Economic evaluation of a 100% whey-based partially hydrolyzed infant formula in the prevention of atopic dermatitis among Danish children

Figures & data

Table 1.  Epidemiological and clinical parameters applied in the base case analysis and in the primary sensitivity analysis.

	Quantity applied	Reference
Initial cohort
Newborns in Denmark in 2009	63,411	26
Exclusively breastfed infants in Denmark	78.5%	27
Percentage of ‘at risk’ newborns	33%	3,5,6
Infants forming starting cohort	4544	Calculation
Of formula-fed infants in Denmark, average percentage who are exclusively formula-fed	2.5%	Calculation29
Of formula-fed infants in Denmark, average percentage who are both formula-fed and breastfed	97.5%	Calculation29
Incidence rates of AD with PHF-W
Time points
0–3 months	0.97%	13,14
3–6 months	1.35%	13,14
6–12 months	3.83%	13,14
12–18 months	0.96%	13,14
18–24 months	0.97%	13,14
24–30 months	1.48%	13,14
30–36 months	1.86%	13,14
Nominal relative risk of developing AD
PHF-W vs EHF-Whey
0–3 months	1.0	14
3–6 months	1.0	14
6–12 months	1.8	14
12–18 months	1.3	14
18–24 months	1.3	14
24–30 months	1.1	14
30–36 months	1.1	14
PHF-W vs EHF-Casein
0–3 months	0.9	14
3–6 months	0.9	14
6–12 months	0.9	14
12–18 months	0.7	14
18–24 months	0.7	14
24–30 months	0.9	14
30–36 months	0.9	14
Distribution of cases of AD
Face
Mild	9.9%	EP
Moderate	1.8%	EP
Severe	2%	EP
Body
Mild	28.4%	EP
Moderate	6.6%	EP
Severe	6.3%	EP
Face and Body
Mild	28.4%	EP
Moderate	8.3%	EP
Severe	8.3%	EP
Management approach for infants less that 6 months old
Therapeutic management	80%	EP
Combined management	20%	EP
Estimated response rates to the therapeutic management approach
First-line treatment
Mild	89.5%	EP
Moderate	86%	EP
Severe	82.5% on the face and 70% for the rest	EP
Second-line treatment
Mild	95%	EP
Moderate	91%	EP
Severe	90%	EP
Third-line treatment
Mild	100%	EP
Moderate	97%	EP
Severe	95%	EP
Fourth-line treatment
Mild	Not required	EP
Moderate	100%	EP
Severe	99%	EP
Estimated response rates to the combined management approach
First-line treatment
Mild	98.75% on the face and 98.25% for the rest	EP
Moderate	89.25%	EP
Severe	61%	EP
Second-line treatment
Mild	100%	EP
Moderate	96.25%	EP
Severe	88.5%	EP
Third-line treatment
Mild	Not required	EP
Moderate	99%	EP
Severe	93.5%	EP
Fourth-line teatment
Mild	Not required	EP
Moderate	100%	EP
Severe	99%	EP
Rates of AD flare-ups
Mild	25%	EP
Moderate	30%	EP
Severe	50%	EP
Mortality rate in the general Danish population
At the end of the first year of life	0.39%	30
At the end of the second year of life	0.03%	30

AD, Atopic dermatitis; EHF, Extensively hydrolyzed formula; EP, Expert panel; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

Table 2.  Economic parameters applied in the base case analysis and in the primary sensitivity analysis.

