Prevalence, Health Care Utilization, and Costs of Fibromyalgia, Irritable Bowel, and Chronic Fatigue Syndromes in the Military Health System, 2006-2010 - Insurance News | InsuranceNewsNet

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September 15, 2014 Newswires
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Prevalence, Health Care Utilization, and Costs of Fibromyalgia, Irritable Bowel, and Chronic Fatigue Syndromes in the Military Health System, 2006-2010

Dorris, Joseph
By Dorris, Joseph
Proquest LLC

ABSTRACT Objective: We compared prevalence, health care utilization, and costs over time for nonelderly adults diagnosed with fibromyalgia syndrome (FMS), irritable bowel syndrome (IBS), and chronic fatigue syndrome (CFS) in relation to timing of federal approvals for FMS drugs. Data Source: We used military health care claims from October 2006 to September 2010. Study Design/Analysis: Retrospective, multiple-year comparisons were conducted using trend analyses, and time series regression-based generalized linear models. Results: Over 5 years, FMS prevalence rates increased from 0.307% to 0.522%, whereas IBS and CFS prevalence rates remained stable. The largest increase in FMS prevalence occurred between 2007 and 2008. Health care utilization was higher for FMS cases compared to IBS and CFS cases. Over 5 years, the total cost for FMS-related care increased $163.2 million, whereas IBS costs increased $14.9 million and CFS cost increased $3.7 million. Between 2006 and 2010, total pharmacy cost for FMS cases increased from $55 million ($3,641/person) to $96.3 million ($3,557/person). Conclusion: Although cause and effect cannot be established, the advent of federally approved drugs for FMS in concert with pharmaceutical industry marketing of these drugs coincide with the observed changes in prevalence, health care utilization, and costs of FMS relative to IBS and CFS.

INTRODUCTION

Medically unexplained physical symptoms (MUPS) are func- tional disorders without known etiology or structural cause. As reviewed elsewhere, there is no agreement on MUPS diag- nostic nosology or diagnostic criteria.1-4 Such disorders, char- acterized by symptom clusters, are commonly referred to as psychosomatic disorders, or viewed as mood disorders with comorbid pain, gastrointestinal syndromes, or profound fatigue.4-6 Numerous reports document the concurrence of mood disorders and MUPS,7-12 but there is little empirical evidence for psychological etiology.13

Three common MUPS conditions are fibromyalgia syn- drome (FMS), irritable bowel syndrome (IBS), and chronic fatigue syndrome (CFS). The exact prevalence of these condi- tions is unknown but 2% of the U.S. population are estimated to have a FMS diagnosis,14,15 at least 10% are assumed to have IBS,16,17 and 0.4% are estimated to have CFS.18 Com- pared to civilian populations, higher rates of CFS19 and FMS have been reported among U.S. military veterans deployed to the Persian Gulf during the 1991 Gulf War.20 Such health conditions have long been recognized by the U.S. military as impacting readiness and job productivity.21

MUPS conditions are of interest to health care systems because of high health care utilization and costs.22,23 High costs are attributed to the number of diagnostic tests and procedures needed to rule out other conditions,24,25 comor- bid conditions that complicate diagnostic evaluations,23,25-27 and number of drug prescriptions.23,25,28-31 Medications contributing to high FMS costs include antidepressants,23,32 anxiolytics, nonsteroidal anti-inflammatory drugs, gabapentin, pregabalin, and duloxetine.33 Since the U.S. Food and Drug Administration (FDA) approved pregabalin, duloxetine, and milnacipran for use in FMS, qualitative research has linked high pharmacy costs for FMS to pharmaceuti- cal marketing.34

Study Purpose

As part of an internal Department of Defense (DoD) review of high cost/high utilization medical conditions among DoD health care beneficiaries, we examined 2005-2010 preva- lence, health care utilization, and costs associated with MUPS diagnoses. Our preliminary findings led to the hypothesis that the timing of FDA-approved drugs for FMS coincided with observed changes in prevalence, health care utilization, and costs among those diagnosed with FMS. As a comparison, we examined the same outcomes for individ- uals diagnosed with IBS and CFS, MUPS conditions with- out new drug approvals during the same 5-year period.

