The budget impact of introducing delayed-release dimethyl fumarate for treatment of relapse-remitting multiple sclerosis in Canada

Figures & data

Table 1. Treatment mix scenarios.

Treatment	Without delayed-release DMF			With delayed-release DMF
	2014	2015	2016	2014	2015	2016
Delayed-release DMF	—	—	—	6.8%	11.5%	20.4%
Interferon beta-1a	24.9%	25.7%	26.3%	23.2%	22.7%	20.9%
Interferon beta-1a SC 22 mg	13.0%	12.6%	12.3%	12.1%	11.2%	9.8%
Interferon beta-1a SC 44 mg	13.0%	12.6%	12.3%	12.1%	11.2%	9.8%
Interferon beta-1b (Betaseron)	12.1%	11.3%	10.5%	11.3%	10.0%	8.4%
Interferon beta-1b Extavia	2.3%	2.7%	3.0%	2.2%	2.4%	2.4%
Glatiramer acetate	34.7%	35.2%	35.6%	32.3%	31.1%	28.3%

Table 2. Population distribution and relapse rates according to EDSS distribution.

EDSS	Population distribution^a	Annual relapse rate due to natural history^b
0	5.05%	1.26
1	8.52%	1.32
2	34.08%	1.32
3	22.94%	1.35
4	20.64%	1.36
5	8.64%	1.43
6	0.13%	1.18
7	0.00%	1.23
8	0.00%	1.23
9	0.00%	1.23

^aDerived from pooled analysis of the intent to treat population of relevant DR-DMF clinical trials (CONFIRM and DEFINE).

^bAnnualized natural history relapse rates per person per year sourced from pooled baseline data from the DR-DMF trials, which documented the annual relapse rate in the 12 months before enrolment in the studies.

Table 3. Discontinuation and relapse rates by treatment.20

Treatment	Discontinuation rate	Annualized relapse rate*
Delayed-release DMF	10.9%	0.5556
Interferon beta-1a	11.2%	0.8150
Interferon beta-1a SC 22 mg	16.5%	0.7431
Interferon beta-1a SC 44 mg	14.6%	0.6959
Interferon beta-1b (Betaseron)	7.2%	0.6915
Interferon beta-1b Extavia	7.2%	0.6915
Glatiramer acetate	9%	0.6718

*Relative to placebo; adjusted for treatment discontinuation.

Figure 1. Difference in total annual cost. All costs reported in 2013 Canadian dollars.

Table 4. Total cost outcomes.

Total costs per year	2014	2015	2016
Per patient
With delayed-release DMF	$24,950	$25,077	$25,345
Without delayed-release DMF	$24,732	$24,706	$24,683
Difference	$217	$371	$662
Whole population
With delayed-release DMF	$1,456,386,096	$1,478,585,789	$1,509,493,681
Without delayed-release DMF	$1,443,700,722	$1,456,738,377	$1,470,063,757
Difference	$12,685,374	$21,847,412	$39,429,925

All costs reported in 2013 Canadian dollars.

Table 5. Disaggregated cost outcomes.

Disaggregated costs per patient per year	2014	2015	2016
Drug acquisition cost
With delayed-release DMF	$18,457	$18,649	$19,046
Without delayed-release DMF	$18,139	$18,108	$18,080
Difference	$318	$541	$996
Drug administration and monitoring cost
With delayed-release DMF	$180	$180	$180
Without delayed-release DMF	$180	$180	$180
Difference	$0	$0	$0.58
Relapse cost
With delayed-release DMF	$6,312	$6,247	$6,118
Without delayed-release DMF	$6,413	$6,418	$6,423
Difference	−$101	−$171	−$304

All costs reported in 2013 Canadian dollars.

Figure 2. Results of the deterministic sensitivity analysis on the 2016 budget. All costs reported in 2013 Canadian dollars.

Hutchinson M, Fox RJ, Havrdova E, et al. Efficacy and safety of BG-12 (dimethyl fumarate) and other disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison. Curr Med Res Opin 2014;30:613-27

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