Budget impact analysis of the fentanyl buccal tablet for treatment of breakthrough cancer pain

Figures & data

Figure 1 Target study population.

Abbreviation: BTcP, breakthrough cancer pain.

Table 1 Opioids, presentations, costs per dose, and allocation percentages

Drugs	Strength	Cost (€) per dose in 2012a	Utilization	Discount applied (RD August 2010)d
OTFC	200 μg	5.81	37%b	15%
	400 μg	5.81	33%b	15%
	600 μg	5.81	12%b	15%
	800 μg	6.02	6%b	15%
	1,200 μg	6.02	6%b	15%
	1,600 μg	6.02	6%b	15%
FSL	100 μg	5.44	NA	7.5%
	200 μg	5.44	NA	7.5%
	300 μg	5.44	NA	7.5%
	400 μg	5.44	NA	7.5%
	600 μg	5.44	NA	7.5%
	800 μg	5.44	NA	7.5%
FPNS
One spray	100 μg	4.99	20%c	7.5%
Two sprays	200 μg	9.97	23%c	7.5%
One spray	400 μg	4.99	38%c	7.5%
Two sprays	800 μg	9.97	19%c	7.5%
INFS
One spray	50 μg	6.05	12%b	7.5%
Two sprays	100 μg	12.10	12%b	7.5%
One spray	100 μg	6.05	26%b	7.5%
Two sprays	200 μg	12.10	9%b	7.5%
One spray	200 μg	6.05	31%b	7.5%
Two sprays	400 μg	12.10	11%b	7.5%
FBT	100 μg	5.44	NA	7.5%
	200 μg	5.44	NA	7.5%
	400 μg	5.44	NA	7.5%
	600 μg	5.44	NA	7.5%
	800 μg	5.44	NA	7.5%

Notes:

a Spanish medication database;³⁴

b Mercadente (2009);²³

c Fallon et al (2011);²⁸

d mandatory discount by Spanish Ministry of Health.³⁵

Abbreviations: OTFC, oral transmucosal fentanyl citrate; FBT, fentanyl buccal tablet; FSL, sublingual fentanyl; INFS, intranasal fentanyl spray; FPNS, fentanyl-pectin nasal spray; NA, not applicable, RD, royal decree.

Table 2 Average number of drug doses and costs in EUR on a day with BTcP episodes

Doses (n)	Patients (%)a
	OTFC	FSL	FPNS	INFS	FBT
One	23%	25%	21%	27%	25%
Two	40%	40%	28%	37%	38%
Three	26%	28%	43%	27%	28%
Four	11%	8%	8%	10%	10%
Average daily cost (€)b	13.22	11.83	16.78	17.61	12.10

Notes:

a Clinical expert panel of oncologists;

b Spanish medication database.³⁴

Abbreviations: OTFC, oral transmucosal fentanyl citrate; FBT, fentanyl buccal tablet; FSL, sublingual fentanyl; INFS, intranasal fentanyl spray; FPNS, fentanyl-pectin nasal spray; BTcP, breakthrough cancer pain.

Table 3 Drug costs, medical resource utilization, unit costs, and annual mean cost per patient

Annual resources	OTFC	FSL	FPNS	INFS	FBT	Unit costs (€) in 2012
Drug cost (€)	2,612	2,338	3,315	3,480	2,391	–
Medical visits
Primary care	20.7	20.7	20.7	20.7	20.7	37.90a
Specialist physician	10.7	10.7	10.7	10.7	10.7	68.62b
Annual cost (€)	1,515	1,515	1,515	1,515	1,515	–
Hospital visits
Emergency visit	5.0	4.7	4.0	4.3	2.7	117.20
Annual cost (€)	586	547	469	508	313	–
Other nonpharmacologic treatments (number of visits)
Physiotherapy	1.3	1.3	0.7	1.5	1.3	20.93c
Psychology	8.3	8.0	8.0	8.3	8.0	68.56c
Acupuncture	0.7	0.7	0.7	0.7	0.7	34.28c
TNS	0.7	0	0.0	0.3	0	20.81c
Annual cost (€)	336	599	585	335	599	–
Incidence rates of OISEsd
Vomiting and nausea	10.7%	10.0%	12.3%	16.7%	10.0%	53.20
Headache	6.7%	6.7%	6.7%	8.3%	6.7%	48.23
Somnolence	11.7%	15.0%	10.0%	25.0%	11.7%	65.67
Diarrhea	0.3%	0.3%	0.3%	1.7%	0.3%	2.47
Pruritus	2.0%	2.0%	2.0%	0.0%	2.0%	28.99
Constipation	20.0%	20.0%	16.7%	36.7%	16.7%	53.42
Dysgeusia	2.0%	2.3%	0.3%	0.0%	2.0%	12.75
Anxiety	1.7%	1.7%	1.7%	3.3%	1.7%	17.87
Opioid intoxication	2.0%	2.0%	2.0%	2.0%	2.0%	62.90
Annual cost (€)	30	32	27	51	28	–
Total cost per patient (€)	5,079	5,030	5,912	5,889	4,846	–

Notes: Sources:

a DOGC Núm. 5325⁴²;

b DOGC Núm. 5907⁴³;

c DOG Núm. 213⁴⁴;

d DOC Núm. 85⁴⁵. Unit costs for OISEs are based on input from clinical experts and resource consumption of side effects.