METHODS

Data Source and Definitions

TRICARE Institutional Review Board approved the study on May 18, 2011, with exempt status. The TRICARE Man- agement Activity Office of Privacy and Civil Liberties approved data use on December 12, 2011, with full waiver of authorization.

Procedures for data extraction of administrative claims data from the Military Health System Data Repository conformed to guidelines established by the TRICARE Office of Privacy and Civil Liberties. All DoD beneficiaries diag- nosed with FMS, IBS, and CFS between October 2006 and September 2010 were included. Other inclusion criteria were residence in the continental United States and Hawaii; age 18 to 64; and, within each year, two or more outpatient visit claims, or one inpatient stay claim for a primary diagnosis of FMS (ICD-9 729.1, "Myositis and Myalgia, unspecified"), IBS (ICD-9 564.1), or CFS (ICD-9 780.71). Each person was counted once per year. Individuals with two or more of selected MUPS conditions were counted once per year and assigned the first primary MUPS diagnostic category. The resulting data set underwent quality review with respect to completeness, duplication, and out-of-range values. All cases used in the analysis met the inclusion criteria.

Definitions of Outcome Variables

Prevalence was derived by the yearly proportion of the beneficiary population who submitted claims with a pri- marydiagnosisofFMS,IBS,orCFS,andmetourinclu- sion criteria.

Health care utilization was measured by the number of ambulatory encounters per person per fiscal year. Ambula- tory encounters included any services or procedures provided in outpatient clinics, hospital outpatient departments, emer- gency departments, or ambulatory surgical facilities.

All encounters were included in the analysis even if the encounter did not specify a MUPS diagnosis. Costs were standardized to 2010 dollars. Total cost data were based on claims paid by DoD for ambulatory encounters, inpatient stays, ancillary costs (i.e., radiology, pathology/laboratory), filled prescriptions, facility costs, and professional services. Costs incurred in military treatment facilities were standard- ized using published 2010 DoD "Green Book" rates, which contain a 50/50 contribution split of Operations & Manage- ment, and military personnel rates. Costs incurred in civilian facilities were standardized using Bureau of Labor Statistics Medical Consumer Price Index rates.

Definitions of Explanatory Variables

Age was grouped into four categories: 18 to 24, 25 to 34, 35 to 44, and 45 to 64 years. Although age was analyzed with both continuous and categorical variables, we report on the categorical age values because they yielded similar patterns within the final models, and were more indicative of groupwise patterns than the continuous effect of age, linear or nonlinear.

Beneficiary category refers to the type of sponsor or family member eligible for DoD health care coverage. Spon- sors are active duty or military retired personnel from the Army, Navy, Marine Corps, Air Force, Coast GuardCommissioned Corps of the U.S. Public Health Service, and Commissioned Corps of the National Oceanic and Atmo- spheric Association, National Guard or Reserve personnel, or are recipients of Medals of Honor. Family members are spouses and children of these sponsors. For regression models, beneficiary category was collapsed into active duty, active duty family member, and retirees/retiree family members/others.

Service affiliation is the sponsor's branch of uniformed services, categorized as Army, Navy, Marine Corps, Air Force, Coast Guard and Other.

Health care system refers to use of military treatment facilities (MTF) or civilian facilities. Comparisons between the systems were restricted to beneficiaries who used the military system only and the civilian system only.

Prime versus non-Prime reflects the type of beneficiary enrollment in TRICARE, the DoD health care program. Prime is the managed care option, and non-Prime is the fee- for-service plan. About two-thirds of beneficiaries are eligi- ble for Prime coverage, which is delivered through MTF and assigned, civilian primary care managers. Active duty per- sonnel are required to enroll in Prime, whereas others youn- ger than age 65 may elect to use Prime if they reside in regions where Prime is offered. Non-Prime coverage includes a number of plan options depending on eligibility status (e.g., Standard and Extra, Reserve Select, Retired Reserve, Young Adult). Beneficiaries with non-Prime may have higher out-of-pocket costs, are not assigned a primary care manager, and generally do not need prior authorization for referrals.

