Migraine Burden of Disease: From the Patient's Experience to a Socio-Economic View.

Migraine is one of the most common diseases worldwide and, importantly, a major cause of disability. This translates into a huge clinical and economic burden to individuals and society. Despite existing data on how migraine affects populations, the disease continues to be underdiagnosed and therefore undertreated, so the scale of the public health problem may be underestimated. The impact on the daily lives of patients and their families has also been underappreciated. Clinical and regulatory guidelines are encouraging the use of patient-reported outcome tools (PROs), as these may help in disease management and facilitate physician-patient interactions. In clinical trials in migraine, PRO data are key to evaluating the effects of new therapies on patients, such as disability assessment, productivity, quality of life, and emotional and physical functioning. Digital technologies have enabled the development of ePRO tools, which may play a growing role in the collection of PRO data in the future. Here, we will consider the current view of the burden imposed by migraine on patients and society, illustrate this with two patient case studies, and examine the initiatives underway to use our knowledge to improve our management approaches for the disease.

Variation in Prescription Drug Coverage for Triptans: Analysis of Insurance Formularies.

OBJECTIVES: To analyze triptan coverage by insurers to examine (1) possible disparities in coverage for different formulations (oral, intranasal, etc) and (2) quantity limits and stepped care requirements to obtain triptans. BACKGROUND: Triptans are FDA approved migraine abortive medications. Patients frequently state that they have difficulty accessing triptans prescribed to them. METHODS: We searched the 2015 drug formularies of commercial and government health insurers providing coverage in NY State. We created a spreadsheet with all of the commercially available triptans and included information about covered formulations, tier numbers and quantity limits for each drug. We then calculated the number of listed plans that cover or do not cover each triptan or triptan formulation, the total number of medications not covered by an insurance provided across all of its plans, as well as the percentage of plans offered by individual companies and across all companies that covered each drug. We also calculated the number and proportion of plans that imposed quantity limits or step therapy for each drug. RESULTS: Of the 100 formularies searched, generic sumatriptan (all formulations), naratriptan, and zolmitriptan tablets were covered by all plans, and rizatriptan tablets and ODTs were covered by 98% of plans. Brand triptans were less likely to be covered: 4/36 Medicaid plans covered brand triptans. Commercial insurers were more likely to cover brand triptans. All plans imposed quantity limits on 1+ triptan formulations, with >80% imposing quantity limits on 14/19 formulations studied. Almost all plans used tiers for cost allocation for different medications. Generic triptans were almost always in Tier 1. Brand triptans were most commonly in Tier 3. Approximately 40% of brand triptans required step therapy, compared with 11% of generic triptans. CONCLUSIONS: There are substantial variations in coverage and quantity limits and a high degree of complexity in triptan coverage for both government and commercial plans.

Two center, randomized pilot study of migraine prophylaxis comparing paradigms using pre-emptive frovatriptan or daily topiramate: research and clinical implications.

OBJECTIVE: To compare the efficacy and clinical benefit of 2 paradigms of migraine prevention using pre-emptive frovatriptan and daily topiramate. The study compares the paradigms of pre-emptive use of frovatriptan, a drug approved for acute migraine, and the daily use of topiramate, a Federal Drug Administration-approved and -accepted standard for migraine prophylaxis. BACKGROUND: Traditionally, preventive treatment of migraine required daily medication. However, recent studies suggest that pre-emptive prophylaxis may be beneficial to those migraineurs who can predict an attack of migraine based on premonitory symptoms and treat during that phase. METHODS: A total of 76 adult subjects with a diagnosis of migraine were screened for the study. During a 1-month baseline period, subjects demonstrated through a daily diary that they predicted at least 50% of migraine attacks during the premonitory phase and treated with their usual medication. Of these, 55 were randomized to either Group A (daily topiramate) or Group B (frovatriptan during premonitory symptoms); 44 completed the study. The treatment period lasted 2 months. The subjects answered the Migraine-Specific Quality of Life Questionnaire at randomization, and at Weeks 4 and 8. The revised Patient Perception of Migraine Questionnaire was answered 24 hours after taking frovatriptan (Group A, for break-through headaches; Group B, treatment during premonitory symptoms). RESULTS: The number of migraine attacks and headache days per month decreased significantly from baseline for both Groups A and B. Subjects in Group A had considerably more adverse events leading to study withdrawal than in Group B (18% vs 4%). Though this study was not powered to directly compare the efficacy of the 2 drugs, topiramate showed superiority over frovatriptan at Month 2 in reduction of headache days, which was a secondary end point in the study (P = .036). CONCLUSIONS: This pilot study demonstrated that statistical benefit for reduction of headache days over baseline for both pre-emptive frovatriptan and daily topiramate. Subjects utilizing pre-emptive frovatriptan experienced fewer adverse events leading to study withdrawal. Subjects utilizing daily topiramate had fewer headache days at Month 2.

