The HI-STAR study: resource utilization and costs associated with serologic testing for antibody-positive patients at four United States medical centers.

BACKGROUND: Little is known about how the resource utilization and costs of serologic work ups for positive antibody screens vary across subpopulations based on diagnosis, transfusion history, and serologic testing history. STUDY DESIGN AND METHODS: Detailed data were collected on patient demographics, diagnoses, transfusion history, history of known allo- and autoantibodies, and specific serologic tests performed for 6077 consecutive serologic work ups in 3608 antibody-positive patients between 2009 and 2011 at four US academic medical centers. Direct testing costs were also determined at each site for each serologic test performed to calculate total costs per work up and per patient over the duration of the study. RESULTS: The mean direct cost of serologic testing was $114 per work up and $195 per patient. The mean cost per patient was significantly higher for 12 of 19 diagnostic categories evaluated, including autoimmune hemolytic anemia (mean cost per patient, $1490; p < 0.001), hematologic malignancies ($640, p < 0.001), and transplant recipients ($462, p = 0.019). Patient transfusion and serologic testing characteristics associated with greatest increases in costs included history of a warm autoantibody ($626, p < 0.001) and more than five prior transfusions ($404, p < 0.001). CONCLUSION: Antibody-positive patients with complex diagnoses or transfusion histories require significantly more resources and incur greater cost to assess red blood cell antibody status.

Cost-effectiveness of KRAS testing in metastatic colorectal cancer patients in the United States and Germany.

The objective of this study was to determine the cost-effectiveness of testing for KRAS mutations before administering EGFR inhibitors such as cetuximab and panitumumab for patients with advanced metastatic colorectal cancer (mCRC) in the United States and Germany. We developed a lifetime Markov model of costs and survival associated with treating mCRC patients to assess the impact of KRAS testing before administering EGFR inhibitor-containing chemotherapy regimens. Overall, combination therapies involving cetuximab plus irinotecan/FOLFIRI had a better life expectancy (25.83 weeks) than cetuximab or panitumumab alone. Use of KRAS testing (assuming KRAS mutant patients receive only irinotecan) was equally effective and saved $12,428 per patient in the United States. When KRAS mutant patients received best supportive care, the life expectancy decreased slightly (24.26 weeks vs. 25.83 weeks) and the costs decreased by $13,501 in the United States and €9,560 in Germany. For patients treated with cetuximab alone, use of KRAS testing to identify mutations lowered costs by $8,040 per patient in the U.S. analysis and €3,856 per patient in the German analysis. For patients treated with panitumumab alone, use of KRAS testing to identify mutations lowered costs by $7,546 per patient in the U.S. analysis and €4,612 per patient in the German analysis. Model results were sensitive to the cost of chemotherapy regimens and the prevalence of KRAS mutations in the population. Under most scenarios, using KRAS testing to select patients for EGFR inhibitor therapy saved $7,500-$12,400 per patient in the United States and €3,900-€9,600 per patient in Germany with equivalent clinical outcomes.

Cost-effectiveness of using human papillomavirus 16/18 genotype triage in cervical cancer screening.

OBJECTIVE: Testing for human papillomavirus (HPV) 16 and 18 genotypes, which are known to cause approximately 65-70% of invasive cervical cancer cases, may allow clinicians to identify women at highest risk for underlying cervical intraepithelial neoplasia missed by Pap cytology. Our objective was to determine the cost-effectiveness of adding HPV-16 and 18 genotype triage to current cervical cancer screening strategies in the United States. METHODS: We developed a lifetime Markov model to assess the cost-effectiveness of the following cervical cancer screening algorithms: (1) liquid-based cytology (LBC), (2) LBC+HPV triage, (3) HPV+LBC triage, (4) co-screening, (5) co-screening+HPV genotyping, and (6) HPV only+HPV genotyping. Costs were estimated from a payer perspective in 2007 U.S. dollars. Outcome measures included lifetime risk of cervical cancer, quality-adjusted life years saved (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: In our model, the use of HPV genotyping strategies prevented 51-73 deaths per 100,000 women screened compared to screening using LBC followed by HPV triage and 4-26 deaths compared to co-screening with LBC and high-risk HPV. Use of HPV genotyping to triage all high-risk HPV-positive women every three years had an ICER of $34,074 per QALY compared to HPV and LBC co-screening. HPV genotyping with co-screening was the most effective strategy and had an ICER of $33,807 per QALY compared to HPV genotyping for all high-risk HPV-positive women. CONCLUSION: The addition of HPV-16 and -18 genotype triage to HPV and LBC co-screening was a cost-effective screening strategy in the United States.

