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

2021 ◽  
Author(s):  
Kiesha Prem ◽  
Yoon Hong Choi ◽  
Élodie Bénard ◽  
Emily A Burger ◽  
Liza Hadley Mmath ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Hpv Vaccine ◽  
Dose Regimen ◽  
Hpv Vaccination ◽  
Health Benefits ◽  
Vaccination Schedule ◽  
Global Impact ◽  
The One

SummaryBackgroundTo eliminate cervical cancer as a public health problem, WHO currently recommends routine vaccination of adolescent girls with two doses of the human papillomavirus (HPV) vaccine before sexual debut. However, many countries have yet to implement this because of financial or logistical barriers to delivering two doses outside the infant immunisation programme.MethodsUsing three independent HPV transmission models, we estimated the long-term health benefits and cost-effectiveness of one-dose versus two-dose HPV vaccination, in 192 countries, assuming that 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 one-year catch-up of 80% 11–14-year-old girls on the first year of the programme.FindingsOver the next century, one-dose vaccination at 80% coverage could avert 64 million (80%UI 62·2–64·8) and 66·6 million (80%UI 63·4–69·1) cervical cancer cases should one dose of the vaccine confer 20 and 30 years of protection, respectively. Should one dose of the vaccine provide lifelong protection at 80% vaccine efficacy, 68·4 million (80%UI 63·8–69·4) cervical cancer cases could be prevented. Across all country income groups, two-dose schedules conferring lifelong protection would avert only slightly more cases (2·1–8·7 million) than the one-dose scenarios explored. Around 330 to 5230 additional girls need to be vaccinated with the second dose to prevent one cervical cancer case, depending on the epidemiological profiles of the country.InterpretationResults 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.FundingBill & Melinda Gates FoundationResearch in contextEvidence before this studyPrimary prevention of cervical cancer is now available with human papillomavirus (HPV) vaccination. Initially administered as a three-dose regimen, the HPV vaccine schedule recommended by WHO has now switched to two doses for individuals below the age of 15 years. Although WHO recommends all countries to routinely immunise adolescent girls with two doses, many low- and middle-income countries, with high disease burden, have yet to implement national HPV vaccination programmes because of the challenges of delivering two vaccine doses to adolescent females. Recently, HPV vaccine implementation in many countries has been further delayed due to constraints in vaccine supply and difficulties in access during COVID-19 epidemics. These financial, logistical, and supply constraints have motivated research into one-dose vaccination schedules. Evidence emerging from trials and observational studies suggests that one dose may also provide a high level of protection against incident and persistent HPV infections. If proven effective, the one-dose HPV vaccination schedule would simplify vaccine delivery and lower costs of national vaccination programmes, potentially enabling more countries to implement one and as a result, facilitating global cervical cancer prevention. We searched PubMed for trials, cohort and modelling studies published in 2018 and 2020, with the terms “(health impact OR impact OR modelling OR cost-effectiveness OR CEA OR durability OR effectiveness) AND (HPV OR human papillomavirus OR cervical cancer)” and identified 151 results. Ten published articles—four trials, three cohort studies, two modelling analyses, one systematic review of trials—evaluated the population impact of one dose of the vaccine on cervical cancer disease outcome among females and all studies showed one dose of the vaccine might be as effective as two doses in preventing HPV infection. However as the trials and cohorts were single-country studies in select populations, the global impact remains unknown. Both published modelling analyses only used one model to estimate the impact of one-dose vaccination, and only examined a few countries. To our knowledge, no published article has modelled the global impact of routine one-dose vaccination on cervical cancer prevention by synthesising the results from more than one model.Added value of this studyThis study presents the first evidence on the potential global impact of a routine one-dose regimen, from a comparative modelling analysis that synthesises results from three published dynamic models calibrated to countries with varying epidemiological and demographic profiles. We found consistent results across all models suggesting that routine one-dose vaccination provides the majority of health benefits to the two-dose programme should a single dose of the vaccine confer more than 20 years of protection at full potential efficacy or 80% efficacy with lifelong protection.Implications of all the available evidenceFindings suggest that routine one-dose vaccinations could avert almost as many cervical cancer cases as a two-dose programme. The one-dose regimen would be cheaper and easier to implement for most countries while alleviating vaccine supply constraints. To cope with the COVID-19 pandemic, many governments have had to implement stringent physical distancing measures, which has led to the suspension of routine immunisation programmes. Public health authorities grapple with the logistic challenges of delivering immunisation services while minimising the risk of SARS-CoV-2 transmission. Compared to the two-dose vaccination schedule, a one-dose vaccination schedule would reduce interactions between vaccinees and health workers, simplifying vaccine delivery while also decreasing SARS-CoV-2 exposure.