Budget impact of lasmiditan for the acute treatment of migraine in the United States.

BACKGROUND: Three novel acute treatments for migraine-lasmiditan, ubrogepant, and rimegepant-were approved by the FDA in 2019 and 2020 for adults with migraine with and without aura. American Headache Society guidance recommends that these novel acute treatments be considered for patients who are contraindicated to or fail to respond or tolerate oral triptans, the current standard of acute care. OBJECTIVE: To estimate, from a US commercial plan perspective, the budget impact of adding lasmiditan as an option to a formulary that already includes ubrogepant and rimegepant. METHODS: Epidemiologic data were drawn from US Census data, the American Migraine Prevalence and Preventive study, and the first wave of the OVERCOME US survey, a web-based survey that included 21,000 patients with migraine. A model with a 3-year time horizon was built assuming that demand for the novel acute treatments would not vary based on whether lasmiditan is included in the formulary. The model examined a variety of populations, in particular beneficiaries with previous use of 1 or more oral triptans or contraindicated to triptans and beneficiaries with previous use of 2 or more oral triptans or contraindicated to triptans. Primary outcomes were the incremental differences in total cost and average cost per member per month (PMPM) between scenarios with and without lasmiditan. One-way sensitivity analyses with model parameters that were varied by plus or minus 15% were conducted to assess the effect of key parameters on the incremental total cost over 3 years. RESULTS: The addition of lasmiditan to a formulary that already includes ubrogepant and rimegepant resulted in a total savings of -$927,657 (-1.5% compared with the scenario without lasmiditan) over a 3-year time horizon in the population with previous history of using 1 or more oral triptans or contraindicated to a triptan. In the population with previous history of using 2 or more oral triptans or contraindicated, the addition of lasmiditan resulted in a total budget impact of -$466,518 (-1.3%) over a 3-year time horizon. Most of the cost savings was attributable to reductions in drug acquisition cost. Savings in total costs resulted in average incremental cost per PMPM of -0.03 and -$0.01, respectively. CONCLUSIONS: The addition of lasmiditan to the formulary as a novel acute treatment option for migraine alongside ubrogepant and rimegepant resulted in lower budget impact on a 3-year time horizon from a US commercial payer's perspective. This result is important to US commercial payers as they seek to incorporate the emerging novel acute treatments for migraine into their benefit designs. DISCLOSURES: This work was funded by Eli Lilly and Company. Milev and Sun are employed by Evidera, which received funding from Eli Lilly and Company for work on this project. Pohl, Mason, Njuguna, and Loo are employees and stockholders of Eli Lilly and Company.

Prescribing for migraine with the focus on selective 5HT1-receptor agonists: a pharmacy database analysis.

OBJECTIVE: The primary aim was to determine the prescribing patterns and cost of drugs for migraine focusing on selective 5HT1-receptor agonists (triptans) in a primary care patient population. METHODS: A retrospective drug utilization consumption study was conducted. Data were obtained from a South African national private pharmacy group. The database consisted of all central nervous system prescriptions dispensed by the pharmacy group for 2008. RESULTS: A total of 22,102 patients (71.05% females) received 43,144 items for migraine a cost of R3,622,552 (average cost of R83.96 per item). The average age of patients was 44.90 (SD = 13.83) years, with 70.76% of patients between 30 and 59 years of age. A two-sample t-test assuming equal variances was conducted to compare prescribing to females and males. There was a significant difference. There were proportionally more females in the younger age groups and proportionately more males over 60 years. Patients were prescribed an average of 1.95 items for migraine over the year. The Lorenz curve was used to illustrate skewness in prescribing. Clonidine was the most frequently prescribed active ingredient (46.15%), followed by the combination of cyclizine, ergotamine and caffeine (29.62%). The agents for the prophylaxis of migraine (clonidine, flunarizine and pizotifen) accounted for 50.48% of prescribing frequency, but only 29.04% of cost. The triptans accounted for 18.94% of prescribing frequency and 53.54% of cost. Rizatriptan was the most frequently prescribed triptan. CONCLUSIONS: The findings were generally in agreement with other studies, but a lower prescribing rate for triptans was observed.

Economic analysis of triptan therapy for acute migraine: a Medicaid perspective.

