Cary Sennett, MD, PhD

To refine a previously published standardized quality and utilization measurement set for migraine care and to establish performance benchmarks.

 Retrospective application of the migraine measurement set to health plan data in order to assess patterns of health service utilization. Methods: Measurement specifications were applied to data from 10 health plans for measurement year 2009.

Of the 2.9 million continuously enrolled members of the health plans, 138,004 (4.7%) met inclusion criteria for the migraine population. Of these, 26% did not have a migraine diagnosis, but were utilizing migraine drugs; 12% had a computed tomography scan within the year (range 8%-25% across plans); and 8% had magnetic resonance imaging (range 6%-11%). Nearly 18% of the migraineurs had 1 or more visits to an emergency department/urgent care center for migraine; few (6%) were followed up with primary care visits. Approximately one-fourth of the migraineurs were not being routinely monitored by a physician. Medication utilization also was examined for members of the migraine population with pharmacy benefits. A significant proportion (42%) were given a migraine preventive, 38% had at least 1 prescription for a triptan, and 2% of those on triptans were potentially overutilizing the medication. Among patients aged 18 to 49 years who were given triptans,

3% had a cardiac contraindication; this percentage rose to 7% for patients aged 50 to 64 years.

 This study demonstrates the value of standardized measures in identifying potential quality issues for migraine care, including underdiagnosis, overutilization of imaging, and underutilization of preventive drugs.

Although migraine is a prevalent and costly chronic condition, a standardized mechanism for measuring health service utilization at the health plan level does not exist. Our research provides a strategy for health plans to:

		Identify and standardize measurement of health service utilization for a migraine population.

		Apply the migraine quality of care measurement set to identify and examine care for health plan members with migraine.

Migraine is a highly prevalent, chronic, episodic condition that is often misdiagnosed and undertreated. The associated healthcare costs are significant, and lost workplace productivity secondary to migraine headache is substantial.

 Migraineurs have poorer health-related quality of life than individuals with diabetes, hypertension, or depression, thus making it a significant public health concern that is not often recognized.

Migraine affects approximately 12% of adults in a given year, with prevalence 3 times higher in women than men.

 Partly due to its episodic nature, migraine remains undiagnosed in as many as 56% of sufferers, and nearly half of migraineurs have never contacted a physician or used medication to manage their headaches.

Although 1 in 4 migraineurs is eligible for preventive treatment, only 12% receive it.

At the personal level, migraine can be debilitating and impair quality of life. At the system level, costs associated with migraine care, both direct costs of medical care and indirect costs of lost productivity, are significant.

 Direct costs for those who do seek treatment have been estimated at anywhere from $1.25 billion to $11.1 billion annually.

 If poorly managed, the condition leads to annual lost productivity estimated in the range of $16.2 to $28.7 billion.

 In the workplace, absenteeism due to migraine can result in up to 7 days a year of lost productivity, costing $709 to $4453 per migraineur.11 Migraine also continues to be among the top 5 conditions with the greatest impact on presenteeism, and thus represents a substantial burden for employers.

Because migraine is prevalent and costly, standardized measures are needed to manage and improve care. In 2006, a literature review revealed that no standardized measures existed for monitoring migraine care.

In order to begin developing a measurement set, an expert panel was assembled and a set of 20 measures with detailed specifications was developed. These measures focused on quality issues that could be captured through claims data readily available from health plans.

 An unpublished pilot test was conducted using 2 data sets in 2007, and the measurement specifications were clarified to address identified ambiguities and inconsistencies. In this study we report on the subsequent pilot test of the measurement set.

This work builds on the previously reported measures.

 A literature review update was conducted to determine whether any new care standards or measures related to migraine care had been published or endorsed since the original measuredevelopment project. The original measures and the findings from the literature review were presented to an advisory group consisting of clinical experts and quality measurement professionals.

