Alan R. Hinman, MD, MPH Chair, NVAC Workgroup on IOM Report October 6, 2004

1. IOM Report on Financing Vaccines in the 21st Century:National Vaccine Advisory Committee Follow-up Alan R. Hinman, MD, MPH Chair, NVAC Workgroup on IOM Report October 6, 2004

3. Charge to IOM Committee “Identify financial strategies designed to: • “Achieve an appropriate balance of roles & responsibilities in public & private health sectors • “Integrate federal & state roles in supporting the purchase & administration of recommended vaccines... • “Develop a framework for identifying pricing strategies that can contribute to achieving... national... goals for children & adults

4. Conclusions - 1 • “Current public and private financing strategies for immunization have had substantial success, especially in improving immunization rates for young children. However, significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations.”

5. Conclusions - 2 • “Substantial increases can be expected to occur in public and private health expenditures as new vaccine products become available. While these cost increases will be offset by the health and other social benefits associated with these advances in vaccine development, the growing costs of vaccines will be increasingly burdensome to all health sectors. Alternatives to current vaccine pricing and purchasing programs are required to sustain stable investment in the development of new vaccine products and attain their social benefits for all.”

6. Conclusions - 3 • “Many young children, adolescents, and high-risk adults have no or limited insurance for recommended vaccines. Gaps and fragmentation in insurance benefits create barriers for both vulnerable populations and clinicians that can contribute to lower immunization rates.”

7. Conclusions - 4 • “Current government strategies for purchasing and assuring access to recommended vaccines have not addressed the relationships between the financing of vaccine purchases and the stability of the US vaccine supply. Financial incentives are necessary to protect the existing supply of vaccine products, as well as to encourage the development of new vaccine products.”

8. Conclusions – 5 • “The vaccine recommendation process does not adequately incorporate consideration of a vaccine’s price and societal benefits.”

9. Twin goals of financing strategies • Assuring access to recommended vaccines • Sustaining the availability of vaccines in the future

10. Funding strategy goals • Eliminate individual financial barriers to immunization • Increase incentives to the industry to invest in R & D and production capacity • Reduce provider burden and improve provider compensation • Minimize fragmentation of financing and delivery • Maintain existing community and provider relationships • Control escalation of costs and increasing fiscal burden on state budgets

11. Seven alternative approaches - 1 • Maintain the current system • Expand the VFC program to include additional eligibility categories • Provide universal coverage through federal purchase and supply of all recommended vaccines • Provide a federal block grant to the states for vaccine purchase

12. Seven alternative approaches - 2 • Use public vouchers to purchase recommended vaccines for disadvantaged populations • Create an insurance mandate that would require public and private health plans to cover all recommended vaccines • Combine features of the insurance mandate and voucher alternatives into a new funded mandate system

13. Recommendations - 1 • “The committee recommends the implementation of a new insurance mandate, combined with a government subsidy, and voucher plan, for vaccines recommended by the Advisory Committee on Immunization Practices (ACIP).”

14. Recommendations - 2 • “The Secretary of the Department of Health and Human Services should propose changes in the procedures and members of ACIP so that its recommendations can associate vaccine coverage decisions with social benefits and costs, including consideration of the impact of the price of a vaccine on recommendations for its use.”

15. Recommendations – 3a • “As part of the implementation of recommendations 1 & 2, the National Vaccine Program Office should convene a series of stakeholder deliberations on the administrative, technical, and legislative issues associated with a shift from vaccine purchase to a vaccine mandate, subsidy, and voucher finance strategy. In addition, the Centers for Disease Control and Prevention (CDC) should sponsor a postimplementation evaluation study (in 5 years, for example).”

16. Recommendations – 3b • “CDC should also initiate a research program aimed at improving the measurement of the societal value of vaccines, addressing methodological challenges, and providing a basis for comparing the impact of different measurement approaches in achieving national immunization goals.”

