The concepts and default values in this application are supported by peer-reviewed published literature on migraines. Throughout the application, there are links to view both formal and informal abstracts on specific topics. The following list contains all articles which are used in the application.
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Adelman JU, Sharfman M. Impact of oral sumatriptan on workplace productivity, health related Quality-of-Life, Healthcare use and patient satisfaction with medication in nurses with migraine. Am J Manag Care 1996; December.
This study looked at the effect of oral sumatriptan on total disability time in nurses suffering from migraines. Nurses kept a diary and used their usual therapy for 2 months then were allowed to treat an unlimited number of migraine attacks for up to 6 months with oral sumatriptan. On average, total disability time (ie, lost workplace productivity + lost activity time) because of migraine was 31% lower with sumatriptan than with usual therapy (P <0.001). Other quality of life factors were measured. No control group was used.
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| (2) |
Beers MH and Berkow R. The Merck Manual of Diagnosis and Therapy, 17th edition. Whitehouse Station, NJ: Merck Research Laboratories, 1999.
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| (3) |
Biddle AK, Shih YC, Kwong WJ. Cost-benefit analysis of sumatriptan tablets versus usual therapy for treatment of migraine. Pharmacotherapy 2000; 20(11):1356-1364.
A cost-benefit analysis of sumatriptan was conducted using data from the open-label trial conducted by Adelman. Direct medical care costs including costs for drug, physician, and emergency room visits were considered. The authors concluded there was a net benefit of sumatriptan over usual therapy of $114-540 per patient.
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Cady RC, Ryan R, Jhingran P, O'Quinn S, Pait DG. Sumatriptan injection reduces productivity loss during a migraine attack: results of a double-blind, placebo-controlled trial. Arch Intern Med 1998; 158(9):1013-1018.
This double-blind, randomized trial compared the effect of sumatriptan injection with placebo on productivity losses at work. Patients in this study experienced moderate or severe migraine headaches. Sumatriptan injection significantly lowered productivity loss by about 50%.
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| (5) |
Clouse JC, Osterhaus JT. Healthcare resource use and costs associated with migraine in a managed healthcare setting. Ann Pharmacother 1994; 28(5):659-664.
The medical and pharmacy claims of 1,336 people with and without migraine were compared in this study. Migraineurs generated nearly twice as many medical claims as comparison group patients, and nearly 2.5 times as many pharmacy claims. The migraineurs cost significantly more: total medical and pharmacy claims costs were $3.4 million for the migraine group and $2.1 million for the comparison group.
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| (6) |
Cohen JA, Beall D, Beck A et al. Sumatriptan treatment for migraine in a health maintenance organization: economic, humanistic, and clinical outcomes. Clin Ther 1999; 21(1):190-204.
Individuals who experienced moderate or severe migraine headaches were referred by their healthcare provider to participate in an open-label study of subcutaneous sumatriptan. Participants were allowed to treat an unlimited number of migraine attacks in a 12 month period. Use of sumatriptan was associated with reductions in health care use and improved health-related quality of life, productivity, and patient satisfaction with medication.
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| (7) |
Dasbach EJ, Carides GW, Gerth WC, Santanello NC, Pigeon JG, Kramer. Work and productivity loss in the rizatriptan multiple attack study. Cephalalgia 2000; 20(9):830-834.
This study looked at the effect of rizatriptan compared to placebo on productivity at work. Rizatriptan significantly reduced migraine-related work loss associated with absenteeism and decreased effectiveness on the job in migraineurs suffering from moderate and severe headaches. Total work loss was improved by 25% in those taking rizatriptan.
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Davies GM, Santanello N, Gerth W, Lerner D, Block GA. Validation of a migraine work and productivity loss questionnaire for use in migraine studies. Cephalalgia 1999; 19(5):497-502.
Although this study assessed the validity of a migraine questionnaire, it also provided data on the efficacy of rizatriptan. The questionnaire demonstrated favorable measurement characteristics and also showed those taking rizatriptan had a 40% improvement in productivity loss at work compared to usual migraine therapy.
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| (9) |
Dodick DW. Epidemiology and acute care of migraine headache. Manag Care Interface 2004; 17 Suppl D: 6-10, discussion 11-13.
Abstract: It is well known that migraine is a common medical disorder with a prevalence of about 12% in the United States. This article reviews the cost burden of migraine, its acute treatment, the benefits of early treatment, and menstrual migraines.