Within the United States, TRICARE regions are North, South, and West, each of which serves about 3 million bene- ficiaries. Each region is managed by a different contractor responsible for regional networks, authorizations, and pro- cessing claims.

Statistical Analysis

Using SAS software version 9.2 (Cary, North Carolina), variables were first analyzed with univariate and bivar- iate methods, quantitatively and graphically, to identify patterns of dispersion and 2-way relationship between pairs of independent and independent/dependent vari- ables. This process informed coding for the regres- sion modeling.

Stata software version 10.1 (College Station, Texas) "reg" and "fit" procedures were used to perform generalized least squares regression and account for non-normal error var- iance distribution with weighting by cohort size N. Although serial correlation using autoregressive AR(1) process was used in initial models, no autoregressive modeling was used in final models. The estimation procedure used was Stata's "xtreg" procedure. The reference groups for the regression analyses were active duty, males, age 18 to 24, Army, non- Prime, and West region.

RESULTS

Prevalence

The number of MUPS cases for the selected conditions steadily increased in 5 years, from 20,585 (total population N = 4,936,721) to 33,654 (total population N = 5,183,395). Eighty percent of MUPS cases were female and this per- centage remained stable over time. Figure 1 shows FMS prevalence rates, based on the number of beneficiaries for each year. Between 2006 and 2007, the prevalence rate increased 0.026%; between 2007 and 2008, the prevalence rate increased 0.070%. Prevalence rates for IBS and CFS negligibly increased in a smooth projection over the 5 years. The correlations of determination for the prevalence rates over time indicate strong correlations between the number of cases and time for FMS and CFS cases; for IBS, only a moderate association was found.

The FMS prevalence trend analysis (Table I), controlling for demographic variables, found the highest prevalence among the 45 to 64 age group, females, and those affiliated with the Marine Corps. The prevalence rate increased fastest among individuals in the age group 35 to 44. The prevalence rate among females increased faster than the rate for males, as did the rate for Prime beneficiaries relative to non- Prime beneficiaries.

The IBS model showed significantly higher prevalence compared to the reference groups for females ( p < 0.001, 95% CI [0.113,0.129]); 25 to 34 age group(p < 0.001,95% CI [0.058, 0.082]), 35 to 44 age group ( p < 0.001, 95% CI [0.071, 0.096]), and 45 to 64 age group ( p < 0.001, 95% CI [0.089, 0.111]); Air Force ( p < 0.001, 95% CI [0.006, 0.015]) and Coast Guard ( p < 0.001, 95% CI [0.015, 0.037]); North region ( p < 0.001, 95% CI [0.010, 0.030]) and South region ( p < 0.001, 95% CI [0.016, 0.036]); active duty family members ( p = 0.001, 95% CI [0.004, 0.016]) and retirees/retiree family members/others ( p < 0 .001, 95% CI [0.033 0.044]); and Prime enrollees ( p < 0.001, 95% CI [0.07, 0.088]). IBS prevalence rates slightly increased over time ( p < 0.001, 95% CI [0.010, 0.017]. Relative to other age groups, the 18- to 24-year-old age group had greater increase in prevalence for IBS over time. Compared to non- Prime beneficiaries, Prime beneficiaries' increase for rate of prevalence over time was slightly lower ( p = 0.003, 95% CI [-0.007, -0.001]).

The CFS model showed highest prevalence rates among the 45 to 64 age group ( p < 0.001, 95% CI [0.008, 0.016]), females ( p < 0.001, 95% CI [0.006, 0.012]), Coast Guard ( p < 0.001, 95% CI [0.008, 0.016]), Marines ( p = 0.038, 95% CI [0.0001, 0.005]), other Services ( p = 0.002, 95% CI [0.006, 0.027]), active duty family members ( p = 0.002, 95% CI [0.001, 0.006]), retirees/retiree family members/ others ( p < 0.001, 95% CI [0.006, 0.010]), and Prime enrollees ( p = 0.002, 95% CI [0.002, 0.009]). Marginally lower CFS prevalence rates occurred in the South region compared to the West region ( p = 0.05, 95% CI [-0.007, 0.000]). CFS prevalence rates remained stable over time for the total population, although rates increased slightly for the 35 to 44 age group ( p < 0.022, 95% CI [0.000, 0.003]), and females (p < 0.001, 95% CI[0.001, 0.003]).

