Adjuvant HPV vaccination for anal cancer prevention in HIV-positive men who have sex with men: The time is now

ImportanceOutcomes of treating high-grade squamous intraepithelial lesions (HSIL), a precursor to anal cancer, remain uncertain. Emerging evidence shows that post HSIL treatment adjuvant quadrivalent human papillomavirus (qHPV) vaccination improves the effectiveness of treatment. However, no recommendations exist regarding the use of qHPV vaccine as an adjuvant form of therapy. Our objective was to determine whether post-treatment adjuvant vaccination should be adopted in HIV-infected MSM (individuals at highest risk for anal cancer) on the basis of cost-effectiveness determined using existing evidence or whether future research is needed.MethodsWe developed a Markov (state-transition) cohort model to assess the cost-effectiveness of post-treatment adjuvant HPV vaccination of 27 years or older HIV-infected MSM. We first estimated cost-effectiveness and then performed value-of-information (VOI) analysis to determine whether future research is required by estimating the expected value of perfect information (EVPI). We also estimated expected value of partial perfect information (EVPPI) to determine what new evidences should have highest priority.ResultsWith the incremental cost-effectiveness ratio (ICER) of $71,937/QALY, “treatment plus vaccination” was the most cost-effective HSIL management strategy using the willingness-to-pay threshold of 100,000/QALY. We found that population-level EVPI for conducting future clinical research evaluating HSIL management approaches was US$12 million (range $6–$20 million). The EVPPI associated with adjuvant qHPV vaccination efficacy estimated in terms of hazards of decreasing HSIL recurrence was $0 implying that additional data from a future study evaluating efficacy of adjuvant qHPV vaccination will not change our policy conclusion that “treatment plus vaccination” was cost-effective. Both the ICER and EVPI were sensitive to HSIL treatment compliance.ConclusionPost-treatment adjuvant qHPV vaccination in HIV-infected MSM aged 27 or above is likely to be cost-effective. Use of adjuvant qHPV vaccination could be considered as a potential strategy to reduce rising anal cancer burden among these high-risk individuals.     

Model for assessing human papillomavirus vaccination strategies

We present a transmission dynamic model that can assess the epidemiologic consequences and cost-effectiveness of alternative strategies of administering a prophylactic quadrivalent (types 6/11/16/18) human papillomavirus (HPV) vaccine in a setting of organized cervical cancer screening in the United States. Compared with current practice, vaccinating girls before the age of 12 years would reduce the incidence of genital warts (83%) and cervical cancer (78%) due to HPV 6/11/16/18. The incremental cost-effectiveness ratio (ICER) of augmenting this strategy with a temporary catch-up program for 12- to 24-year-olds was US $4,666 per quality-adjusted life year (QALY) gained. Relative to other commonly accepted healthcare programs, vaccinating girls and women appears cost-effective. Including men and boys in the program was the most effective strategy, reducing the incidence of genital warts, cervical intraepithelial neoplasia, and cervical cancer by 97%, 91%, and 91%, respectively. The ICER of this strategy was $45,056 per QALY.     

Should I or shouldn't I: decision making, knowledge and behavioral effects of quadrivalent HPV vaccination in men who have sex with men

Prior to FDA licensure in men, a surgical practice (SG) offered the quadrivalent HPV vaccine (qHPV) off-label to men who have sex with men (MSM). We administered a written or telephone survey to MSM to elicit drivers and barriers to vaccination, sexual behavior changes post-vaccination, and knowledge. 191 subjects enrolled: 68 refused qHPV, 71 received qHPV <1 year ago, and 52 received qHPV >1 year ago. History of HPV infection (86%, n = 164) and level of HPV and qHPV knowledge were high, with a mean of 10.8 of 13 knowledge questions correct. Ninety-seven percent of participants understood that qHPV does not cure present infection or disease. MSM refused qHPV for reasons including cost and not FDA approved; prevention of future HPV infection was the paramount driver for immunization. Vaccination did not affect sexual behavior.     