STUDY OBJECTIVE: To compare triptan therapies for migraine in terms of the cost to treat 100 migraine attacks and the cost per successfully treated patient (cost/success), by analyzing utilization and reimbursement data from state Medicaid programs. DESIGN: Pharmacoeconomic analysis. DATA SOURCE: Clinical efficacy data were obtained from a previously published meta-analysis for 11 triptan-dose combinations: almotriptan 12.5 mg; eletriptan 20 and 40 mg; naratriptan 2.5 mg; rizatriptan 5 and 10 mg; sumatriptan 25, 50, and 100 mg; and zolmitriptan 2.5 and 5 mg. Triptan reimbursement data were obtained from the Medicaid Drug Rebate Program of seven geographically dispersed states (Florida, Georgia, Illinois, North Carolina, Ohio, Wisconsin, and West Virginia). MEASUREMENTS AND MAIN RESULTS: Efficacy measures were derived based on data from the published meta-analysis that evaluated headache pain status at 2 and 24 hours after triptan dosing. Reimbursement data for the triptans were applied to a previously developed model of migraine treatment outcomes to calculate the cost to treat 100 migraine attacks and the cost/success. Sensitivity analysis around dosing assumptions was conducted to assess robustness of estimates. Across the seven states, the two treatments associated with the lowest cost to treat 100 migraine attacks were eletriptan 20 mg (range $1549-$1658) and eletriptan 40 mg ($1578-$1661). Naratriptan 2.5 mg (range $1734-$2018), sumatriptan 25 mg ($1853-1954), and zolmitriptan 5 mg ($1854-$1960) were associated with the highest cost to treat 100 migraine attacks. Eletriptan 40 mg was associated with the lowest cost/success (range $57.03-$60.05); naratriptan 2.5 mg ($99.39-$115.65), sumatriptan 25 mg ($107.11-$112.93), and rizatriptan 5 mg ($99.41-$111.25) were associated with the highest cost/success values. Changes in dosing assumptions did not significantly change the rank ordering of triptans across either economic end point. CONCLUSIONS: Eletriptan 20- and 40-mg doses were shown to be associated with the lowest cost to treat 100 migraine attacks and the lowest cost/success in both the baseline and sensitivity analyses. These findings are consistent with results of similar economic analyses that compared multiple triptan therapies.

Influence of an e-mail with a drug information attachment on sales of prescribed drugs: a randomized controlled study.

BACKGROUND: To provide doctors with producer-independent information to facilitate choice of treatment is an important task. The objective of the present study was to evaluate if an e-mail with a drug information attachment has effects on sales of prescribed drugs and if the design of the attachment is of importance. METHODS: The Swedish pharmaceutical benefit board found rizatriptan (Maxalt) 10 mg to be the most cost-effective triptan. All 119 heads of primary care units in western Sweden were randomized to receive information concerning this conclusion via (i) e-mail with attachment I, (ii) e-mail with attachment II or (iii) no information (control). Attachment I was a short one (heading plus three lines text), whereas attachment II was a long one (heading plus one page text and one page with tables). The change in percentage rizatriptan of total triptans sold before and after the intervention (May - July 2004 and May - July 2005, respectively) was compared between the groups. RESULTS: Totally 48,229 (2004) and 50,674 (2005) defined daily doses of triptans were prescribed and sold during May - July in primary care units in the western part of Sweden. The absolute change in percentage rizatriptan was greater in the intervention groups compared with the control group 2 (25th - 75th percentile: -3 - 7) vs 0 (-7 - 5), P = 0.031). The absolute change in percentage rizatriptan did not differ between the two attachment groups (P = 0.93). CONCLUSION: An e-mail with a drug information attachment may influence sales of prescribed drugs. No difference between different designs of the attachment could be detected.

Safety and efficacy of eletriptan in the treatment of acute migraine.

Eletriptan is a new selective serotonin agonist approved for the treatment of acute migraine headaches. To review the pharmacologic, pharmacodynamic, pharmacokinetic, safety, and clinical efficacy data for eletriptan, we searched the literature in PubMed/MEDLINE, EMBASE, International Pharmaceutical Abstracts, and Science Direct databases to gather all published reports from January 1996-October 2004. All English-language reports (abstract or full trial reports) about the pharmacology, pharmacokinetics, clinical efficacy, and safety of eletriptan were reviewed. Eletriptan's pharmacokinetic and pharmacodynamic parameters translate into a favorable safety and efficacy profile. The drug is rapidly absorbed when administered orally, has good bioavailability and central nervous system penetration due to its lipophilicity, and has a long half-life, which contributes to its ability to prevent recurrent headaches. Compared with other serotonin agonists, eletriptan has a longer duration of action and greater lipophilicity. Eletriptan is metabolized through the cytochrome P450 3A4 system; therefore, it does have the potential for clinically significant drug interactions. In clinical trials, eletriptan demonstrated efficacy superior to that of placebo and similar or superior efficacy to that of other serotonin agonists, with limited adverse effects. With clinical use, headache and pain-free responses and headache recurrence rates were similar to those of other serotonin agonists, but the agent is superior to ergotamine tartrate-caffeine. Based on pharmaco-economic data, eletriptan is more cost-effective than other agents in its class. Eletriptan is a safe and cost-effective option for the treatment of migraine headaches.

