Cost-effectiveness of primary human papillomavirus triage approaches among vaccinated women in Norway: A model-based analysis.

As Norway considers revising triage approaches following their first adolescent cohort with human papillomavirus (HPV) vaccination entering the cervical cancer screening program, we analyzed the health impact and cost-effectiveness of alternative primary HPV triage approaches for women initiating cervical cancer screening in 2023. We used a multimodeling approach that captured HPV transmission and cervical carcinogenesis to evaluate the health benefits, harms and cost-effectiveness of alternative extended genotyping and age-based triage strategies under five-yearly primary HPV testing (including the status-quo screening strategy in Norway) for women born in 1998 (ie, age 25 in 2023). We examined 35 strategies that varied alternative groupings of high-risk HPV genotypes ("high-risk" genotypes; "medium-risk" genotypes or "intermediate-risk" genotypes), number and types of HPV included in each group, management of HPV-positive women to direct colposcopy or active surveillance, wait time for re-testing and age at which the HPV triage algorithm switched from less to more intensive strategies. Given the range of benchmarks for severity-specific cost-effectiveness thresholds in Norway, we found that the preferred strategy for vaccinated women aged 25 years in 2023 involved an age-based switch from a less to more intensive follow-up algorithm at age 30 or 35 years with HPV-16/18 genotypes in the "high-risk" group. The two potentially cost-effective strategies could reduce the number of colposcopies compared to current guidelines and simultaneously improve health benefits. Using age to guide primary HPV triage, paired with selective HPV genotype and follow-up time for re-testing, could improve both the cervical cancer program effectiveness and efficiency.

2019 ASCCP Risk-Based Management Consensus Guidelines: Updates Through 2023.

ABSTRACT: This Research Letter summarizes all updates to the 2019 Guidelines through September 2023, including: endorsement of the 2021 Opportunistic Infections guidelines for HIV+ or immunosuppressed patients; clarification of use of human papillomavirus testing alone for patients undergoing observation for cervical intraepithelial neoplasia 2; revision of unsatisfactory cytology management; clarification that 2012 guidelines should be followed for patients aged 25 years and older screened with cytology only; management of patients for whom colposcopy was recommended but not completed; clarification that after treatment for cervical intraepithelial neoplasia 2+, 3 negative human papillomavirus tests or cotests at 6, 18, and 30 months are recommended before the patient can return to a 3-year testing interval; and clarification of postcolposcopy management of minimally abnormal results.

Data gaps and opportunities for modeling cancer health equity.

Population models of cancer reflect the overall US population by drawing on numerous existing data resources for parameter inputs and calibration targets. Models require data inputs that are appropriately representative, collected in a harmonized manner, have minimal missing or inaccurate values, and reflect adequate sample sizes. Data resource priorities for population modeling to support cancer health equity include increasing the availability of data that 1) arise from uninsured and underinsured individuals and those traditionally not included in health-care delivery studies, 2) reflect relevant exposures for groups historically and intentionally excluded across the full cancer control continuum, 3) disaggregate categories (race, ethnicity, socioeconomic status, gender, sexual orientation, etc.) and their intersections that conceal important variation in health outcomes, 4) identify specific populations of interest in clinical databases whose health outcomes have been understudied, 5) enhance health records through expanded data elements and linkage with other data types (eg, patient surveys, provider and/or facility level information, neighborhood data), 6) decrease missing and misclassified data from historically underrecognized populations, and 7) capture potential measures or effects of systemic racism and corresponding intervenable targets for change.

Adapting a model of cervical carcinogenesis to self-identified Black women to evaluate racial disparities in the United States.