Targeted human papillomavirus vaccination for young men who have sex with men in Australia yields significant population benefits and is cost-effective

BackgroundWe investigated the effectiveness and cost-effectiveness of a targeted human papillomavirus (HPV) vaccination program for young (15–26) men who have sex with men (MSM).MethodsWe developed a compartmental model to project HPV epidemic trajectories in MSM for three vaccination scenarios: a boys program, a targeted program for young MSM only and the combination of the two over 2017–2036. We assessed the gain in quality-adjusted-life-years (QALY) in 190,000 Australian MSM.ResultsA targeted program for young MSM only that achieved 20% coverage per year, without a boys program, will prevent 49,283 (31,253–71,500) cases of anogenital warts, 191 (88–319) person-years living with anal cancer through 2017–2036 but will only stablise anal cancer incidence. In contrast, a boys program will prevent 82,056 (52,100–117,164) cases of anogenital warts, 447 (204–725) person-years living with anal cancers through 2017–2036 and see major declines in anal cancer. This can reduce 90% low- and high-risk HPV in young MSM by 2024 and 2032, respectively, but will require vaccinating ≥84% of boys. Adding a targeted program for young MSM to an existing boys program would prevent an additional 14,912 (8479–21,803) anogenital wart and 91 (42–152) person-years living with anal cancer. In combination with a boys’ program, a catch-up program for young MSM will cost an additional $AUD 6788 ($4628–11,989) per QALY gained, but delaying its implementation reduced its cost-effectiveness.ConclusionsA boys program that achieved coverage of about 84% will result in a 90% reduction in HPV. A targeted program for young MSM is cost-effective if timely implemented.     

Cost-effectiveness of a potential vaccine for human papillomavirus

Human papillomavirus (HPV) infection, usually a sexually transmitted disease, is a risk factor for cervical cancer. Given the substantial disease and death associated with HPV and cervical cancer, development of a prophylactic HPV vaccine is a public health priority. We evaluated the cost-effectiveness of vaccinating adolescent girls for high-risk HPV infections relative to current practice. A vaccine with a 75% probability of immunity against high-risk HPV infection resulted in a life-expectancy gain of 2.8 days or 4.0 quality-adjusted life days at a cost of $246 relative to current practice (incremental cost effectiveness of $22,755/quality-adjusted life year [QALY]). If all 12-year-old girls currently living in the United States were vaccinated, >1,300 deaths from cervical cancer would be averted during their lifetimes. Vaccination of girls against high-risk HPV is relatively cost effective even when vaccine efficacy is low. If the vaccine efficacy rate is 35%, the cost effectiveness increases to $52,398/QALY. Although gains in life expectancy may be modest at the individual level, population benefits are substantial.     

The potential economic value of a Staphylococcus aureus vaccine among hemodialysis patients

Staphylococcus aureus infections are a substantial problem for hemodialysis patients. Several vaccine candidates are currently under development, with hemodialysis patients being one possible target population. To determine the potential economic value of an S. aureus vaccine among hemodialysis patients, we developed a Markov decision analytic computer simulation model. When S. aureus colonization prevalence was 1%, the incremental cost-effectiveness ratio (ICER) of vaccination was ≤$25,217/quality-adjusted life year (QALY). Vaccination became more cost-effective as colonization prevalence, vaccine efficacy, or vaccine protection duration increased or vaccine cost decreased. Even at 10% colonization prevalence, a 25% efficacious vaccine costing $100 prevented 29 infections, 21 infection-related hospitalizations, and 9 inpatient deaths per 1000 vaccinated HD patients. Our results suggest that an S. aureus vaccine would be cost-effective (i.e., ICERs ≤ $50,000/QALY) among hemodialysis patients over a wide range of S. aureus prevalence, vaccine costs and efficacies, and vaccine protection durations and delineate potential target parameters for such a vaccine.     