	Quantity applied	Reference	Cost per unit	Reference
Formula
PHF-W (Nestlé – NAN-HA 1®)	Varied with the age of the subject and with the rate of partial breastfeeding^a	Calculation	DKK 80.95/600 g	^b
EHF-Whey (ALK – Profylac®)		Calculation	DKK 198.50/400 g	^b
EHF-Casein (Mead Johnson – Nutramigen®)		Calculation	DKK 198.00/400 g	^b
Amino Acid Based Formula (Mead Johnson – Nutramigen AA®)		Calculation	DKK 198.00/400 g	^b
Medical visits
General Practitioner	All 1^st-line Tx, 2^nd-line Tx of all mild cases and 50% of moderate cases	EP	DKK 129.40/visit	32
Specialist (Dermatologist or Allergist)	2^nd-line Tx of 50% of moderate cases and all severe cases, 3 ^rd-line Tx and beyond of mild, moderate, and severe cases	EP	DKK 650.00/first two visits, then DKK 462.00/visit	33
Re-assessment visit in case of non-response to Tx	2 weeks after Tx failure	EP	As above	32,33
Hospitalization	1% of severe cases	EP	DKK 3528	Survey of a local hospital
Treatment
Emollient Creams Archiv®	2 L per 2-month period	EP	DKK 67/200 ml	^b
Topical Corticosteroids
Class I – Hydrocortisone 10 mg/g (Mildison Lipid®)	Varied with severity and location of AD and subject’s age^c	EP	DKK 34.50/15 g	35
Class II – Clobetasone 0.05% (Emovat®)		EP	DKK 52.15/25 g	35
Class III – Betamethasone 1 mg/g (Betnovate®)		EP	DKK 51.15/30 g	35
Class IV – Clobetasol 0.5 mg/g (Dermovat®)		EP	DKK 42.25/25 g	35
Immunosuppressants
Pimecrolimus (Elidel®)	Varied with severity and location of AD and subject’s age^c	EP	DKK 240.60 €/15 g	35
Tacrolimus 0.03% (Protopic®)		EP	DKK 131.25 €/10 g	35
Tacrolimus 0.1% (Protopic®)		EP	DKK 147.40 €/10 g	35
Laboratory tests
Prick Test	Used once in 50% of moderate cases and all severe cases	EP	DKK 220.00/test	Survey of a local clinic
Oral Provocation Test	Used once in 50% of moderate cases and all severe cases	EP	DKK 289.00/test	See above
Food Eviction Test	Used once in 10% of severe cases	EP	DKK 707.00/test	See above
Specific IgE Test	Used once in 10% of moderate or severe cases	EP	Included in the medical visit	See above
MOH reimbursement rates
Infant formulas used for prevention	60% for up to 4 months	28
Infant formulas used for treatment	60% for up to 6 months	28
Prescribed medication	60% for up to DKK 1410; 75% between DKK 1410–3045; 85% if over DKK 3045	36
Emollients	0%	EP
Medical visits, laboratory testing, and hospitalization	100%	EP
Participation in the workforce in Denmark	76.7%	37
Time loss
Physician visits and laboratory testing	4 h for each visit	Assumption	DKK 248.81/hour	38,39
Child care for 2 days after the initial medical visit	8 h per day	Assumption	DKK 248.81/hour	38,39
Application of emollient cream	20 min daily over the application period	Assumption	DKK 248.81/hour	38,39
Application of topical medications (corticosteroids and immunosuppressants)	10 min daily over the application period	Assumption	DKK 248.81/hour	38,39
Hospitalization	2 days, 7.27 h per day	EP	DKK 248.81/hour	38,39
Travel	Travel to and from physician visits or laboratory testing (10 km each way)	Assumption	DKK 232.00/two-way trip	Surveyed in Aarhus, Denmark

^aThe full breakdown of the daily quantity of formula consumed over 6 months is available upon request.

^bBased on a survey of costs in pharmacies and in large retailers.

^cDetails of the medical treatment regimen are available upon request.

Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

AD, atopic dermatitis; DKK, Danish kroner; EHF, Extensively hydrolyzed formula; EP, Expert panel; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula; Tx, Treatment.

Figure 1.  Decision tree model depicting the treatment patterns of atopic dermatitis in Denmark in a population ranging from newborns to 3-year olds.

Table 3.  Results of the base case analysis presented from the perspective of the Ministry of Health, of the family of the subject, and of society as a whole.

Perspective	Formula acquisition costs (in DKK)			Savings with PHF-W (in DKK)*
	PHF-W	EHF-Whey	EHF-Casein	PHF-W vs EHF-Whey	PHF-W vs EHF-Casein
Danish MOH	3,526,041	12,968,735	12,937,461	(9,442,695)	(9,411,420)
Family	7,113,852	26,615,100	26,553,744	(19,501,247)	(19,439,892)
Society	10,639,893	39,583,835	39,491,205	(28,943,942)	(28,851,312)

*These savings are presented in parentheses because they are negative values.

Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

DKK, Danish kroner; EHF, Extensively hydrolyzed formula; MOH, Ministry of Health; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

Table 4.  Results of the primary sensitivity analysis comparing PHF-W to EHF-Whey, presented from the perspective of the Ministry of Health, of the family of the subject, and of society as a whole.

