# Presentation: 706958

## 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**

## Topics

**Current program and stressors**
**Resources available to programs**
**Current implementations**
**Search for solutions**

## 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**

## 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**

## 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**

## 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***

## Childhood Vaccine Doses Distributed by Funding SourceCalendar Year 2005

**Childhood Vaccine Doses Distributed by Funding Source****Calendar Year 2005**

- Source: Vaccine manufacturers Biologics Surveillance Data 2005
- Note: Does not include influenza vaccine

## VFC and Section 317 Vaccine Funding to Immunization Programs

## 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**

## 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**

## 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**

## Stressors

## Federal Contract Prices for Vaccines Recommended Universally for Children and Adolescents 1985, 1995, 2006

**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

**$45**

**$155**

**$894**

## 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**

## Current Implementations

## 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**

**Notes:**
The fabric of the childhood vaccine program is beginning to unravel by the development of two-tiered vaccination policies in many states.

## 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**

## Pneumococcal Conjugate Vaccine (PCV) Two-Tier Policies, by State, United States*

**Pneumococcal Conjugate Vaccine (PCV) ****Two-Tier Policies, by State, ****United States***

**States with a two-tiered PCV policy ****(19 states are not implementing PCV with 317 funds)****States without a two-tiered PCV policy**

- D.C.

- *As of February 2003

**Notes:**
When PCV7 was introduced, 20 states were unable to vaccinate underinsured children in health department clinics.  

## Grantees Provision of Vaccines to Underinsured Children, 2006 (N=49)

- Source:  Grace Lee et al; Harvard University

## 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**

## 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?**

## Search for Solutions

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

## Acknowledgments

**Help with suggestions, reviewing, editing**
**Jeanne Santoli**
**Ray Strikas**
**Angela Shen**
**Claire Hannan**
**JR Ransom**
**Anna DeBlois**

## Extra Slides

## President’s Proposed Extension of Access to VFC Vaccine