BACKGROUND: Self-identified Black women in the United States have higher cervical cancer incidence and mortality than the general population, but these differences have not been clearly attributed across described cancer care inequities. METHODS: A previously established microsimulation model of cervical cancer was adapted to reflect demographic, screening, and survival data for Black US women and compared with a model reflecting data for all US women. Each model input with stratified data (all-cause mortality, hysterectomy rates, screening frequency, screening modality, follow-up, and cancer survival) was sequentially replaced with Black-race specific data to arrive at a fully specified model reflecting Black women. At each step, we estimated the relative contribution of inputs to observed disparities. RESULTS: Estimated (hysterectomy-adjusted) cervical cancer incidence was 8.6 per 100 000 in the all-race model vs 10.8 per 100 000 in the Black-race model (relative risk [RR] = 1.24, range = 1.23-1.27). Estimated all-race cervical cancer mortality was 2.9 per 100 000 vs 5.5 per 100 000 in the Black-race model (RR = 1.92, range = 1.85-2.00). We found the largest contributors of incidence disparities were follow-up from positive screening results (47.3% of the total disparity) and screening frequency (32.7%). For mortality disparities, the largest contributor was cancer survival differences (70.1%) followed by screening follow-up (12.7%). CONCLUSION: To reduce disparities in cervical cancer incidence and mortality, it is important to understand and address differences in care access and quality across the continuum of care. Focusing on the practices and policies that drive differences in treatment and follow-up from cervical abnormalities may have the highest impact.

Global impact and cost-effectiveness of one-dose versus two-dose human papillomavirus vaccination schedules: a comparative modelling analysis.

BACKGROUND: To eliminate cervical cancer as a public health problem, the World Health Organization had recommended routine vaccination of adolescent girls with two doses of the human papillomavirus (HPV) vaccine before sexual initiation. However, many countries have yet to implement HPV vaccination because of financial or logistical barriers to delivering two doses outside the infant immunisation programme. METHODS: Using three independent HPV transmission models, we estimated the long-term health benefits and cost-effectiveness of one-dose versus two-dose HPV vaccination, in 188 countries, under scenarios in which one dose of the vaccine gives either a shorter duration of full protection (20 or 30 years) or lifelong protection but lower vaccine efficacy (e.g. 80%) compared to two doses. We simulated routine vaccination with the 9-valent HPV vaccine in 10-year-old girls at 80% coverage for the years 2021-2120, with a 1-year catch-up campaign up to age 14 at 80% coverage in the first year of the programme. RESULTS: Over the years 2021-2120, one-dose vaccination at 80% coverage was projected to avert 115.2 million (range of medians: 85.1-130.4) and 146.8 million (114.1-161.6) cervical cancers assuming one dose of the vaccine confers 20 and 30 years of protection, respectively. Should one dose of the vaccine provide lifelong protection at 80% vaccine efficacy, 147.8 million (140.6-169.7) cervical cancer cases could be prevented. If protection wanes after 20 years, 65 to 889 additional girls would need to be vaccinated with the second dose to prevent one cervical cancer, depending on the epidemiological profiles of the country. Across all income groups, the threshold cost for the second dose was low: from 1.59 (0.14-3.82) USD in low-income countries to 44.83 (3.75-85.64) USD in high-income countries, assuming one dose confers 30-year protection. CONCLUSIONS: Results were consistent across the three independent models and suggest that one-dose vaccination has similar health benefits to a two-dose programme while simplifying vaccine delivery, reducing costs, and alleviating vaccine supply constraints. The second dose may become cost-effective if there is a shorter duration of protection from one dose, cheaper vaccine and vaccination delivery strategies, and high burden of cervical cancer.

Designing Guidelines for Those Who Do Not Follow Them: The Impact of Adherence Assumptions on Optimal Screening Guidelines.

