Implementing New Vaccines and Vaccine Recommendations

1. Implementing New Vaccines and Vaccine Recommendations National Vaccine Advisory Committee Washington, DC September 26, 2006 Lance E. Rodewald, MD Director, Immunization Services Division National Center for Immunization and Respiratory Diseases

2. Topics • Current program and stressors • Resources available to programs • Current implementations • Search for solutions

3. Special Relationship between ACIP and VFC • VFC • Entitlement is to the child • Funding is mandatory • Implementation stresses ease of use • Accountability for vaccine is important challenge • ACIP • Sole authority to add vaccines to VFC program

4. ACIP / VFC and Vaccine Cost • Evidence used to make vaccine recommendations include economic considerations • Part of public health perspective • Acceptable methods becoming standardized • VFC resolutions cannot consider costs • Key consideration is whether the vaccine is recommended for VFC-entitled children • The price of the vaccine is not a consideration for the resolution

5. State-Based Vaccine Implementation • States make finance-based policies to implement new vaccines • Full access to vaccines is expensive • Gaps exist for underinsured children • Options for states • Implement VFC only • Implement VFC and arrange financing for underinsured • Health department only for underinsured • HD and private providers for underinsured

6. Financial Resources for States • States’ appropriated funds • Federal Section 317 program funds • Discretionary, not an entitlement • Has been “gap filler” for VFC • No restrictions on use • Neither funding source has kept pace with VFC’s need-based funding

7. Childhood Vaccine Doses Distributed by Funding SourceCalendar Year 2005 Source: Vaccine manufacturers Biologics Surveillance Data 2005 Note: Does not include influenza vaccine

8. VFC and Section 317 Vaccine Funding to Immunization Programs

9. Federal Vaccine Contracts • Negotiated only after VFC resolution • Timeliness has been a CDC priority • Contracting delays have occurred • Varicella – shipping concerns • RotaShield – cost concerns • Discount smaller with newer vaccines • Vaccines through hep B: 51% average discount • Vaccines from varicella on: 17% average discount

10. Private Sector Role in Vaccine Financing • To date, private health insurance usually includes immunization benefit • Private sector financing is largely independent of government purchase policies • Some children have insurance that does not cover vaccines • In general, their parents must pay for the vaccines • IOM estimate: 5% to 14%% of the U.S. childhood population

11. Private Health Insurance and Immunization Challenges • Establishing payment for new vaccines • May not pay entire cost of vaccine • May have time lag to establish code • May not include all vaccines • Preventive care caps • ERISA–exempt insurance plans • Self-insured companies • States cannot place mandates into these plans

12. Stressors

13. Federal Contract Prices for Vaccines Recommended Universally for Children and Adolescents 1985, 1995, 2006 $894 $155 $45 Federal contract price shown for 1985 and 1995 are averages that account for price changes within that year. The 2006 estimated contract prices do not include HPV vaccine, because there is not a federal contract at this time. The catalog price for HPV vaccine is $360 for the 3-dose series. Current as of September 20, 2006

14. Why So Many New Vaccines? • Biotechnology advances • VFC characteristics • Designed to foster development of new vaccines, which was a CII goal • ACIP recommendation with VFC resolution • Committee of scientific experts admits vaccines to VFC • Guarantees substantial market • Becomes a Healthy People objective • Uncapped prices for vaccines with new Biologics License number

15. Current Implementations

16. Two-Tiered State Vaccination Policies at Local Health Departments • Traditionally, health department clinics vaccinated any child brought for vaccination • Underinsured children ineligible for VFC vaccine except at FQHCs and RHCs (~3,000 clinics) • VFC designated FQHCs and RHCs as safety-net providers for underinsured children • State and 317 funding used for underinsured • Due to inadequate state/317 funding, many states cannot purchase vaccine for underinsured children • Result is a two-tiered policy • Government purchased vaccine not available to underinsured at health department clinics • Access to new vaccines for some based on insurance • Ethical tension for public health officials and providers

17. Implementation Guidance When Need Outstrips Resources • VFC resolution implementation is mandatory to programs • Timing is unresolved issue • Non-VFC population is the concern • New vaccines and underinsured • Adult priority populations • Programs are placed in difficult situation of identifying priorities • CDC has not prioritized one vaccine over another • Geographic / need-based population prioritization possible • States tend to prioritize by vaccine, not population

18. Pneumococcal Conjugate Vaccine (PCV) Two-Tier Policies, by State, United States* D.C. *As of February 2003 States with a two-tiered PCV policy (19 states are not implementing PCV with 317 funds)States without a two-tiered PCV policy

19. Grantees Provision of Vaccines to Underinsured Children, 2006 (N=49) Source: Grace Lee et al; Harvard University

20. Two-Tiered States: 2005 • Invasive pneumococcal disease • 13 states did not purchase PCV7 vaccine for underinsured children in health department clinics • Invasive meningococcal disease • 31 states did not purchase MCV4 vaccine for underinsured children in health department clinics • These states do not have a public health department safety net to vaccinate children against these diseases

21. Implications for Discussion • Whither the safety net • Constraints on state and 317 funding result in two-tiered implementation of all new vaccines • Problem goes beyond lack of medical home for primary care • Is a patchwork implementation of vaccines acceptable?

22. Search for Solutions • IOM report on financing vaccines of the 21st century and NVAC response • President’s VFC legislative proposal of 2003 • AAP’s Immunization Task Force • NVAC’s Vaccine Financing Working Group

23. Acknowledgments • Help with suggestions, reviewing, editing • Jeanne Santoli • Ray Strikas • Angela Shen • Claire Hannan • JR Ransom • Anna DeBlois

24. Extra Slides

25. President’s Proposed Extension of Access to VFC Vaccine