ACIP Highlights from 2005 and Issues for 2006 or How Do We Pay for These Great Vaccines? JON S. ABRAMSON, M.D. DEPARTMENT OF PEDIATRICS BRENNER CHILDREN'S HOSPITAL WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE WINSTON-SALEM, NC

ACIP Approved New Vaccines Possible Recommendation MCV4 Universal vaccination of 11/12 & 14/15 year olds Tdap Substitute Tdap for Td in adolescents and adults MMRV Combines MMR and varicella vaccine Rotavirus Universal vaccination of infants a

ACIP New Vaccines Currently Under Consideration Possible Recommendation HPV Universal vaccination of adolescents and adults Zoster Universal vaccination of older adults a

ACIP Approved Expanded Use of Licensed Vaccines Possible Expanded Recommendation Hepatitis A Universal vaccination of all children in the U. S. at 2 yrs of age Hepatitis B Increased focus on newborn vaccination in hospital Expansion of use in high risk adults a

ACIP Expanded Use of Licensed Vaccines Currently Under Consideration Possible Expanded Recommendation Influenza Universal vaccination of all people >6 months of age- stepwise approach Varicella Second dose at 15/18 months of age or at 5 yrs of age a

Recommended Childhood and Adolescent Immunization Schedule:United States 2007-8 Range of recommended ages Catch-up vaccination Preadolescent assessment Vaccine/ Age 4-6 yr 11-12 yr 13-18 yr Birth 1mo 2mo 4mo 6 mo 12 mo 15mo 18mo 24mo Hepatitis B HepB#1 HBsAg(-) mom Hep B Series HepB#2 HepB#3 dTaP Td Diphtheria, Tetanus, Pertussis DTaP DTaP DTaP DTaP DTaP Hib Hib Hib Hib H. flu B eIPV Inactivated Polio eIPV eIPV eIPV Measles Mumps Rubella, Varicella MMR-V#1 MMR-V#2 MMR-V#2 eIPV Pneumo Conj PCV13 PCV13 PCV13 PCV13 Influenza Influenza ( Yearly ) Influenza ( Yearly ) Meningococcal Conjugate MCV4 MCV4 Rotavirus ( PO ) RVV5 RVV5 RVV5 Hepatitis A Hepatitis A Series Human Papilloma Virus HPV Vaccines below this line are for select populations PCV7 PPV Injections ( total) 1 (1) 5 (6) 4 ( 10 ) 6 ( 16 ) 4 ( 20 ) 4 ( 24) 2 (26 ) 4 ( 30 ) 5 ( 35 )

Meningococcal Vaccine Estimated Cost per Case Prevented Strategy # of cases prevented $ per case $ per case prevented (excludes productivity loss) Infant (4 doses) 447 $1,923,000 $2,044,000 Toddler (1 dose) 436 $629,000 $741,000 Adolescent 282 $633,000 $845,000

Federal Contract Prices for Vaccines Universally Recommended for Children and Adolescents 1985 – 2005 $621 $155 $45 Federal contract price shown for 1985 and 1995 are averages that account for price changes within that year. The 2005 contract prices reflect prices on the Sept 1st, 2005. In 2005, Tdap replaced Td as the adolescent booster.

Percent Increase of the Cost of Full Series vs Percent Increase of the Cost of Full Series vs. Percent Increase of Appropriation The 2005 estimate includes one dose of MCV4 and one dose of Tdap in adolescents.

Vaccine Purchase Policy: 50 States, DC, VI, PR: 2005

Childhood Vaccine Doses Distributed by Funding Source in 2004 Source: Biologics Surveillance Data 2004

Number of Children and Adolescents Who Could Potentially Receive Full Series with 317 funds 2005 estimate includes the cost to vaccinate one adolescent with one dose of Meningococcal and one dose of Td. 2004 and 2005 reflect new budget lines 1) Business Services Support and 2) Public Health Improvement & Leadership — which were created to the show CDC indirect cost assessments to programs Td was not included in the cost of the full series 1999-2004. States negotiated their own contracts because there was no federal contract for this vaccine. TdaP is expected to be licensed and recommended in FY2006; CDC estimates the new vaccine may be used 50% of the time in adolescents and the current Td vaccine used the remaining 50% of the time.

Cost to Administer Three Vaccines Medicaid average admin fee 2000 Fontanesi J et al. The Price of Prevention: Cost of Recommended Activities to Improve Immunization. Am J Prev Med 2003; 1:41-45.

Actual vs Allowable Medicaid VFC Vaccine Administration Fees in Each State- CY2000 * * Universal purchase states are allowed to develop their own maximum fees

ACIP Role in VFC Program By statute: ACIP establishes, maintains, and revises the VFC vaccine list With regard to VFC resolutions, Congress has indicated that ACIP should conduct its work objectively Only concerns: public health and medicine Work separated from budget considerations Only HHS Secretary can question validity of ACIP recommendation, and propose changes to Congress Funding for vaccines in the ACIP list is mandatory, implying that ACIP can raise vaccine funding for about 45% of U.S. children by a vote

ACIP Vote Implications VFC entitlement must be fulfilled States’ options for underinsured Raise funding consistent with purchase policy Selectively implement a vaccine Providers’ options for underinsured- none are good Ask parents to pay Refer patients out, if possible Take a financial loss Stop vaccinating

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 If all States implemented PCV and flu, the 2004 funding shortfall would be $55 Million

Questions

How States Finance Vaccines Universal 1 (total- 8 states) Alaska Idaho Maine Massachusetts New Hampshire New Mexico Rhode Island Washington Universal Select2 (total- 6 states) Connecticut Nevada North Carolina North Dakota South Dakota Vermont 1Universal: Immunization program supplies all vaccines to all providers. 2Universal-Select: Immunization program supplies all vaccines to all providers with the exception of one or more vaccines (e.g., pneumococcal conjugate vaccine).

How States Finance Vaccines VFC & Underinsured3 (total- 13 states) Arizona Maryland California Michigan Delaware Minnesota Florida Hawaii Georgia Utah South Carolina West Virginia Kentucky VFC & Underinsured Select4 (total- 4 states) Illinois Texas Virginia Wyoming VFC only5 (total- 17 states) Alabama Nebraska Arkansas New Jersey Colorado Ohio Indiana Oklahoma Iowa Oregon Kansas Pennsylvania Louisiana Tennessee Mississippi Wisconsin Missouri 3VFC & Underinsured: Immunization program supplies all vaccines for VFC –eligible and underinsured children to all VFC-enrolled providers. 4VFC & Underinsured-Select: Immunization program supplies most vaccines for VFC-eligible and underinsured children to all VFC-enrolled providers (e.g., pneumococcal conjugate vaccine supplied only VFC-eligible children). 5VFC-Only: Immunization program supplies only VFC vaccine to all VFC enrolled providers. However, public health clinics may provide all vaccines to all children who present for vaccination.