OBJECTIVES: Model-based cost-effectiveness analyses can inform decisions about screening guidelines by quantifying consequences of alternative algorithms. Although actual screening adherence is imperfect, incorporating nonadherence into analyses that aim to determine optimal screening may affect the policy recommendations. We evaluated the impact of nonadherence assumptions on the optimal cervical cancer screening in Norway. METHODS: We used a microsimulation model of cervical carcinogenesis to project the long-term health and economic outcomes under alternative screening algorithms and adherence patterns. We compared 18 algorithms involving primary human papillomavirus testing (5-yearly) that varied follow-up management of different human papillomavirus results. We considered 12 adherence scenarios: perfect adherence, 8 high- and low-coverage "random-complier" scenarios, and 3 "systematic-complier" scenarios that reflect conditional screening behavior over a lifetime. We calculated incremental cost-effectiveness ratios and considered a strategy with the highest incremental cost-effectiveness ratio < 55 000 US dollars/quality-adjusted life-year as "optimal." RESULTS: Under perfect adherence, the least intensive screening strategy was optimal; in contrast, assuming any nonadherence resulted in a more intensive optimal strategy. Accounting for lower adherence resulted in both lower costs and health benefits, which allowed for a more intensive strategy to be considered optimal, but more harms for women who screen according to guidelines (ie, up to 41% more colposcopies when comparing the optimal strategy in the lowest-adherence scenario with the optimal strategy under perfect adherence). CONCLUSIONS: Assuming nonadherence in analyses designed to inform national guidelines may lead to a relatively more intensive recommendation. Designing guidelines for those who do not adhere to them may lead to over-screening of those who do.

The Cost-effectiveness of Transplanting Hearts From Hepatitis C-infected Donors Into Uninfected Recipients.

BACKGROUND: The DONATE HCV trial demonstrated the safety and efficacy of transplanting hearts from hepatitis C viremic (HCV+) donors. In this report, we examine the cost-effectiveness and impact of universal HCV+ heart donor eligibility in the United States on transplant waitlist time and life expectancy. METHODS: We developed a microsimulation model to compare 2 waitlist strategies for heart transplant candidates in 2018: (1) status quo (SQ) and (2) SQ plus HCV+ donors (SQ + HCV). From the DONATE HCV trial and published national datasets, we modeled mean age (53 years), male sex (75%), probabilities of waitlist mortality (0.01-0.10/month) and transplant (0.03-0.21/month) stratified by medical urgency, and posttransplant mortality (0.003-0.052/month). We assumed a 23% increase in transplant volume with SQ + HCV compared with SQ. Costs (2018 United States dollar) included waitlist care ($2200-190 000/month), transplant ($213 400), 4-wk HCV treatment ($26 000), and posttransplant care ($2500-11 300/month). We projected waitlist time, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs [$/QALY, discounted 3%/year]; threshold ≤$100 000/QALY). RESULTS: Compared with SQ, SQ + HCV decreased waitlist time from 8.7 to 6.7 months, increased undiscounted life expectancy from 8.9 to 9.2 QALYs, and increased discounted lifetime costs from $671 400/person to $690 000/person. Four-week HCV treatment comprised 0.5% of lifetime costs. The ICER of SQ + HCV compared with SQ was $74 100/QALY and remained ≤$100 000/QALY with up to 30% increases in transplant and posttransplant costs. CONCLUSIONS: Transplanting hearts from HCV-infected donors could decrease waitlist times, increase life expectancy, and be cost-effective. These findings were robust within the context of current high HCV treatment costs.

Identifying a Single Optimal Integrated Cervical Cancer Prevention Policy in Norway: A Cost-Effectiveness Analysis.

