Budget impact model of a 5-grass sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis

Figures & data

Figure 1. Model framework.

Table 1. Target population.

Parameter	Percentage of previous row	Number of patients	Sources
Covered population		1,000,000	Assumption
Patients aged 10–65^a	74.50%	744,996	US Census Bureau31
Patients aged 10–65 who were diagnosed with AR in the past year^b	7.99%	59,548	Bloom et al.32; Schiller et al.33
Patients aged 10–65 who were diagnosed with AR and are allergic to grass pollen^c	44.20%	26,320	Salo et al.1
Total target population		26,320

^aCensus population estimate as of July 1, 2012.

^bChildren (between the ages of 10–17) who had AR during the past year and adults who reported a diagnosis of AR during the past year as told by a physician or healthcare professional. Estimates weighted by US census data to account for the proportion of patients in each age range to create a weighted average.

^cBased on the percentage of patients with AR with detectable levels of allergen-specific IgEs for rye grass among a representative sample of the US population.

Table 2. Base case market share with and without the 5-grass SLIT tablet.

	Market share without 5-grass SLIT tablet^a			Market share with 5-grass SLIT tablet^b
	Year 1	Year 2	Year 3	Year 1	Year 2	Year 3
5-grass SLIT tablet	0.00%	0.00%	0.00%	10.00%	12.00%	14.00%
Untreated or OTC	40.83%	40.83%	40.83%	38.76%	38.35%	37.94%
SCIT	14.09%	14.09%	14.09%	14.09%	14.09%	14.09%
INS	12.60%	12.60%	12.60%	11.97%	11.84%	11.71%
Ophthalmic anti-allergic	0.70%	0.70%	0.70%	0.66%	0.66%	0.65%
Antihistamine	3.12%	3.12%	3.12%	2.96%	2.93%	2.89%
Montelukast	3.19%	3.19%	3.19%	3.03%	3.00%	2.97%
SCIT + INS + Ophthalmic anti-allergic + Antihistamine + Montelukast	0.17%	0.17%	0.17%	0.17%	0.17%	0.17%
SCIT + INS + Ophthalmic anti-allergic + Antihistamine	0.28%	0.28%	0.28%	0.28%	0.28%	0.28%
SCIT + INS + Ophthalmic anti-allergic + Montelukast	0.25%	0.25%	0.25%	0.25%	0.25%	0.25%
SCIT + INS + Antihistamine + Montelukast	0.80%	0.80%	0.80%	0.80%	0.80%	0.80%
SCIT + Ophthalmic anti-allergic + Antihistamine + Montelukast	0.08%	0.08%	0.08%	0.08%	0.08%	0.08%
INS + Ophthalmic anti-allergic + Antihistamine + Montelukast	0.14%	0.14%	0.14%	0.13%	0.13%	0.13%
SCIT + INS + Ophthalmic anti-allergic	0.56%	0.56%	0.56%	0.56%	0.56%	0.56%
SCIT + INS + Antihistamine	1.82%	1.82%	1.82%	1.82%	1.82%	1.82%
SCIT + INS + Montelukast	1.75%	1.75%	1.75%	1.75%	1.75%	1.75%
SCIT + Ophthalmic anti-allergic + Antihistamine	0.15%	0.15%	0.15%	0.15%	0.15%	0.15%
SCIT + Ophthalmic anti-allergic + Montelukast	0.15%	0.15%	0.15%	0.15%	0.15%	0.15%
SCIT + Antihistamine + Montelukast	0.50%	0.50%	0.50%	0.50%	0.50%	0.50%
INS + Ophthalmic anti-allergic + Antihistamine	0.30%	0.30%	0.30%	0.28%	0.28%	0.28%
INS + Ophthalmic anti-allergic + Montelukast	0.27%	0.27%	0.27%	0.25%	0.25%	0.25%
INS + Antihistamine + Montelukast	0.91%	0.91%	0.91%	0.87%	0.86%	0.85%
Ophthalmic anti-allergic + Antihistamine + Montelukast	0.06%	0.06%	0.06%	0.06%	0.06%	0.06%
SCIT + INS	5.98%	5.98%	5.98%	5.98%	5.98%	5.98%
SCIT + Ophthalmic anti-allergic	0.51%	0.51%	0.51%	0.51%	0.51%	0.51%
SCIT + Antihistamine	1.77%	1.77%	1.77%	1.77%	1.77%	1.77%
SCIT + Montelukast	2.00%	2.00%	2.00%	2.00%	2.00%	2.00%
INS + Ophthalmic anti-allergic	0.80%	0.80%	0.80%	0.76%	0.75%	0.74%
INS + Antihistamine	2.67%	2.67%	2.67%	2.54%	2.51%	2.48%
INS + Montelukast	2.62%	2.62%	2.62%	2.49%	2.46%	2.43%
Ophthalmic anti-allergic + Antihistamine	0.20%	0.20%	0.20%	0.19%	0.19%	0.19%
Ophthalmic anti-allergic + Montelukast	0.14%	0.14%	0.14%	0.13%	0.13%	0.13%
Antihistamine + Montelukast	0.61%	0.61%	0.61%	0.58%	0.57%	0.57%

^aBase case market shares without entry of the 5-grass SLIT tablet were derived from an analysis of the OptumHealth database (April 1, 2012 to March 31, 2013).