Health Care Utilization

Among beneficiaries who used civilian systems only, the number of FMS cases increased from 7,042 (2006) to 13,121 (2010) over 5 years. Among those who used military systems only, there was a little change in the number of FMS cases per year over time. For IBS, the number of civilian system only cases increased from 1,997 to 2,637 over 5 years, whereas the number of military system only cases decreased from 998 to 725 over 5 years. For CFS, there was a modest increase over time in the number of beneficiaries who used civilian system only (305-505), whereas the number using military treatment facilities only decreased (90 to 61).

The increase in average number of ambulatory encounters per person per year for FMS cases increased less for civilian care system (35.37 in 2006 to 39.01 in 2010) than for military care system (27.78 in 2006 to 33.72 in 2010). The average number of ambulatory encounters for IBS civilian system only cases increased from 22.58 to 26.52 over 5 years, whereas the corresponding number of military system only cases increased from 22.06 to 27.87. Among CFS civilian system only cases, the average number of annual encounters increased from 24.51 (2006) to 29.86 (2010); in contrast, military system only encounters had a sporadic pattern throughout the period.

Costs

Total inflation-adjusted cost for all beneficiaries diag- nosed with FMS increased from $174.5 million in 2006 to $337.7 million in 2010 (Fig. 2). Total civilian care FMS cost increased an average of $29.8 million per year, doubling over 5 years, $119.5 million to $232.1 million. Total military care cost for beneficiaries diagnosed with FMS increased an aver- age of $13.5 million per year (p = 0.001), nearly doubling over 5 years, $55.0 million to $105.6 million. The average annual cost of care in 2006 for individuals diagnosed with FMS was $11,520; by 2010, it was $12,472. The average cost per person diagnosed with FMS increased $79 each year for care received within military facilities compared to $159 for care received within civilian facilities.

Table II shows the results of the cost trend rate model for FMS cases. Controlling for other factors, subgroups with the highest costs per person were in the age group 25 to 34; females, whose total costs were, on average, $1,997 a year higher than males; those affiliated with the Army compared to those affiliated with the Air Force or Coast Guard; active duty Service members; and the North region compared to the West region. Over time, total costs per person increased at a significantly higher rate for males compared to females, and for Prime compared to non- Prime beneficiaries.

Among IBS cases, total cost increased from $48.2 million to $63.1 million in the 5 years. On average, total cost of IBS care in civilian care increased $2.85 million per year, whereas total cost in care in military facilities increased $1.1 million per year. Over the same time period, the average per person cost did not significantly increase for IBS care. In 2006, the average annual cost per person was $9,557; in 2010, it was $10,501. Less cost increase over time per person was found for IBS cases receiving care from military facili- ties compared to civilian care ($40 vs. $266 average increase per person per year).

Controlling for other factors, total cost per person trend rate model for IBS cases found higher per person costs in the 45 to 64 age group compared to the reference 18 to 24 age group by $1,748 per year per person ( p = 0.026, CI 95% [$214, $3,282]); females had higher total cost per person than males by $1,726 a year ( p = 0.001, CI 95% [$682,$2,770]); the Air Force (p = 0.005, CI95% [-$1,070, -$190]) and Coast Guard (p < 0.001, CI 95% [-$3,622, -$1,404]) had lower costs per person than the Army; active duty Service members had higher costs than those in other beneficiary categories; and Prime beneficia- ries had lower costs per person than non-Prime beneficia- ries (p = 0.04, CI 95% [-$2,010, -$49]). Examining the cost trend rate differences, total cost per person for Prime beneficiaries was significantly higher over time relative to those with non-Prime by $641 per person per year ( p < 0.001, 95% CI [$351, $930]).