BACKGROUND: Interventions targeting the same disease but at different points along the disease continuum (e.g., screening and vaccination to prevent cervical cancer [CC]) are often evaluated in isolation, which can affect cost-effectiveness profiles and policy conclusions. We evaluated nonavalent human papillomavirus (HPV) vaccine (9vHPV) compared with bivalent HPV vaccine (2vHPV) alongside deintensified screening intervals for a vaccinated birth cohort to inform a single optimal integrated CC prevention policy. METHODS: Using a multimodeling approach, we evaluated the health and economic impacts of alternative CC screening strategies for a Norwegian birth cohort eligible for HPV vaccination in 2021 assuming they received 1) 2vHPV or 2) 9vHPV. We conducted 1) a restricted analysis that evaluated the optimal HPV vaccine under current screening guidelines; and 2) a comprehensive analysis including alternative screening and vaccination strategy combinations. We calculated incremental cost-effectiveness ratios (ICERs) and evaluated them according to different cost-effectiveness thresholds. RESULTS: Assuming a cost-effectiveness threshold of $40,000 per quality-adjusted life year (QALY) gained, we found that, while holding screening intensity fixed, switching the routine vaccination program in Norway from 2vHPV to 9vHPV would not be considered cost-effective (ICER of $132,700 per QALY gained). However, when allowing for varying intensities of CC screening, we found that switching to 9vHPV would be cost-effective compared with 2vHPV under an alternative threshold of $55,000 per QALY gained, if coupled with reductions in the number of lifetime screens. CONCLUSIONS: Our analysis highlights the importance of evaluating the full potential policy landscape for country-level decision makers considering policy adoption, including nonindependent primary and secondary prevention efforts, to draw appropriate conclusions and avoid sub-optimal outcomes. HIGHLIGHTS: Without evaluating the full potential policy landscape, including primary and secondary prevention efforts, country-level decision makers may not be able to draw appropriate policy conclusions, resulting in suboptimal outcomes.An applied example from cervical cancer prevention in Norway compared a restricted analysis of current screening guidelines to a comprehensive analysis including alternative screening and vaccination strategy combinations.We found that a switch from bivalent to nonavalent human papillomavirus vaccine would be considered cost-effective in Norway if coupled with reductions in the number of lifetime screens compared with the current screening strategy.A comprehensive analysis that considers how different types of interventions along the disease continuum affect each other will be critical for decision makers interpreting cost-effectiveness analysis results.

Cost-Effectiveness of Early Intervention in Psychosis: A Modeling Study.

OBJECTIVE: Programs for early intervention in psychosis have shown clinical efficacy. The authors aimed to evaluate the cost-effectiveness of early intervention programs compared with standard care for the treatment of first-episode psychosis in the United States. METHODS: A decision-analytic model integrating published data on clinical efficacy, costs, and health utilities was developed to evaluate early intervention versus standard care over the lifetime of patients after their first psychotic episode. Model input data were derived from meta-analyses, clinical trials, and U.S. national data. The main outcomes included hospitalizations, employment rate, quality-adjusted life years (QALYs), lifetime health care costs, and incremental cost-effectiveness ratios (ICERs). RESULTS: Compared with patients receiving standard care, patients in the early intervention strategy had 3.2 fewer hospitalizations and 2.7 more years of employment over the course of their remaining life expectancy. From a health care perspective, early intervention had an ICER of approximately $51,600 per QALY. From a societal perspective, early intervention saved costs (i.e., yielded greater health benefits and had lower costs compared with standard care). Results were sensitive to the effect of early intervention on suicide, cost of standard care, cost of early intervention, and the effect (relative risk) of early intervention on employment. A scenario analysis that excluded the effect (i.e., hazard ratio) of early intervention on suicide yielded an ICER of approximately $197,000 per QALY. CONCLUSIONS: These results suggest that it is economically beneficial to fund early intervention in psychosis programs in the United States. The findings indicate that early intervention in psychosis saves costs (from the societal perspective) and is cost-effective (health care sector perspective).

Impact of Delaying Effective and Cost-Effective Policy Decisions: An Example From Cervical Cancer Prevention in Norway.

Introduction. Delayed implementation of evidence-driven interventions has consequences that can be formally evaluated. In Norway, programs to prevent cervical cancer (CC)-screening and treatment of precancerous lesions and prophylactic vaccination against human papillomavirus (HPV) infection-have been implemented, but each encountered delays in policy implementation. To examine the effect of these delays, we project the outcomes that would have been achieved with timely implementation of two policy changes compared with the de facto delays in implementation (in Norway). Methods. We used a multimodeling approach that combined HPV transmission and cervical carcinogenesis to estimate the health outcomes and timeline for CC elimination associated with the implementation of two CC prevention policy decisions: a multicohort vaccination program of women up to age 26 years with bivalent vaccine in 2009 compared with actual "delayed" implementation in 2016, and a switch from cytology to primary HPV-based testing in 2015 compared with "delayed" rollout in 2020. Results. Timely implementation of two policy changes compared with current Norwegian prevention policy timeline could have averted approximately 970 additional cases (range of top 10 sets: 830-1060) and accelerated the CC elimination timeline by around 4 years (from 2039 to 2035). Conclusions. If delaying implementation of effective and cost-effective interventions is being considered, the decision-making process should include quantitative analyses on the effects of delays.

