HPV DNA testing in the triage of atypical squamous cells of undetermined significance (ASCUS): cost comparison of two methods.

Human papillomavirus (HPV) DNA testing for triage of cervical cytologies showing atypical squamous cells of undetermined significance (ASCUS) has become the standard of practice. Currently, Hybrid Capture II (HCII) is the preferred method for ASCUS triage. In situ hybridization for HPV represents an alternative to HCII and appears to have a superior specificity but is more expensive. We compare the reimbursement rates of ASCUS triage (HPV high risk) using the methods of HCII and INFORM (in situ hybridization for HPV) in a series of 431 ASCUS patients. The patients were followed for 1 yr, during which each patient had either colposcopic biopsy or follow-up cervical cytology after ASCUS HPV DNA triage. Eighty-nine patients were excluded from the analysis because of incomplete follow-up. The HPV triage percentages, colposcopic biopsy positivity rates and cervical cytology positivity percentages were calculated for each method. The reimbursement rates of the tests/procedures used in the analysis were those in effect at the University of Utah in 2003. The total triage and follow-up reimbursement costs were calculated for HCII and INFORM and compared.HCII referred 19.9% of patients to colposcopy, with a biopsy positivity rate of 25.6% for dysplasia. INFORM referred 11.8% of patients to colposcopy, of whom 34% had a biopsy diagnosis of dysplasia. HCII negative cases revealed 19% to have ASCUS or higher on the follow-up cervical cytology, while 19.9% of INFORM negative cases had a reading of ASCUS or higher at follow-up cytologic examination. The 1-yr HPV DNA triage and follow-up reimbursements for HCII were 316,942.00 US dollars per 1,000 women, and for the INFORM methodology, the reimbursements were 369,484.00 US dollars per 1,000 women. The INFORM method was associated with higher specificity and sent fewer (41%) patients to colposcopy than did HCII. Although this smaller referral rate reduced reimbursement costs associated with colposcopy, the increased reimbursement paid for follow-up cytologies and office visits of HPV DNA negative patient and the greater cost of the INFORM test results in higher overall reimbursement for INFORM. Based on these costs and diagnostic accuracies, it appears that the INFORM HPV technology represents a viable option to HCII ASCUS triage. INFORM HPV appears to be 16% more expensive than HCII but has the advantage of sending 41% fewer women to colposcopy.

Gene medicine : a new field of molecular medicine.

Gene therapy has emerged as a new concept of therapeutic strategies to treat diseases which do not respond to the conventional therapies. The principle of gene therapy is to introduce genetic materials into patient cells to produce therapeutic proteins in these cells. Gene therapy is now at the stage where a number of dinical trials have been carried out to patients with gene-deficiency disease or cancer. Genetic materials for gene therapy are generally composed of gene expression system and gene delivery system. For the dinical application of gene therapy in a way which conventional drugs are used, researches have been focused on the design of gene delivery system which can offer high transfection efficiency with minimal toxicity. Currently, viral delivery systems generally provide higher transfection efficiency compared with non-viral delivery systems while non-viral delivery systems are less toxic, less immunogenic and manufacturable in large scale compared with viral systems. Recently, novel strategies towards the design of new non-viral delivery system, combination of viral and non-viral delivery systems and targeted delivery system have been extensively studied. The continued effort in this area will lead us to develop gene medicine as 'gene as a drug' in the near future.

Cost-effectiveness of testing hepatitis B-positive pregnant women for hepatitis B e antigen or viral load.