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Eastern Research Group, Inc. (February 2001). Profile of the prescription drug wholesaling industry: Examination of entities defining supply and demand in drug distribution (Task order N. 13, Contract No. 223-98-8002). Lexington, MA. Prepared for the Department of Health and Human Services.
This report details several aspects of the prescription drug industry, starting with current federal and state regulations. A review of major categories of wholesalers is presented, along with models of drug distribution. Information about pharmaceutical purchasing organizations and typical industry discounts is also provided.
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Edmeads J, Mackell JA. The economic impact of migraine: an analysis of direct and indirect costs. Headache 2002; 42(6):501-509.
Using the National Health and Wellness Study, individuals with migraine were matched to a migraine-free control group. Participants were then surveyed about their use of healthcare resources and lost productivity due to migraine. Migraineurs cost more in terms of total direct and indirect costs ($1,242 in a 6 month period) than the comparison group ($929 dollars). This difference was statistically significant.
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Gerth WC, Carides GW, Dasbach EJ, Visser WH, Santanello NC. The multinational impact of migraine symptoms on healthcare utilisation and work loss. Pharmacoeconomics 2001; 19(2):197-206.
This study surveyed headache clinic patients who were participating in a clinical trial of rizatriptan. On average, each patient reported 2.78 doctor visits, 0.53 emergency room visits and 0.06 hospitalisations related to migraine per year. Patients self-reported losing 19.5 workday equivalents (8.3 days due to absenteeism, 11.2 days due to reduced workday equivalents) due to migraine per year. The levels of self-reported healthcare resources utilised for migraine and work loss were generally consistent across geographic regions.
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| (13) |
Gerth WC, Sarma S, Hu XH, Silberstein SD. Productivity cost benefit to employers of treating migraine with rizatriptan: a specific worksite analysis and model. J Occup Environ Med 2004; 46(1):48-54.
Using data from a population based survey, an economic model was developed to estimate the productivity costs of migraine and the savings that would accrue if migraineurs were treated with rizatriptan. Analyses were run for both a major financial services corporation and a representative U.S. company. The major financial services corporation (87,821 employees), was projected to lose 538 person-years annually, at an estimated cost of 23.8 million dollars. The value of the annual work loss avoided if migraine is treated with rizatriptan is projected at 10.3 million dollars for the financial services corporation. Treatment costs were not included in the calculations.
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Greiner DL, Addy SN. Sumatriptan use in a large group-model health maintenance organization. Am J Health Syst Pharm 1996; 53(6):633-638.
This study evaluated sumatriptan's effects on migraine headache. Patients completed a telephone survey after they received sumatriptan. Migraine headache improved in two thirds of the patients. The mean number of migraine headaches per patient per month decreased from 7.4 to 4.2. Eighty-three percent reported missing fewer days from work. A retrospective review showed that utilization of the HMO's resources was reduced with sumatriptan.
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| (15) |
Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med 1999; 159(8):813-818.
This frequently cited study quantified the costs of migraine in the US using data from several sources. Migraine costs American employers about $13 billion a year because of missed workdays and impaired work function; close to $8 billion was directly due to missed workdays. Annual direct medical costs for migraine care were about $1 billion and about $100 was spent per diagnosed patient. This study highlights the high indirect costs of migraine headaches.
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IMS Consulting. Longitudinal Analysis of the Migraine Market. February 2005. IMS Health Inc., Plymouth Meeting, PA.
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International Classification of Headache Disorders: 2nd edition. Cephalalgia 2004; 24 Suppl 1:9-160.
Abstract: This important document was intended to aid both researchers and clinicians in appropriately classifying headaches. Diagnostic standards that serve as the basis for classifying migraineurs in research and clinical practice are presented
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| (18) |
Jhingran P, Cady RK, Rubino J, Miller D, Grice RB, Gutterman DL. Improvements in health-related quality of life with sumatriptan treatment for migraine. J Fam Pract 1996; 42(1):36-42.
This study looked at the effect of sumatriptan on quality of life measures in those suffering from migraine headaches. The impact of migraine on productivity and disability was also assessed. Sumatriptan treatment was associated with significant improvements in several quality of life measures. Patient-rated productivity improved and reductions in patient-rated disability also occurred. Patients using sumatriptan experienced improvements in disability and productivity as well as in health-related quality of life.
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| (19) |
Joish VN, Cady PS, Shaw JW. Health care utilization by migraine patients: a 1998 Medicaid population study. Clin Ther 2000; 22(11):1346-1356.
