Cost-effectiveness of SQ^® HDM SLIT-tablet in addition to pharmacotherapy for the treatment of house dust mite allergic rhinitis in Germany

Figures & data

Table 1 Health care resource use from phase III randomized controlled trial

Resource	Unit price (€)	SQ HDM SLIT-tablet patients		Pharmacotherapy patients
		Mean annual values	Total annual cost (€)	Mean annual values	Total annual cost (€)
SQ HDM SLIT-tableta	2.53	365 tablets	916	0 tablets	0
Desloratadine 5 mgb	68.62	151 tablets	104	179 tablets	123
Budesonide spray 64 μgb	18.17	78 doses	14.13	91 doses	16.43
Azelastine eye drops 0.05%b	11.25	27 doses	1.64	28 doses	1.69
Doctor visitsc	29.35	0.098 visits	2.899	0.1037 visits	3.04

Notes: Five health care resources were included in the analysis. Unit prices for the resources (2015 prices) were combined with the resource use (mean annual values) to estimate the total annual cost. The resource use was recorded within the phase III randomized controlled trial (MT-06) by patients who used electronic diaries to record day-to-day usage.

a Source: correspondence with ALK-Abello, Horsholm, Denmark;

b source: https://www.gkv-spitzenverband.de;

c source: http://www.kbv.de/html/.

Abbreviations: HDM, house dust mite; SLIT, sublingual allergy immunotherapy; SQ, standardized quality.

Figure 1 An overview of the analysis structure.

Notes: A pharmacoeconomic analysis was undertaken to assess the impact of SQ HDM SLIT-tablet on allergic rhinitis patients with poor disease control despite taking pharmacotherapy. Two treatment options were included: SQ HDM SLIT-tablet plus pharmacotherapy and pharmacotherapy alone. A nine-year time horizon was used, with SQ HDM SLIT-tablet patients given treatment for three years. Over this nine-year horizon, the total costs and QALYs were estimated for each treatment group, and compared via the calculation of the ICER.
Abbreviations: QALY, quality-adjusted life-year; ICER, incremental cost-effectiveness ratio; HDM, house dust mite; SLIT, sublingual allergy immunotherapy; SQ, standardized quality.

Table 2 Summary of the utility changes assessed in each scenario

Scenario	Utility change – SQ HDM SLIT-tablet			Utility change – pharmacotherapy
	Years 2–3	Years 4–5	Years 6–9	Years 2–3	Years 4–5	Years 6–9
Base case	+5%	0%	−10%	0%	0%	−5%
1	0%	0%	0%	0%	0%	0%
2	0%	0%	−5%	0%	0%	−5%
3	+5%	0%	0%	0%	0%	0%

Notes: Within all four scenarios, utility scores (ie, quality of life) were based on one-year results from the MT-06 trial. For all remaining years, utility scores were altered via an annual rate of change, to highlight the impact that long-term changes in patient outcomes had on the results. The rates of change in each scenario are shown in the table.

Abbreviations: HDM, house dust mite; SLIT, sublingual allergy immunotherapy; SQ, standardized quality.

Table 3 Summary of the distributions applied for the PSA

Parameter	Mean	Standard error	Alpha	Beta	Distribution type
SQ HDM SLIT-tablet
Desloratadine 5 mg	20.18	1.3055	238.95	0.08	Gamma
Budesonide spray 64 μg	10.8	0.8628	156.69	0.07	Gamma
Azelastine eye drops 0.05%	3.75	0.5984	39.27	0.10	Gamma
Doctor visits	0.011	0.0061	3.30	0.00	Gamma
Change in utility	0.0286	0.0040	50.793	1,725.19	Beta
Utility change – on treatment	5%	0.025	N/A	N/A	Normal
Utility change – all remaining years	−10%	0.025	N/A	N/A	Normal
Pharmacotherapy
Desloratadine 5 mg	24.45	1.3822	312.92	0.08	Gamma
Budesonide spray 64 μg	12.76	0.9338	186.72	0.07	Gamma
Azelastine eye drops 0.05%	4.02	0.5708	49.61	0.08	Gamma
Doctor visits	0.013	0.0067	3.82	0.00	Gamma
Change in utility	0.0141	0.0046	9.374	655.45	Beta
Utility change - on treatment	0%	0.025	N/A	N/A	Normal
Utility change - all remaining years	−5%	0.025	N/A	N/A	Normal

Notes: Mean and standard error values for all parameters, except utility change, were taken from MT-06 trial data. The mean and standard error values for the utility change parameters were based on conservative assumptions and, during PSA, were designed to achieve approximately a ±5% variation from the mean value. A specific distribution was fitted to each parameter with the type of distribution chosen to ensure the spread of values was accurately modeled.

Abbreviations: HDM, house dust mite; SLIT, sublingual allergy immunotherapy; PSA, probabilistic sensitivity analysis; N/A, not applicable; SQ, standardized quality.

Table 4 Summary of the results from the base case and other scenarios

Scenario	QALY difference	ICER (€)
Base case	0.31	7,519
1	0.17	13,848
2	0.16	14,551
3	0.68	3,359

Notes: A total of four scenarios were used to investigate changes in the long-term effectiveness of SQ HDM SLIT-tablet. Within the base case scenario, SQ HDM SLIT-tablet patients were assumed to have an initial improvement in outcomes (years 2 to 3), followed by a longer-term decline (years 6 to 9). Scenario one investigated the impact of stability in both treatment groups for the full time horizon. Within scenario two it was assumed that there was a stable phase initially, followed by a small long-term decline in effectiveness in both treatment groups (years 6 to 9). Scenario three investigated an increase in effectiveness for SQ HDM SLIT-tablet with no subsequent decline.

Abbreviations: QALY, quality-adjusted life year; ICER, incremental cost-effectiveness ratio; HDM, house dust mite; SLIT, sublingual allergy immunotherapy; SQ, standardized quality.

Table 5 Summary of the deterministic sensitivity analysis

Parameter	Base case value	Range tested		Results (ICER)
		Low	High	Low (€)	High (€)
Cost of SQ HDM SLIT-tablet	€2.53	€2.00	€3.00	10,469	9,437
Baseline utility – SQ HDM SLIT-tablet	0.919	0.85	0.95	−8,475	12,337
Baseline utility – pharmacotherapy	0.898	0.85	0.95	24,120	−5,521
Annual change in utility, years 2 and 3 – SQ HDM SLIT- tablet	5.00%	−5%	10%	−28,698	11,236
Annual change in utility, years 2 and 3 – pharmacotherapy	0.00%	−5%	10%	21,486	−13,206
Annual change in utility, years 6 to 9 – SQ HDM SLIT-tablet	−10.00%	−15%	10%	−2,377	38,551
Annual change in utility, years 6 to 9 – pharmacotherapy	−5.00%	−15%	10%	33,135	−16,262

Notes: Sensitivity analysis was undertaken to view the impact of changes in the value of input parameters applied in the model. The range of values tested for each parameter is displayed via the highest and lowest value adopted in that range. The overall results of the model can be deemed to be sensitive to changes in an individual parameter if the ICER changes substantially from the base case value of €7,519. In the table, a number of negative ICERs are presented, which indicate when SQ HDM SLIT-tablet is less effective and more costly (and therefore not cost-effective). For all parameters, with the exception of the cost of the SQ HDM SLIT-tablet, the ICER value changed substantially within the range tested.

Abbreviations: ICER, incremental cost-effectiveness ratio; HDM, house dust mite; SLIT, sublingual allergy immunotherapy; SQ, standardized quality.