Switching clinic-based cervical cancer screening programs to human papillomavirus self-sampling: A cost-effectiveness analysis of vaccinated and unvaccinated Norwegian women.

Several countries have implemented primary human papillomavirus (HPV) testing for cervical cancer screening. HPV testing enables home-based, self-collected sampling (self-sampling), which provides similar diagnostic accuracy as clinician-collected samples. We evaluated the impact and cost-effectiveness of switching an entire organized screening program to primary HPV self-sampling among cohorts of HPV vaccinated and unvaccinated Norwegian women. We conducted a model-based analysis to project long-term health and economic outcomes for birth cohorts with different HPV vaccine exposure, that is, preadolescent vaccination (2000- and 2008-cohorts), multiage cohort vaccination (1991-cohort) or no vaccination (1985-cohort). We compared the cost-effectiveness of switching current guidelines with clinician-collected HPV testing to HPV self-sampling for these cohorts and considered an additional 44 strategies involving either HPV self-sampling or clinician-collected HPV testing at different screening frequencies for the 2000- and 2008-cohorts. Given Norwegian benchmarks for cost-effectiveness, we considered a strategy with an additional cost per quality-adjusted life-year below $55 000 as cost-effective. HPV self-sampling strategies considerably reduced screening costs (ie, by 24%-40% across cohorts and alternative strategies) and were more cost-effective than clinician-collected HPV testing. For cohorts offered preadolescent vaccination, cost-effective strategies involved HPV self-sampling three times (2000-cohort) and twice (2008-cohort) per lifetime. In conclusion, we found that switching from clinician-collected to self-collected HPV testing in cervical screening may be cost-effective among both highly vaccinated and unvaccinated cohorts of Norwegian women.

Cost-effectiveness analysis of the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines for the management of abnormal cervical cancer screening tests and cancer precursors.

BACKGROUND: The guidelines for managing abnormal cervical cancer screening tests changed from a results-based approach in 2012 to a risk-based approach in 2019. OBJECTIVE: We estimated the cost-effectiveness of the 2019 management guidelines and the changes in resource utilization moving from 2012 to 2019 guidelines. STUDY DESIGN: We utilized a previously published model of cervical cancer natural history and screening to estimate and compare the lifetime costs and the number of screens, colposcopies, precancer treatments, cancer cases, and cancer deaths associated with the 2012 vs 2019 management guidelines. We assessed these guidelines under the scenarios of observed screening practice and perfect screening adherence to 3-year cytology starting at age 21, with a switch to either 3-year or 5-year cytology plus human papillomavirus cotesting at age 30. In addition, we estimated the lifetime costs and life years to determine the cost-effectiveness of shifting to the 2019 management guidelines. RESULTS: Under the assumptions of both observed screening practice and perfect screening adherence with a strategy of 3-year cytology at ages 21 to 29 and switching to 3-year cotesting at age 30, the management of the screening tests according to the 2019 guidelines was less costly and more effective than the 2012 guidelines. For 3-year cytology screening at ages 21 to 29 and switching to 5-year cotesting at age 30, the 2019 guidelines were more cost-effective at a willingness-to-pay threshold of $100,000 per life year gained. Across all scenarios, the 2019 management guidelines were associated with fewer colposcopies and cancer deaths. CONCLUSION: Our model-based analysis suggests that the 2019 guidelines are more effective overall and also more cost-effective than the 2012 guidelines, supporting the principle of "equal management of equal risks."

Cost-utility analysis of heart surgeries for young adults with severe rheumatic mitral valve disease in India.