Cost-effectiveness of high-risk human papillomavirus testing for cervical cancer screening in Québec, Canada.

OBJECTIVES: Human papillomavirus (HPV) testing is not widely used for triage of equivocal Pap smears or primary screening in Québec, Canada. Our objective was to evaluate the cost-effectiveness of cervical cancer screening strategies utilizing HPV testing. METHODS: We used a lifetime Markov model to estimate costs, quality of life, and survival associated with the following strategies: 1) cytology; 2) cytology with HPV testing to triage equivocal Pap smears; 3) HPV testing followed by colposcopy for HPV-positive women; 4) HPV testing with cytology to triage HPV-positive women; and 5) simultaneous HPV testing and cytology. Cytology was used in all strategies prior to age 30. Outcome measures included disease incidence, quality-adjusted life-years saved (QALYs), lifetime risk of cervical cancer, and incremental cost-effectiveness ratios. RESULTS: All strategies incorporating HPV testing as a primary screening test were more effective and less expensive than annual cytology alone, while HPV testing to triage equivocal Pap smears annually was very cost-effective ($2,991 per QALY gained compared to annual cytology alone). When compared to cytology every three years, HPV-based strategies cost an additional $8,200 to $13,400 per QALY gained. CONCLUSION: Strategies incorporating HPV testing are not only more effective than screening based on cytology alone but are also highly cost-effective. Provincial policy-makers should evaluate incorporating HPV-based strategies into current cervical cancer screening guidelines.

Cost effectiveness of high-risk HPV DNA testing for cervical cancer screening in South Africa.

OBJECTIVE: To determine the cost effectiveness of several cervical cancer screening strategies utilizing HPV testing in South Africa. METHODS: We developed a lifetime Markov model of the costs, quality of life, and survival associated with screening and treating cervical cancer and its precursors. Screening strategies evaluated included: 1) conventional cytology, 2) cytology followed by HPV testing for triage of equivocal cytology, 3) HPV testing, 4) HPV testing followed by cytology for triage of HPV-positive women, and 5) co-screening with cytology and HPV testing. Primary outcome measures included quality-adjusted life-years saved (QALYs), incremental cost-effectiveness ratios, and lifetime risk of cervical cancer. Costs are in 2006 South African Rand (R). RESULTS: In a cohort of 100,000 women, starting at age 30 and screening once every 10 years reduced the lifetime risk of cervical cancer by 13-52% depending on the screening strategy used, at an incremental cost of R13,000-R42,000 per QALY. When strategies were compared incrementally, cytology with HPV triage was less expensive and more effective than screening using cytology alone. HPV testing with the use of cytology triage was a more effective strategy and costs an additional R42,121 per QALY. HPV testing with colposcopy for HPV-positive women was the next most effective option at an incremental cost of R1541 per QALY. Simultaneous HPV testing and cytology co-screening was the most effective strategy and had an incremental cost of R25,414 per QALY. CONCLUSIONS: In our model, HPV testing to screen for cervical cancer and its precursors is a cost-effective strategy in South Africa.

Cost-effectiveness of alternative strategies for initiating and monitoring highly active antiretroviral therapy in the developing world.

OBJECTIVE: Determine the cost-effectiveness of initiating and monitoring highly active antiretroviral therapy (HAART) in developing countries according to developing world versus developed world guidelines. DESIGN: Lifetime Markov model incorporating costs, quality of life, survival, and transmission to sexual contacts. METHODS: We evaluated treating patients with HIV in South Africa according to World Health Organization (WHO) "3 by 5" guidelines (treat CD4 counts 100,000 copies/mL, and monitor CD4 cell counts and viral load every 3 months. RESULTS: Incorporating transmission to partners (excluding indirect costs), treating patients according to developed versus developing world guidelines increased costs by US $11,867 and increased life expectancy by 3.00 quality-adjusted life-years (QALYs), for an incremental cost-effectiveness of $3956 per QALY. Including indirect costs, over the duration of the model, there are net cost savings to the economy of $39.4 billion, with increased direct medical costs of $60.5 billion offset by indirect cost savings of $99.9 billion. CONCLUSIONS: Treating patients with HIV according to developed versus developing world guidelines is highly cost-effective and may result in substantial long-term savings.