Cost-Effectiveness of a Proteomic Test for Preterm Birth Prediction

Figures & data

Table 1 Model Inputs

	Base Case Value	Range (Lower–Upper)	Source
Number of live births (Jan–Dec 2016)	62,093	NA	HIRD
Number (%) of preterm births under usual care	4360 (7.0%)	NA	HIRD
Proportion of women opting to be tested	0.85	0.70–1.00	Expert opinion
Characteristics of PreTRM^® test
Sensitivity*	0.75	0.5–0.83	Saade 2016^Citation14; data on file
Specificity*	0.74	0.49–0.82	Saade 2016^Citation14; data on file
Cost (one-time)	$745	$395–1000	Expert opinion
Proportion of women identified as high-risk opting to receive treatment	0.90	0.60–1.00	Expert opinion
Characteristics of treatment for high-risk pregnancies
Proportion of treated women who adhere to the treatment	0.80	0.60–1.00	Expert opinion
Cost of high-intensity case management, including additional MFM specialist visits, weekly nurse monitoring, additional ultrasounds for cervical length assessment, and daily low-dose aspirin (per week)	$54.2	$34.2–58.2	CMS physician fee schedule for office visits and transvaginal ultrasounds (2019), plus generic cost of low-dose aspirin
Cost of progesterone (per week)	$26	$20–50	Average wholesale price for 200mg/day. Lower bound represents generic oral progesterone.** Upper bound based on average of branded oral and vaginal formulations
Effectiveness of treatment (risk ratio for preterm birth reduction)	0.13–0.68; depending on gestational week	0.01–0.83; depending on gestational week	Analysis of published literature on multi-component regimens (see Appendix Table A2 and “Methods Comments” section for details)

Notes: Usual care assumes no testing and minimal progesterone use. *Sensitivity and specificity are linked via the following equation: Specificity = 2.0062 + 2.4210 × ln (1-Sensitivity) −2.6145 × Sensitivity + 7.2006 × Sensitivity². **Based on expert opinion, we assumed the majority of vaginal progesterone use is via suppository or direct insertion of an oral progesterone formulation.

Abbreviations: CMS, Center for Medicare and Medicaid Services; HIRD, HealthCore Integrated Research Database; MFM, maternal-fetal medicine.

Table 2 Model Results: Base Case and Scenario Analyses

	Usual Care	Risk-Screening-and-Treat Strategy	Incremental Difference	Savings per Prevented PTB*	Savings per Pregnant Woman
Base case
Cost (USD)	$2611m	$2558m	-$53.6m	$61,581	$863
Number of preterm births	4360	3490	−870
Scenario 1: Lower treatment effectiveness
Cost (USD)	$2611m	$2613m	$1.7m	$3989 (ICER)	N/A
Number of preterm births	4360	3924	−436
Scenario 2: Higher treatment effectiveness
Cost (USD)	$2611m	$2518m	-$93.6m	$70,722	$1508
Number of preterm births	4360	3036	−1324
Scenario 3: Alternate infant cost definition
Cost (USD)	$2876m	$2803m	-$73.4m	$84,344	$1182
Number of preterm births	4360	3490	−870
Scenario 4: Infant costs 0–12 months only
Cost (USD)	$2438m	$2387m	-$51.1m	$58,727	$823
Number of preterm births	4360	3490	−870
Scenario 5: Infant costs 0–12 months only, with alternate infant cost definition
Cost (USD)	$2548m	$2481m	-$67.7m	$77,779	$1090
Number of preterm births	4360	3490	−870

Notes: In Scenario 1, where incremental costs are positive, there are no savings and the number presented equals the actual ICER. Costs presented in 2018 USD. Incremental costs = risk-screening-and-treat strategy costs minus usual care costs. Risk-screening-and-treat is dominant (cost-saving and at least 1 preterm birth prevented) in the base case and all scenarios except Scenario 1. See Appendix for definitions of lower (Scenario 1) and higher (Scenario 2) treatment effectiveness. In Scenario 3, only costs from infants who were fully enrolled in their health plan over the 30-month follow-up time period were utilized (vs also using costs of those with <30-months enrollment; see Appendix Table A4). Scenario 4 truncated the modelling timeframe to the first 12 months after birth to observe a shorter-term impact (vs using 30 months). Scenario 5 used fully enrolled 12-month infant costs and a 12-month modelling horizon (a combination of Scenarios 3 and 4). *Equal to the absolute value of the ICER.

Abbreviations: PTB, preterm birth; m, million.

Figure 1 Health care costs for the first year of life and preterm birth rates by gestational age, usual care, 2016 data from the HealthCore Integrated Research Database.

Table 3 Model Results: Base Case Additional Endpoints

Outcome	Usual Care	Risk-Screening-and-Treat Strategy	Incremental Difference (%)
Total cost (USD) for births <37 weeks	$566m	$426m	−$140m (−24.8%)
Number of PTBs (% relative to total population)
<32 weeks’ gestational age	525 (0.85%)	351 (0.57%)	−174 (−33.1%)
<35 weeks' gestational age	1698 (2.73%)	1250 (2.01%)	−448 (−26.4%)
<37 weeks’ gestational age (total)	4360 (7.02%)	3490 (5.62%)	−870 (−20.0%)
Infant outcomes for births <37 weeks
Any NICU admission (% relative to total population)	2821 (4.54%)	2194 (3.53%)	−628 (−22.2%)
Length of stay (days)	17.83	16.37	−1.46 (−8.2%)
NICU length of stay (days)	16.52	15.00	−1.52 (−9.2%)
Mean neonatal morbidity/mortality index over 30 days from birth	1.32	1.26	−0.06 (−4.5%)
Neonatal morbidity/mortality index ≥3 (% relative to total population)	870 (1.40%)	632 (1.02%)	−238 (−27.4%)
Infant outcomes for all births
Any NICU admission (% relative to total population)	5939 (9.56%)	5358 (8.63%)	−581 (−9.8%)
Length of stay (days)	4.04	3.75	−0.29 (−7.2%)
NICU length of stay (days)	1.53	1.22	−0.31 (−20.3%)
Mean neonatal morbidity/mortality index over 30 days from birth	0.19	0.16	−0.02 (−11.0%)
Neonatal morbidity/mortality index ≥3 (% relative to total population)	1037 (1.67%)	801 (1.29%)	−236 (−22.7%)

Notes: Costs presented in 2018 US dollars (USD). Percentages are relative to the total population of 62,093.

Abbreviations: NICU, neonatal intensive care unit; PTB, preterm birth; m, million.

Figure 2 Model results: Sensitivity analyses. (A) Univariate sensitivity analysis (tornado diagram), base case. The tornado diagram (upper panel) ranks input parameters by their influence on the incremental cost-effectiveness ratio (ICER), from highest to lowest. (B) Probabilistic sensitivity analysis, base case. Each blue dot in the ICER scatter plot (lower panel) represents one of the 10,000 PSA simulation outcomes. The scatter plot is wedge-shaped with all mass in the second quadrant. All dots below the x-axis represent cost savings. In the base case, all simulations are associated with cost savings and PTB reductions.

Abbreviations: PTB, preterm birth; PSA, probabilistic sensitivity analysis; HICM, high-intensity case management; CI, confidence interval (95%).

Saade GR, Boggess KA, Sullivan SA, et al. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016;214(5):633.e1–633.e24. doi:10.1016/j.ajog.2016.02.001

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