BACKGROUND: Rheumatic mitral valve disease (RMVD) is a major cause of acquired valvular disease in India. We compared the cost-effectiveness of surgical treatment strategies for young adults with severe RMVD from an Indian public payer perspective. METHODS: We developed a Markov model to reflect the burden of RMVD among a hypothetical cohort of 20-year-olds in India and to estimate quality-adjusted life years (QALYs) and lifetime costs associated with three strategies: (1) Repair; (2) Mechanical valve replacement (MVR-M); and (3) Bioprosthetic valve replacement (MVR-B), compared to a baseline strategy involving a mix of surgeries approximating the standard of care in India (32% Repair, 33% MVR-M, 35% MVR-B). Data on disease burden, intervention effects, and direct medical costs (2018 US$) were obtained from the literature. Deterministic and probabilistic sensitivity analyses were conducted to assess model uncertainty. RESULTS: Repair ($2530, 9.7 QALYs) was less costly and more effective than the standard of care ($2990, 8.7 QALYs) and MVR-M ($3220, 6.2 QALYs). The incremental cost-effective ratio for MVR-B ($3190, 10.1 QALYs) compared to Repair was $1590 per QALY, which may be cost-effective at a threshold of India's per-capita gross domestic product (GDP: $2005). The optimal choice between Repair or MVR-B was sensitive to variations in surgery costs, background mortality, and risks for reoperation. CONCLUSIONS: Our model-based analysis suggests that Repair is the optimal strategy and MVR-M should not be recommended for this subpopulation. MVR-B may be cost-effective in contexts where quality of Repair is not assured, newer generation bioprostheses are used, or the costs of the bioprosthetic valve decrease.

Health gains and financial protection from human papillomavirus vaccination in Ethiopia: findings from a modelling study.

High out-of-pocket (OOP) medical expenses for cervical cancer (CC) can lead to catastrophic health expenditures (CHEs) and medical impoverishment in many low-resource settings. There are 32 million women at risk for CC in Ethiopia, where CC screening is extremely limited. An evaluation of the population health and financial risk protection benefits, and their distributional consequences across socioeconomic groups, from human papillomavirus (HPV) vaccination will be critical to support CC prevention efforts in this setting. We used a static cohort model that captures the main features of HPV vaccines and population demographics to project health and economic outcomes associated with routine HPV vaccination in Ethiopia. Health outcomes included the number of CC cases, and costs included vaccination and operational costs in 2015 US dollars over the years 2019-2118 and CC treatment costs over the lifetimes of cohorts eligible for vaccination in Ethiopia. We estimated the household OOP medical expenditures averted (assuming 68% of direct medical expenditures were financed OOP) and cases of CHE averted. A case of CHE was defined as 40% of household consumption expenditures, and the cases of CHE averted depended on wealth quintile, disease incidence, healthcare use and OOP payments. Our analysis shows that, assuming 100% vaccine efficacy against HPV-16/18 and 50% vaccination coverage, routine HPV vaccination could avert up to 970 000 cases of CC between 2019 and 2118, which translates to ∼932 000 lives saved. Additionally, routine HPV vaccination could avert 33 900 cases of CHE. Approximately one-third of health benefits would accrue to the poorest wealth quintile, whereas 50% of financial risk protection benefits would accrue to this quintile. HPV vaccination can reduce disparities in CC incidence, mortality and household health expenditures. This understanding and our findings can help policymakers in decisions regarding targeted CC control efforts and investment in a routine HPV vaccination programme following an initial catch-up programme.

Impact and cost-effectiveness of strategies to accelerate cervical cancer elimination: A model-based analysis.

Following the global call for action by the World Health Organization to eliminate cervical cancer (CC), we evaluated how each CC policy decision in Norway influenced the timing of CC elimination, and whether introducing nonavalent human papillomavirus (HPV) vaccine would accelerate elimination timing and be cost-effective. We used a multi-modeling approach that captured HPV transmission and cervical carcinogenesis to estimate the CC incidence associated with six past and future CC prevention policy decisions compared with a pre-vaccination scenario involving 3-yearly cytology-based screening. Scenarios examined the introduction of routine HPV vaccination of 12-year-old girls with quadrivalent vaccine in 2009, a temporary catch-up program for females aged up to 26 years in 2016-2018 with bivalent vaccine, the universal switch to bivalent vaccine in 2017, expansion to include 12-year-old boys in 2018, the switch from cytology- to HPV-based screening for women aged 34-69 in 2020, and the potential switch to nonavalent vaccine in 2021. Introducing routine female vaccination in 2009 enabled elimination to be achieved by 2056 and prevented 17,300 cases. Cumulatively, subsequent policy decisions accelerated elimination to 2039. According to our modeling assumptions, switching to the nonavalent vaccine would not be considered 'good value for money' at relevant cost-effectiveness thresholds in Norway unless the incremental cost was $19 per dose or less (range: $17-24) compared to the bivalent vaccine. CC control policies implemented over the last decade in Norway may have accelerated the timeframe to elimination by more than 17 years and prevented over 23,800 cases by 2110.

