Supplements New Approaches for the Management and Treatment of Migraine
The Cost of Migraine and Its Treatment
A small open-label trial of botulinum toxin was conducted in 5 patients with migraine that was unresponsive to conventional antimigraine medications. After 1 year of injections at 3-month intervals, the use of other migraine medications had decreased from pretreatment levels, as measured by the change in annual costs for other medications. These costs declined from the $1002 to $3524 range before botulinum toxin treatment to the $0 to $1285 range after treatment. When the cost of the botulinum treatment itself was included, the total change in annual medication cost ranged from an increase of $648 to a decrease of $2717. All of the patients showed substantial clinical improvement with no reported adverse events; migraine symptoms typically decreased within a few days after each injection, and maximal effects were noted over the 2 months after treatment.21 Since then, a number of controlled studies have assessed the tolerability and effectiveness of botulinum toxin as prophylaxis in patients with migraine.22-28
High-dose riboflavin (typically, 400 mg/day) has been reported to be an effective approach to migraine prophylaxis since 1994. Several trials indicate that it is significantly better than placebo and generally well tolerated.29-32 In addition, the low cost of riboflavin suggests that it should be cost-effective; however, there have been no well-designed clinical trials providing a direct comparison between this novel approach and standard migraine prevention drugs.
A Budget Management Model
A budgetary model provides a theoretical basis for predicting the cost outcome of selecting a given approach to migraine management. This model focuses on the use of botulinum toxin for prophylaxis in chronic migraine patients enrolled in a commercial managed care plan. The goal is to assess the impact of a decision to allow the use of botulinum toxin, in terms of cost effect for the plan as a whole.
Certain assumptions about the target population are made. Prophylaxis will be given to migraine patients who seek treatment and are determined to have a chronic condition based on experiencing headache on at least 15 days each month. It is estimated that 12% of the population has migraine, that 40% of migraine patients seek treatment, that 25% of patients who seek treatment have chronic migraine (at least 15 episodes per month), and that 2% of patients with chronic migraine receive botulinum toxin as prophylaxis. Thus, in a population of 1 million patients, 240 will receive botulinum toxin as prophylaxis for chronic migraine:
1 000 000 × 0.12 × 0.40 × 0.25 × 0.02 = 240
In calculating the cost of prophylaxis with botulinum toxin, treatment at a standard interval of 3 months means that patients would receive 4 treatments per year. With the cost of each treatment given as $521.25, the yearly cost per patient is $2085, and the total yearly cost for 240 patients is $500 400.
Offsetting these costs, prophylaxis is expected to reduce the amount of headache medication (abortive treatment) required.28,33 For example, a 65% reduction in the overall use of triptans represents a decrease of $576 760 for headache-related medications over the course of 1 year; $576 760 minus $500 400 acquisition cost for botulinum toxin yields a net annual savings of $76 360. Thus, in a plan with 1 million members, the savings associated with migraine prophylaxis using botulinum toxin represents a change of less than 1 cent in overall cost per member per month ($76 360 divided by 12 million member months is a reduction of approximately $0.006 per member per month). The point, however, is not the insignificant change in cost, but that superior clinical outcomes in migraine management can be obtained with no increase in cost.
Not counted in this model, a decrease in emergency department visits and hospitalization as a result of effective migraine prophylaxis would be expected to augment these savings. This expectation is consistent with the findings of a prospective, open-label, observational study in which patients with headache, referred by physicians or identified from emergency department records, attended a group session led by a registered nurse practitioner, followed by individual consultation. The goal was to assess the cost of triptan drugs and headache-related visits for 6 months before and after the intervention. Among 264 patients, the 6-month cost for triptan costs increased by $5423 (19%), but headache-related visits to the office and emergency department were reduced by 32% and 49%, respectively. These reductions in headache-related visits resulted in a net savings of $18 757, despite the increase in costs for triptans. The greatest clinical improvements were seen in patients whose conditions were most severe at baseline. 32 In summary, it is reasonable to expect improved management to yield meaningful cost savings despite increased expenditures for antimigraine medications.
These types of analyses can provide a rational basis for managed care to make appropriate decisions about treatment and coverage for patients with migraine.
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