Assessment of clinical, service, and cost outcomes of a conversion program of sumatriptan to rizatriptan ODT in primary care patients with migraine headaches.

OBJECTIVE: Managed care organizations can increase the value of drug therapy by negotiating discounts on drug acquisition costs with pharmaceutical manufacturers and promoting use of preferred drugs, including the conversion of patients to preferred medications. This investigation was designed to assess conversion success, migraine drug utilizations, and patient satisfaction with a clinical pharmacist-managed conversion program from sumatriptan to rizatriptan ODT, both formulary drugs. METHODS: This was a retrospective cohort study conducted in a managed care organization for patients aged 18 years or older who had picked up at least one outpatient prescription for any sumatriptan dosage form at the pharmacy between January 2002 and June 2002. Patients. pharmacy and medical data were reviewed to assess eligibility (e.g., no history of rizatriptan failure) for conversion from sumatriptan to rizatriptan orally disintegrating tablet (ODT). There was no copayment difference for members for rizatriptan ODT versus sumatriptan. A questionnaire was developed to assess 2 domains: (1) patient satisfaction with the medication conversion process and (2) preference for rizatriptan ODT or sumatriptan. A random sample of 315 patients who initiated conversion to rizatriptan ODT was surveyed. Electronic pharmacy claims were reviewed to determine the number of patients who were successfully converted from sumatriptan to rizatriptan ODT. Pharmacy expenditures and total health care utilization and expenditures in the 180 days prior to (baseline) and after the conversion (followup) to rizatriptan ODT were compared for the cohorts of subjects who were successfully converted and those patients who were not successfully converted. RESULTS: Therapeutic conversion from sumatriptan to rizatriptan ODT was attempted in 457 patients; 214 (47%) were successfully converted. The only difference between the 2 cohorts at baseline for the 6 months prior to attempted conversion was a higher mean number of sumatriptan doses per patient per month (PPPM) in the 243 failed conversions (mean 3.5, SD 2.9) compared with the 214 successful conversions (mean 2.8, SD 2.8, P =0.003). The median triptan doses increased by 1.0 PPPM in both cohorts (P =0.882), from 2.0 to 3.0 doses PPPM in the group of successful conversions and from 2.7 to 4.0 in the group of unsuccessful conversions. The survey response rate was 55% for both successful and for unsuccessful conversions. More than 90% of the patients in both cohorts were satisfied with the level of care provided by the clinical pharmacy staff during medication conversion, and there was no difference between the 2 cohorts in patient satisfaction (P=0.761). Rizatriptan ODT was preferred by 68.0% and 8.5% of successful and failed conversion subjects, respectively (P <0.001). Using representative group purchase prices, triptan expenditures for successful conversion subjects were reduced by a median of -2 dollars (6 %) PPPM while triptan expenditures for unsuccessful conversions increased by a median of 8 dollars (P <0.001). There were no differences for either cohort in median PPPM changes in migraine-related office visits (0.0 median change in office visits, P =0.748) or office-visit costs (0 dollars median change, P =0.861) for preconversion versus postconversion attempts Regression modeling identified that lower total counts of sumatriptan doses filled during baseline period was an independent predictor of successful conversion to rizatriptan ODT (P <0.001). There was an average of 3.5 triptan medication fills per patient for successful conversion during the 6-month follow-up period, with 78% of these subjects filling at least 2 prescriptions for rizatriptan ODT during this period. CONCLUSIONS: This conversion program for sumatriptan to rizatriptan ODT was successful in converting almost half of primary care patients to the preferred product despite the absence of a copayment incentive for members to agree to the conversion. There were no measurable medical or economic consequences of the conversion, and patient satisfaction with the quality of care was maintained. Future efforts are likely to have a higher success rate if focused on converting patients with less-severe migraine headaches, as measured by the need for baseline rescue medication, since lower acuity was the only independent predictor of successful conversion in this conversion program for 2 triptan drugs.