Likewise, we found a significant increase in CFS cost over time with total cost increasing from $6.4 million to $10.1 million over the 5 years. On average, cost of CFS care in civilian facilities increased $1.0 million per year over time ( p = 0.001) compared to $194,000 per year over time in military treatment facilities ( p = 0.80). In 2006, average cost per person among CFS cases was $10,042; in 2010, it was $10,797. Among CFS cases, there was a $534 average increase per person per year among those using the civilian system ( p = 0.04), and a $286 average increase per person per year among those using the military system.

After controlling for other factors, higher costs for CFS cases was associated with the 25 to 34 age group compared to the reference age group ( p = 0.018, 95% CI [$1,497, $16,081]), and "other" Service affiliation compared to Army affiliation ( p = 0.47, 95% CI [$109, $15,066]). CFS cases with Navy affiliation had lower costs per person compared to those with Army affiliation ( p = 0.017, 95% CI [-$378, -$3,798]), and active duty family members had lower costs per person than active duty Service members by $3,347 per person per year ( p = 0.011, 95% CI [-$753, -$5,941]). Total cost per person for the 25 to 34 age group decreased over time compared to the 18 to 24 reference age group ( p = 0.003, 95% CI [- $991, -$4,981]), whereas total cost over time increased at a significantly faster rate among Prime beneficiaries compared to non-Prime beneficiaries by $1,078 per person per year ( p = 0.028, 95% CI [$118, $2,038]).

Pharmacy Costs

Figure 3 shows pharmacy costs over time by MUPS condi- tion, with vertical hatched lines indicating the dates of FDA approval of pregabalin (Lyrica; June 2007), duloxetine (Cymbalta; June 2008), and milnacipran (Savella; January 2009). Total 2006 pharmacy cost for FMS cases was $55,171,402 ($3,641/person); by 2010, it was $96,301,571 ($3,557/person). The top five drugs prescribed to individuals diagnosed with FMS in 2006 were zolpidem, duloxetine, oxycodone, lansoprazole, and venlafaxine, $6,632,153 of the 2006 FMS pharmacy costs. In 2010, the top five prescrip- tions were duloxetine, pregabalin, esomeprazole, celecoxib, and montelukast, costing $16,976,827. In 2010, milnacipran assumed the sixth position with an additional cost of $1,016,823. Between 2006 and 2010, pregabalin costs totaled $15,935,950, duloxetine costs totaled $18,444,406, and milnacipran costs totaled $1,016,823. Opioids were the fourth most common drug prescribed for FMS in 2006 and 2008- 2010, and the fifth most common drug in 2007. Annual costs of opioids for FMS cases tripled from 2006 ($1,163,895) to 2010 ($3,160,432). Over 5 years, total cost of opioids exceeded $9.3 million among FMS cases.

Total pharmacy costs for IBS cases were $11,503,429 ($2,281/person) in 2006 and $13,595,948 ($2,264/person) in 2010. In 2006, the top five drugs most commonly prescribed to individuals diagnosed with IBS were telgaserod, rabeprazole sodium, lansoprazole, zolpidem, and escitalopram, costing $1,792,347. In 2010, the top five prescriptions were esomeprazole, montelukast, lubiprostone, duloxetine, and escitalopram, costing $1,948,162.

Total 2006 and 2010 pharmacy costs for individuals diagnosed with CFS were $1,773,778 ($2,776/person) and $2,643,441 ($2,812/person), respectively. In 2006, the top five drugs prescribed to individuals diagnosed with CFS were zolpidem, oxycodone, sertraline, escitalopram, and duloxetine, costing $184,417; by 2010, the top five drugs were esomeprazole, duloxetine, pregabalin, escitalopram, and venlafaxine, costing $393,122.