Advisors were chosen based on contributions to the literature on migraine clinical care and measurement, as well as recommendations from the co-primary investigator (SS), a national expert on the topic. The group of advisors engaged in the initial phase of measurement development were invited to continue their participation through the pilot test reported on here. The advisory group is a convenience sample of thought leaders that we the authors believed would contribute to the discussion and review processes. The advisors’ recommendations were incorporated into a revised set of measures and specifications.

Measurement specifications were modeled after the Healthcare Effectiveness Data and Information Set (HEDIS) measures on effectiveness of care and utilization. The main categories of measures included diagnosis of migraine, radiology utilization, physician utilization, emergency department (ED)/urgent care center utilization, and utilization of pharmaceuticals. A summary of the measures is provided in 

The sampling frame for the measures was defined as members of a health plan who were aged 18 to 64 years, were insured through either a commercial provider or Medicaid, and had continuous enrollment as defined by HEDIS during the measurement year. The migraine population was identified based on medical and/or pharmacy claims data. Because migraine is underdiagnosed and undercoded, the migraine population, as defined in the specifications, also includes those individuals who did not have a diagnosis of migraine but did have 1 or more claims with a diagnosis of headache, or who were given a drug specific to migraine care.

The Medical Outcomes Research for Effectiveness and Economics Registry (MORE2) was selected as the validation study data source because it contained data on multiple health plans and included a wide range of plan sizes and geographic locations. Inovalon was asked to identify 10 health plans for inclusion in the study. The Thomas Jefferson University Institutional Review Board evaluated the study protocol and determined that it was exempt from further review.

The selected health plans covered a total of 2.9 million lives (

). Of the 10 included plans, 5 had commercial members, 3 had Medicaid members, and 2 had both. The plan sizes ranged from 69,359 to 834,285 members, with an average plan size of 292,161 members. The migraine population identified across the 10 plans for measurement year 2009 included 138,004 members. Of these, 27% (36,579) had 1 or more claims/encounters with a coded diagnosis of migraine; 16% (21,718) had multiple episodes of headache, not coded as migraine; 26% (36,223) had at least 1 prescription for a migraine drug; and the remaining 32% of the members (43,484) met more than 1 of these 3 criteria for inclusion in the migraine population.

The 26 migraine quality of care measures were applied to the data for this identified population. Data were analyzed at the plan level and aggregated across plans, with examination of median values and ranges across plans, in order to begin to establish plan-level benchmarks for the measures. The analytic findings were reviewed with expert advisors in November 2010 during an in-person meeting (see Acknowledgments). In addition to review of the findings, the intent of this meeting was to seek input from the advisors on modifications to the measurement set based on the reviewed findings and to improve the utility of the measures for health plans. The data presented in this article are based on the measurement set that was presented to the advisors in November. A number of recommendations (see the Discussion section) were considered in addition to research opportunities that would expand on this work and further validate the measurement set.

As noted above, the migraine population included 138,004 members. The majority of these (80.9%) were female. Migraineurs were identified in 2 separate calculations based on their benefits coverage. Of the individuals with medical benefits, 4.7% had a diagnosis of migraine or medical claims indicative of migraine; 4.9% of those with medical and pharmaceutical benefits were identified as migraineurs.

Findings regarding the measures of radiologic testing, physician visits, and use of emergent and urgent care services are presented in

. Within the migraine population, 12% had a computed tomography (CT) scan for migraine during the measurement period, and 8% had a magnetic resonance imaging (MRI) scan. There was variation in utilization of MRI and CT scans in the range of 6% to 11% and 8% to 25%, respectively, across the 10 plans. To be consistent with the evidencebased guidelines, the timing and location of the test were also considered.

 More than 73% of CT scans and MRIs were completed within 48 hours of an ED visit. The proportion of individuals who had multiple scans was of great importance to this assessment, since they would likely be the population driving utilization. However, we found that only 2% of the migraine population had multiple CT and/or MRI scans, and that more than half of these scans (53%) occurred outside of an ED visit.

