Cost-Effectiveness of Reclassifying Triptans in Australia: Application of an Economic Evaluation Approach to Regulatory Decisions.

BACKGROUND: Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources. OBJECTIVES: To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia. METHODS: The study design included decision-analytic modeling combining data from various sources. Behavior before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies. RESULTS: Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained. CONCLUSIONS: The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans.

Tripstar: a comprehensive patient-based approach to compare triptans.

Several second-generation triptans have been introduced that differ in their pharmacologic profiles relative to each other and to sumatriptan. As therapeutic options multiply, clinicians must be able to distinguish among these compounds. Recently, a meta-analysis was conducted on data from 53 double-blind, randomized, placebo- or active-controlled trials involving over 24,000 patients receiving oral triptans. Results indicated that almotriptan 12.5 mg, rizatriptan 10 mg, and eletriptan 80 mg are generally superior to sumatriptan 100 mg based on individual treatment attributes, such as pain relief, sustained pain freedom, consistency of response, and tolerability. Meta-analyses are limited, however, as the analysis can only be performed for individual end points, whereas patients and prescribers balance a variety of treatment attributes when assessing drug acceptability. A flexible overall scoring system ("Tripstar") is proposed that compares triptans to a hypothetical "ideal" using meta-analysis data combined with ratings of the relative importance of clinically relevant treatment criteria. An informal test of the Tripstar model indicated that sumatriptan is most similar to a hypothetical ideal for both mild and severe migraine, primarily due to its high worldwide clinical exposure. However, after exclusion of worldwide exposure as a contributing factor, almotriptan 12.5 mg is most similar to the ideal, principally because of its good tolerability. Further tests of the Tripstar model are planned that will gauge the relative importance of a broader range of attributes.