HPV Vaccine Policy Model

Decision models to guide the development and evaluation of HPV vaccines and diagnostics
Investigators:

 

In response to new etiologic evidence, improved technology, and promising HPV vaccine efforts, cervical cancer epidemiologic and preventive efforts are being reshaped throughout the world. The Harvard School of Public Health (Center for Health Decision Science), the International Agency for Research on Cancer (IARC), PATH, and the World Health Organization (WHO) are undertaking activities focused on preparing for HPV vaccine introduction in developing countries. These activities, funded by the Bill & Melinda Gates Foundation, represent a multifaceted, coordinated strategy for making HPV vaccines available, acceptable, and affordable to those most in need.

In the last few years, an increasing number of studies have provided support for the potential benefits and cost-effectiveness of novel cervical cancer strategies for low-income countries. These include focusing screening efforts on women between 30 and 45 years of age, minimizing loss to follow-up by delivering screening and treatment in as few visits as possible, and considering a range of screening test options in addition to cytology, such as HPV DNA testing and visual inspection methods. From a global perspective, a preventive vaccine will offer an additional very promising strategy to dramatically reduce cervical cancer in developing countries. Yet, there is considerable uncertainty about type-specific efficacy, heterogeneity and durability of vaccine response, risk of replacement with non-vaccine targeted HPV types, time to widespread accessibility, and the feasibility of broad coverage in an adolescent population.

Through funding from the Bill and Melinda Gates Foundation, the goal of the Harvard School of Public Health project is to develop a series of models to guide the development and evaluation of HPV vaccines and diagnostics to facilitate and accelerate the implementation of cost-effective strategies to reduce mortality from cervical cancer.

Specific goals include:

(1) To develop regional and country-specific models representing different epidemiologic settings using empiric data from multiple study sites on cancer incidence, type-specific HPV prevalence and distribution across the disease spectrum, and key cofactors.

(2) To conduct comprehensive policy analyses to estimate the avertable burden of disease and cost-effectiveness of various HPV vaccination strategies, and identify potential synergies between vaccination and screening, and the most influential factors on the sustainability and affordability of different policy alternatives.

(3) To develop a Core Modeling Center that will analytically support partner activities (e.g., PATH operational research in four countries), assist with or conduct cost-effectiveness analyses for different stakeholders in the HPV vaccine initiative (e.g., analyses to support GAVI investment case), and inform country decision making with analyses that reflect local costs and regional priorities.

This project is a collaboration of the Center for Health Decision Science at the Harvard School of Public Health, and organizations that coordinate large-scale efforts to develop, conduct, and implement novel cervical cancer prevention efforts in developing countries. The partners include:

(1) The International Agency for Research on Cancer (IARC), which coordinates and conducts epidemiological and laboratory research on the causes of cancer. In this partnership, IARC collates published data on HPV type distribution in cervical cancer around the globe and co-ordinates new studies in regions where such data are missing, with special reference to populations where HIV is common. IARC also conducts surveys to determine the age-specific and genotype-specific prevalence of HPV in populations where very little or no knowledge is available.

(2) PATH, an international nonprofit organization that improves the health of people around the world through sustainable and culturally-relevant health related solutions. PATH is organizing HPV vaccination operational research projects in four countries (India, Peru, Uganda, and Vietnam) to generate experience addressing the sociocultural, logistic, policy, and clinical needs related to HPV vaccine introduction. In addition, PATH is negotiating partnerships with HPV vaccine manufacturers to accelerate access to HPV vaccine in developing countries. PATH is working with the partners to develop an investment case for public-sector HPV vaccine financing by potential funders (the GAVI Alliance, bilateral donors, and countries), and will disseminate research project results and other educational and advocacy messages to global, regional, and national audiences.

(3) The World Health Organization’s Initiative for Vaccine Research (WHO-IVR), charged with reinforcing linkages between vaccine research and development and immunization. WHO-IVR focuses on harmonizing and standardizing laboratory procedures and creating a global HPV Laboratory Network to facilitate vaccine licensure and monitoring in developing countries. Additionally, WHO-IVR generates an enabling environment for HPV vaccine introduction by creating an international multidisciplinary policy platform and setting a global agenda for future HPV vaccine introduction in consultation with regions and countries.

(4) Catalan Institute of Oncology (ICO)’s Epidemiology and Cancer Registration Unit, in Barcelona, Spain, which has been involved in the design and development of research initiatives around the world related to the causes and prevention of cancer. ICO analyzes data to assess the prevalence and natural history of HPV infections, the etiology of cervical cancer, and the attributable risk due to cofactors. In partnership with WHO, ICO has created an Information Centre on HPV and Cervical Cancer to facilitate global, regional, and country-specific decisions on current and novel options for cervical cancer prevention.

Although millions of women in poor countries have died of invasive cervical cancer in just two decades, with the availability of new options for cervical cancer screening, and an effective, safe preventive vaccine, there is real hope for reducing these numbers. Our global HPV vaccine model serves as a durable tool that informs and responds to all phases of a well-coordinated major initiative to reduce HPV-related cervical cancer in developing countries. Using an iterative approach to combine empiric data collection with decision analytic modeling this project contributes to the development, application, and sustainability of global HPV vaccine efforts through the evaluation of the feasibility, effectiveness, and cost-effectiveness of global cervical cancer prevention strategies.