Claims data were used to identify cases suffering from migraine. Four controls were also matched and the two groups were compared based on physician services, hospital services, emergency room services, and prescription use. Migraine patients had significantly higher health care resource consumption than matched controls. The authors concluded the results of this study suggest that migraine is a significant economic burden to the Medicaid program.
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Legg RF, Sclar DA, Nemec NL, Tarnai J, Mackowiak JI. Cost-effectiveness of sumatriptan in a managed care population. Am J Manag Care 1997; 3(1):117-122.
An open-label study used self-report to evaluate whether sumatriptan decreased healthcare costs and migraine-related disability. Participants were surveyed at one point in time and indicated that their number of monthly migraine disability days decreased from 6.5 days per month before to 3.9 days per month after sumatriptan. Healthcare utilization rates (ie, number of hospitalizations, emergency department visits) and costs were lower after the patients began taking sumatriptan.
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| (21) |
Legg RF, Sclar DA, Nemec NL, Tarnai J, Mackowiak JI. Cost benefit of sumatriptan to an employer. J Occup Environ Med 1997; 39(7):652-657.
Self-reported workplace productivity before and after sumatriptan use was assessed at one point in time. This study reported that lost labor costs were decreased after sumatriptan treatment was initiated. Incremental benefit of this reduction in lost productivity was valued at $435/month per employee. The benefit-to-cost ratio is 10:1. The authors concluded there was a net benefit to the employer with sumatriptan treatment.
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Lipton RB, Diamond S, Reed M, Diamond ML, Stewart WF. Migraine diagnosis and treatment: results from the American Migraine Study II. Headache 2001; 41(7):638-645.
Similar to results from Philadelphia County, this study found that 48% of migraineurs reported a physician diagnosis of migraine. Forty-one percent used prescription drugs for headaches and 57% used over-the-counter medications. Results comparing severity and frequency of headache as well as duration of activity restriction are also presented by physician diagnostic status. Migraine continues to cause significant disability whether or not there has been a physician diagnosis.
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Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology 2002; 58(6):885-894.
Another population-based study to determine the prevalence and distribution of migraine in the United States was conducted in Philadelphia County. This study found the 1-year prevalence of migraine was 17.2% in females and 6.0% in males, similar to the American Migraine Study. Healthcare patterns were also assessed and revealed only 48% of migraine sufferers had seen a doctor for headache within the last year and 31% had never done so in their lifetimes. Of all migraine sufferers, 49% were treated with over-the-counter medications only, 23% with prescription medication only, 23% with both, and 5% with no medications at all. Only 20% of the prescription-only group mentioned triptans as their first-choice medication.
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Lipton RB, Scher AI, Steiner TJ et al. Patterns of health care utilization for migraine in England and in the United States. Neurology 2003; 60(3):441-448.
Two parallel epidemiologic surveys were conducted in the US and UK to assess patterns of medical consultation, diagnosis, and medication use in adults with migraine. Patients with migraine in the UK were more likely to have consulted a doctor for headache at least once in their lifetime (86% vs 69%, p < 0.0001), but also were more likely to have lapsed from medical care (37% vs 21%, p < 0.001). Patients with migraine in the UK were more likely to receive a medical diagnosis of migraine (UK 67%, US 56%; p < 0.05). Most people in both countries treated their migraines with over-the-counter (OTC) medications and a low percentage using triptans. Substantial disability occurred in a high proportion of those who never consulted (UK 60%, US 68%), never received a correct medical diagnosis (UK 64%, US 77%), and treated only with OTC medication (UK 72%, US 70%).
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| (25) |
Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache 2001; 41(7):646-657.
A questionnaire was mailed to a representative sample of households in the US in order to describe the prevalence and burden of migraine. Questions relating to headache frequency, disability and severity were asked and respondents were then classified based on modified International Headache Society criteria. The prevalence of migraine was 18.2% among females and 6.5% among males. Several other population-based studies have produced similar prevalence estimates and these figures are cited widely in the literature. The number of migraineurs was approximately 27.9 million in 1999.
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Litaker DG, Solomon GD, Genzen JR. Impact of sumatriptan on clinic utilization and costs of care in migraineurs. Headache 1996; 36(9):538-541.
This retrospective, exploratory study used a consecutive sample of patients regularly attending a headache clinic to estimate utilization and costs associated with sumatriptan treatment of migraine headaches. After initiation of sumatriptan treatment, direct costs went from $228.59 per person to $135.93. The median number of visits made by study subjects to the headache clinic also fell significantly following sumatriptan test dosing. However, pharmacy costs were unavailable for this analysis.