Abbreviations: TNS, transcutaneous nerve stimulation; OTFC, oral transmucosal fentanyl citrate; FBT, fentanyl buccal tablet; FSL, sublingual fentanyl; INFS, intranasal fentanyl spray; FPNS, fentanyl-pectin nasal spray; BTcP, breakthrough cancer pain; OISEs, opioid-induced side effects.

Table 4 Distribution of treatments (%): base case analysis and alternative scenario

	2012	2013	2014	2015
Current scenario
OTFC	47.0%	41.0%	36.2%	32.8%
FSL	24.0%	27.0%	28.2%	27.8%
FPNS	11.0%	12.0%	13.2%	13.8%
INFS	1.0%	4.0%	5.2%	6.8%
FBT	17.0%	16.0%	17.2%	18.8%
Alternative scenario
OTFC	47.0%	41.0%	36.2%	32.8%
FST	24.0%	27.0%	28.2%	27.8%
FPNS	11.0%	11.0%	11.2%	11.6%
INFS	1.0%	2.0%	3.4%	4.8%
FBT	17.0%	19.0%	21.0%	23.0%

Abbreviations: OTFC, oral transmucosal fentanyl citrate; FBT, fentanyl buccal tablet; FSL, sublingual fentanyl; INFS, intranasal fentanyl spray; FPNS, fentanyl-pectin nasal spray.

Table 5 Target population for BTcP treatment

Target population	2012	2013	2014	2015
Adult patients with cancer	138,325	138,577	138,814	139,048
Adult patients with cancer who experience cancer BTcP	56,852	56,955	57,052	57,149
Adult patients with cancer BTcP treated with opioids	40,507	40,580	40,650	40,718
Adult patients with cancer BTcP treated with oral opioids	23,291	23,334	23,374	23,413

Abbreviation: BTcP, breakthrough cancer pain.

Table 6 Results of the base case budget impact analysis in EUR

	2012	2013	2014	2015	Total
Current scenario
OTFC	55,598,511	49,296,933	44,909,054	42,678,954	184,847,989
FSL	28,119,830	32,201,321	34,803,385	36,143,621	125,265,311
FPNS	15,147,363	16,772,584	18,983,937	20,730,465	68,296,918
INFS	1,371,594	5,563,805	7,428,965	10,119,791	23,036,901
FBT	19,187,405	18,366,491	20,396,703	23,426,397	77,683,271
Total cost (€)	119,424,703	122,201,134	126,522,043	133,099,228	479,130,390
Alternative scenario
OTFC	55,598,511	49,296,933	44,909,054	42,678,954	1,84,847,989
FSL	28,119,830	32,201,321	34,803,385	36,143,621	1,25,265,311
FPNS	15,147,363	15,374,868	16,107,583	17,425,609	61,204,261
INFS	1,371,594	2,781,903	4,857,400	7,143,382	15,188,242
FBT	19,187,405	21,810,208	24,902,951	28,659,954	90,063,702
Total cost (€)	119,424,703	121,465,233	125,580,373	132,051,519	476,569,506
Budget impact savings	0	−735,901	−941,670	−1047,709	−2560,884
Annual cost per patient (€)	2012	2013	2014	2015	Average
Current scenario	5,127	5,237	5,413	5,685	5,366
Alternative scenario	5,127	5,206	5,373	5,640	5,336

Abbreviations: OTFC, oral transmucosal fentanyl citrate; FBT, fentanyl buccal tablet; FSL, sublingual fentanyl; INFS, intranasal fentanyl spray; FPNS, fentanyl-pectin nasal spray.

Table 7 One-way sensitivity analysis for the most influential variables in the budget impact model

One-way sensitivity analysis			Budget impact analysis in EUR
Model parameter	Value in model	Sensitivity analysis	2012	2013	2014	2015	Total
Percentage of patients with BTcP episodes	41%	33%	0	−590,869	−756,086	−841,226	−2,056,184
		65%	0	−1,163,834	−1,489,260	−1,656,961	−4,050.060
Percentage of patients treated with opioids	71%	40%	0	−413,137	−528,657	−588,188	−1,437,689
		95%	0	−981,201	−1,255,561	−1,396,945	−3,414,512
Percentage of patients treated with oral or nasal opioids	58%	30%	0	−383,948	−491,306	−546,631	−1,336,113
Days with cancer BTcP episodes	3.8	80%	0	−1,023,862	−1,310,150	−1,457,682	−3,562,969
		1.9	0	−374,079	−496,679	−554,844	−1,339,112
		5.7	0	−1,097,723	−1,386,662	−1,554,575	−3,782,656
Market share projection, FBT (percent annual increase)	2%	1%	0	−681,442	−832,217	−882,401	−2,253,561
		3%	0	−790,359	−1,051,124	−1,213,017	−2,868,207
Cost per day (EUR), FBT	12.10	6.05	0	−1,572,900	−2,003,681	−2,223,491	−5,450,558
		18.15	0	101,098	120,340	128,073	328,790

Abbreviations: BTcP, breakthrough cancer pain; FBT, fentanyl buccal tablet.

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