More than half of migraineurs (61%) visited their primary care provider to manage their condition, while 13% visited a neurologist. Nearly 18% visited the ED or an urgent care center for migraine-related issues. Few migraineurs (6%) followed up with a primary care provider or neurologist in the month after an ED or urgent care center visit. The data indicated that a quarter of migraineurs were not annually being monitored by a physician, which may have contributed to ED or urgent care utilization. Studies demonstrate that close monitoring of migraine pain by a physician affects how well the condition is controlled.

Findings for the pharmacy utilization measures, calculated for those individuals in the migraine population who had pharmacy benefits, are shown in 

. Medication use was common among the study population (RX1-RX4), regardless of a migraine diagnosis: 42% of individuals had at least 2 prescriptions for a migraine preventive (defined as any betablocker, tricyclic antidepressant, selective serotonin reuptake inhibitor [SSRI], serotonin-norepinephrine reuptake inhibitor [SNRI], anticonvulsant, calcium channel blocker, cyproheptadine, methylergonnovine, or botulinum toxin type A); nearly 38% had at least 1 prescription for a triptan; and fewer than 1% had a prescription for an ergot alkaloid/derivative. Short-acting opioids were used frequently (50%), whereas long-acting opioids (4%) and rapid-acting fentanyl products (0.1%) were not. Considerable variation was noted in pharmacy utilization rates across plans, with the exception of ergot alkaloid/derivatives and rapid-acting fentanyl products, which both had very low utilization across all plans.

Several measures (RX.5-RX7) looked more closely at triptan use. For those individuals with at least 1 triptan prescription in the measurement year, 52% had at least 1 prescription for a migraine preventive and 2% averaged more than 12 triptan doses per month over the 12-month period. Of those averaging more than 12 triptan doses per month, 70% had at least 1 prescription for a migraine preventive. All 3 of these measures had substantial variations between health plans (Table 4).

Measures RX.8 and RX.9 looked at whether individuals in the migraine population who were given triptans had lower rates of concurrent cardiac contraindications (ischemic cardiac syndromes, cerebrovascular syndromes, coronary artery disease, peripheral vascular syndromes, or uncontrolled hypertension) or concurrent SSRI/SNRI therapy than those in the migraine population who were not given triptans. Nearly 5% of the migraine population was using triptans despite having cardiac contraindications. Individuals aged 18 to 49 years who were given triptans had a 3% rate of cardiac contraindications, whereas those not given triptans had a 6% rate of cardiac contraindications. In individuals aged 50 to 64 years, a more conservative approach was observed, with 7% of those given a triptan having a cardiac contraindication and 19% of those not given a triptan having a cardiac contraindication. Nearly 30% of the migraine population was concurrently given an SSRI/SNRI and a triptan. Individuals aged 18 to 49 years who were given a triptan were observed to be on concurrent SSRI/ SNRI therapy 28% of the time, whereas those not given a triptan were on SSRI/SNRI therapy 24% of the time. Those aged 50 to 64 years exhibited similar rates and trends, with 32% of those given a triptan receiving SSRI/SNRI therapy, and 29% of those not given a triptan during the measurement year receiving SSRI/SNRI therapy.

The final 2 RX measures examined multiple prescriptions for opioids and butalbital products in the migraine population. More than one-third (35%) of the migraine population were dispensed an average of 10 doses of opioids per month over a 6-month period (RX.10). Ten percent of the migraine population were given an average of 10 doses of butalbital-containing products per month over a 6-month period (RX.11). Considerable variability was observed for RX.10 between plans, but variability was more modest for RX.11

This study demonstrates several potential quality concerns associated with migraine care and the potential utility of the measurement set in helping health plans examine care for their members with migraine.

Migraine is significantly underdiagnosed and undercoded, with 42% of the migraine population in this study identified by means other than a diagnosis code or visit for migraine in the measurement year. The identified population prevalence (4.7%-4.9%) using the measurement specifications was significantly lower than the 10% to 12% population prevalence rates derived from survey and chart review studies,

suggesting that many people with migraine may not seek out treatment, or may be misdiagnosed and/or undertreated.