scholarly journals Cost-effectiveness of human papillomavirus vaccine in China: a systematic review of modelling studies

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052682
Author(s):  
Wenchuan Shi ◽  
Xiaoli Cheng ◽  
Haitao Wang ◽  
Xiao Zang ◽  
Tingting Chen
Keyword(s):  
Systematic Review ◽  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Study Quality ◽  
The Cost

ObjectivesChina suffers from high burdens of human papillomavirus (HPV) and cervical cancer, whereas the uptake of HPV vaccine remains low. The first Chinese domestic HPV vaccine was released in 2019. However, collective evidence on cost-effectiveness of HPV vaccination in China has yet to be established. We summarised evidence on the cost-effectiveness of HPV vaccine in China.DesignSystematic review and narrative synthesisData sourcesPubMed, EMBASE, China National Knowledge Infrastructure and Wanfang Data were searched through 2 January 2021Eligibility criteria for selecting studiesCost-effectiveness studies using a modelling approach focusing on HPV vaccination interventions in the setting of China were included for review.Data extraction and synthesisWe extracted information from the selected studies focusing on cost-effectiveness results of various vaccination programmes, key contextual and methodological factors influencing cost-effectiveness estimates and an assessment of study quality.ResultsA total of 14 studies were included for review. Considerable heterogeneity was found in terms of the methodologies used, HPV vaccination strategies evaluated and study quality. The reviewed studies generally supported the cost-effectiveness of HPV vaccine in China, although some reached alternative conclusions, particularly when assessed incremental to cervical cancer screening. Cost of vaccination was consistently identified as a key determinant for the cost-effectiveness of HPV vaccination programmes.ConclusionsImplementing HPV vaccination programmes should be complemented with expanded cervical cancer screening, while the release of lower-priced domestic vaccine offers more promising potential for initiating public HPV vaccination programmes. Findings of this study contributes important evidence for policies for cervical cancer prevention in China and methodological implications for future modelling efforts.

A cost-effectiveness analysis of adding a human papillomavirus vaccine to the Australian National Cervical Cancer Screening Program

Sexual Health ◽  
2007 ◽  
Vol 4 (3) ◽  
pp. 165 ◽  
Author(s):  
Shalini Kulasingam ◽  
Luke Connelly ◽  
Elizabeth Conway ◽  
Jane S. Hocking ◽  
Evan Myers ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Hpv Vaccine ◽  
Screening Program ◽  
Herd Immunity ◽  
Vaccination Program ◽  
Catch Up ◽  
The Cost ◽  
Current Screening

Background: The cost-effectiveness of adding a human papillomavirus (HPV) vaccine to the Australian National Cervical Screening Program compared to screening alone was examined. Methods: A Markov model of the natural history of HPV infection that incorporates screening and vaccination was developed. A vaccine that prevents 100% of HPV 16/18-associated disease, with a lifetime duration of efficacy and 80% coverage offered through a school program to girls aged 12 years, in conjunction with current screening was compared with screening alone using cost (in Australian dollars) per life-year (LY) saved and quality-adjusted life-year (QALY) saved. Sensitivity analyses included determining the cost-effectiveness of offering a catch-up vaccination program to 14–26-year-olds and accounting for the benefits of herd immunity. Results: Vaccination with screening compared with screening alone was associated with an incremental cost-effectiveness ratio (ICER) of $51 103 per LY and $18 735 per QALY, assuming a cost per vaccine dose of $115. Results were sensitive to assumptions about the duration of vaccine efficacy, including the need for a booster ($68 158 per LY and $24 988 per QALY) to produce lifetime immunity. Accounting for herd immunity resulted in a more attractive ICER ($36 343 per LY and $13 316 per QALY) for girls only. The cost per LY of vaccinating boys and girls was $92 052 and the cost per QALY was $33 644. The cost per LY of implementing a catch-up vaccination program ranged from $45 652 ($16 727 per QALY) for extending vaccination to 14-year-olds to $78 702 ($34 536 per QALY) for 26-year-olds. Conclusions: These results suggest that adding an HPV vaccine to Australia’s current screening regimen is a potentially cost-effective way to reduce cervical cancer and the clinical interventions that are currently associated with its prevention via screening alone.

scholarly journals Stakeholders’ Understandings of Human Papillomavirus (HPV) Vaccination in Sub-Saharan Africa: A Rapid Qualitative Systematic Review

