Economic consequences of migraine in Sweden and Implications for the cost- effectiveness of onabotulinumtoxinA (Botox) for chronic migraine in Sweden and Norway

DOI: https://doi.org/10.1186/s10194- 020- 01162- x

Abstract-Summary This study aimed to describe the economic consequences of migraine in Sweden using cost of illness survey data and, based on this data, assess the cost- effectiveness

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of onabotulinumtoxinA (Botox) for the treatment of chronic migraine in Sweden and Norway.

Resulting costs were estimated as annual averages over subgroups of average

monthly headache days.

Some results were used to inform a Markov cost-effectiveness chronic

migraine model.

Results from the cost of illness analysis (n = 454) indicated a clear correlation between decreased QoL and increased costs with increasing monthly headache days. Total annual costs ranged from EUR 6221 in patients with 0–4 headache days per

month, to EUR 57,832 in patients with 25–31.

The cost-effectiveness analyses indicated that in Sweden, Botox was associated with 0.223 additional QALYs at an additional cost of EUR 4126 compared to pla- cebo, resulting in an incremental cost-effectiveness ratio (ICER) of EUR 18,506.

In Norway, Botox was associated with 0.216 additional QALYs at an additional

cost of EUR 4301 compared to placebo, resulting in an ICER of EUR 19,954.

In people with migraine, an increase in monthly headache days is clearly related to lower QoL and higher costs, indicating considerable potential costs-savings in reducing the number of headache days.

Botox reduces headache days and is a cost-effective treatment for chronic

migraine in Sweden and Norway.

Extended: In Norway, Botox is reimbursed for CM in patients who previously

tried a beta-blocker (propranolol, metoprolol or atenolol) and topiramate.

In Norway, Botox treatment was associated with 5.480 QALYs and a cost of

EUR 11,501 per patient over a 10-year time horizon.

When considering indirect costs, Botox is dominating, i.e. Botox provide addi-

tional outcome at a lower cost.

Background A Swedish survey study found that increased monthly migraine days are associated with significant QoL losses and cost increases, with productivity losses comprising the vast majority (80%) of the total [439].

Pharmaceutical treatments for migraine in Sweden and Norway include acute medications for symptom relief during migraine attacks and prophylactic medica- tions intended to prevent and reduce severity of future attacks.

Botox is indicated in both Sweden and Norway for symptom relief in adults ful- filling criteria for chronic migraine (CM) in patients who have responded inade- quately or are intolerant of prophylactic migraine medications [440].

In Sweden, erenumab and fremanezumab are reimbursed in patients with CM who have responded insufficiently or are intolerant to at least two prophylactic migraine treatments.

In Norway, erenumab, fremanezumab and galcanezumab are reimbursed for CM in patients who have responded insufficiently or are intolerant to at least three dif- ferent classes of prophylactic migraine treatments.

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Methods Thirdly, the primary endpoint in the pivotal trials for Botox in patients with CM was the number of headache days per month.

This was a conservative approach, as placebo patients in the trials saw consider- able reductions in number of headache days, which is unlikely to be observed in best supportive care in a real-world setting.

In the base case scenario, patients who did not see a ≥ 30% reduction in head- ache days within the first two cycles (24 weeks) were assumed to discontinue treat- ment and remain in the “no treatment” health states on placebo transition probabilities for the remainder of the simulation.

The model contains transition probabilities calculated from the clinical trial data- base for several different patient populations, defined by the number of previously tried oral prophylactics and including or excluding patients overusing acute medications.

Results Average annual indirect costs ranged from EUR 5105  in the 0–4 headache days group to EUR 52,521 in the 25–31 headache days group.

In Sweden, Botox treatment was associated with 5.711 quality adjusted life years

(QALYs) and a cost of EUR 20,700 per patient over a 10-year time horizon.

Botox was associated with 0.223 additional QALYs at an additional cost of EUR 4126 as compared to placebo, resulting in an incremental cost-effectiveness ratio (ICER) of EUR 18,506.

In Norway, Botox treatment was associated with 5.480 QALYs and a cost of

EUR 11,501 per patient over a 10-year time horizon.

In Sweden, the probabilistic incremental cost was EUR 4081 with corresponding

incremental QALYs of 0.220, resulting in a probabilistic ICER of 18,556.

In Norway, the probabilistic incremental cost was EUR 4270 with corresponding

incremental QALYs of 0.215, resulting in a probabilistic ICER of EUR 19,872.

Discussion A 2013 UK study assessed the CE of Botox in adults in CM compared to placebo, and estimated an ICER of GBP 15,028, assuming a 2-year time horizon and not including indirect costs.

In 2014, an Italian study comparing Botox to placebo in patients with CM esti- mated an ICER of EUR 9407, assuming a 2-year time horizon and not including indirect costs.

When attempting to mirror the CGRP analyses as closely as possible (patients with ≥3 previous treatments, 10-year time horizon, 30% stopping rule and using utility values mapped from MSQ to EQ-5D) the difference in QALYs for Botox vs placebo were 0.209 and with a corresponding ICER of EUR 16,625 in Sweden and 0.203 QALY difference with a corresponding ICER of 18,462 in Norway.

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Conclusions In people with migraine the number of average monthly headache days is clearly related to lower QoL and higher costs, indicating considerable potential costs- savings in reducing the number of headache days.

The CE results indicate that considering a 10-year time horizon, Botox is a cost-

effective treatment option for migraine in Sweden and Norway.

When considering indirect costs, Botox is dominating, i.e. Botox provide addi-

tional outcome at a lower cost.

Acknowledgement A machine generated summary based on the work of Hansson-Hedblom, Amanda; Axelsson, Isabelle; Jacobson, Lena; Tedroff, Joakim; Borgström, Fredrik. 2020 in The Journal of Headache and Pain.

My Migraine Voice survey: disease impact on healthcare resource utilization, personal and working life in Finland