DISCUSSION

Data based on DoD health care claims provide an opportunity to examine population-based prevalence, utilization, and costs of MUPS conditions where equal benefits and access to care extend to all beneficiaries. Although military-related and civilian populations have differences in health status, our findings indicate the prevalence rates of U.S. nonelderly adults diagnosed with FMS, IBS, and CFS are 0.7%, 0.12%, and 0.02%, respectively. Prevalence rates for conditions coded with same ICD-9 codes should remain stable over time unless there are changes in diagnostic classification, biomed- ical advances, health risks, or environmental exposures. Indeed, prevalence rates for IBS and CFS remained relatively stable compared to FMS. The 2007 uptick in FMS rates cannot be attributed to diagnostic classification given the 1990-1992 diagnostic criteria for FMS were not modified until 2010.35 Likewise, there have been no medical break- throughs on FMS etiology, nor known changes in risk factors. Since the contemporary term "fibromyalgia" first appeared in 1981,36 the only risk factors associated with FMS have been female sex and middle age. Hence, we strongly suspect that the rise in FMS prevalence between 2006 and 2008 is due to drug marketing activities between September 2005 and Octo- ber 2008, the period when Pfizer "illegally promoted the sale and use of Lyrica [pregabalin] for a variety of off-label con- ditions (including chronic pain...) ...[and] offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Lyrica, in violation of the Federal Anti-Kickback Statute...."37 Without proof of cau- sality, we infer that the observed changes in annual FMS prevalence reflect the FDA approval of the three FMS- approved drugs and associated pharmaceutical marketing to providers and consumers. By 2008, manufacturers of these drugs began direct consumer marketing34 and increased grant monies for FMS provider education and research, and for FMS advocacy groups. Of the top 25 drugs promoted directly to consumers in 2010, Cymbalta was third, and Lyrica was ninth in the amount of money spent on direct consumer advertising, $206 million and $112 million, respectively.38 In 2008, Pfizer provided about $4 million in grants to U.S. physicians, nurses, and other health profes- sionals to educate them about FMS.39 Coinciding with these marketing costs are FMS clinical guidelines developed by consensus and literature reviews. The 2009 guidelines, based on a meeting funded by "an independent educational grant from Pfizer," were developed by U.S. experts40 with docu- mented conflicts of interest with manufacturers of FMS- approved drugs. Subsequent guidelines were published by interdisciplinary Canadian, German, and Israeli teams com- posed of experts with similar conflicts of interest.41 The sole team not strongly recommending the FMS drugs was the group led by experts in Germany where there is no approval of FMS-specific drugs.

It should be noted that published conflicts of interest are also apparent in Cochrane reviews of FMS drugs. For exam- ple, the four authors of a 2013 Cochrane review examining the evidence for anticonvulsant drug use in FMS42 (e.g., pregabalin) have conflicts of interest with Pfizer and (or) Eli Lilly, or with a pharmaceutical manufacturer whose proposed FMS-drug (sodium oxydate) was disapproved by the FDA; on average, pregabalin was found to reduce substantial pain 8% more than found for placebo. Of the 10 authors who participated in a 2013 Cochrane review of antiepileptic drugs used in FMS, all but two have declared conflicts of interest with pharmaceutical companies43; at least three of those authors have received remuneration from Pfizer per informa- tion gathered elsewhere. In this latter review, pregabalin was found to reduce substantial pain about 11% more than the effects of placebo. The latest review, which examined the use of duloxetine in FMS, was conducted by three authors with no declared conflicts of interest44; low to moderate evi- dence was found for duloxetine efficacy in FMS pain control, but effects were dependent on the presence of mood comor- bidities. A non-Cochrane systematic review of FMS treat- ment is currently being conducted by a 27-member international team, none of whom have published conflicts of interest with the pharmaceutical industry45; its results should prove highly useful to clinicians as well as federal health care reimbursement systems.

Utilization of ambulatory services by DoD beneficiaries diagnosed with FMS, IBS, and CFS are at least five times higher than utilization for all conditions in the insured U.S. population,46 and at least four times higher than TRICARE Prime beneficiaries with medical-surgical ambulatory encounters.47 Among FMS cases, we found higher health care utilization in civilian facilities compared to military facilities. This latter finding was expected given the higher numbers of women and non-active duty beneficiaries diag- nosed with FMS, the majority of whom do not use military facilities. The unrestricted use of health care afforded to TRICARE beneficiaries may explain higher utilization in civilian care than reported in earlier studies.23,25

