Budget impact analysis of two immunotherapy products for treatment of grass pollen-induced allergic rhinoconjunctivitis

Figures & data

Table 1 General model assumptions

Overall assumptions	Details
Grass AIT
Duration of treatment	Patients are treated for 3 years according to Summary of Product Characteristics.
Immunotherapy treatment and visits	Year 1: treatment is initiated by two consultations, ie, administration of first tablet in the clinic, and investigation of desired treatment effect approximately one month later. Initial consultations are followed by an additional follow-up consultation. Years 2 and 3: two follow-up consultations per year. In total, seven consultations per treatment course (3 years).
Treatment setting	Initiation of treatment takes place either at the general practitioner’s office, at medical specialist in private clinic or at medical specialist in hospital setting. All follow-up consultations take place at the general practitioner’s office.
Additional medical supervision	No peak flow measurements are performed.
Compliance	Compliance is set to 80%.a
Package size	Treatment is based on packs with 100 tablets and packs with 30 tablets.
Grass SCIT
Duration of treatment	Duration of treatment differs between hospitals (3 or 5 years). It is assumed that 80% of patients are treated for 3 years and 20% are treated for 5 years.
Immunotherapy treatment and visits	Treatment is initiated with weekly injections at the clinic for 15 weeks (uptitration). This is followed by a transition phase with one injection 2 weeks after last uptitration injection and an additional injection 4 weeks after the first transition injection. Maintenance injections with 8 weeks interval. In total, 33 consultations in a 3-year treatment course; 47 consultations in a 5-year treatment course.
Treatment setting	Uptitration of treatment takes place at the general practitioner’s office, at a medical specialist’s private clinic or with a medical specialist in a hospital setting. In the maintenance phase, 1/5 of patients uptitrated by a medical specialist are referred back to their own general practitioner. Treatment at medical specialists in private clinic is performed by internal medicine specialists, dermatologists, or ear, nose and throat specialists.
Additional medical supervision	Peak flow measurements are performed before and after each injection.
Compliance	Compliance in uptitration phase is set to 100%. Compliance in maintenance phase is set to 90%.a
Vials	Vials are personal and cannot be shared between patients. A maintenance vial (5 mL) contains 4.7 injections. All liquid in vials is used. If extra liquid is left after end of treatment, patients will receive extra injection at an additional visit.

Note:

a Based on experiences from daily practice in Denmark.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

Table 2 Resource use (health care utilization)

Resource category	Resource type	Year 1	Year 2	Year 3	Year 4	Year 5
Grass AIT
Medication	Number of tablets (tablet/day × compliance)a	292	292	292	–	–
Physician	Number of initial visits (visit/year)b	2	–	–	–	–
	Treatment by general practitioner	0.2	–	–	–	–
	Treatment in private clinic	1.6	–	–	–	–
	Treatment in hospital setting	0.2	–	–	–	–
	Number of follow-up visits (visit/year)c	1	2	2	–	–
	Treatment by general practitioner	1	2	2	–	–
	Treatment in private clinic	–	–	–	–	–
	Treatment in hospital setting	–	–	–	–	–
Patient	Travel distance (km/visit)d	30	20	20	–	–
	Time lost (hours/visit)e	6	4	4	–	–
Grass SCIT
Medication	Number of uptitration kits	1	–	–	–	–
	Number of maintenance vials needed (actual)f	1.06	0.34	0.83	1.11	0.60
	Number of maintenance vials needed (rounded)g	2	1	1	2	1
	Remaining injections in opened vial at the end of the yearh	4.4	3.1	0.8	4.2	1.9
Physician	Uptitration visits	15	–	–	–	–
	Maintenance visits	5	6	7	6	8
	Number of peak flow measurementsi	10	12	14	12	16
Patient	Travel distance (km/visit)d	200	60	70	60	80
	Time lost (hours/visit)e	40	12	14	12	16

Notes:

a One tablet/day; compliance = 80%;

b two initial visits;

c One follow-up visit 1st year; 2 follow-up visits the following years;

d 10 km/visit based on experiences from daily practice in Denmark;

e 2 hours/visit based on experiences from daily practice in Denmark;

f number of maintenance visits (injections)/no of injections per maintenance vial; ie, no of maintenance visits (injections)/4.7;

g number of maintenance vials rounded to nearest whole vial;

h [number of maintenance vial needed (rounded) – number of maintenance vials (actual)] × number of injections per maintenance vial. Remaining injections in opened vial at the end of the year are used in the following year;

i peak flow measurements are performed before and after each injection. Peak flow measurements are included in medical specialist costs (private clinic/hospital setting), but not in general practice costs. Because general practitioners perform part of the maintenance visits, peak flow measurements are calculated based on number of maintenance visits.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

Table 3 Cost input (in €)

