Implementing New Vaccines and Implementing New Vaccines and Vaccine RecommendationsVaccine Recommendations

Implementing New Vaccines and Implementing New Vaccines and Vaccine RecommendationsVaccine Recommendations

National Vaccine Advisory CommitteeNational Vaccine Advisory CommitteeWashington, DCWashington, DC

September 26, 2006September 26, 2006

Lance E. Rodewald, MDLance E. Rodewald, MDDirector, Immunization Services DivisionDirector, Immunization Services Division

National Center for Immunization and Respiratory DiseasesNational Center for Immunization and Respiratory Diseases

TopicsTopics

Current program and stressorsCurrent program and stressors

Resources available to programsResources available to programs

Current implementationsCurrent implementations

Search for solutionsSearch for solutions

Special Relationship between Special Relationship between ACIP and VFCACIP and VFC

VFCVFC– Entitlement is to the childEntitlement is to the child– Funding is mandatoryFunding is mandatory– Implementation stresses ease of useImplementation stresses ease of use– Accountability for vaccine is important Accountability for vaccine is important

challengechallenge

ACIPACIP– Sole authority to add vaccines to VFC Sole authority to add vaccines to VFC

programprogram

ACIP / VFC and Vaccine CostACIP / VFC and Vaccine Cost

Evidence used to make vaccine Evidence used to make vaccine recommendationsrecommendations include economic include economic considerationsconsiderations– Part of public health perspectivePart of public health perspective– Acceptable methods becoming standardizedAcceptable methods becoming standardized

VFC VFC resolutionsresolutions cannot consider costs cannot consider costs– Key consideration is whether the vaccine is Key consideration is whether the vaccine is

recommended for VFC-entitled childrenrecommended for VFC-entitled children– The price of the vaccine is not a consideration for The price of the vaccine is not a consideration for

the resolutionthe resolution

State-Based Vaccine State-Based Vaccine ImplementationImplementation

States make finance-based policies to States make finance-based policies to implement new vaccinesimplement new vaccines– Full access to vaccines is expensiveFull access to vaccines is expensive

– Gaps exist for underinsured childrenGaps exist for underinsured children

Options for statesOptions for states– Implement VFC onlyImplement VFC only

– Implement VFC and arrange financing for Implement VFC and arrange financing for underinsuredunderinsured Health department only for underinsuredHealth department only for underinsured HD and private providers for underinsuredHD and private providers for underinsured

Financial Resources for StatesFinancial Resources for States

States’ appropriated fundsStates’ appropriated funds

Federal Section 317 program fundsFederal Section 317 program funds– Discretionary, not an entitlementDiscretionary, not an entitlement– Has been “gap filler” for VFCHas been “gap filler” for VFC– No restrictions on useNo restrictions on use

Neither funding source has kept pace Neither funding source has kept pace with VFC’s need-based fundingwith VFC’s need-based funding

317 Immunization

Grants 6%

Vaccines for Children (VFC)

43%State

5%

Private Sector46%

Childhood Vaccine Doses Childhood Vaccine Doses Distributed by Funding SourceDistributed by Funding Source

Calendar Year 2005Calendar Year 2005

Source: Vaccine manufacturers Biologics Surveillance Data 2005

Note: Does not include influenza vaccine

VFC and Section 317 Vaccine VFC and Section 317 Vaccine Funding to Immunization Funding to Immunization

ProgramsPrograms

$0

$200,000,000

$400,000,000

$600,000,000

$800,000,000

$1,000,000,000

$1,200,000,000

$1,400,000,000

$1,600,000,000

$1,800,000,000

$2,000,000,000

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

PB

Section 317

VFC

Federal Vaccine ContractsFederal Vaccine Contracts

Negotiated only after VFC resolutionNegotiated only after VFC resolution

Timeliness has been a CDC priorityTimeliness has been a CDC priority

Contracting delays have occurredContracting delays have occurred– Varicella – shipping concernsVaricella – shipping concerns– RotaShield – cost concernsRotaShield – cost concerns

