Cost–consequence analysis of ¹⁸F-fluciclovine for the staging of recurrent prostate cancer

Figures & data

Table 1. Imaging utilization

Diagnostic test/product	Local	Regional	Metastatic
Base Case
MRI	4.8%	8.7%	6.9%
CT	90.5%	87.0%	46.3%
SPECT ProstaScint	4.8%	4.3%	0.5%
SPECT (99mTc)	0%	0%	46.3%
PET/CT (^18 F-fluciclovine)	0%	0%	0%
Scenario
MRI	4.9%	17.4%	7.0%
CT	44.1%	39.1%	39.5%
SPECT ProstaScint	2.0%	0%	0%
SPECT (99mTc)	0%	0%	46.5%
PET/CT (18 F-fluciclovine)	49.0%	43.5%	7.0%
Incremental utilization (Scenario – Base Case)
MRI	0.1%	8.7%	0%
CT	−46.4%	−47.8%	−6.8%
SPECT ProstaScint	−2.8%	−4.3%	−0.5%
SPECT (99mTc)	0%	0%	0.2%
PET/CT (18 F-fluciclovine)	49.0%	43.5%	7.0%

Figure 1. Model structure

Table 2. Demographic inputs

Parameter	Value	Source
Demographics and Epidemiology
Proportion of men	49.3%	US Census[13]
Epidemiology
Complete Prevalence of PCa	2.6%	SEER[12]
Incidence of suspected or recurring PCa	30.0%	Caire et al, 2009[2]
Mix of PCa after recurrence 1–5 years after Initial Treatment (relative rates)
Metastatic	5.3%	SEER[12]
Regional	12.6%	SEER[12]
Local	82.1%	SEER[12]
Mix of PCa after recurrence following false negative Dx Outcome
Metastatic	25.0%	Clinical Expert Opinion*
Regional (Defined volume)	35.0%	Clinical Expert Opinion*
Local	40.0%	Clinical Expert Opinion*

*Clinical experts: Urologists from two leading academic centers (Duke Cancer Center, Durham, North Carolina and Massachusetts General Hospital, Boston, Massachusetts).

Table 3. Test specifications

	Test outcome rate
	+/+	-/-
Diagnostic test/product	TP (Sensitivity)	TN (Specificity)
Diagnostic Test Performance Specifications – Prostatic Bed (Local)
MRI	24.3%	100.0%
CT	11.6%	48.3%
SPECT ProstaScint	67.2%	56.7%
PET/CT (^18 F-fluciclovine)	90.2%	40.0%
Diagnostic Test Performance Specifications – Extra-Prostatic Bed (Regional and Metastatic/Distant)
MRI	39.3%	80.6%
CT	13.1%	96.7%
SPECT (ProstaScint)	10.0%	86.7%
SPECT (99mTc)	18.9%	85.0%
PET/CT (^18 F-fluciclovine)	55.0%	96.7%

TP = True Positive; TN = True Negative.

Table 4. Changes in patient management with conventional and ¹⁸ F-fluciclovine imaging

	Management plan based on conventional imaging (LOCATE pre-scan plan)	Management plan based on ^18 F-fluciclovine imaging (LOCATE post-scan plan)	Expected change in Management plan with ^18 F-fluciclovine imaging	Remain on Initial Management plan	Expected changed RT Field with ^18 F-fluciclovine imaging
Confirmed Local
Active Surveillance	0.0%	11.9%	N/A	N/A	N/A
RT	28.6%	33.3%	0.0%	100.0%	16.7%
ADT	33.3%	9.5%	71.4%	28.6%	N/A
RT+ ADT	16.7%	16.7%	0.0%	100.0%	42.9%
Prostatectomy	4.8%	9.5%	0.0%	100.0%	N/A
Lymphadenectomy	2.4%	0.0%	100.0%	0.0%	N/A
Cryotherapy	9.5%	11.9%	0.0%	100.0%	N/A
Brachytherapy	2.4%	2.4%	0.0%	100.0%	N/A
Other	2.4%	4.8%
Confirmed Regional Prostate Cancer
Active Surveillance	0.0%	3.2%	0.0%	0.0%	N/A
RT	19.4%	22.6%	0.0%	100.0%	66.7%
ADT	41.9%	22.6%	46.2%	53.8%	N/A
RT+ ADT	32.3%	32.3%	0.0%	100.0%	30.0%
Prostatectomy	0.0%	6.5%	0.0%	0.0%	N/A
Lymphadenectomy	0.0%	0.0%	0.0%	0.0%	N/A
Cryotherapy	3.2%	0.0%	100.0%	0.0%	N/A
Brachytherapy	0.0%	0.0%	0.0%	0.0%	N/A
Other	3.2%	12.9%	0.0%	100.0%	N/A
Confirmed Metastatic Prostate Cancer
Active Surveillance	0.0%	7.4%	0.0%	0.0%	N/A
RT	28.8%	16.7%	40.0%	60.0%	33.3%
ADT	42.3%	24.1%	36.4%	63.6%	N/A
RT+ ADT	21.2%	37.0%	0.0%	100.0%	9.1%
Prostatectomy	0.0%	0.0%	0.0%	0.0%	N/A
Lymphadenectomy	0.0%	0.0%	0.0%	0.0%	N/A
Cryotherapy	7.7%	3.7%	50.0%	50.0%	N/A
Brachytherapy	0.0%	0.0%	0.0%	0.0%	N/A
Other	0.0%	11.1%	0.0%	0.0%	N/A

RT = Radiation Therapy; ADT = androgen deprivation therapy.

Table 5. Economic inputs

Parameter	Value
Weighted average Evaluation and Management (CPT 99,211–99,215)	$249.99
MRI (CPT 72,197)	$353.31
CT (CPT 72,194)	$279.08
SPECT (CPT 78,803)	$120.95
PET/CT (CPT 78,816)	$752.30
(MRI) Omniscan	$319.68
(CT) Isovue	$429.31
(SPECT) ProstaScint	$1,463.70
(SPECT) 99mTc	$490.35
(PET/CT) Fluciclovine	$3,675.00
Initial Treatment (0–12 months)
Active Surveillance	$14,906
Radiation Therapy (RT)	$27,203
Androgen deprivation therapy (ADT)	$16,733
RT + ADT	$35,569
Prostatectomy	$10,324
Lymphadenectomy (HCPCS 38,571)	$7,595
Cryotherapy	$6,111
Brachytherapy	$2,500
Other	$29,884
Continuous Treatment (13–60 months)
Active Surveillance	$36,889
RT	$18,525
ADT	$44,417
RT + ADT	$26,353
Other	$149,324
Additional Health Resource Assumptions
Proportion of initial care consumed before false positive is discovered	50.0%
Number of expected retests before conclusive test outcome	3.7
Ratio of Local: Metastatic Health care costs	1.52

Figure 2. Deterministic sensitivity analysis (DSA) results (without treatment costs)

Figure 3. Health outcomes for the base case and scenario

Figure 4. Economic results

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