In DoD, FMS-related total costs increased 93.5% between 2005 and 2010; for the same period, the National Health Expenditure rate for the U.S. population increased 27.9%.48 The 2010 average pharmacy cost per beneficiary diagnosed with FMS was $3,557 compared to the average pharmacy cost of $923 per beneficiary for all DoD beneficiaries.47 Total pharmacy costs increased 83.6% for FMS cases over 5 years, partly because of increased prevalence. In contrast, total IBS and CFS pharmacy costs increased 16.6% and 50%, respec- tively. To put these increases in perspective, total drug expenditures in the United States increased, on average, 4.48% annually between 2005 and 2010, with the largest increase (8.7%) occurring between 2005 and 2006,49 and the smallest increase (1.8%) occurring between 2007 and 2008.50

Most of the increase for FMS pharmacy costs is due to the three FDA-approved drugs that cost DoD $34.7.3 million between 2006 and 2010. Another $9.3 million in FMS phar- macy costs was spent on opioids; opioids have no established efficacy in FMS.51

Independent of our study, beginning in 2007, the DoD Pharmacoeconomics Center tracked FMS-approved drugs for their level of effectiveness compared to equivalent drugs and associated costs. In 2010, DoD classified milnacipran as a nonformulary drug, and in 2012 pregabalin and duloxetine were classified as nonformulary52 with equivalent drugs being provisionally required in newly diagnosed FMS cases. The minimal increase in FMS-related pharmacy costs between 2009 and 2010 appears to be a direct consequence of DoD evaluation of FMS drugs and cost containment efforts. It remains to be seen, however, if the nonformulary classification of these drugs will impact the prevalence, health care utilization, and overall costs related to FMS sub- sequent to 2010. In a Medicare cohort, more than half of which included beneficiaries diagnosed with FMS, restric- tions of pregabalin prescriptions increased pharmacy costs by 4.6% because of increased prescriptions for opioid anal- gesics, nonopioid analgesics, selective serotonin reuptake inhibitors, and gabapentin.53

Limitations

We did not consider FMS comorbidities, nor establish the date of first FMS diagnosis as done elsewhere.23,29 We also did not control for severity of illness, or restrict health care utilization to encounters where MUPS was theprimarydiagnosis.Wehadnoinformationonsystem capacity, referrals to medical specialists, reason for pre- scribed medications, patient outcomes, or out-of-pocket expenses. Also, the doubling of FMS total costs in mili- tary settings may be due to an unknown number of active duty personnel given the diagnostic code of ICD-9 729.1 for conditions related to soft tissue and muscle strain and trauma. Finally, we could not determine if non-Prime enrollees submitted health care claims as completely as Prime enrollees.

Conclusion

Our study appears to be the first to compare the preva- lence, health care utilization, and costs over time of indi- viduals diagnosed with FMS to those diagnosed with IBS and CFS, and the first to examine these MUPS conditions in a military-connected population. Consistent with the liter- ature, we found disproportionate rates among middle-aged females, and higher average costs for women. Active duty personnel also incurred greater costs once controlling for other factors. Although we cannot establish causality, our findings strongly suggest that the DoD beneficiary popu- lation and their health care providers are susceptible to FDA-drug approvals and to pharmaceutical marketing. We recommend that health care systems closely monitor diag- nostic and treatment patterns, and costs for MUPS con- ditions especially those associated with newly-approved pharmaceuticals. The high rates of health care utilization among individuals diagnosed with FMS relative to IBS and CFS may signal inadequate control of unexplained wide- spread pain symptoms, a situation that may benefit from case management approaches.

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Diana D. Jeffery, PhD*; Lakmini Bulathsinhala, MPH[dagger]; Michelle Kroc, PhD, RN[double dagger]; Joseph Dorris, MA§

*Department of Defense, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

[dagger]U.S. Army Research Institute of Environmental Medicine, Kansas Street, Natick, MA 01760-5007.

[double dagger]Altarum Institute, 4401 Ford Avenue #800, Alexandria, VA 22302.

§Altarum Institute, 3520 Green Court # 300 Ann Arbor, MI 48105.

doi: 10.7205/MILMED-D-13-00419

Copyright:  (c) 2014 Association of Military Surgeons of the United States
Wordcount:  6169

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