Cost-effectiveness analysis of rizatriptan and sumatriptan versus Cafergot in the acute treatment of migraine.

BACKGROUND: Both ergotamine and selective serotonin 5-HT(1B/1D) receptor agonists ('triptans') are currently used in the treatment of moderate to severe migraine. Ergotamine is a traditional therapy with a lower drug acquisition cost compared with triptans. It has been shown that triptans are more efficacious than ergotamine, but the higher acquisition costs and shorter duration of action are disadvantages of triptans compared with ergotamine. OBJECTIVE: The purpose of this study was to provide a comparison of the cost-effectiveness of rizatriptan 10 mg and sumatriptan 50 mg tablets with that of a fixed-dose combination of ergotamine tartrate plus caffeine (Cafergot) in the treatment of an acute migraine attack. The cost-effectiveness of rizatriptan in comparison with sumatriptan was also assessed. METHODS: Three separate decision tree models were developed (model 1: rizatriptan vs Cafergot; model 2: sumatriptan vs Cafergot; model 3: rizatriptan vs sumatriptan). The time horizon was 1 year. Cost-effectiveness analysis was conducted from the societal perspective using cost and effectiveness estimates from the literature. All costs were converted to US dollars (2003). The cost-effectiveness ratio was expressed as incremental cost per quality-adjusted life-year (QALY) gained. RESULTS: Base case evaluation showed that both rizatriptan and sumatriptan dominated Cafergot. The net annual saving associated with use of rizatriptan was US dollars 622.98 per patient, with an incremental QALY of 0.001. Use of sumatriptan resulted in a saving of US dollars 620.90 and an increase in QALY. The cost-effective ratios were not sensitive to changes in key variables such as efficacy, utility, drug costs, hospitalisation cost and patient preference over alternative therapies. The study further showed that rizatriptan is more cost effective than sumatriptan, as evidenced by its lower cost and greater effectiveness. Sensitivity analysis showed that the cost-effectiveness ratios were sensitive to moderate changes in drug efficacy. CONCLUSION: Rizatriptan and sumatriptan were less costly and more effective than Cafergot in the treatment of an acute migraine attack. Rizatriptan was somewhat less costly and more effective than sumatriptan. Additional quality-of-life studies are needed to confirm the benefits of using triptans in the management of migraine.

Oral serotonin receptor agonists: a review of their cost effectiveness in migraine.

Migraine headache is a highly prevalent chronic, episodic condition. The direct and indirect costs of migraine headache have a tremendous economic impact in the US. Research has shown that serotonin (5HT(1B/D)) receptor agonists reduce healthcare costs, improve health-related QOL (HR-QOL), decrease migraine disability and keep patients effective in the workplace. The purpose of this manuscript is to examine the cost effectiveness of oral 5HT(1B/D) receptor agonists for the treatment of migraine headache. In general, 5HT(1B/D) receptor agonists are associated with increases in direct healthcare costs; however, they are also associated with reductions in the indirect costs associated with migraine headache. Therefore, it appears that the relatively high acquisition cost of these medications is offset and, as a class, these medications appear to be cost effective and demonstrate net benefits from the societal perspective. Based on meta-analyses in which data on eletriptan were not available, it appears that within the class, almotriptan and rizatriptan are the most cost effective. In a prospective study comparing eletriptan with sumatriptan, it appears that the former may be more cost effective than the latter. Additional investigations are needed to further explore the application of the friction-cost approach and QALYs to cost-effectiveness analyses of this class of medication.

An economic evaluation of rizatriptan in the treatment of migraine.

BACKGROUND: Migraine is a common, chronic, neurovascular disorder, generally characterised by attacks of severe headache and autonomic nervous system dysfunction. Triptans are selective serotonin 5-HT(1B/1D) receptor agonists that represent effective therapeutic options for moderate-to-severe migraine attacks but with higher acquisition costs relative to usual care therapies. OBJECTIVE: The objective of this study was to examine the cost effectiveness of rizatriptan treatment compared with 'Usual Care' or other triptans available in Canada for patients with moderate-to-severe migraine for whom other therapies (e.g. NSAIDs, simple analgesics) are insufficient or contraindicated. METHODS: A decision-analysis model was created to estimate migraine treatment costs over a 24-hour period in patients with a diagnosis of moderate-to-severe migraine as defined by the International Headache Society criteria. Costs and clinical outcomes were observed over a 24-hour period from therapy initiation. Efficacy measures consisted of 'pain-free response at 2 hours' and 'sustained pain free for 2-24 hours'. Oral rizatriptan 10 mg was compared with other oral triptans (i.e. sumatriptan 50 or 100 mg), naratriptan 2.5 mg and zolmitriptan 2.5 mg, based on a meta-analysis and compared with 'Usual Care' based on a naturalistic study of people who experience migraine and who were similar to the target population. 'Usual Care' was defined as an aggregate of medications prescribed for the Canadian population for the indication of migraine, weighted by the relative frequency of use of prescriptions over a 1-year period. Analyses were conducted from the Ontario (Canada) Ministry of Health and Long-Term Care (MOH

Rizatriptan: a pharmacoeconomic review of its use in the acute treatment of migraine.