^bAssumptions about market share of the 5-grass SLIT tablet after market entry were based on market shares of SLIT in other countries35^,36. The base case for this model assumed that 65% of AR patients treated with the 5-grass SLIT tablet would use it as an add-on to existing pharmacological therapy29. The 5-grass SLIT tablet was assumed not to replace or be used in addition to treatment combinations that include SCIT. Where the 5-grass SLIT tablet replaced patients’ existing pharmacological therapy, it was assumed that the market share of the existing therapy would be reduced in proportion to the treatment’s market share prior to entry of the 5-grass SLIT tablet.

Table 3. Base case pharmacy costs.

Treatment	Average cost per month^a	Average months per year prior to allergy season^b	Average months per year during allergy season^b	Compliance rate	Actual months of use per year	Co-payment^a	Dispensing fee per fill^a	Yearly total drug cost
INS	$53.05	0	2	100%	2	$9.02	$1.69	$91.44
Ophthalmic anti-allergic	$107.74	0	2	100%	2	$15.05	$1.69	$188.75
Antihistamine	$60.32	0	2	100%	2	$9.81	$1.69	$104.40
Montelukast	$91.79	0	2	100%	2	$11.87	$1.69	$163.23
Untreated or OTC pharmacotherapy only	$0.00	0	0	100%	0	$0.00	$1.69	$0.00
5-grass SLIT tablet	$300.00	4	2	100%	6	$56.12	$1.69	$1473.42
Epinephrine auto-injector dual pack^c (yearly cost)	$262.69	1	0	100%	1	$56.12	$1.69	$208.26

^aAverage cost per month and co-payment for INS, ophthalmic anti-allergics, antihistamines, and montelukast were based on the OptumHealth Reporting and Insight claims analysis. The dispensing fee per fill was based on an average of the dispensing fee for branded and generic drugs for a 30-day retail supply37.

^bAverage duration of treatment (both prior to and during the allergy season) for the 5-grass SLIT tablet was based on the results of a US study in 473 adults aged 18 through 65 years.29

^cYearly epinephrine auto-injector cost was based on average of Red Book® price data for various epinephrine auto-injector dual pack products, as of February 10, 201438. For 5-grass SLIT tablet patients only, one epinephrine auto-injector fill per year was assumed.

Table 4. Resource utilization by encounter and treatment type.

Resource use	Children (<18 years)	Adults (≥18 years)	Source
SCIT
Number of inpatient stays per month	0.002	0.010	Hankin et al.39
Number of AIT-related outpatient visits per month	1.322	0.789	Hankin et al.39
Number of non-AIT outpatient visits per month	1.267	1.251	Hankin et al.39
Number of allergy tests per month	0.028	0.028	Assumption
Antihistamines/INS/Montelukast/Untreated/OTC
Number of inpatient stays per month	0.001	0.006	Hankin et al.39
Number of AIT-related outpatient visits per month	0.000	0.000	Hankin et al.39
Number of non-AIT outpatient visits per month	2.185	1.794	Hankin et al.39
Number of allergy tests per month	0.000	0.000	Assumption
5-grass SLIT tablet
Number of inpatient stays per month	0.002	0.010	Assumption
Number of AIT-related outpatient visits per month	0.167	0.167	Assumption
Number of non-AIT outpatient visits per month	1.267	1.251	Assumption
Number of allergy tests per month	0.028	0.028	Assumption

Table 5. Budget impact (2013 USD).

	Year 1	Year 2	Year 3
Total budget impact
Pharmacy
Without 5-grass SLIT tablet	$1,962,528	$1,966,257	$1,969,993
With 5-grass SLIT tablet	$6,329,067	$7,216,059	$8,106,399
Incremental	$4,366,539	$5,249,802	$6,136,406
Medical
Without 5-grass SLIT tablet	$117,181,331	$117,403,976	$117,627,043
With 5-grass SLIT tablet	$114,656,811	$114,368,796	$114,079,272
Incremental	−$2,524,520	−$3,035,180	−$3,547,771
Total
Without 5-grass SLIT tablet	$119,143,859	$119,370,233	$119,597,036
With 5-grass SLIT tablet	$120,985,878	$121,584,855	$122,185,672
Incremental	$1,842,019	$2,214,623	$2,588,636
PMPM budget impact
Pharmacy
Without 5-grass SLIT tablet	$0.164	$0.164	$0.164
With 5-grass SLIT tablet	$0.527	$0.601	$0.676
Incremental	$0.364	$0.437	$0.511
Medical
Without 5-grass SLIT tablet	$9.765	$9.784	$9.802
With 5-grass SLIT tablet	$9.555	$9.531	$9.507
Incremental	−$0.210	−$0.253	−$0.296
Total
Without 5-grass SLIT tablet	$9.929	$9.948	$9.966
With 5-grass SLIT tablet	$10.082	$10.132	$10.182
Incremental	$0.154	$0.185	$0.216

Figure 2. Sensitivity analysis of total PMPM costs with ±20% variation from base case inputs – Year 1. For the overall compliance rate, the sensitivity analysis only considered a low input of 80% relative to the base case of 100%. For the percent poly-sensitized among 5-grass SLIT tablet users, the sensitivity analysis considered 0% and 100% relative to the base case of 65%.

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