Vaccines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 496
Author(s):  
Caroline Deignan ◽  
Alison Swartz ◽  
Sara Cooper ◽  
Christopher J. Colvin
Keyword(s):  
Systematic Review ◽  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Sub Saharan Africa ◽  
African Countries ◽  
Qualitative Systematic Review ◽  
Sub Saharan ◽  
And Gender

Cervical cancer rates in Sub-Saharan Africa (SSA) are amongst the highest worldwide. All three of the Human Papillomavirus (HPV) vaccines (9-valent, quadrivalent and bivalent HPV vaccine) provide primary protection against the most common cancer-causing strains of HPV (types 16 and 18) that are known to cause 70% of cervical cancers. Over the last five years, there has been an increase in Sub-Saharan African countries that have introduced the HPV vaccine. The majority of research has been conducted on supply-side barriers and facilitators to HPV vaccination uptake in SSA, yet little research has been conducted on demand-side or end-user perspectives of, and decisions around, HPV vaccination. In order to complement existing research, and inform current and future HPV vaccination implementation approaches, this qualitative systematic review explored Stakeholders’ understandings of HPV vaccination in SSA. This review searched the following databases: Embase (via Scopus), Scopus, MEDLINE (via PubMed), PubMed, EBSCOhost, Academic Search Premier, Africa-Wide Information, CINAHL, PsycARTICLES, PsycINFO, SocINDEX, Web of Science, and the Cochrane Controlled Register of Trials (CENTRAL) and found a total of 259 articles. Thirty-one studies were found eligible for inclusion and were analyzed thematically using Braun and Clarke’s methods for conducting a thematic analysis. The quality of included studies was assessed using the Critical Appraisal Skills Programme (CASP) checklist. Three major themes emerged from this analysis; knowledge of HPV vaccination and cervical cancer is intertwined with misinformation; fear has shaped contradictory perceptions about HPV vaccination and gender dynamics are relevant in how stakeholders understand HPV vaccination in SSA.

Human papillomavirus (HPV) vaccination: from clinical studies to immunization programs

2019 ◽  
Vol 29 (8) ◽  
pp. 1317-1326 ◽  
Author(s):  
Raúl Murillo ◽  
Camila Ordóñez- Reyes
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Population Based ◽  
Immunization Programs ◽  
Hpv Vaccines ◽  
Middle Income ◽  
Middle Income Countries

Cervical cancer incidence and mortality have decreased in high-income countries, but low- and middle-income countries continue to bear a significant burden from the disease. Human papillomavirus (HPV) vaccines are a promising alternative for disease control; however, their introduction is slow in settings with greater need. We conducted a review of HPV vaccine efficacy and effectiveness reported in clinical trials and population-based studies. Efficacy of HPV vaccines is close to 100% when using a three-dose schedule in HPV-negative young women (<25 years old) for protection against persistent infection and HPV vaccine-type associated pre-cancerous lesions. Furthermore, sustained protection for up to 12 years of follow-up has been demonstrated; cross-protection against non-vaccine types is particularly observed for the bivalent vaccine, and preliminary data regarding impact on invasive cancer have emerged. Given its lower efficacy, catch-up vaccination beyond 19 years of age and proposals for vaccinating adult women deserve careful evaluation in accurately designed studies and economic analyses. Despite positive results regarding immunogenicity and post-hoc analysis for cervical intra-epithelial neoplasia in clinical trials, population-based data for prime and booster two-dose schedules are not available. Evaluation of vaccine safety from surveillance systems in immunization programs that have already distributed more than 270 million doses found no association of HPV vaccination with serious side effects. The introduction of HPV vaccination in national immunization programs remains the main challenge in tackling the burden of cervical cancer (up to 2018, only 89 countries have introduced vaccination worldwide, and most of these are high-income countries). Access models and technical capacity require further development to help low- and middle-income countries to increase the pace of vaccine delivery. Alternative approaches such as one-dose schedules and vaccination at younger ages may help reduce the programmatic and economic challenges to adolescent vaccination.

scholarly journals Cost-effectiveness of a bivalent human papillomavirus vaccination program in Japan

Sexual Health ◽  
2015 ◽  
Vol 12 (6) ◽  
pp. 520 ◽  
Author(s):  
Luke B. Connelly ◽  
Ha N. D. Le
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Screening Program ◽  
Vaccine Coverage ◽  
Precancerous Lesions ◽  
Hpv Vaccination ◽  
Vaccination Program ◽  
Human Papillomavirus Vaccination ◽  
The Cost