Age-Based Programs for Vaccination against HPV

Background:  The risk of infection with human papillomavirus (HPV) increases with age. Answering the question of which age groups are appropriate to target for catch-up vaccination with the newly licensed quadrivalent HPV vaccine (types 6/11/16/18) will be important for developing vaccine policy recommendations.
Objectives:  To assess the value of varying female HPV vaccination strategies by specific age groups of a catch-up program in the United States.
Methods:  The authors used previously published mathematical population dynamic model and cost-utility analysis to evaluate the public health impact and cost-effectiveness of alternative quadrivalent HPV (6/11/16/18) vaccination strategies. The model simulates heterosexual transmission of HPV infection and occurrence of cervical intraepithelial neoplasia (CIN), cervical cancer, and external genital warts in an age-structured population stratified by sex and sexual activity groups. The cost-utility analysis estimates the cost of vaccination, screening, diagnosis, and treatment of HPV diseases, and quality-adjusted survival.
Results:  Compared with the current screening practices, vaccinating girls and women ages 12 to 24 years was the most effective strategy, reducing the number of HPV6/11/16/18-related genital warts, CIN grades 2 and 3, and cervical cancer cases among women in the next 25 years by 3,049,285, 1,399,935, and 30,021; respectively. The incremental cost-effectiveness ratio of this strategy when compared with vaccinating girls and women ages 12 to 19 years was $10,986 per quality-adjusted life-year gained.
Conclusion:  Relative to other commonly accepted health-care programs, vaccinating girls and women ages 12 to 24 years appears cost-effective.     

Cost-effectiveness of human papillomavirus vaccination in the United States

We describe a simplified model, based on the current economic and health effects of human papillomavirus (HPV), to estimate the cost-effectiveness of HPV vaccination of 12-year-old girls in the United States. Under base-case parameter values, the estimated cost per quality-adjusted life year gained by vaccination in the context of current cervical cancer screening practices in the United States ranged from $3,906 to $14,723 (2005 US dollars), depending on factors such as whether herd immunity effects were assumed; the types of HPV targeted by the vaccine; and whether the benefits of preventing anal, vaginal, vulvar, and oropharyngeal cancers were included. The results of our simplified model were consistent with published studies based on more complex models when key assumptions were similar. This consistency is reassuring because models of varying complexity will be essential tools for policy makers in the development of optimal HPV vaccination strategies.     

How very young men who have sex with men view vaccination against human papillomavirus

Background

HPV vaccination of men who have sex with men (MSM) prior to the commencement of sexual activity would have the maximum impact on preventing HPV and anal cancer in this population. However, knowledge and attitudes towards HPV vaccination among very young MSM have not been previously studied.

Methods

Two hundred MSM aged 16 to 20 were recruited via community and other sources. Participants were asked about their knowledge and attitudes towards HPV and HPV vaccination.

Results

Most (80%, 95% confidence interval (CI) 72.2–87.2%) men were not willing to purchase the vaccine because of its cost (AUD$450). However, if the vaccine was offered to MSM free of charge, 86% (95% CI: 80–90%) reported they would be willing to disclose their sexuality to a health care provider in order to obtain the vaccine. Over half (54%, 95%: 47–61%) of men would only be willing to disclose their sexuality to receive the HPV vaccine after their first experience of anal intercourse. The age at first insertive anal intercourse and the age at first receptive anal intercourse were 0.21 (IQR: −2.5 to 3.2) and 0.17 (IQR: −2.9 to 2.7) years earlier than the age that men would be willing to disclose their sexuality to receive the HPV vaccine, respectively. Willingness to receive the vaccine at a younger age was associated with younger age at first insertive anal intercourse.

Conclusion

Overall, very young MSM expressed high acceptance of HPV vaccination. Early, opportunistic vaccination of very young MSM may be feasible in settings where very young MSM have not been vaccinated through universal programs targeting school aged males. However, given HPV infections occur early on, the effectiveness of this approach will be less than vaccination targeting school aged boys.     

Cost-Effectiveness of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: An Economic Evaluation Based on Network Meta-Analysis

ObjectivesTo assess the cost-effectiveness of systemic treatments for metastatic castration-sensitive prostate cancer from the US healthcare sector perspective with a lifetime horizon.MethodsWe built a partitioned survival model based on a network meta-analysis of 7 clinical trials with 7287 patients aged 36 to 94 years between 2004 and 2018 to predict patient health trajectories by treatment. We tested parameter uncertainties with probabilistic sensitivity analyses. We estimated drug acquisition costs using the Federal Supply Schedule and adopted generic drug prices when available. We measured cost-effectiveness by an incremental cost-effectiveness ratio (ICER).ResultsThe mean costs were approximately $392 000 with androgen deprivation therapy (ADT) alone and approximately $415 000, $464 000, $597 000, and $959 000 with docetaxel, abiraterone acetate, enzalutamide, and apalutamide, added to ADT, respectively. The mean quality-adjusted life-years (QALYs) were 3.38 with ADT alone and 3.92, 4.76, 3.92, and 5.01 with docetaxel, abiraterone acetate, enzalutamide, and apalutamide, added to ADT, respectively. As add-on therapy to ADT, docetaxel had an ICER of $42 069 per QALY over ADT alone; abiraterone acetate had an ICER of $58 814 per QALY over docetaxel; apalutamide had an ICER of $1 979 676 per QALY over abiraterone acetate; enzalutamide was dominated. At a willingness to pay below $50 000 per QALY, docetaxel plus ADT is likely the most cost-effective treatment; at any willingness to pay between $50 000 and $200 000 per QALY, abiraterone acetate plus ADT is likely the most cost-effective treatment.ConclusionsThese findings underscore the value of abiraterone acetate plus ADT given its relative cost-effectiveness to other systemic treatments for metastatic castration-sensitive prostate cancer.     