OBJECTIVE: To estimate the cost-effectiveness of testing pregnant women with hepatitis B (hepatitis B surface antigen [HBsAg]-positive) for hepatitis B e antigen (HBeAg) or hepatitis B virus (HBV) DNA, and administering maternal antiviral prophylaxis if indicated, to decrease breakthrough perinatal HBV transmission from the U.S. health care perspective. METHODS: A Markov decision model was constructed for a 2010 birth cohort of 4 million neonates to estimate the cost-effectiveness of two strategies: testing HBsAg-positive pregnant women for 1) HBeAg or 2) HBV load. Maternal antiviral prophylaxis is given from 28 weeks of gestation through 4 weeks postpartum when HBeAg is positive or HBV load is high (10 copies/mL or greater). These strategies were compared with the current recommendation. All neonates born to HBsAg-positive women received recommended active-passive immunoprophylaxis. Effects were measured in quality-adjusted life-years (QALYs) and all costs were in 2010 U.S. dollars. RESULTS: The HBeAg testing strategy saved $3.3 million and 3,080 QALYs and prevented 486 chronic HBV infections compared with the current recommendation. The HBV load testing strategy cost $3 million more than current recommendation, saved 2,080 QALYs, and prevented 324 chronic infections with an incremental cost-effectiveness ratio of $1,583 per QALY saved compared with the current recommendations. The results remained robust over a wide range of assumptions. CONCLUSION: Testing HBsAg-positive pregnant women for HBeAg or HBV load followed by maternal antiviral prophylaxis if HBeAg-positive or high viral load to reduce perinatal hepatitis B transmission in the United States is cost-effective.

Cost and effectiveness comparison of immediate colposcopy versus human papillomavirus DNA testing in management of atypical squamous cells of undetermined significance in Turkish women.

BACKGROUND: A small but significant proportion of cases with atypical squamous cells of undetermined significance (ASCUS) may harbour CIN 2-3, or even invasive carcinoma. Although immediate colposcopy, HPV-DNA testing or expectant management are three recommended options in ASCUS triage, a consensus does not currently exist on which one of these approaches is the most efficient. In this study, we aimed to compare the performance and cost of immediate colposcopy and colposcopy based on the human papillomavirus (HPV) testing for detecting histologically confirmed high-grade cervical intraepithelial neoplasia (CIN) in women with ASCUS. MATERIALS AND METHODS: Records of 594 women with an index Papanicolaou smear showing ASCUS were retrospectively analyzed. Women in the immediate colposcopy arm were referred directly to colposcopy (immediate colposcopy group, n=255) and those in the HPV triage arm were proceeded to colposcopy if the high-risk HPV (hrHPV) test was positive (HPV triage group, n=339). High grade CIN (CIN2+) detection rate and treatment costs were compared between the groups. RESULTS: The detected rate of CIN2+ was higher in the HPV triage group compared to immediate colposcopy group (8% vs. 1.6%, p=0.011). In the HPV triage group, the total cost, cost per patient, and the cost for detecting one case of high grade CIN were higher than the immediate colposcopy group (p<0.001). CONCLUSIONS: In women with ASCUS cytology, HPV DNA testing followed by colposcopy is more costly than immediate colposcopy, but this approach is associated with a higher rate of CIN2+ detection. This findings suggest that HPV DNA testing combined with cervical cytology could reduce the referral rate to colposcopy.

Clinical and economic benefit of HPV-load testing in follow-up and management of women postcone biopsy for CIN2-3.

This study aimed to evaluate the clinical and economic implications of integrating human papilloma virus (HPV) load testing into the follow-up and management protocol of women postconisation for high-grade cervical intraepithelial neoplasia (CIN2-3). We evaluated 130 suitable women: 63 were screened biannually by Pap smears ('conventional approach') and 67 also had HPV-load testing ('HPV approach'). More stringent criteria for undergoing colposcopy or reconisation were observed by the former group compared to the latter. Both approaches were analysed for cost effectiveness. There were 33 out of 67 (49.2%) colposcopic referrals and 24 out of 67 (35.8%) reconisation/hysterectomies with the 'conventional approach' compared to 9 out of 63 (14.2%) and 7 out of 63 (11.1%) with the 'HPV approach'. Cervical intraepithelial neoplasia 2-3 residual disease was detected in 7 out of 67 (10.5%) and 7 out of 63 (11.1%) women. The 'conventional approach' had more negative colposcopic biopsies and more negative reconisation/hysterectomy histologies than the 'HPV approach'. The respective cost per detection of one case of residual disease was US$3573 and US$3485. The 'HPV approach' required fewer colposcopic and reconisation procedures to detect one case of residual CIN2-3. Its higher positive predictive value than that of cytology provided a significant decrease in false positive rates and a reduction of US$88 per detected case.