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Abstract
Objectives
To assess the clinical and cost-effectiveness of human papillomavirus (HPV) primary screening triage with p16/Ki-67 dual stain cytology compared to cytology.
Methods
We conducted an Excel®-based budget impact model to estimate the preinvasive and invasive cervical cancer cases identified, mortality rate, direct medical costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness analysis of two strategies from the healthcare payer perspective. The study population is a cohort of women 30–65 years of age presenting for cervical screening.
Results
HPV primary screening triage with p16/Ki-67 dual stain showed higher sensitivity without losing specificity compared to conventional Pap smear. The improving the screening performance leads to decrease the prevalence of precancerous lesion, annual incidence and mortality of cervical cancer. The incidence of cervical cancer case detected by new algorithm compared with conventional method were 31,607 and 38,927, respectively. In addition, the new algorithm was more effective and more costly (average QALY 24.03, annual cost $13,262,693) than conventional cytology (average QALY 23.98, annual cost $7,713,251). The incremental cost-effective ratio (ICER) per QALY gained was $1,395. The sensitivity analysis showed if the cost of cytology and HPV test increased three times, the ICER would fall to $303/QALY gained and increased to $4,970/QALY gained, respectively.
References
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Fig. 1.
A model of the patient flow through a cervical cancer screening. CIN, cervical intraepithelial neoplasia; FU, follow up; HPV, human papillomavirus.
Fig. 2.
Screening model. (A) Cytology: screening with conventional cytology. (B) HPV/dual stain: HPV DNA test with genotyping 16&18 plus triage with p16/Ki-67 dual stain. ASCUS, atypical squamous cells of undetermined significance; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; ICC, invasive cervical cancer. * Women with negative colposcopy return to routine screening, women with CIN or ICC were referred to treatment.
Fig. 3.
The prevalence of preinvasive cervical cancer, cervical cancer, and mortality rate from cancer. CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus.
Table 1.
Data of HPV infection and cancer based on published reference
Table 2.
Details of total direct medical costs
| Cost parameters | Input value (USD*) |
|---|---|
| Screening costs [41] | |
| Office visit (routine/repeat screening) | 2.00 |
| Cytology test (lab fee) | 5.30 |
| Cytology test (professional fee) | 3.00 |
| HPV DNA test | 17.00 |
| P16/Ki-67 Dual staining | 35.00 |
| Diagnosis costs [41] | |
| Office visit (diagnostic follow-up) | 12.86 |
| Colposcopy plus biopsy | 21.42 |
| CINtec® p16 Histology | 25.37 |
| Treatment costs [41–43] | |
| Treatment for CIN2/CIN3 | 1,292.00 |
| Treatment for ICC† | 7,403.00 |
| • Stage IA1 | 1,206.29 |
| • Stage IA2–IIA | 2,904.94 |
| • Stage IIB–IVA | 163,334.63 |
| • Stage IVB | 9,168.74 |
| End of life cancer treatment cost | 10,019.00 |
| Discounting rate [20] | |
| Discount rate for cost | 0.035 |
| Discount rate for health outcomes | 0.035 |
Table 3.
Screening performance, cost, average QALY and ICER per QALY gained
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