HIV自检模式在男男性行为者中的成本效果分析

目的 分析珠海市MSM中HIV自我检测（HIVST）模式和现场HIV快速检测（HIV-RDT）模式的成本效果和支付意愿,为政府合理配置卫生资源提供参考依据。方法 以卫生服务提供者的视角,收集珠海市在2019年1-9月MSM参与两种HIV检测模式的成本投入和效果产出,采用TreeAge Pro 2019软件构建10 000名MSM队列决策树模型,测算成本效果比（CER）和增量成本效果比（ICER）,以敏感性分析模型中各参数的不确定性,绘制成本效果可支付曲线评价策略的可支付性。结果 珠海市男同社会组织通过互联网+社交媒体动员参与HIVST和现场HIV-RDT的MSM人次数为2 303 vs.816,发现HIV筛查阳性者人数为33 vs.35,筛查阳性率为1.7% vs.4.3%。每筛查1例的成本为60.45元vs.240.43元,每发现1例筛查阳性的成本为4 218元vs.5 606元。决策树模型运行结果显示,每检测1例MSM的平均费用为44.67元vs.148.42元,ICER为负值。当发现1例HIV筛查阳性支付意愿低于6 528元时,HIVST更具成本效果的选择;当投入高于该阈值时,现场HIV-RDT是更具成本效果的选择。结论 珠海市现行的HIVST模式是具有经济学价值的公共卫生项目,决策者应加大社会组织扶持力度,推广HIVST在MSM中的应用。     

The cost-effectiveness of counseling strategies to improve adherence to highly active antiretroviral therapy among men who have sex with men.

OBJECTIVE: Inadequate adherence to highly active antiretroviral therapy (HAART) may lead to poor health outcomes and the development of HIV strains that are resistant to HAART. The authors developed a model to evaluate the cost-effectiveness of counseling interventions to improve adherence to HAART among men who have sex with men (MSM). METHODS: The authors developed a dynamic compartmental model that incorporates HIV treatment, adherence to treatment, and infection transmission and progression. All data estimates were obtained from secondary sources. The authors evaluated a counseling intervention given prior to initiation of HAART and before all changes in drug regimens, combined with phone-in support while on HAART. They considered a moderate-prevalence and a high-prevalence population of MSM. RESULTS: If the impact of HIV transmission is ignored, the counseling intervention has a cost-effectiveness ratio of $25,500 per quality-adjusted life year (QALY) gained. When HIV transmission is included, the cost-effectiveness ratio is much lower: $7400 and $8700 per QALY gained in the moderate- and high-prevalence populations, respectively. When the intervention is twice as costly per counseling session and half as effective as estimated in the base case (in terms of the number of individuals who become highly adherent, and who remain highly adherent), then the intervention costs $17,100 and $19,600 per QALY gained in the 2 populations, respectively. CONCLUSIONS: Counseling to improve adherence to HAART increased length of life, modestly reduced HIV transmission, and cost substantially less than $50,000 per QALY gained over a wide range of assumptions but did not reduce the proportion of drug-resistant strains. Such counseling provides only modest benefit as a tool for HIV prevention but can provide significant benefit for individual patients at an affordable cost.     