The findings for the identified population nonetheless show that migraineurs are utilizing a considerable number of healthcare services related to their condition. About 20% of migraineurs had a CT scan or MRI scan in the measurement year (2% had multiple scans), close to 18% went to the ED or an urgent care center, and 38% utilized an abortive medication (triptan, ergot alkaloid/derivative, or butalbital-containing product). The data presented in this study represent a sample of 10 plans with broad variability. The migraine quality of care measures provide guidance for the establishment of national benchmarks for utilization of healthcare services and medications for migraine care. This study represents initial efforts to identify benchmarks and provide evidence of how health plans can use them to classify and manage their migraine patients.

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The management of hypercholesterolemia continues to be a topic of active research–reflecting, no doubt, the enormous burden of cost and illness that cardiovascular disease (CVD) represents; the importance of hypercholesterolemia as a risk factor; and the gap between current risk and minimum risk in the US population. 

This research is providing new insights to guide clinical management. To begin with, we appreciate how complex are the physiologic systems that govern serum cholesterol–and are challenged to consider interventions to address multiple components of those systems to achieve desired results. More recently, we have come to understand that historical targets for lowdensity lipoprotein (LDL) cholesterol–especially in patients with (or at high risk for) CVD–may not be low enough. Finally, we have recognized the expansion of the therapeutic armamentarium–in particular, the efficacy of a cholesterol absorption inhibitor, such as ezetimibe, in combination with a statin, as a means by which to achieve LDL cholesterol control. 

These findings suggest that cholesterol control targets are moving–lower levels seem to lead to better outcomes and seem increasingly achievable. This has real implications for managed care organizations (MCOs). The challenges these imply are even more noteworthy, given evidence that many patients are not managed even to current National Cholesterol Education Program goals. 

There is, in these findings, great opportunity for MCOs to improve care. At the same time, there are very real issues on the financial front. Expansion of the group of patients at high risk for CVD increases the number of individuals eligible for (what is usually costly) pharmaceutical therapy. Furthermore, the lowering of targets for control will increase the intensity (and the cost) of that therapy. 

While the use of higher doses of statins may have little effect on cost, the addition of new agents (like ezetimibe) that act synergistically could increase cost quite significantly. 

How many patients will be prescribed ezetimibe is difficult to know. But with "usual care" achieving target less than 50% of the time (data elsewhere in this supplement)–and with a clear physiologic rationale for intervention elsewhere in the cholesterol pathway–the likelihood that ezetimibe plus a statin will become the standard of care is very high. Although that should lead to significantly better control–and better clinical outcomes–it seems certain that it will lead to higher costs in the short run. Whether the intriguing results from Sweden, that suggest lower health care costs for CVD, will persist and generalize remains to be seen. For the moment, it seems only that it will exacerbate a health care cost problem that is already formidable. 

How can MCOs respond? I think they need to lay out–and communicate to their networks and to their members–rational protocols for cholesterol management. In addition, they need to consider what mechanisms they have to encourage and enable their adoption and use. Those protocols must map out treatment paths for patients with hypercholesterolemia that drive toward targets but assure that medications are added rationally and cost-effectively. 

Statins will remain the first-line therapy–ideally with diet and exercise. Guidelines will need to consider when to advance statin therapy and when to add other agents. There will be enthusiasm, no doubt, to add ezetimibe–early and often. MCOs will need to provide guidance to assure that potentially cost-effective alternatives (bile acid sequestrants, niacin) are appropriately considered. 

This will mean education and judicious use of incentives. Pharmacy benefits should provide members with incentives to move along the most cost-effective treatment path. Perhaps no aspect of care, though, is more amenable to measurement-based systems to influence physician decisions. The outcome of cholesterol management is measurable (and obtainable relatively inexpensively from laboratory datasets), and the cost of achieving those outcomes is readily obtainable from claims data. 

The opportunity for feedback–or value-based incentives–is clear. In combination with education (of members and physicians), the potential to rationalize but also to improve care should be clear as well.

Cary Sennett, MD, PhD

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