New England Journal of Medicine
November 10, 2011 Vol. 365 No. 19
The Role of Cost-Effectiveness in U.S. Vaccination Policy
Jane J. Kim, Ph.D.
N Engl J Med 2011; 365:1760-1761 November 10, 2011
Vaccination policy is driven by several factors, including vaccine safety and efficacy, avertable disease burden, acceptability, and societal value. One measure of value is an intervention’s cost-effectiveness, defined as the additional cost required per additional unit of health benefit produced as compared with the next-most-effective alternative. It is important to differentiate cost-effectiveness (value for money) from affordability (financial resources required); indeed, interventions with high value may not always be affordable. Although information on the cost-effectiveness of health interventions is increasingly being used in health policy globally, the extent to which this information influences decisions varies by country. For example, the governments in Britain and Australia explicitly and routinely incorporate findings from cost-effectiveness analyses into coverage and reimbursement decisions; in contrast, in the United States, it has been essentially taboo for anyone in the public sector to refer explicitly to cost as a factor in health decisions.
One exception is the Advisory Committee on Immunization Practices (ACIP), an independent expert advisory board that formally includes cost-effectiveness among the types of evidence it considers when making vaccine-policy recommendations to the Centers for Disease Control and Prevention (CDC). The ACIP strives to be transparent and balanced, inviting perspectives from stakeholders ranging from scientists to patient groups, and tries to harmonize its recommendations with those of professional organizations, such as the American Academy of Family Physicians and the American Academy of Pediatrics.
Historically, ACIP recommendations have influenced coverage decisions by both private and public insurers. Through a separate process, the ACIP also determines what vaccines are to be covered by the federal Vaccines for Children (VFC) program, which covers children who are Medicaid-eligible, uninsured or underinsured, or American Indians or Alaska natives up to the age of 18. With nearly 50% of U.S. children eligible for VFC coverage,1 the ACIP faces dual pressures: it must maximize underserved children’s access to vaccines while selecting vaccines that provide the most bang for the buck. This pressure will increase with the rollout of the Affordable Care Act, which mandates coverage of all ACIP-recommended childhood immunizations.
With low cost and high efficacy, many vaccines are estimated to be cost-saving — the up-front expenditure for vaccination is entirely offset by costs averted through disease prevention. However, newly licensed and expensive vaccines, such as those against human papillomavirus (HPV, the virus causally linked to cervical cancer) and meningococcal disease, are being considered for use in ways that raise questions regarding their overall public health value as estimated in cost-effectiveness analyses.
In late October, the ACIP is expected to vote on routine HPV vaccination in boys and young men and to discuss meningococcal vaccination in infants, including its cost-effectiveness. Since 2007, routine HPV vaccination has been recommended for girls 11 to 12 years of age (and as early as 9 years), with “catch-up” vaccination recommended up to the age of 26, despite evidence of rapidly diminishing marginal returns and decreasing cost-effectiveness after 21 years of age.2
After the Food and Drug Administration (FDA) approved the quadrivalent HPV (HPV4) vaccine for males in 2009, the ACIP voted for “permissive” — but not routine — use of it in boys and men 9 to 26 years of age for prevention of genital warts. Despite this less enthusiastic stance, the ACIP voted in favor of VFC coverage for eligible males 9 to 18 years of age. The committee was persuaded not to recommend routine male HPV vaccination in part by evidence that it may not be cost-effective, especially if vaccine uptake in girls and young women is high, given the sexual transmission of HPV infections and expected herd-immunity benefits through female-only vaccination. Recent data on uptake among adolescent girls, however, show less than 50% completion of the three-dose series, suggesting that HPV vaccination of boys may be cost-effective at this time. Furthermore, since the 2009 guidelines were issued, the indications for HPV4 have expanded to include prevention of anal cancers. Routine male HPV vaccination, especially if targeted at an early age, when the vaccines are expected to have highest benefit, would maximize protection for men who have sex with men, a group at high risk for HPV-related cancers that would receive little herd-immunity protection from female-only vaccination.
With respect to meningococcal vaccination, in October 2010, the ACIP decided in a narrow vote to recommend a single booster dose of the quadrivalent meningococcal conjugate vaccine (MCV4) at the age of 16 despite evidence that routine adolescent MCV4 vaccination does not provide good value for money, largely because of low disease incidence rates and relatively high vaccine cost. Since then, the FDA has approved the licensure of one meningococcal vaccine for use in infants and is reviewing the licensing application for another. In considering expanding use to infants, the ACIP will need to contend with evidence that MCV4 vaccination at such young ages, which requires at least two doses, is even less cost-effective than adolescent vaccination.3
The cost-effectiveness of vaccines is influenced by several factors, including vaccine efficacy and durability, severity of disease burden, vaccine price, and delivery-program costs. The meningococcal and HPV vaccines are among the most expensive vaccines on the market, with costs of $82 and $109 per dose, respectively, in the public sector (private-sector costs are 20 to 30% higher).4 With the relatively high costs of new vaccines, the U.S. immunization program is placing an increasing financial strain on the health system. Today, the schedule of recommended routine child and adolescent vaccines includes more than 30 doses against 16 diseases — more than double the number in 1980. The public-sector cost of fully vaccinating one person as recommended through adulthood (not including annual influenza vaccines) is roughly $1,450 for males and $1,800 for females, of which the HPV and meningococcal vaccinations alone account for more than 25% at current prices.
Cost-effectiveness analysis provides information on whether the health gain associated with each new vaccine is worth the cost, as compared with other options for health spending. For example, the VFC program must weigh the cost of covering expensive vaccines against an alternative use of those dollars, such as outreach to improve uptake of other routine vaccines in the eligible population. Indeed, a recent CDC analysis showed that it would be more cost-effective to spend up to the purchase price of the HPV vaccine on improving vaccine uptake among girls than it would be to extend the program to boys.5
As the use of cost-effectiveness information increases, we should consider some important limitations of current analyses. The tendency to evaluate single diseases or interventions in isolation is restrictive. Individual vaccines may appear cost-effective, but the overall U.S. vaccination program may be unaffordable or provide less value than other bundled preventive health services targeting the same age group. Real-world obstacles should also be integrated into analyses; for example, the lack of organized vaccine-delivery mechanisms for older age groups can affect vaccine-uptake rates among adolescents and adults, and shortages in vaccine supply (as experienced with influenza vaccines) can influence cost-effectiveness results. To make cost-effectiveness analysis a more practical tool, analysts should evaluate investments across multiple diseases and interventions and include the influences of nonmonetary constraints.
As we confront sobering proposals to cut more than $300 billion in federal health spending over the next decade, public health decision makers will increasingly have to make explicit choices among health investments while keeping a vigilant eye on total expenditures. Identification of high-value health interventions through comparative effectiveness analysis has been prioritized by the new Patient-Centered Outcomes Research Institute. Evidence of cost-effectiveness, if provided in a transparent, standardized, and comprehensive manner, can help to highlight important tradeoffs and contribute to policy recommendations for vaccinations and other health interventions.
Editor’s Note: On October 25, the ACIP voted to recommend that boys 11 to 12 years of age be routinely vaccinated against HPV, indicating that the vaccine series can be started as early as age 9 and that men up to age 21 who have not yet received the vaccine should be vaccinated.