Rizatriptan (Maxalt; Maxalt-MLT; Maxalt-Melt) is an oral serotonin 5-HT(1B/1D) receptor agonist (triptan) used in the acute treatment of migraine with or without aura in adults. Rizatriptan 5 mg and 10 mg are effective in relieving the symptoms of migraine and the 10 mg dose provided faster pain relief than sumatriptan 50 mg, naratriptan 2.5 mg, ergotamine/caffeine 2 mg/200 mg and possibly zolmitriptan 2.5 mg, while displaying similar tolerability. Two cost-utility analyses performed from a societal perspective indicated that rizatriptan 10 mg was dominant over ergotamine/caffeine 2 mg/200 mg, sumatriptan 50 mg or 100 mg, naratriptan 2.5 mg, zolmitriptan 2.5 mg and analgesic-based usual care in the acute treatment of migraine. In one analysis also performed from the perspective of a healthcare payer, rizatriptan was still dominant over naratriptan, sumatriptan and zolmitriptan. Rizatriptan was cost effective compared with usual care with an incremental cost per quality-adjusted life-year (QALY) gained of 31,845 Can dollars (2002 values) and an incremental cost per additional attack aborted of 49.82 Can dollars. A modelled cost-effectiveness analysis conducted from a healthcare payer's perspective indicated that almotriptan 12.5 mg was more cost effective than rizatriptan 10 mg as a result of better tolerability. The incremental cost per additional successfully treated patient (defined as being sustained pain free without adverse events) with almotriptan was 6.94 US dollars (1999 values). In other nonmodelled cost-effectiveness analyses, rizatriptan 10 mg, eletriptan 40 mg and almotriptan 12.5 mg most consistently displayed the greatest cost effectiveness in different analyses using different clinical endpoints. A modelled analysis of the costs of migraine-related productivity losses in US corporations indicated that the use of rizatriptan rather than usual care to treat migraines could result in annual cost offsets of approximately 84-118 US dollars (2000 values) per employee in lost productivity avoided. An intervention study in Spanish postal service workers demonstrated that replacement of usual care with rizatriptan reduced the mean per-patient cost of lost productivity per migraine attack from 34.47 euros (2001/2002 values) before the intervention to 13.94 euros and 4.59 euros for the first and second post-intervention migraine attacks. In conclusion, rizatriptan is one of the more clinically effective and therefore cost-effective oral triptans available for the acute treatment of migraine. The available data from cost-utility analyses suggest that rizatriptan is more cost effective than ergotamine/caffeine, simple analgesics, naratriptan, zolmitriptan and sumatriptan. The economic value of rizatriptan depends on the payer's perspective, as the greatest savings can be expected to be achieved in terms of reduced migraine-related loss of work productivity compared with less effective treatments. For healthcare payers, the high acquisition cost appears to be at least partly offset by reduced migraine-related healthcare resource use when compared with usual care. The comparative cost effectiveness of the newer triptans requires further elucidation from comprehensive direct comparisons.

Tegaserod treatment for IBS: a model of indirect costs.

Irritable bowel syndrome (IBS) has been associated with substantial time lost from work (absenteeism) and reduced productivity at work (presenteeism), which are the indirect costs of illness. This article presents a productivity model demonstrating the indirect costs associated with IBS and the reduction in those costs for a cohort of female employees hypothetically treated with tegaserod, a new selective serotonin (5-hydroxytryptamine [5-HT]) type 4 (5-HT4) receptor agonist, which is approved by the US Food and Drug Administration for treating women with IBS-C. The model is based on economic and epidemiologic published literature and clinical trial results. In this model, tegaserod treatment resulted in 1882 dollars in avoided lost productivity per treated female employee. Considering only the benefits of decreased work loss and the costs of medical therapy, the model predicts a benefit/cost ratio of 3.75 in the base case. From an employer's perspective, medical therapy for IBS with tegaserod is cost-effective under a series of assumptions for the treatment of women with IBS with constipation.