Discount smaller with newer vaccinesDiscount smaller with newer vaccines– Vaccines through hep B: 51% average discountVaccines through hep B: 51% average discount– Vaccines from varicella on: 17% average discountVaccines from varicella on: 17% average discount

Private Sector Role in Vaccine Private Sector Role in Vaccine FinancingFinancing

To date, private health insurance usually To date, private health insurance usually includes immunization benefitincludes immunization benefit

Private sector financing is largely Private sector financing is largely independent of government purchase independent of government purchase policiespolicies

Some children have insurance that does not Some children have insurance that does not cover vaccinescover vaccines– In general, their parents must pay for the vaccinesIn general, their parents must pay for the vaccines– IOM estimate: 5% to 14%% of the U.S. childhood IOM estimate: 5% to 14%% of the U.S. childhood

populationpopulation

Private Health Insurance and Private Health Insurance and Immunization ChallengesImmunization Challenges

Establishing payment for new vaccinesEstablishing payment for new vaccines– May not pay entire cost of vaccineMay not pay entire cost of vaccine

– May have time lag to establish codeMay have time lag to establish code

– May not include all vaccinesMay not include all vaccines

– Preventive care capsPreventive care caps

ERISA–exempt insurance plansERISA–exempt insurance plans– Self-insured companiesSelf-insured companies

– States cannot place mandates into these plansStates cannot place mandates into these plans

StressorsStressorsStressorsStressors

Federal Contract Prices for Vaccines Recommended Federal Contract Prices for Vaccines Recommended Universally for Universally for

Children and Adolescents 1985, 1995, 2006Children and Adolescents 1985, 1995, 2006

$0

$100

$200

$300

$400

$500

$600

$700

$800

$900

$1,000

1985 1995 2006 est.

Dollars

3 RV

2 Hep A

1 Mening

1 Td/ Tdap

4 PCV7

6 Influenza

2 Var

2-3 Hep B

3-4 Hib

1-2 MMR

4 Polio

5 DTaP

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?Why So Many New Vaccines?

Biotechnology advancesBiotechnology advances

VFC characteristicsVFC characteristics– Designed to foster development of new vaccines, Designed to foster development of new vaccines,

which was a CII goalwhich was a CII goal

– ACIP recommendation with VFC resolutionACIP recommendation with VFC resolution Committee of scientific experts admits vaccines to VFCCommittee of scientific experts admits vaccines to VFC Guarantees substantial marketGuarantees substantial market Becomes a Healthy People objectiveBecomes a Healthy People objective

– Uncapped prices for vaccines with new Biologics Uncapped prices for vaccines with new Biologics License numberLicense number

Current ImplementationsCurrent ImplementationsCurrent ImplementationsCurrent Implementations

Two-Tiered State Vaccination Policies Two-Tiered State Vaccination Policies at Local Health Departmentsat Local Health Departments

Traditionally, health department clinics vaccinated any child Traditionally, health department clinics vaccinated any child brought for vaccinationbrought for vaccination

Underinsured children ineligible for VFC vaccine except at Underinsured children ineligible for VFC vaccine except at FQHCs and RHCs (~3,000 clinics)FQHCs and RHCs (~3,000 clinics)– VFC designated FQHCs and RHCs as safety-net providers for VFC designated FQHCs and RHCs as safety-net providers for

underinsured childrenunderinsured children– State and 317 funding used for underinsuredState and 317 funding used for underinsured– Due to inadequate state/317 funding, many states cannot purchase Due to inadequate state/317 funding, many states cannot purchase

vaccine for underinsured childrenvaccine for underinsured children

Result is a two-tiered policyResult is a two-tiered policy– Government purchased vaccine not available to underinsured at Government purchased vaccine not available to underinsured at

health department clinicshealth department clinics– Access to new vaccines for some based on insuranceAccess to new vaccines for some based on insurance– Ethical tension for public health officials and providersEthical tension for public health officials and providers