Background Human papillomavirus (HPV) vaccines and their widespread adoption have the potential to relieve a large part of the burden of cervical cancer morbidity and mortality, particularly in countries that have low screening rates or, like Japan, lack a cohesive universal screening program. An economic evaluation was conducted to assess the cost-effectiveness of introducing a bivalent HPV vaccination program in Japan from a healthcare perspective. Methods: A Markov model of the natural history of HPV infection that incorporates both vaccination and screening was developed for Japan. The modelled intervention, a bivalent HPV vaccine with a 100% lifetime vaccine efficacy and 80% vaccine coverage, given to a cohort of 12-year-old Japanese girls in conjunction with the current screening program, was compared with screening alone in terms of costs and effectiveness. A discount rate of 5% was applied to both costs and utilities where relevant. Results: Vaccination alongside screening compared with screening alone is associated with an incremental cost-effectiveness ratio (ICER) of US$20 315 per quality-adjusted-life-year gained if 80% coverage is assumed. The ICER at 5% coverage with the vaccine plus screening, compared with screening alone, is US$1158. Conclusion: The cost-effectiveness results suggest that the addition of a HPV vaccination program to Japan’s cervical cancer screening program is highly likely to prove a cost-effective way to reduce the burden of cervical cancer, precancerous lesions and HPV16/18-related diseases.

Cost-effectiveness analysis of the introduction of a quadrivalent human papillomavirus vaccine in France

2008 ◽  
Vol 24 (01) ◽  
pp. 10-19 ◽  
Author(s):  
Christine Bergeron ◽  
Nathalie Largeron ◽  
Ruth McAllister ◽  
Patrice Mathevet ◽  
Vanessa Remy
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Hpv Vaccine ◽  
Screening Program ◽  
Sensitivity Analyses ◽  
Quadrivalent Hpv Vaccine ◽  
Hpv Types ◽  
Current Screening

Objectives:A vaccine to prevent diseases due to human papillomavirus (HPV) types 6, 11, 16, and 18 is now available in France. The objective of this study was to assess the health and economic impact in France of implementing a quadrivalent HPV vaccine alongside existing screening practices versus screening alone.Methods:A Markov model of the natural history of HPV infection incorporating screening and vaccination, was adapted to the French context. A vaccine that would prevent 100 percent of HPV 6, 11, 16, and 18-associated diseases, with lifetime duration and 80 percent coverage, given to girls at age 14 in conjunction with current screening was compared with screening alone. Results were analyzed from both a direct healthcare cost perspective (DCP) and a third-party payer perspective (TPP). Indirect costs such as productivity loss were not taken into account in this analysis.Results:The incremental cost per life-year gained from vaccination was €12,429 (TPP) and €20,455 (DCP). The incremental cost per quality-adjusted life-year (QALY) for the introduction of HPV vaccination alongside the French cervical cancer screening program was €8,408 (TPP) and €13,809 (DCP). Sensitivity analyses demonstrated that cost-effectiveness was stable, but was most sensitive to the discount rate used for costs and benefits.Conclusions:Considering the commonly accepted threshold of €50,000 per QALY, these analyses support the fact that adding a quadrivalent HPV vaccine to the current screening program in France is a cost-effective strategy for reducing the burden of cervical cancer, precancerous lesions, and genital warts caused by HPV types 6, 11, 16, and 18.

scholarly journals Efficacy and safety of human papillomavirus vaccine for primary prevention of cervical cancer: A review of evidence from phase III trials and national programs

2013 ◽  
Vol 02 (04) ◽  
pp. 187-192 ◽  
Author(s):  
Partha Basu ◽  
Dipanwita Banerjee ◽  
Priyanka Singh ◽  
Chandrani Bhattacharya ◽  
Jaydip Biswas
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Safety Data ◽  
Phase Iii ◽  
Adult Women ◽  
Efficacy And Safety ◽  
Immunization Programs ◽  
National Immunization

AbstractThe Human Papillomavirus (HPV) vaccines have been widely introduced in the national immunization programs in most of the medium and high income countries following endorsement from national and international advisory bodies. HPV vaccine is unique and its introduction is challenging in many ways – it is the first vaccine developed to prevent any cancer, the vaccine is gender specific, it targets adolescent females who are difficult to reach by any health intervention programs. It is not unusual for such a vaccine to face scepticism and reservations not only from lay public but also from professionals in spite of the clinical trial results convincingly and consistently proving their efficacy and safety. Over the last few years millions of doses of the HPV vaccine have been administered round the world and the efficacy and safety data have started coming from the real life programs. A comprehensive cervical cancer control program involving HPV vaccination of the adolescent girls and screening of the adult women has been proved to be the most cost‑effective approach to reduce the burden of cervical cancer. The present article discusses the justification of HPV vaccination in the backdrop of natural history of cervical cancer, the mechanism of action of the vaccines, efficacy and safety data from phase III randomized controlled trials as well as from the national immunization programs of various countries.