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Lofland JH, Johnson NE, Batenhorst AS, Nash DB. Changes in resource use and outcomes for patients with migraine treated with sumatriptan: a managed care perspective. Arch Intern Med 1999; 159(8):857-863.
One hundred seventy-eight patients suffering from migraine in a mixed model managed care organization completed a study to assess the efficacy of sumatriptan on healthcare resource use, health-related quality of life, migraine-related workplace and non-workplace productivity. Significant decreases were seen in healthcare resource use and productivity measures while improvements were seen in health-related quality of life measures.
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Lofland JH, Kim SS, Batenhorst AS et al. Cost-effectiveness and cost-benefit of sumatriptan in patients with migraine. Mayo Clin Proc 2001; 76(11):1093-1101.
The prospective, observational outcomes study conducted by Lofland et al (Arch Intern Med, 1999) was used as the basis for this cost-effectiveness and cost-benefit analysis. The authors found that the overall net cost savings after sumatriptan was initiated in these patients was $222,332 ($1249 per patient) with a benefit-to-cost ratio of $5.67 gained for each health care dollar spent from a societal perspective. The incremental cost-effectiveness ratio was $25 for each additional migraine-disability-day averted by using sumatriptan vs nontriptan drug therapy.
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Lofland JH, Locklear JC, Frick KD. Different approaches to valuing the lost productivity of patients with migraine. Pharmacoeconomics 2001; 19(9):917-925.
This study used data from the prospective observational outcomes study conducted by Lofland et al (Arch Intern Med, 1999) to compare two different methods for calculating the cost of lost productivity of migraineurs. The human capital approach (HCA) resulted in an estimated total cost of lost productivity for 6 months following the initiation of sumatriptan at $US117,905 (1996 values) while the friction cost approach (FCA) estimated lost productivity at $US28,329. Although these two estimates vary substantially, most published research uses the HCA to estimate lost productivity.
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Miller DW, Martin BC, Loo CM. Sumatriptan and lost productivity time: a time series analysis of diary data. Clin Ther 1996; 18(6):1263-1275.
Using time series analysis, this paper took two previously conducted clinical studies assessing lost workplace productivity to evaluate whether improvements seen were due to sumatriptan or regression to the mean. The study suggested that the change was due to sumatriptan itself, rather than some statistical phenomenon.
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Mushet GR, Miller D, Clements B, Pait G, Gutterman DL. Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine. Headache 1996; 36(3):137-143.
This small, prospective, open-label study evaluated the effects of subcutaneous sumatriptan versus usual therapy on workplace productivity, activity time outside of work, and health-related quality of life. Lost Workplace Productivity and Nonworkplace Activity Time was 35% lower with sumatriptan therapy (1.5 hours) compared with usual therapy (2.3 hours). Scores on each of the three Migraine-Specific Quality of Life Questionnaire dimensions and on the Role-Emotional dimension of the Short Form-36 were significantly more favorable after sumatriptan than after usual therapy.
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| (32) |
Osterhaus JT, Gutterman DL, Plachetka JR. Healthcare resource and lost labour costs of migraine headache in the US. Pharmacoeconomics 1992; 2(1):67-76.
This frequently cited study surveyed patients who participated in two clinical trials to estimate the cost of migraine headache in the US. Using 1986 estimates of median earnings for the US work force, the extrapolated costs to employers ranged from $US5.6 billion to $US17.2 billion dollars annually due to decreased productivity and missed work days.
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| (33) |
Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000 55: 754-762.
Abstract: The American Academy of Neurology (AAN) developed practice parameters for physicians treating migraineurs. These were based on the results from four in-depth, evidence-based reviews on the management of patients with migraine. They summarize guidelines on acute, preventive, and nonpharmacologic treatments.
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| (34) |
Schulman EA, Cady RK, Henry D et al. Effectiveness of sumatriptan in reducing productivity loss due to migraine: results of a randomized, double-blind, placebo-controlled clinical trial 46. Mayo Clin Proc 2000; 75(8):782-789.
A randomized, double-blind trial was conducted to evaluate the efficacy of self-injected sumatriptan on reducing hours lost from work. Across an 8 hour work shift sumatriptan reduced mean productivity loss by 49% compared to placebo. A greater number of sumatriptan patients also experienced headache relief 1 hour after injection compared with placebo-treated patients (63% vs 33%, P = .004).