Implementation Guidance When Implementation Guidance When Need Outstrips ResourcesNeed Outstrips Resources

VFC resolution implementation is mandatory to VFC resolution implementation is mandatory to programsprograms– Timing is unresolved issueTiming is unresolved issue

Non-VFC population is the concernNon-VFC population is the concern– New vaccines and underinsuredNew vaccines and underinsured– Adult priority populationsAdult priority populations

Programs are placed in difficult situation of Programs are placed in difficult situation of identifying prioritiesidentifying priorities– CDC has not prioritized one vaccine over anotherCDC has not prioritized one vaccine over another– Geographic / need-based population prioritization possibleGeographic / need-based population prioritization possible– States tend to prioritize by vaccine, not populationStates tend to prioritize by vaccine, not population

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

United States*United States*

States with a two-tiered PCV policy States with a two-tiered PCV policy (19 states are not implementing PCV with 317 funds)(19 states are not implementing PCV with 317 funds)

States without a two-tiered PCV policyStates without a two-tiered PCV policy

D.C.D.C.

*As of February 2003*As of February 2003

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

0%

20%

40%

60%

80%

100%

% s

upply

ing to u

nderinsu

red Yes No/Not yet Missing

Source: Grace Lee et al; Harvard University

Two-Tiered States: 2005Two-Tiered States: 2005

Invasive pneumococcal diseaseInvasive pneumococcal disease– 13 states did not purchase PCV7 vaccine for 13 states did not purchase PCV7 vaccine for

underinsured children in health department underinsured children in health department clinicsclinics

Invasive meningococcal diseaseInvasive meningococcal disease– 31 states did not purchase MCV4 vaccine for 31 states did not purchase MCV4 vaccine for

underinsured children in health department underinsured children in health department clinicsclinics

These states do not have a public health These states do not have a public health department safety net to vaccinate children department safety net to vaccinate children against these diseasesagainst these diseases

Implications for DiscussionImplications for Discussion

Whither the safety netWhither the safety net– Constraints on state and 317 funding Constraints on state and 317 funding

result in two-tiered implementation of all result in two-tiered implementation of all new vaccinesnew vaccines

– Problem goes beyond lack of medical Problem goes beyond lack of medical home for primary carehome for primary care

Is a patchwork implementation of Is a patchwork implementation of vaccines acceptable?vaccines acceptable?

Search for SolutionsSearch for Solutions

IOM report on financing vaccines of the 21IOM report on financing vaccines of the 21stst century and NVAC responsecentury and NVAC response

President’s VFC legislative proposal of 2003President’s VFC legislative proposal of 2003

AAP’s Immunization Task ForceAAP’s Immunization Task Force

NVAC’s Vaccine Financing Working GroupNVAC’s Vaccine Financing Working Group

AcknowledgmentsAcknowledgments

Help with suggestions, reviewing, Help with suggestions, reviewing, editingediting– Jeanne SantoliJeanne Santoli

– Ray StrikasRay Strikas

– Angela ShenAngela Shen

– Claire HannanClaire Hannan

– JR RansomJR Ransom

– Anna DeBloisAnna DeBlois

Extra SlidesExtra SlidesExtra SlidesExtra Slides

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

Children Eligible for VFC Vaccine.

State & Local Public Health

ClinicsPrivate

Providers

Federally Qualified Health Clinics (FQHC)

Rural Health Clinics (RHC)

VFC Current LawUninsured X X X XMedicaid Eligible X X X XAmerican Indian/ Alaska Native X X X XUnderinsured * X X

VFC Proposed LawUninsured X X X XMedicaid Eligible X X X XAmerican Indian/ Alaska Native X X X XUnderinsured * X X X

*Children whose insurance does not cover the cost of immunizations.

VFC Vaccination Access Points