17. Response to IOM report • New York Times and Wall Street Journal editorials • Briefing at American Enterprise Institute • Forum at National Partnership for Immunization • Pediatrics editorial comment • ACPM policy statement • NVAC stakeholder interviews • NVAC workgroup

18. Initial “environmental scan” of stakeholders • 30-60 minute telephone interviews conducted Sept. 25 – Oct. 3 • Interview team • Bruce Gellin, NVPO • Alan Hinman, NVAC • Nicole Smith, NIP/CDC • Interviews were informal, “not for attribution”

19. Stakeholders interviewed • Vaccine companies (6) • Federal government agencies (2) • Public Health Agency organizations (3) • Provider organizations (3) • Payers/insurers (1)

20. Interview summary - 1 • Commend IOM for • Highlighting value of vaccines • Highlighting need to vaccinate adults as well as children • Attempting to ensure access to vaccines by all children • Identifying factors contributing to instability in vaccine research, development, production, and supply

21. Interview summary - 2 • Skepticism that recommended approaches would provide needed incentives • Concern about dramatic shift to unproven new system • Concern about lack of detail on how the system would operate • Concern about cost of the new system

22. Interview summary - 3 • Questioned whether system was broken enough to require this fix • Felt that improvements in current system might go a long way: • Expanding VFC • Removing price caps • Giving providers choice • Regulatory harmonization • Encouraging expansion of plan benefits

23. NVAC Vaccine Financing Meeting - 1 • June 28-29, 2004, Washington DC • 61 participants • Perspectives: • Large manufacturers and biotech firms • Fed, state, local health departments • Distributors/purchasers • Health care providers • Consumers

24. NVAC Vaccine Financing Meeting - 2 Questions: • Pros and cons of options considered • Additional options that should be considered • Which option they support and why

25. Summary of June 28-29 meeting - 1 • Widespread agreement on: • Importance of vaccines and immunization • Exciting prospects for new vaccines • Vaccines are undervalued • Need to assure access by everyone • Need to assure providers are adequately reimbursed for giving vaccines • Need to markedly improve efforts to vaccinate adolescents and adults

26. Summary of June 28-29 meeting - 2 • Need for regulatory harmonization • Need to strengthen liability protection • Need for better understanding of insurance and health plan coverage • Need for better understanding of factors responsible for low immunization coverage in adolescents and adults

27. Summary of June 28-29 meeting - 3 • No one felt IOM proposal for mandate, subsidy, and voucher is practicable • Many did not feel it would solve current problems and might be counterproductive • Concern about how, and by whom, societal benefits would be calculated

28. Summary of June 28-29 meeting - 4 • Many favored improvements in current system: • Expanding VFC coverage for underinsured children • Removing VFC price caps • Vaccine for Adults entitlement • Increased support for childhood immunization through Section 317 • Specific support for adolescent and adult immunization through Section 317

29. Proposed NVAC recommendations - 1 • NVAC does not feel it is advisable to adopt the IOM recommendation to replace the current system with an insurance mandate and system of subsidies and vouchers • NVAC does not support the recommended changes in composition or charter of the ACIP

30. Proposed NVAC recommendations - 2 • Expanded and stable funding through Section 317 for program infrastructure and operations as well as vaccine purchase • Expanded funding through Section 317 to support adolescent and adult immunization programs and vaccine purchase • Rapid appropriation through Section 317 when new vaccines are recommended for universal use

31. Proposed NVAC recommendations - 3 • Expansion of VFC • Include underinsured children in all public health clinics • Remove price caps • Give providers choice of vaccines • Regulatory harmonization to facilitate introduction into the US of vaccines licensed in other countries that are in compliance with FDA-approved harmonized standards

32. Proposed NVAC recommendations - 4 • Further exploration of regulatory and other factors impeding vaccine research and development to alleviate barriers • Increased communication between industry and FDA throughout the process of vaccine research and development • Promoting “first dollar” insurance coverage for immunization and promoting re-calculation of capitation rates when new vaccines are recommended

33. Proposed NVAC recommendations - 5 • Assuring adequate reimbursement for administration of vaccines • Expanded discussion about need, desirability, and feasibility of a Vaccines for Adults (or Vaccines for All) program to ensure that adults have access to vaccines, regardless of whether they have insurance

34. Next steps • Discussion • NVAC approval/endorsement/adoption of workgroup report (with any needed revisions based on discussion) • ?Publication of journal article?