Budget impact of tegaserod on a managed care organization formulary.

We sought to develop a budget impact model that assesses the economic effect of adding tegaserod for the management of irritable bowel syndrome (IBS) with constipation to the formulary of a managed care organization (MCO). The model estimates the per patient economic impact and the per member, per month (PMPM) economic impact of patients 6 months before and 6 months after the initiation of tegaserod. Resource utilization data, taken from medical and pharmacy administrative claims data, were based on a retrospective, longitudinal study of 3365 patients administered tegaserod through a large, geographically diverse MCO. Costs were estimated for 2 patient subgroups, women with IBS and other gastrointestinal (GI) diagnoses. Sensitivity analyses were performed by varying several model input parameters. The base-case model resulted in an incremental PMPM budget impact associated with the use of tegaserod of 0.01 dollars. Total per patient budget impact (for all resources, including tegaserod) for a 6-month period was 274.34 dollars for women with IBS and 301.84 dollars for women with other GI diagnoses. Overall, 25.9% (29.0% for women with IBS group and 21.9% for women with other GI diagnoses group) of the cost of tegaserod was offset by decreases in resource utilization. Key drivers of post-tegaserod reductions in resource costs were hospital stays, outpatient office visits, emergency department visits, endoscopic procedures, and nonendoscopic procedures. Tegaserod therapy can decrease GI-related resource utilization, resulting in a significant cost-offset percentage. When the associated budget impact of adding tegaserod to its formulary is absorbed across an entire MCO population, the PMPM impact of tegaserod is small.

Triptans for migraine therapy: a comparison based on number needed to treat and doses needed to treat.

OBJECTIVE: Managed care and other decision makers need sound comparative information to support the formulary selection process and reimbursement decisions for the treatment of migraine. The objective of this study was to compare currently marketed triptan therapies using number-needed-to-treat (NNT) and doses-needed-to-treat (DNT) measures. DNT was further used to derive triptan treatment cost to achieve 100 successfully treated patients such that the cost-effectiveness of each treatment regime could be compared from the payer perspective. METHODS: Using published meta-analysis data to categorize patients as treatment success or failure, an NNT and a DNT were derived for each triptan. Treatment success was defined as achieving a 2-hour pain response, sustained through 24 hours postdose. Costs were derived by multiplying DNT by the average wholesale price (AWP) minus 15% for each triptan. RESULTS: Eletriptan 40 mg had the lowest NNT, with 361 patients needing to be treated in order to have 100 patients achieve clinical benefit; rizatriptan 5 mg had the highest NNT (597 patients). Eletriptan 40 mg required 388 doses to successfully treat 100 patients.the lowest number of doses of the triptans considered; rizatriptan 5 mg required the highest number (662 doses). Eletriptan 40 mg had the lowest total triptan cost of USD 5,630 to successfully treat 100 patients. The highest total triptan cost of treatment was USD 11,136 for naratriptan 2.5 mg. CONCLUSIONS: Eletriptan 40 mg provides the best value in terms of the lowest DNT, assuming an approximately equal AWP discount for each triptan. Eletriptan 40 mg also was found to have the lowest total triptan cost to successfully treat 100 patients. Future research should further explore the utility of DNT in managed care decision making.

Costs and utilization of triptan users who receive drug prophylaxis for migraine versus triptan users who do not receive drug prophylaxis.

OBJECTIVES: The objectives were 2-fold: (1) to describe the utilization patterns of new users of triptan therapy and (2) to measure the direct (pharmacy and medical) costs of migraine-related health care services in moderate-to-severe migraine patients treated with drug prophylaxis compared with migraine patients who are not treated with drug prophylaxis. METHODS: A retrospective administrative database study was conducted from the perspective of a managed care health plan. Patients initiating triptan therapy were identified, and utilization in the 12 months following initiation of drug therapy was determined. In addition, moderate-to-severe migraine patients were identified based on the quantity of triptan medication dispensed. Patients were classified as utilizing or not utilizing migraine prophylaxis. Migraine-specific health services costs in the 12 months following identification were determined. A multivariate ordinary least squares regression model was constructed to determine the impact of the use of drug prophylaxis on total cost. Utilizing the model, the difference in health services costs was predicted for each subject and the average treatment effect was computed. RESULTS: Thirty-nine percent of new triptan users received only 1 triptan claim during the 12-month follow-up period, accounting for 11.5% of the total triptan cost incurred by the health plan for this cohort. For new triptan users, triptan use in the first or second quarter was correlated with triptan use in the entire 12-month follow-up period (r = 0.187 and 0.279, respectively). The mean migrainerelated pharmacy cost per patient during the follow-up was $871; however, continuous users had mean costs ($1,505) nearly 3 times the mean costs for new users ($506, P<0.05). The average treatment effect of drug prophylaxis in moderate-to-severe migraine patients was a decrease of $560 ($514-$607) per patient per year in 1998-2001 dollars. CONCLUSION: High utilizers of migraine therapy can be identified early in treatment. Drug prophylaxis for migraine is cost saving, and an intervention program that increases the use of migraine prophylaxis in potential candidates could be cost beneficial.