Human papillomavirus vaccination for adults aged 30 to 45 years in the United States: A cost-effectiveness analysis.

BACKGROUND: A nonavalent human papillomavirus (HPV) vaccine has been licensed for use in women and men up to age 45 years in the United States. The cost-effectiveness of HPV vaccination for women and men aged 30 to 45 years in the context of cervical cancer screening practice was evaluated to inform national guidelines. METHODS AND FINDINGS: We utilized 2 independent HPV microsimulation models to evaluate the cost-effectiveness of extending the upper age limit of HPV vaccination in women (from age 26 years) and men (from age 21 years) up to age 30, 35, 40, or 45 years. The models were empirically calibrated to reflect the burden of HPV and related cancers in the US population and used standardized inputs regarding historical and future vaccination uptake, vaccine efficacy, cervical cancer screening, and costs. Disease outcomes included cervical, anal, oropharyngeal, vulvar, vaginal, and penile cancers, as well as genital warts. Both models projected higher costs and greater health benefits as the upper age limit of HPV vaccination increased. Strategies of vaccinating females and males up to ages 30, 35, and 40 years were found to be less cost-effective than vaccinating up to age 45 years, which had an incremental cost-effectiveness ratio (ICER) greater than a commonly accepted upper threshold of $200,000 per quality-adjusted life year (QALY) gained. When including all HPV-related outcomes, the ICER for vaccinating up to age 45 years ranged from $315,700 to $440,600 per QALY gained. Assumptions regarding cervical screening compliance, vaccine costs, and the natural history of noncervical HPV-related cancers had major impacts on the cost-effectiveness of the vaccination strategies. Key limitations of the study were related to uncertainties in the data used to inform the models, including the timing of vaccine impact on noncervical cancers and vaccine efficacy at older ages. CONCLUSIONS: Our results from 2 independent models suggest that HPV vaccination for adult women and men aged 30 to 45 years is unlikely to represent good value for money in the US.

Cost-Effectiveness of Offering Cervical Cancer Screening with HPV Self-Sampling among African-American Women in the Mississippi Delta.

BACKGROUND: African-American women in the United States have an elevated risk of cervical cancer incidence and mortality. In the Mississippi Delta, cervical cancer disparities are particularly stark. METHODS: We conducted a micro-costing study alongside a group randomized trial that evaluated the efficacy of a patient-centered approach ("Choice" between self-collection at home for HPV testing or current standard of care within the public health system in Mississippi) versus the current standard of care ["Standard-of-care screening," involving cytology (i.e., Pap) and HPV co-testing at the Health Department clinics]. The interventions in both study arms were delivered by community health workers (CHW). Using cost, screening uptake, and colposcopy adherence data from the trial, we informed a mathematical model of HPV infection and cervical carcinogenesis to conduct a cost-effectiveness analysis comparing the "Choice" and "Standard-of-care screening" interventions among un/underscreened African-American women in the Mississippi Delta. RESULTS: When each intervention was simulated every 5 years from ages 25 to 65 years, the "Standard-of-care screening" strategy reduced cancer risk by 6.4% and was not an efficient strategy; "Choice" was more effective and efficient, reducing lifetime risk of cervical cancer by 14.8% and costing $62,720 per year of life saved (YLS). Screening uptake and colposcopy adherence were key drivers of intervention cost-effectiveness. CONCLUSIONS: Offering "Choice" to un/underscreened African-American women in the Mississippi Delta led to greater uptake than CHW-facilitated screening at the Health Department, and may be cost-effective. IMPACT: We evaluated the cost-effectiveness of an HPV self-collection intervention to reduce disparities.