Innovative Models to Assess the Costs, Benefits, and Cost-effectiveness of Cervical Cancer Screening

Principal Investigator: Sue J. Goldie, MD, MPH
Roger Irving Lee Professor of Public Health
Director, Center for Health Decision Science
sue_goldie@harvard.edu

Co-Investigator: Jane J. Kim, PhD
Assistant Professor of Health Decision Science
Center for Health Decision Science
jkim@hsph.harvard.edu

Department of Health Policy and Management
Harvard School of Public Health
Boston, Massachusetts

What's the problem?

Cervical cancer is the most common cause of cancer death in women worldwide. In recent years, an improving understanding of the natural history of the human papillomavirus (HPV), promising new screening approaches using HPV DNA testing, and the development of an HPV vaccine have significantly changed the approach to preventing and controlling cervical cancer.

However, improved decision-making tools would contribute significantly to the ability of scientists and policymakers to develop prevention and treatment strategies and apply them in the most effective way in different populations at risk.

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How is this research addressing the problem?

Drs. Goldie and Kim use the tools of decision science to develop and validate mathematical models that link the basic biology of a disease and its epidemiology to outcomes in large populations. By linking these two elements, the models provide clues about the relative significance of different components of preventive and treatment strategies. In doing so, they accommodate “real-world” variability and uncertainties and allow investigators to see how outcomes may differ if the values of specific model parameters are changed, such as application in different population groups.

Since 2002, Dr. Goldie has led a project team that represents an experienced, multidisciplinary group with strong individual track records of collaborative research in mathematical modeling of HPV and cervical cancer, epidemiologic studies of HPV and cervical neoplasia, cervical cancer screening studies in multiple countries, and economic evaluation. The team has developed a series of models to assess the relative costs, benefits, and cost-effectiveness of various prevention strategies – primary (i.e., vaccination), secondary (i.e., screening) and combined strategies. The most comprehensive simulation model incorporates the natural history of the disease, incorporates multiple HPV types, and is calibrated to the US population and risk behaviors. It is capable of forecasting the incidence, mortality, and costs associated with these different cervical cancer control strategies.

Most recently, Kim and Goldie have developed a dynamic transmission model of HPV 16 and 18 – the two most common, high-risk types of HPV – so as to estimate the population-level impact of a type-specific vaccination. Dr. Kim has led this component of the modeling work and has developed methods to account for a variety of biological and host factors, vaccine properties, and behavioral issues. This is one of the first models to include all HPV-related cancers and other HPV-related outcomes. The team also is assessing the effects of various vaccination strategies and policies, such as vaccinating boys in addition to girls and restricting or expanding vaccination to specific populations, and projecting temporal trends in type-specific HPV prevalence.

The third aim of the project is to assess the cost-effectiveness of alternative cervical cancer prevention strategies for the general US population as well as for subgroups that differ in their socioeconomic, demographic, and cervical cancer risk profile. The team is exploring how the cost-effectiveness of a combined screening and vaccination program could change over time and evaluating the effect of vaccination on the test performance of current HPV diagnostics. The study team also is assessing how vaccine delivery (target age, upper age limit, coverage by age and risk group), vaccine characteristics, and programmatic features influence projected benefits and cost-effectiveness.

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Significance of the study & results

An unprecedented amount of new information from clinical studies and vaccine trials has emerged in the past few years and these data have been invaluable in developing this innovative new Cervical Cancer Control Model. Using data analysis and model-based data synthesis, this grant has directly supported a series of analyses that have and will continue to inform policy for the US population. Of special significance is the interim policy analyses rapidly generated for the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) to generate critical information at the time of vaccine policy decisions. The team continues to incorporate the most recent data, and generates important analyses to guide interim clinical and policy decisions, inform the design of clinical studies, explore anticipated debates, and predict potential disparities associated with different vaccine uptake patterns. The results also will be a major contribution to developing appropriate clinical practice guidelines for subgroups of American women who differ in risk profiles and socioeconomic, demographic, and vaccination status.

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Recent related publications of interest

Goldhaber-Fiebert JD, Stout NK, Ortendahl J, Kuntz KM, Goldie SJ, Salomon JA. Modeling human papillomavirus and cervical cancer in the United States for analyses of screening and vaccination. Population Health Metrics 2007;5:11. [View Abstract]

Goldhaber-Fiebert JD, Stout NK, Salomon JA, Kuntz KM, Goldie SJ. Cost-effectiveness of cervical cancer screening with human papillomavirus DNA testing and HPV-16,18 vaccination. Journal of the National Cancer Institute 2008;100(5):308-320. [View Abstract]

Goldie SJ, O'Shea MK, Diaz M, Kim SY. Benefits, cost requirements, and cost-effectiveness of the HPV 16,18 vaccine for cervical cancer prevention in developing countries: policy implications. Reproductive Health Matters 2008;16(32):86-96. [View Abstract]

Hu D, Goldie S. The economic burden of noncervical human papillomavirus disease in the United States. American Journal of Obstetrics and Gynecology 2008;198(5):500.e1-e7. [View Abstract]

Kim JJ, Goldie SJ. Cost-effectiveness of including boys in a Human Papillomavirus (HPV) vaccination program in the United States. British Medical Journal 2009;339:b3884. [View Abstract]

Kim JJ, Goldie SJ. Health and economic implications of HPV vaccination in the United States. New England Journal of Medicine 2008;359(8):821-832. [View Abstract]

Kim JJ, Ortendahl J, Goldie SJ. Cost-effectiveness of human papillomavirus vaccination and cervical cancer screening in women older than 30 years in the United States. Annals of Internal Medicine 2009;151(8):538-545. [View Abstract]

Stout NK, Goldhaber-Fiebert JD, Ortendahl J, Goldie SJ. Trade-offs in cervical cancer prevention: balancing benefits and risks. Archives of Internal Medicine 2008;168(17):1881-1889. [View Abstract]

Kim JJ, Brisson M, Edmunds WJ, Goldie SJ. Modeling cervical cancer prevention in developed countries. Vaccine 2008 Aug 19;26 Suppl 10:K76-86. [View Abstract]

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