Implementation Issues for HPV Vaccine Howard Backer, MD, MPH Chief, Immunization Branch California Dept of Health Services Chair, Association of Immunization Managers

Implementation of HPV Vaccine: Challenges Financing The vaccine that broke the bank Infrastructure New partners; New patients Policy implications School mandate and consent

Financing VFC: Uninsured and medicaid (age 9-18) COVERED (age 19-26) LIMITED COVERAGE Insured MOSTLY COVERED Underinsured LIMITED COVERAGE 317 funding State/local funding

AIM Survey Feb 2007 N = 50

California Funding Decisions Public sector All 11 through 18 years of age using combination of VFC and 317 dollars MediCal 9-18 years Governor’s budget proposal for MediCal 19-26 yrs Private sector VFC eligible 11 through 18 years of age All managed care, group insurance (by law) Underinsured NOT covered 19-26 yr depends on health plan/insurance

Provider Financing Private providers on the ropes Vaccine financing VFC or Universal vs private/HMO insurance Inventory investment $100,000/mo for 5-6 MD practice Vaccine and administration fee reimburse Infrastructure-admin 20-25% above vaccine cost Vaccination infrastructure Trained staff Storage, monitoring, loss insurance

Infrastructure Support Adolescents: new and different strategies Adolescent immunization staff New public health/medical partners Cross-over for other adult vaccines (HBV) Non-traditional providers Medical home model?

HPV Vaccine Workgroup Goal: Provide statewide leadership, coordination and support for HPV vaccine implementation efforts Lead agencies: Immunization Branch STD Control Branch Cancer Control Branch State partners: Office of Women’s Health Department of Education Maternal Child and Adolescent Health Office of Family Planning Office of AIDS

New partners Enthusiastic but poor understanding of vaccine implementation issues New VFC providers Office infrastructure lacking Staff education, storage and handling Single vaccine interest against VFC rules Quality assurance: AFIX—1 size fits all? Ability to add new VFC requirements for certain providers

HPV Epidemiology-Surveillance Infection No reportable, no routine culture or testing, no reliable marker of infection STD and GYN clinic studies Major long-term outcome Cancer registries and Pap results Vaccine coverage and safety Preventive practices Pap screening Sexual practices KAB of parents and adolescents Can’t follow closely on a yearly basis

Survey Data Sources National Immunization Survey (U.S. estimates only, no state data) Women’s Health Survey (CA adults) California Health Interview Survey

School HPV Vaccine Requirement Discussions “School vaccine mandates should only be used in appropriate settings and situations, taking into account multiple factors, including epidemiologic, economic, and ethical concerns.” AIM Position Statement School and Child Care Immunization Requirements, 2006

School mandate At least 20 states (including CA) with legislation pending Texas Governor Executive Order Legislative initiative to override Virginia initiative passed legislature Federal legislation to restrict mandate H. R. 1153 -- To prohibit Federal funding or other assistance for mandatory human papillomavirus (HPV) vaccination programs

Vaccine development and FDA licensure Defined process Implementation period Public health need as disease control measure Ethical issues Insurance coverage and additional funding Public and Provider Acceptance Supply Vaccine safety Burden on schools ACIP Recommendation School mandate

Acknowledgements Claire Hannan (AIM Executive Director) Eileen Yamada, MP, MPH (Immunization) Heidi Bauer, MD, MPH (STD) Jenny Dai Biller, UCB Graduate Intern Christina Sadorra