scholarly journals Cost-effectiveness and value-based prices of the 9-valent human papillomavirus vaccine for the prevention of cervical cancer in China: an economic modelling analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031186 ◽  
Author(s):  
Y Jiang ◽  
Weiyi Ni ◽  
Jing Wu
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Hpv Vaccine ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Economic Modelling ◽  
Current Price ◽  
The Cost

ObjectivesTo evaluate the cost-effectiveness of the 9-valent human papillomavirus (HPV) vaccine for the prevention of cervical cancer in China.DesignHealth economic modelling using the Papillomavirus Rapid Interface for Modelling and Economics (PRIME) model populated with China-specific data.SettingIndividual cervical cancer prevention in China using the 9-valent HPV vaccine from the perspective of private sector purchasers in relation to receiving other HPV vaccines and not receiving vaccination for 16-year-old girls in China who had not been previously infected with HPV.ParticipantsNot applicable.InterventionsVaccination using the 9-valent, the quadrivalent and the bivalent vaccines.Primary outcome measureIncremental costs per disability-adjusted life year (DALY) prevented.ResultsIn the base case, the incremental costs per DALY prevented were, respectively, US$35 000 and US$50 455 compared with the quadrivalent and the bivalent vaccines, both of which were above the cost-effective threshold of US$25 920/DALY prevented. To be cost-effective in these comparisons, the 9-valent vaccine should be priced at $550 and $450 for the full doses, respectively. To be highly cost-effective, the price thresholds were $435 and $335. The incremental costs per DALY prevented in relation to no vaccination was US$23 012, making the 9-valent vaccine marginally cost-effective. The results were robust in most one-way sensitivity analyses including changing vaccination age to 13 and 26 years.ConclusionsAt the current price, the 9-valent HPV vaccine is not cost-effective compared with the quadrivalent and the bivalent vaccines for young girls in China who had not been previously infected with HPV. Policymakers and clinicians should keep potential vaccine recipients informed about the economic profile of the 9-valent vaccine and carefully consider expanding its use in China at the current price.

scholarly journals Cervical Cancer, Human Papillomavirus Infection, and Vaccine-Related Knowledge

2018 ◽  
Vol 25 (1) ◽  
pp. 107327481879930 ◽  
Author(s):  
Li Yuanyue ◽  
Zulqarnain Baloch ◽  
Li Shanshan ◽  
Nafeesa Yasmeen ◽  
Wu Xiaomei ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Chinese Women ◽  
Hpv Vaccination ◽  
Health Care Facilities ◽  
Female Population ◽  
Screening Programs ◽  
Papillomavirus Infection ◽  
Incidence And Mortality

Cervical cancer (CC) has a high incidence and mortality and is accompanied by lack of organized CC screening programs, lack of health-care facilities, and a lack of human papillomavirus (HPV) vaccination among female population in the world, particularly China. We recruited 487 females who visited the outpatient department of the First People’s Hospital of Yunnan Province from November 2015 to January 2016 to complete a standardized-designed questionnaire. We found that only 39.6% of the females knew about the role of HPVs in the development of cervical cancer. Moreover, none of the females knew that HPV could cause penile carcinomas, perianal carcinomas, and head and neck carcinomas. The majority of the participants acquired information about cervical cancer, HPV, and the HPV vaccine from medical workers. Only 15.6% of the recruited females had heard about the HPV vaccine. The overall HPV vaccine acceptance rate was higher (91.2%) if the vaccine was available free of cost. In this study, we found high acceptability of the HPV vaccine in Chinese women and high awareness about cervical cancer. However, very low levels of knowledge about HPVs and their role in cancer development among the recruited women is alarming. Therefore, it is very important to initiate educational programs to raise awareness and knowledge about cervical cancer, HPV, and the HPV vaccine in this region.

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

PLoS Medicine ◽  
2021 ◽  
Vol 18 (3) ◽  
pp. e1003534
Author(s):  
Jane J. Kim ◽  
Kate T. Simms ◽  
James Killen ◽  
Megan A. Smith ◽  
Emily A. Burger ◽  
...  
Keyword(s):  
United States ◽  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Cancer Screening ◽  
Hpv Vaccination ◽  
The United States ◽  
The Us ◽  
Age Limit ◽  
The Cost

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.

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