Cost category	Cost type	Unit	Cost/unit
Medication
Grass AIT	Pack with 30 tablets	Per tablet	3.78
	Pack with 100 tablets	Per tablet	3.40
	Average price, model assumptiona	Per tablet	3.48
Grass SCIT	Uptitration kit	Per uptitration	233.80
	Maintenance	Per vial (5 mL)	224.40
Physician visits
General practitioners	Visit	Per visit	17.38
	Peak flow measurement	Per measurement	4.87
Medical specialists in private clinicb	First visit	Per visit	78.86
	Second visit	Per visit	52.43
	Consecutive visit	Per visit	19.34
	First visit including feesc	Per visit	113.49
	Second visit including feesc	Per visit	87.05
	Consecutive visit including fees	Per visit	53.97
Medical specialists in hospital setting	Outpatient visit	Per visit	170.66
	Additional costs, uncomplicated allergy treatment	Per visit	384.03
	Additional costs, complicated allergy treatment	Per visit	528.11
Patient costs
Work	Lost working hoursd	Per hour	36.16
Travel	Travel by private car	Per km	0.48

Notes: All costs are based on 2010 prices unless otherwise stated; medication costs²⁹ physician visit costs;^27,28 patient costs.^25,26

a Treatment based on packs with 100 tablets (80%) and pack with 30 tablets (20%);

b medical specialist costs (private clinic) are based on a weighted average of consultation fees for internal medicine specialists, dermatologists and ear, nose and throat specialists;

c fees include peak flow measurements and fee for injection;

d lost working hours are based on the mean salary/hour for the general population aged 18–65 years in Denmark including the unemployed.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

Figure 1 Decrease in direct treatment costs, patients costs and total costs in relation to treatment with grass AIT as compared with grass SCIT.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

Table 4 Costs (in €) in relation to treatment with grass AIT and grass SCIT

Cost category	Resource type	Year 1	Year 2	Year 3	Year 4	Year 5	Total
Grass AIT
Direct treatment costs	Medication (tablets)	1014	985	956	–	–	2955
	Physician visits	242	34	33	–	–	309
	Treatment by GP	21	34	33	–	–	88
	Treatment in private clinic	110	–	–	–	–	110
	Treatment in hospital setting	111	–	–	–	–	111
Direct treatment costs, total		1256	1019	989	–	–	3264
Direct patient costs	Travel expenses	14	9	9	–	–	32
Direct treatment + patient costs, total		1270	1028	998	–	–	3296
Indirect costs	Patient productivity (time lost)	217	140	136	–	–	493
Total costs		1487	1168	1134	–	–	3789
Grass SCIT
Direct treatment costs	Medication (uptitration kits)	234	–	–	–	–	234
	Medication (maintenance vials)	449	218	212	82	40	1001
	Physician visits	2027	504	571	95	123	3320
	Uptitration visits	1594	–	–	–	–	1594
	Maintenance visits	433	504	571	95	123	1726
Direct treatment costs, total		2710	722	783	177	163	4555
Direct patient costs	Travel expenses	96	28	32	5	7	168
Direct treatment + patient costs, total		2806	750	815	182	170	4723
Indirect costs	Patient productivity (time lost)	1446	421	477	79	103	2526
Total costs		4252	1171	1,292	261	273	7249
Cost reduction (grass AIT – grass SCIT)		−2765	−3	−158	−261	−273	−3460

Note: Costs include 3% discount.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

Figure 2 Relationship between number of patients treated with immunotherapy, treatment costs savings and possibility to initiate additional patients on grass AIT without increasing the current health care budget.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

Table 5 One-way sensitivity analysis (direct treatment costs, in €)

Sensitivity analysis	Mean direct treatment costs (€), grass AIT	Mean and incremental direct treatment costs (€), grass SCIT (difference from grass AIT)
General
Base case	3264	4555 (+1291)
Discount rate
0%	3354	4660 (+1306)
5%	3207	4489 (+1282)
Grass AIT
Base case	3264	4555 (+1291)
Initiation of treatment
100% hospital setting	4148	4555 (+407)
100% general practice	3074	4555 (+1480)
Follow-up treatment
As for grass SCIT	3490	4555 (+1065)
100% general practice	3264	4555 (+1291)
Number of visits/year
4 + 3 + 3	3314	4555 (+1241)
2 + 1 + 1	3213	4555 (+1342)
Compliance
100%	4002	4555 (+553)
60%	2525	4555 (+2030)
Duration of treatment
As for grass SCIT	3688	4555 (+867)
3 years	3264	4555 (+1291)
Grass SCIT
Base case	3264	4555 (+1291)
Injections extracted per vial
+20%	3264	4515 (+1251)
−20%	3264	4836 (+1572)
Uptitration visits
100% hospital setting	3264	11,280 (+8016)
100% general practice	3264	3366 (+102)
Maintenance visits
100% hospital setting	3264	13,891 (+10,627)
100% general practice	3264	3369 (+105)
Number of weeks between injections
10 weeks	3264	3996 (+732)
6 weeks	3264	5301 (+2037)
Compliance, uptitration
100%	3264	4555 (+1291)
80%	3264	4250 (+986)
Compliance, maintenance
100%	3264	4557 (+1293)
70%	3264	4233 (+969)
Duration of treatment
0% treated for 5 yearsa	3264	4214 (+950)
40% treated for 5 years	3264	4894 (+1630)

Note:

a All patients treated for 3 years.

Abbreviations: AIT, allergy immunotherapy tablets; SCIT, subcutaneous immunotherapy.

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