Cost-Effectiveness of Primary versus Secondary Prophylaxis with Pegfilgrastim in Women with Early-Stage Breast Cancer Receiving Chemotherapy

Objective:  Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the risk of febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. We estimated the incremental cost-effectiveness of G-CSF pegfilgrastim primary (starting in cycle 1 and continuing in subsequent cycles of chemotherapy) versus secondary (only after an FN event) prophylaxis in women with early-stage breast cancer receiving myelosuppressive chemotherapy with a ≥20% FN risk.
Methods:  A decision-analytic model was constructed from a health insurer's perspective with a lifetime study horizon. The model considers direct medical costs and outcomes related to reduced FN and potential survival benefits because of reduced FN-related mortality. Inputs for the model were obtained from the medical literature. Sensitivity analyses were conducted across plausible ranges in parameter values.
Results:  The incremental cost-effectiveness ratio (ICER) of pegfilgrastim as primary versus secondary prophylaxis was $48,000/FN episode avoided. Adding survival benefit from avoiding FN mortality yielded an ICER of $110,000/life-year gained (LYG) or $116,000/quality-adjusted life-year (QALY) gained. The most influential factors included FN case-fatality, FN relative risk reduction from primary prophylaxis, and age at diagnosis.
Conclusions:  Compared with secondary prophylaxis, the cost-effectiveness of pegfilgrastim as primary prophylaxis may be equivalent or superior to other commonly used supportive care interventions for women with breast cancer. Further assessment of the direct impact of G-CSF on short- and long-term survival is needed to substantiate these findings.     

Cost-effectiveness of a tetravalent human papillomavirus vaccine in Germany

Aim  Clinical trials have demonstrated the efficacy of the tetravalent human papillomavirus (HPV) vaccination in the prevention of cervical cancer and genital warts associated with HPV types 6, 11, 16 and 18. We used an empirically calibrated Markov cohort model of the natural history of HPV to assess the cost-effectiveness of the vaccine administered to 12-year-old girls alongside existing cervical screening programmes in Germany. Subjects and methods  The model estimated cervical cancer (CC), cervical intraepithelial neoplasia (CIN) and genital wart lifetime risks and total lifetime health care costs, life years gained and quality-adjusted life years (QALY) gained. The analysis was conducted from the perspective of the German health care payer. Results  In the base case (considering a lifetime duration of protection and 100% efficacy) it was estimated that 2,835 cervical cancer cases and 679 deaths could be prevented among a cohort of 400,000, at an incremental cost per QALY gained of 10,530 €. A total of 120 girls needed to be vaccinated to prevent 1 case of CC. Cost-effectiveness is sensitive to a duration of protection of less than 20 years and to the discount rate for costs and benefits. Conclusion  A policy of vaccinating adolescent girls has been recommended by the German Standing Committee on Vaccinations. This study has demonstrated that such a policy is cost-effective based on thresholds of cost-effectiveness that apply in Germany.     

Cost-effectiveness of nonavalent HPV vaccination among males aged 22 through 26 years in the United States

IntroductionIn the United States, routine human papillomavirus (HPV) vaccination is recommended for females and males at age 11 or 12 years; the series can be started at age 9 years. Vaccination is also recommended for females through age 26 years and males through age 21 years. The objective of this study was to assess the health impact and cost-effectiveness of harmonizing female and male vaccination recommendations by increasing the upper recommended catch-up age of HPV vaccination for males from age 21 to age 26 years.MethodsWe updated a published model of the health impact and cost-effectiveness of 9-valent human papillomavirus vaccine (9vHPV). We examined the cost-effectiveness of (1) 9vHPV for females aged 12 through 26 years and males aged 12 through 21 years, and (2) an expanded program including males through age 26 years.ResultsCompared to no vaccination, providing 9vHPV for females aged 12 through 26 years and males aged 12 through 21 years cost an estimated $16,600 (in 2016 U.S. dollars) per quality-adjusted life year (QALY) gained. The estimated cost per QALY gained by expanding male vaccination through age 26 years was $228,800 and ranged from $137,900 to $367,300 in multi-way sensitivity analyses.ConclusionsThe cost-effectiveness ratios we estimated are not so favorable as to make a strong economic case for recommending expanding male vaccination, yet are not so unfavorable as to preclude consideration of expanding male vaccination. The wide range of plausible results we obtained may underestimate the true degree of uncertainty, due to model limitations. For example, the cost per QALY might be less than our lower bound estimate of $137,900 had our model allowed for vaccine protection against re-infection. Models that specifically incorporate men who have sex with men (MSM) are needed to provide a more comprehensive assessment of male HPV vaccination strategies.     