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| (35) |
Schwartz BS, Stewart WF, Lipton RB. Lost workdays and decreased work effectiveness associated with headache in the workplace. J Occup Environ Med 1997; 39(4):320-327.
Results from this study were used as the basis for estimating the number of lost workdays in the migraine model. This was a population-based study that used IHS criteria for migraine classification and was thought to be most representative of the entire migraine population. Subjects lost an average of 8 workdays per year because of migraine.
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| (36) |
Snow V, Weiss K, Mottur-Pilson C. Pharmacologic management of acute attacks of migraine and prevention of migraine headache. Ann Intern Med. 2002 Nov 19;137(10):840-9.
Abstract: This article reviews the diagnosis of migraine as well as options for acute and preventive therapy. Treatment guidelines for primary care physicians were developed by the American Academy of Family Physicians and the American College of Physicians – American Society of Internal Medicine and are presented in this article.
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| (37) |
Stang PE, Osterhaus JT. Impact of migraine in the United States: data from the National Health Interview Survey. Headache 1993; 33(1):29-35.
Migraine prevalence was estimated by self-report using data from the 1989 National Health Interview Survey. The overall prevalence was estimated to be 4.1%, a figure that is now considered an under-estimate of the true prevalence in the US. The potential cost of lost productivity was estimated at $1.4 billion per year for the estimated 6,196,378 migraineurs who worked outside the home.
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| (38) |
Stewart WF, Lipton RB, Liberman J. Variation in migraine prevalence by race. Neurology 1996; 47(1):52-59.
This paper is from the Baltimore County random-digit dialing study and estimated the migraine prevalence in different racial groups. Prevalence was highest in Caucasians, followed by African Americans and Asian Americans. The authors concluded the difference seen were more likely to be due to race-related differences in genetic vulnerability to migraine rather than environmental influences.
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| (39) |
Stewart WF, Lipton RB, Simon D. Work-related disability: results from the American migraine study. Cephalalgia 1996; 16(4):231-238.
This population-based study estimated missed workdays and impairment at work in a sample of 1663 migraine suffers. Homemaker workdays were included. A total of 51.1% of female and 38.1% of male migraineurs experienced six or more LWDE per year. This subgroup of migraine sufferers accounted for about 90% of the total LWDE experienced by all respondents.
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| (40) |
Stewart WF, Lipton RB, Celentano DD, Reed ML. Prevalence of migraine headache in the United States. Relation to age, income, race, and other sociodemographic factors. JAMA 1992; 267(1):64-69.
This national study was undertaken to describe the prevalence, attack frequency, and attack-related disability of migraine headache. A self-administered questionnaire was sent to a sample of 15,000 households. The response rate was 63.4%. 17.6% of females and 5.7% of males were found to be migraineurs. Projecting these percentages to the US population yielded an estimate of 8.7 million females and 2.6 million males suffering from migraine headache. The percentage of people suffering from migraine was similar to that found in the American Migraine Study II, conducted 10 years later.
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| (41) |
Streator SE, Shearer W. Pharmacoeconomic impact of sumatriptan on migraine. Am J Manag Care 1996; February.
A retrospective review of medical and pharmacy claims examined the direct care costs of administering injectable sumatriptan for the treatment of migraine headache. This study found the total direct medical costs were increased by 193 percent despite a decrease in the number of migraine sufferers admitted to the emergency room.
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| (42) |
Von Korff M, Stewart WF, Simon DJ, Lipton RB. Migraine and reduced work performance: a population-based diary study. Neurology 1998; 50(6):1741-1745.
This study is unique in that it is a population based study that characterized both severely and mildly affected migraineurs in terms of lost work day equivalents. Those migraineurs who were clinically confirmed and participated in the study kept a weekly diary about headache symptoms and effectiveness at work. The most disabled 20% of the participants accounted for 77% of the lost workdays; 40% of subjects accounted for 75% of the lost workday equivalents.
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| (43) |
Weaver MB, Mackowiak JI, Solari PG. Triptan therapy impacts health and productivity. J Occup Environ Med 2004; 46(8):812-817.
A survey of new sumatriptan users was conducted in a California health plan. After sumatriptan was initiated, participants reported significantly fewer workdays missed, fewer days worked with headache, and greater productivity while headache symptoms were present. A 70% improvement in total workplace productivity was seen after initiation of sumatriptan.
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