sponsored “copay” assistance programs<br />Manufacturer Sponsored Copay Assistance Programs<br />Fastest growing segment in assistance programs<br />
  14. 14. How do manufacturers determine if their current assistance offerings are meeting existing needs<br />Conduct payer, geographic and product-specific analyses<br />Update program processes to better track and monitor data<br />Number or percent of underinsured patients requestingassistance<br /><ul><li>Insurance profiles
  15. 15. Financial hardship or affordability profiles (Affordability ~ income as it relates to insurance status and/or medical spend)</li></ul>Number or percent of underinsured patients qualifying for assistance<br /><ul><li>Reason for denial
  16. 16. Insurance profiles</li></ul>Number of denied patients requesting exceptions, reasons for request, outcomes <br />There will be an ongoing need to monitor patient “need and utilization” as the number of underinsured patients continues to rise <br />
  17. 17. Evaluate donations to “copay” assistance charities<br />Financial assistance with patient obligations such as copays, deductibles, or premiums (very limited)<br />Assistance can be made available from a variety of charities<br />Charity funding is based on disease-specific funds<br />Available to both federally funded and privately funded insured patients<br />Manufacturers can control the amount of funding they contribute<br />
  18. 18. Addition of New Criteria for Assistance<br />Informed by routine and ongoing surveillance, benchmarking, and analysis of key market influences<br />Guided by development of overall strategic PAP plan and governance approach<br />PAP criteria adjusted to reflect market changes and ensure appropriate assistance continues<br />
  19. 19. New Criteria for Assistance<br />Financial Criteria<br />Insurance Criteria<br />Residency Criteria<br /><ul><li>Hardship Conditions
  20. 20. Other adjustment factors
  21. 21. FPL adjustments
  22. 22. Medicare Part D
  23. 23. Other federally-funded
  24. 24. Privately Insured
  25. 25. Uninsured
  26. 26. Citizenship
  27. 27. Documentation requirements</li></li></ul><li>Increased need for support services to assist patients<br />Education and Awareness<br />Alternate coverage research and counseling<br />Case management and transition support for patients moving from PAP to newly available coverage<br />
  28. 28. Strategies for Industry PAPs to Provide Medications to an Escalating Number of Patients in Need<br />
  29. 29. Financing Options<br />20<br />Screen for existing benefits<br />Gain coverage under existing benefits<br />Petition for coverage via alternative benefit, if cost sharing is prohibitive<br />Work with employers to gain exceptions<br />Gain exceptions as needed<br />Counsel patients on alternatives<br />
  30. 30. What Access Programs Do<br />Open doors for vulnerable patients<br />Investigate patient benefits<br />Facilitate prior authorization<br />Assist with proactive re-certification <br />Appeal claims and prior authorizations<br />Identify alternative funding sources for patients<br />Counsel patients about benefits<br />Coverage limits<br />Costs<br />Access solutions<br />21<br />
  31. 31. Number of Uninsured People<br />22<br />Source: Congressional Budget Office Letter to Majority Leader Reid. page 22. 12/19/09<br />
  32. 32. Patient Assistance as Part of a Company’s Access Strategy <br />Offer assistance for patients with no insurance<br />Must meet eligibility requirements<br />Application by phone, fax, US mail, overnight delivery <br />Drug is either<br />shipped to physician to dispense to patient<br />accessed at pharmacy with a pharmacy card<br />mailed to patient<br />23<br />
  33. 33. The Underinsured: A Growing Segment<br />24<br />Uninsured<br />during year<br />45.5<br />(26%)<br />Insured, not<br />underinsured<br />102.3<br />(58%)<br />Uninsured<br />during year<br />49.5<br />(28%)<br />Insured, not<br />underinsured<br />110.9<br />(65%)<br />Underinsured<br />15.6<br />(9%)<br />Underinsured<br />25.2<br />(14%)<br />2007<br />Adults 19–64<br />(177.0 million)<br />2003<br />Adults 19–64<br />(172.0 million)<br />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.<br />
  34. 34. Types of Assistance for the Underinsured<br />Offer support for specific issues: <br />Lack of insurance<br />Premiums<br />Deductibles<br />High costs during the donut hole <br />Formulary limits <br />Coinsurance<br />Uncovered services or equipment <br />Challenges vary by:<br />Coverage and cost sharing <br />Payer mix<br />Disease area <br />Type of drug (oral or injectable)<br />Drug regimen<br />Degree of symptom relief<br />Side effects<br />Involvement by specialists<br />Network limits<br />25<br />
  35. 35. Ongoing Concerns<br />Corporate commitment to patient assistance at all-time high<br />Increased demand likely to continue <br />Extensive need to coordinate health care and health care financing <br />Lack of eligibility information <br />Time-consuming screening and enrollment<br />26<br />Need user-friendly experience, quality services, coordination of services and financing<br />
  36. 36. Evolving Program Characteristics<br />“Self-service”<br />Research by drug name, program or company<br />On-line screening tools<br />On-line applications<br />Patient outreach and follow up<br />Persistency and adherence support<br />Case management <br />Coordination of services<br />Coordination of financing sources<br />Distribution options – mail order, cards, etc. <br />27<br />
  37. 37. Emerging Operational Needs and Improvements <br />28<br /><ul><li>Cost-effective use of program resources
  38. 38. Online services
  39. 39. Turnaround time and quality
  40. 40. Customer feedback
  41. 41. Complex case management
  42. 42. Data collection and analysis
  43. 43. Understand program sponsors and participants
  44. 44. Inform ongoing program management
  45. 45. Analyze and potentially alter services provided</li></li></ul><li>Components of Health Reform Package Likely to Affect Patient Assistance Programs<br />Expansion of Medicaid<br />Health Insurance Exchange<br />Health Insurance Exchange Navigator<br />Employer mandate<br />Defined benefits for plans in Health Insurance Exchange<br />Likely to:<br />Reduce the number of uninsured<br />Affect cost sharing responsibilities<br />Increase complexity of administering these programs<br />29<br />
  46. 46. Establishment of Health Insurance Exchange Navigators <br />Fund Health Insurance Exchange Navigators to:<br />Conduct public education activities to raise awareness of the availability of health plans<br />Distribute information concerning enrollment in plans, and the availability of premium tax credits<br />Facilitate enrollment in health plans<br />Provide referrals to any applicable office of health insurance consumer assistance or ombudsman<br />30<br />Effect on PAPs: <br /><ul><li> May allow programs single point of contact for coordination of care with exchange plans
  47. 47. Expected to facilitate simplified enrollment in qualified health plans</li></li></ul><li>Pharmaceutical Pricing Scrutiny<br />Pending legislation<br />HHS to negotiate Part D prices <br />Allow re-importation<br />Fund comparative effectiveness research<br />31<br />Prompting companies to<br /><ul><li> Focus on comparative effectiveness research
  48. 48. Seek ways to reduce cost of patient assistance programs</li></li></ul><li>32<br />Screen for existing benefits<br />Gain coverage under existing benefits<br />Petition for coverage via alternative benefit, if cost sharing is prohibitive<br />Work with employers to gain exceptions<br />Gain exceptions as needed<br />Counsel patients on alternatives<br />Offering Alternative Financing Options<br />Refer patient to Health Insurance Exchange Navigator<br />Coordinate case management with federal and/or state Health Insurance Exchange representatives <br />Counsel patients on alternatives<br />
  49. 49. Still have any questions? For additional information on ExLPharma’s Patient Assistance Programs, please visit<br />