Cost-Effectiveness Analysis of a National Pre-Exposure Prophylaxis (PrEP) Program in Ireland

ObjectivesTo estimate the cost-effectiveness of introducing a publicly funded pre-exposure prophylaxis (PrEP) program in Ireland.MethodsWe constructed a state-transition Markov model. This was a cross-sectional population model that tracked all HIV-negative men who have sex with men (MSM) in Ireland over their lifetime. Access to a publicly funded PrEP program (medications + frequent monitoring) in high-risk MSM was compared with no PrEP. The primary outcome measure was the incremental cost-effectiveness ratio (ICER).ResultsIn the base case, introducing a PrEP program was considered cost saving and provided significant health benefits to the population. Univariate sensitivity analysis demonstrated that PrEP efficacy and HIV incidence had the greatest impact on cost-effectiveness. Including an increase in sexually transmitted infections had a negligible impact on the results.Efficacy was a significant driver in the model. PrEP was cost saving at all efficacy values above 60%, and at the lowest reported efficacy in MSM (44% in the iPrEX trial), the ICER was €4711/QALY (highly cost-effective). Event-based dosing (administration during high-risk periods only) was associated with additional cost savings.We estimated that 1705 individuals (95% CI: 617-3452) would join the program in year 1. The incremental budget impact was €1.5m (95% CI: €0.5m to €3m) in the first year and €5.4m over 5 years (95% CI: €1.8m to €11.5m), with 173 cases of HIV averted over 5 years.ConclusionWe found that the introduction of a PrEP program would be considered cost saving in the first cost-effectiveness analysis of its kind in Ireland.     

The clinical benefit and cost-effectiveness of human papillomavirus vaccination for adult women in the Netherlands

Background

The use of human papillomavirus (HPV) vaccines has been universally approved for women from age 12 to 25 years, but those older than 16 years receive no reimbursement for the cost of the vaccine in the Netherlands. Reductions in the vaccine price as well as new insights in the efficacy of HPV vaccines offer renewed arguments to consider HPV vaccination in adult women. We calculated the clinical benefit and cost-effectiveness of vaccinating women aged 17-25 years in 2010.

Methods

The calculations were based on an individual-based simulation model for cervical carcinogenesis, with HPV infection risks obtained from a type-specific HPV transmission model. The indirect protective effect from vaccinating 12 to 16 year-old girls was adjusted for. Cervical screening in the model was incorporated according Dutch screening guidelines, i.e. 7 cytology-based rounds at 5-year intervals from the age of 30. As base-case, we assumed the vaccine to offer full protection against HPV16/18 only if no prior exposure to that type had occurred before vaccination. In sensitivity analyses, we considered partial cross-protection against types 31/33/45/58 and efficacy against all future infections, irrespective of previous or current infection status.

Results

In base-case analyses, vaccinating 17 year-olds reduced their lifetime risk of treatment for precancerous lesions from 7.77% to 3.48% and their lifetime cervical cancer risk from 0.52% to 0.24%. These risks were 6.12% and 0.45%, respectively, for a 25 year-old vaccinee. The incremental cost-effectiveness ratio (ICER) for vaccinating 17-25 year-olds was €22,526 per quality-adjusted life-year (QALY) at a vaccine price of €65 per dose, a 50% reduction of the 2010 pharmacy price in the Netherlands. If cross-protection against types 31/33/45/58 was included, the ICER decreased to €14,734 per QALY. Results were robust to efficacy assumptions with respect to previous or current infection status.

Conclusion

The clinical benefit of HPV vaccination of women up to 25 years moderately depends on cross-protection to non-vaccine types. Refunding the cost of the vaccine to 17-25 year-old women in the Netherlands can be considered cost-effective at anticipated price reductions.     

