IOM Report on Financing Vaccines in the 21st Century: National Vaccine Advisory Committee Followup

1
IOM Report on Financing Vaccines in the 21st
CenturyNational Vaccine Advisory Committee
Follow-up

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

2
(No Transcript)
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
  vaccines 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?