Table 2.
Key model inputs and assumptions
| Variable | Base | Range | Distribution | Reference(s) |
|---|---|---|---|---|
| Annual discount rate | ||||
| Effects and costs | 3.0 % | 2.7–5.0 % | Normal | Assumption |
| Unit costs (2013 USD) | ||||
| Office visit (routine/repeat screening) | $72.81 | $65.53–$80.09 | Normal | CPT 99213 (office visit, established patient) |
| Cytology | $27.85 | $25.07–$30.64 | Normal | CPT 88142, 88143 (cytopathology, cervical or vaginal) |
| HPV DNA pooled test | $48.24 | $43.42–$53.06 | Normal | CPT 87621 (agent detection by nucleic acid; papillomavirus, human, amplified probe technique) |
| HPV-16/18 genotyping test | $48.24 | $43.42–$53.06 | Normal | Same as above |
| Colposcopy plus biopsy | $287.67a | $258.90–$316.44 | Normal | CPT 57455 (colposcopy and biopsy of cervix) |
| Treatment for ≥CIN 3 | $1,292b | $1,162–$1,421.20 | Normal | [11] |
| Cervical cancer treatment | $47,840b | $40,445–$49,432.90 | Normal | [11, 16] |
| Sensitivity for ≥CIN 3 | ||||
| Cytology (with reflex HPV test [ASC-US]) | 56.1 % | 50.5–61.7 % | Beta | ATHENA [7] |
| HPV with genotyping (reflex cytology [ASC-US]) | 72.0 % | 64.8–79.2 % | Beta | ATHENA [7] |
| HPV HR only (with reflex to cytology) | 51.9 % | 46.7–57.1 % | Beta | ATHENA [7] |
| Co-testing (with reflex for ASC-US) | 56.1 % | 50.5–61.7 % | Beta | ATHENA [7] |
| Specificity for ≥CIN 3 | ||||
| Cytology (with reflex HPV test [ASC-US]), | 87.6 % | 78.8–96.4 % | Beta | ATHENA [7] |
| HPV with genotyping (reflex cytology [ASC-US]) | 85.2 % | 76.7–93.7 % | Beta | ATHENA [7] |
| HPV HR only (with reflex to cytology) | 91.3 % | 82.2–100 % | Beta | ATHENA [7] |
| Co-testing (with reflex for ASC-US) | 87.6 % | 78.8–96.4 % | Beta | ATHENA [7] |
| Estimated sensitivities for 1-year follow-up scenario | Base (%) | Range | Distribution | Formula for calculationc |
|---|---|---|---|---|
| Cytology (with reflex HPV test [ASC-US])d | 56.1 | (106 + 0)/189 = 56.1 % | ||
| HPV with genotyping (reflex cytology [ASC-US]) | 89.9 | (136 + 34)/189 = 89.9 % | ||
| HPV HR only (with reflex to cytology) | 89.9 | (98 + 72)/189 = 89.9 % | ||
| Co-testing (with reflex for ASC-US) | 94.2 | (106 + 72)/189 = 94.2 % |
| Health utilities | Base | Range | Distribution | Reference(s) |
|---|---|---|---|---|
| Well | 1.0 | 0.90–1.0 | Beta | [19] |
| CIN 1 | 0.97 | 0.87–1.0 | Beta | [19] |
| CIN 2 | 0.97 | 0.87–1.0 | Beta | [19] |
| CIN 3 | 0.97 | 0.87–1.0 | Beta | [19] |
| Cervical cancer | 0.71e | 0.64–0.78 | Beta | [19, 28] |
ASC-US atypical squamous cells of undetermined significance, ATHENA Addressing THE Need for Advanced HPV Diagnostics, CIN cervical intraepithelial neoplasia, CPT common procedural terminology, DNA deoxyribonucleic acid, HPV human papillomavirus, HPV HR human papillomavirus, high-risk, SEER National Cancer Institute Surveillance Epidemiology and End Results, USD United States dollars
aEstimated cost includes physician’s fee (CPT 88305, US$70.09). Model assumed ratio of colposcopies to biopsies = 1.5; 82.6 % of colposcopy/biopsy procedures were performed in physicians’ offices and 17.4 % were performed in hospital outpatient settings
bCosts were adjusted to 2013 USD using the medical component of the Consumer Pricing Index
cAdjusted sensitivity values were calculated as (baseline + 1-year follow-up)/total ≥ CIN 3, where baseline and 1-year follow-up signified the number of ≥CIN 3 cases detected at baseline screening and 1-year follow-up, respectively, and total ≥CIN 3 (denominator) indicated the total cumulative number of ≥CIN 3 cases prevalent in the ATHENA trial cohort as confirmed by colposcopy and valid biopsy
dThis strategy does not include retesting at 1 year. Women with >ASC-US or who have ASC-US and are high-risk HPV-positive are referred for immediate colposcopy
eAssumption was based on health utilities for cervical cancer in treatment phase (0.79 for Stage I and 0.62 for Stages II–IV), weighted by SEER stage distribution for cervical cancer at diagnosis; value represents weighted mean health utility. Assumed 5 % unstaged patients were distributed as follows: 2 % local; 2 % regional; and 2 % distant disease