Prescribing patterns of anti-migraine medicines in South Africa using a claims database.

BACKGROUND: Migraine is an expensive condition impacting on the economically active sector of the population. Given the expense of anti-migraine medicine, it is important to monitor the impact of generic prescribing and therapeutic substitution. OBJECTIVE: The primary aim was to analyse the prescribing patterns and cost of anti-migraine medicines to determine the impact of generic prescribing and prescribing changes over time. METHOD: A retrospective drug utilisation study was conducted on South African private sector medical insurance claims data for 2011. Results A total of 797 patients received 1583 anti-migraine medicines during 2011. The majority of patients (70.14 %) were females. The average age of patients was 41.61 (SD = 14.91) years. Clonidine was the most frequently prescribed (49.21 % of prescribing frequency; 25.70 % of cost), followed by the triptans [selective serotonin (5-HT1B/1D)-receptor agonists] (27.98 % of prescribing frequency; 45.92 % of cost). Five triptans were prescribed. The average cost per sumatriptan prescription was the lowest (the only triptan with generic equivalents). Rizatriptan was the most frequently prescribed triptan (18.51 % of prescribing frequency; 29.15 % of cost). CONCLUSION: The results were generally in agreement with previous South African studies. The impact of the introduction of newer triptans and of generic equivalents on prescribing patterns was clear.

Prophylaxis of menstrual migraine with triptans: problems and possibilities.

Menstruation is a prominent, predictable attack trigger for many women with migraine. If abortive therapy of menstrual attacks is ineffective, prophylactic therapy is used to prevent attacks or render them shorter and less resistant to acute therapy. Interest is increasing in the use of triptan medications for the prophylaxis of menstrual migraine, and clinical trials to evaluate this approach are underway. Potential problems with triptan prophylaxis of menstrual migraine that deserve attention include the lack of consensus on the definition of menstrual migraine and the difficulty in making a reliable diagnosis of the disorder. Unconvincing demonstrations of efficacy and unresolved cost and safety concerns should temper enthusiasm for their use in this manner. Further studies, using a consistent definition of menstrual association and employing diary validation of the diagnosis, are needed to determine the efficacy of the triptans in women who consistently experience migraine attacks associated with menstruation. Triptans would have to show compelling advantages over other therapy to be a plausible prophylactic treatment for menstrual migraine.

Effectiveness of sumatriptan in reducing productivity loss due to migraine: results of a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: To determine the effect of sumatriptan on migraine-related workplace productivity loss. PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, parallel-group trial, adult migraineurs self-injected 6 mg of sumatriptan or matching placebo to treat a moderate or severe migraine within the first 4 hours of a minimum of an 8-hour work shift. Outcome measures included productivity loss and number of patients returning to normal work performance 2 hours after injection and across the work shift, time to return to normal work performance, and time to headache relief. RESULTS: A total of 206 patients underwent screening, 140 (safety population) of whom returned for clinic treatment. Of these 140 patients, 119 received migraine treatment in the workplace (intent-to-treat population), 116 of whom comprised the study population. Of these 116 patients, 76 self-administered sumatriptan, and 40 self-administered placebo. Sumatriptan treatment tended to reduce median productivity loss 2 hours after injection compared with placebo (25.2 vs 29.9 minutes, respectively; P = .14). Significant reductions in productivity loss were obtained across the work shift after sumatriptan treatment compared with placebo (36.8 vs 72.6 minutes, respectively; P = .001). Significantly more sumatriptan-treated patients vs placebo-treated patients experienced shorter return to normal work performance at 2 hours (53/76 [70%] vs 12/40 [30%], respectively) and across the work shift (64/76 [84%] vs 23/40 [58%], respectively; P < .001). Significantly more sumatriptan-treated patients experienced headache relief 1 hour after injection compared with placebo-treated patients (48/76 [63%] vs 13/40 [33%], respectively; P = .004). CONCLUSION: Across an 8-hour work shift, sumatriptan was superior to placebo in reducing productivity loss due to migraine.