Cost-Effectiveness of Boceprevir in Patients Previously Treated for Chronic Hepatitis C Genotype 1 Infection in the United States

ObjectivesThe phase 3 trial, Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol-2 (RESPOND-2), demonstrated that the addition of boceprevir (BOC) to peginterferon-ribavirin (PR) resulted in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection as compared with PR alone. We evaluated the cost-effectiveness of treatment with BOC in previously treated patients with chronic hepatitis C in the United States using treatment-related data from RESPOND-2 and PROVIDE studies.MethodsWe developed a Markov cohort model to project the burden of HCV disease, lifetime costs, and quality-adjusted life-years associated with PR and two BOC-based therapies—response-guided therapy (BOC/RGT) and fixed-duration therapy for 48 weeks (BOC/PR48). We estimated treatment-related inputs (efficacy, adverse events, and discontinuations) from clinical trials and obtained disease progression rates, costs, and quality-of-life data from published studies. We estimated the incremental cost-effectiveness ratio (ICER) for BOC-based regimens as studied in RESPOND-2, as well as by patient’s prior response to treatment and the IL-28B genotype.ResultsBOC-based regimens were projected to reduce the lifetime incidence of liver-related complications by 43% to 53% in comparison with treatment with PR. The ICER of BOC/RGT in comparison with that of PR was $30,200, and the ICER of BOC/PR48 in comparison with that of BOC/RGT was $91,500. At a willingness-to-pay threshold of $50,000, the probabilities of BOC/RGT and BOC/PR48 being the preferred option were 0.74 and 0.25, respectively.ConclusionsIn patients previously treated for chronic HCV genotype-1 infection, BOC was projected to increase quality-adjusted life-years and reduce the lifetime incidence of liver complications. In addition, BOC-based therapies were projected to be cost-effective in comparison with PR alone at commonly used willingness-to-pay thresholds.     

Probabilistic sensitivity analysis in cost-effectiveness. An application from a study of vaccination against pneumococcal bacteremia in the elderly

OBJECTIVES: We explore the policy implications of probabilistic sensitivity analysis in cost-effectiveness analysis by applying simulation methods to a decision model. METHODS: We present the multiway sensitivity analysis results of a study of the cost-effectiveness of vaccination against pneumococcal bacteremia in the elderly. We then execute a probabilistic sensitivity analysis of the cost-effectiveness ratio by specifying posterior distributions for the uncertain parameters in our decision analysis model. In order to estimate probability intervals, we rank the numerical values of the simulated incremental cost-effectiveness ratios (ICERs) to take into account preferences along the cost-effectiveness plane. RESULTS: The 95% probability intervals for the ICER were generally much narrower than the difference between the best case and worst case results from a multiway sensitivity analysis. Although the multiway sensitivity analysis had indicated that, in the worst case, vaccination in the 85 and older age group was not acceptable from a policy standpoint, probabilistic methods indicated that the cost-effectiveness of vaccination was below $50,000 per quality-adjusted life-year in greater than 92% of the simulations and below $100,000 in greater than 95% of the simulations. CONCLUSIONS: Probabilistic methods can supplement multiway sensitivity analyses to provide a more comprehensive picture of the uncertainty associated with cost-effectiveness ratios and thereby inform policy decisions.     

Cost-effectiveness analysis of Helicobacter pylori screening in prevention of gastric cancer in Chinese

OBJECTIVES: The aim of this study was to evaluate the costs and effectiveness associated with no screening, Helicobacter pylori serology screening, and the 13C-urea breath test (UBT) for gastric cancer in the Chinese population. METHODS: A Markov model simulation was carried out in Singaporean Chinese at 40 years of age (n = 478,500) from the perspective of public healthcare providers. The main outcome measures were costs, number of gastric cancer cases prevented, life-years saved, quality-adjusted life-years (QALYs) gained from the screening age to death, and incremental cost-effectiveness ratios (ICERs), which were compared among the three strategies. The uncertainty surrounding ICERs was addressed by scenario analyses and probabilistic sensitivity analysis using Monte Carlo simulation. RESULTS: The ICER of serology screening versus no screening was $25,881 per QALY gained (95 percent confidence interval (95 percent CI), $5,700 to $120,000). The ICER of UBT versus no screening was $53,602 per QALY gained (95 percent CI, $16,000 to $230,000). ICER of UBT versus serology screening was $470,000 per QALY gained, for which almost all random samples of the ICERs distributed above $50,000 per QALY. CONCLUSIONS: It cannot be confidently concluded that either H pylori screening was a cost-effective strategy compared with no screening in all Chinese at the age of 40 years. Nevertheless, serology screening has demonstrated much more potential to be a cost-effective strategy, especially in the population with higher gastric cancer prevalence.