	PHF-W	EHF-Whey
Outcomes
Number of Cases	453	728
Avoided Cases	274
Costs (in DKK)
Ministry of Health Perspective
Cost of Formula	3,591,340	13,034,530
Physician Costs	371,749	596,623
Treatment Costs	10,057	16,167
Hospitalization Costs	47,975	77,016
Cost of Lab Tests	63,020	101,169
Total Cost	4,084,141	13,825,505
Incr Cost		−9,741,364
Incr C/AC (ICER)		−35,502*
Family Perspective
Cost of Formula	7,157,386	26,658,963
Treatment Costs	310,399	498,312
Cost of Time Lost	4,621,057	7,412,350
Travel Costs	287,355	461,447
Total Cost	12,376,196	35,031,072
Incr Cost		−22,654,875
Incr C/AC (ICER)		−82,565*
Societal Perspective
Total Cost	16,460,337	48,856,577
Incr Cost		−32,396,239
Incr C/AC (ICER)		−118,067*

*EHF-Whey is dominated by PHF-W.

Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

DKK, Danish kroner; EHF, Extensively hydrolyzed formula; ICER, Incremental cost-effectiveness ratio; Incr, Incremental; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

Table 5.  Results of the secondary sensitivity analyses comparing PHF-W to EHF-Whey, presented from the perspective of the Danish Ministry of Health, of the family of the subject, and of society as a whole.

	Outcomes		Costs in DKK
	Cases		Ministry of Health			Subject’s family			Society
	PHF-W	EHF-Whey	PHF-W	EHF-Whey	ICER	PHF-W	EHF-Whey	ICER	PHF-W	EHF-Whey	ICER
MOH covered 100% of infant formula program for treatment	453	728	4,127,674	13,869,368	− 35,503	12,332,663	34,987,209	−82,564	16,460,337	48,856,577	−118,067
MOH covered 100% of infant formula program for prevention	453	728	6,434,835	22,471,329	−58,444	10,025,503	26,385,248	−59,622	16,460,337	48,856,577	−118,067
MOH covered 100% of infant formula program for prevention up to 6 months of age	453	728	11,197,994	40,440,605	−106,574	5,262,344	8,415,972	−11,493	16,460,337	48,856,577	−118,067
MOH covered 60% of infant formula program for prevention up to 6 months of age	453	728	6,942,036	24,607,071	−64,380	9,518,301	24,249,506	−53,687	16,460,337	48,856,577	−118,067
Lower bound CI of the relative risk used	251	731	3,828,725	13,807,400	−20,804	10,033,821	35,082,065	−52,221	13,862,547	48,889,464	−73,024
Upper bound CI of the relative risk used	812	785	4,566,747	13,935,723	349,304	16,543,350	35,650,714	712,381	21,110,098	49,586,437	1,061,684
Lower bound CI of incident rates used	325	531	3,921,094	13,593,755	−47,022	10,889,416	32,779,762	−106,416	14,810,510	46,373,517	−153,438
Upper bound CI of incident rates used	585	932	4,249,493	14,063,954	−28,294	13,897,674	37,361,897	−67,644	18,147,167	51,425,851	−95,937
The rounded down number of cans was taken	453	728	3,860,886	13,281,711	−34,334	12,227,360	34,668,542	−81,786	16,088,246	47,950,252	−116,120
Cases included more severe and moderate cases	453	728	4,295,959	14,165,263	−35,968	12,661,372	35,488,266	−83,192	16,957,331	49,653,530	−119,160
Reduced the response rate to therapeutic management and combined management by 50%	453	728	4,282,771	14,145,261	−35,943	13,032,950	36,086,343	−84,017	17,315,721	50,231,604	−119,961
Excluded hospitalization	453	728	4,036,167	13,748,489	−35,396	12,315,525	34,940,487	−82,456	16,351,692	48,688,977	−117,852
Time Horizon – 6 months	105	106	3,706,122	13,150,471	−8,870,265	8,367,160	27,880,958	−18,327,633	12,073,282	41,031,428	−27,197,898
Time Horizon – 3 years, discounted at 0%	930	1280	4,586,043	14,407,617	−28,115	17,857,049	41,373,188	−67,317	22,443,092	55,780,804	−95,432
Time Horizon – 3 years, discounted at 3%	908	1254	4,562,602	14,381,176	−28,336	17,596,905	41,080,273	−67,771	22,159,507	55,461,448	−96,107
Time Horizon – 3 years, discounted at 5%	894	1239	4,547,994	14,364,683	−28,476	17,434,944	40,897,751	−68,060	21,982,938	55,262,434	−96,537
Time Horizon – 3 years, only costs discounted at 3%	930	1280	4,564,977	14,383,849	−28,107	17,599,217	41,082,879	−67,224	22,164,194	55,466,728	−95,331
Time Horizon – 3 years, only costs discounted at 5%	930	1280	4,551,848	14,369,024	−28,102	17,438,572	40,901,844	−67,165	21,990,420	55,270,868	−95,268

Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

CI, Confidence interval; EHF, Extensively hydrolyzed formula; ICER, Incremental cost-effectiveness ratio; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

Table 6.  Results of the primary sensitivity analysis comparing EHF-Casein to PHF-W, presented from the perspective of the Ministry of Health, of the family of the subject, and of society as a whole.

	EHF-Casein	PHF-W
Outcomes
Number of Cases	428	453
Avoided Cases	26
Costs (in DKK)
Ministry of Health perspective
Cost of Formula	12,999,064	3,591,340
Physician Costs	350,706	371,749
Treatment Costs	9,488	10,057
Hospitalization Costs	45,259	47,975
Cost of Lab Tests	59,453	63,020
Total Cost	13,463,971	4,084,141
Incr Cost		9,379,830
Incr C/AC (ICER)		365,585
Family perspective
Cost of Formula	26,594,813	7,157,386
Treatment Costs	292,829	310,399
Cost of Time Lost	4,359,488	4,621,057
Travel Costs	271,090	287,355
Total Cost	31,518,220	12,376,196
Incr Cost		19,142,024
Incr C/AC (ICER)		746,073
Societal perspective
Total Cost	44,982,191	16,460,337
Incr Cost		28,521,853
Incr C/AC (ICER)		1,111,658

Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

DKK, Danish kroner; EHF, Extensively hydrolyzed formula; ICER, Incremental cost-effectiveness ratio; Incr, Incremental; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

Table 7.  Results of the secondary sensitivity analyses comparing EHF-Casein to PHF-W, presented from the perspective of the Danish Ministry of Health, of the family of the subject and of society as a whole.

	Outcomes		Costs in DKK
	Cases		Ministry of Health			Subject’s family			Society
	PHF-W	EHF-Casein	EHF-Casein	PHF-W	ICER	EHF-Casein	PHF-W	ICER	EHF-Casein	PHF-W	ICER
MOH covered 100% of infant formula program for treatment	453	428	13,505,040	4,127,674	365,489	31,477,151	12,332,663	746,169	44,982,191	16,460,337	1,111,658
MOH covered 100% of infant formula program for prevention	453	428	22,088,945	6,434,835	610,129	22,893,246	10,025,503	501,529	44,982,191	16,460,337	1,111,658
MOH covered 100% of infant formula program for prevention up to 6 months of age	453	428	40,017,715	11,197,994	1,123,268	4,964,476	5,262,344	−11,610	44,982,191	16,460,337	1,111,658
MOH covered 60% of infant formula program for prevention up to 6 months of age	453	428	24,221,233	6,942,036	673,468	20,760,958	9,518,301	438,190	44,982,191	16,460,337	1,111,658
Lower bound CI of the relative risk used	251	339	13,352,890	3,828,725	−107,980	30,514,033	10,033,821	−232,194	43,866,923	13,862,547	−340,175
Upper bound CI of the relative risk used	812	531	13,600,874	4,566,747	32,131	32,680,785	16,543,350	57,394	46,281,659	21,110,098	89,525
Lower bound CI of incident rates used	325	307	13,315,837	3,921,094	510,781	30,138,718	10,889,416	1,046,562	43,454,555	14,810,510	1,557,343
Upper bound CI of incident rates used	585	552	13,614,525	4,249,493	282,977	32,931,459	13,897,674	575,132	46,545,985	18,147,167	858,109
Number of cans rounded down	453	428	12,921,702	3,860,886	353,151	31,156,707	12,227,360	737,784	44,078,409	16,088,246	1,090,935
Cases included more severe and moderate cases	453	428	13,663,799	4,295,959	365,118	31,787,253	12,661,372	745,444	45,451,052	16,957,331	1,110,561
Reduction of the response rate to therapeutic management and combined management by 50%	453	728	13,651,357	4,282,771	365,147	32,137,799	13,032,950	744,624	45,789,156	17,315,721	1,109,771
Exclusion of hospitalization	453	428	13,418,712	4,036,167	365,691	31,460,983	12,315,525	746,207	44,879,695	16,351,692	1,111,898
Time Horizon – 6 months	105	99	13,107,349	3,706,122	1,575,679	27,736,110	8,367,160	3,246,305	40,843,459	12,073,282	4,821,984
Time Horizon – 3 years, discounted at 0%	930	821	13,876,992	4,586,043	84,915	36,036,560	17,857,049	166,153	49,913,552	22,443,092	251,069
Time Horizon – 3 years, discounted at 3%	908	802	13,857,291	4,562,602	87,802	35,817,626	17,596,905	172,121	49,674,916	22,159,507	259,922
Time Horizon – 3 years, discounted at 5%	894	790	13,845,021	4,547,994	89,707	35,681,409	17,434,944	176,059	49,526,430	21,982,938	265,766
Time Horizon – 3 years, only costs discounted at 3%	930	821	13,859,289	4,564,977	84,946	35,819,570	17,599,217	166,526	49,678,859	22,164,194	251,473
Time Horizon – 3 years, only costs discounted at 5%	930	821	13,848,263	4,551,848	84,965	35,684,458	17,438,572	166,760	49,532,722	21,990,420	251,725

Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

CI, Confidence interval; EHF, Extensively hydrolyzed formula; ICER, Incremental cost-effectiveness ratio; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

Table 8.  Parameter distributions and variations in the probabilistic sensitivity analyses and presentations of the results of the probabilistic sensitivity analysis for PHF-W vs EHF-Whey.

Parameter	Distribution type	Selected range
MOH milk program coverage for prevention for a period of 4 months	Uniform	60–100%
MOH milk program coverage for treatment	Uniform	60–100%
Quantity of milk consumed	Uniform	85–141 grams
Relative risk	Log Normal	95%CI
Incidence rates consideration	Uniform	95%CI
Number of subsequent physician visits after finalizing treatment	DUD	1–2 visits
Rounding down or up the number of cans used	DUD	round down or up
Laboratory tests from the diagnostic approach	DUD	include or exclude
Transportation costs	DUD	include or exclude
Cost of time lost for the application of emollients	DUD	include or exclude
Cost of time lost for the application of medication	DUD	include or exclude
Align medical visits and laboratory tests or not	DUD	same or different times
Cost of leisure time lost	DUD	include or exclude
Days lost due to child at home^a	DUD	1 or 2 days
Time horizon	DUD	6 months, 1 year, 3 years
Discount rate	Uniform	0–5%
Discounting of outcomes	DUD	include or exclude
Monte Carlo results for PHF-W vs EHF-Whey	MOH	Family	Society
PHF-W
Average Costs (in DKK)	5,213,150	10,539,607	15,752,757
Average Number of AD Cases	485	485	485
EHF-Whey
Average Costs (in DKK)	17,861,541	28,995,136	46,856,677
Average Number of AD Cases	711	711	711
Monte Carlo ICERs (in DKK)^a	(55,892)	(81,554)	(137,446)
Median ICERs (in DKK)^b	(41,339)	(61,855)	(103,264)
Distribution
Quadrant 1	0%	0%	0%
Quadrant 2	0%	0%	0%
Quadrant 3^c	14%	14%	14%
Quadrant 4^d	86%	86%	86%

^aThese Monte Carlo ICERs were obtained by dividing the average incremental costs by the average avoided cases of AD which were generated from the 10,000 Monte Carlo simulations. The values are in parentheses because they are negative, i.e., they represent savings.

^bThese median ICERS were generated from each Monte Carlo simulation (accounting for the incremental costs and outcomes of each simulation). The values are in parentheses because they are negative, i.e., they represent savings. ^cQuadrant 3 represents the scenario where PHF-W yielded lower incremental costs but fewer avoided cases than EHF-Whey.

^dQuadrant 4 denotes dominance by PHF-W over EHF-Whey as PHF-W is associated with lesser costs and more avoided cases than EHF-Whey. Note: At time of analysis, 1 DKK = 0.134 € = 0.194 USD.

AD, Atopic dermatitis; CI, Confidence interval; DKK, Danish kroner; DUD, Discreet uniform distribution; EHF, Extensively hydrolyzed formula; ICER, Incremental cost-effectiveness ratio; MOH, Ministry of Health; PHF-W, Nestlé brand of 100% whey-based partially hydrolyzed formula.

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