Objectives: To evaluate the effectiveness of the Veterans HealthAdministration (VHA) in providing treatment for tobacco dependence,accomplished by estimating national trends in the numberand percent of smokers receiving smoking cessation aids (SCAs)within the VHA, trends in SCA utilization and expenditures, andthe impact of lifting restrictions on patient access to SCAs.
Study Design and Methods: All patients receiving an outpatientSCA prescription were identified within the Veterans Affairs (VA)Pharmacy Benefits Management database over a 4-year period—October 1, 1998 (n = 61 968) to September 30, 2002 (n = 76 641).Smoking prevalence was based on data from the VA's 1999 LargeHealth Survey of Enrollees. A subsample of sites was classified ashaving restricted access to SCAs if patients were required to attendsmoking cessation classes. Changes in annual SCA utilization ratesand expenditures by SCA type and restriction status were measuredto assess changes in treatment of tobacco dependence.
Results: Approximately 7% of smokers received SCA prescriptions,and SCAs accounted for less than 1% of the VHA's annualoutpatient pharmacy budget in any given year. Following downwardtrends in the cost of 30-day SCA prescriptions, annual SCAexpenditures per patient decreased over time. Expenditures werelower for restricted than unrestricted sites. More than two thirds ofsmokers who were prescribed medications received the nicotinepatch, a quarter received bupropion sustained-release, and fewerthan 10% received nicotine gum.
Conclusions: Measures of SCA utilization and cost are low, stable,and less than the recommended rates in national smoking cessationguidelines, suggesting that this population of smokers isundertreated. Removing SCA restrictions is not prohibitivelyexpensive and improves access to cost-effective care.
(Am J Manag Care. 2005;11:77-85)
Tobacco use continues to be the leading preventablecause of morbidity and mortality in theUnited States and is responsible for more than435 000 premature deaths (18.1% of all deaths) annually.1,2 Smoking contributes to several chronic, life-threateningillnesses, including cardiovascular disease; lungcancer; cancers of the oropharynx, larynx, and pancreas;and chronic obstructive pulmonary disease.3Consequently, smoking produces substantial healthrelatedeconomic costs to society, approaching $157 billionannually during the years 1995 through 1999.4,5 Ina systematic assessment of the value of clinical preventiveservices recommended by the US PreventiveServices Task Force, smoking cessation treatment foradults was one of the highest-ranked services in termsof its cost effectiveness and its potential to reduce theburden of disease.6 Smoking cessation services comparefavorably with other routine preventive healthcareinterventions such as screening for hypertension andannual mammography.7 Therefore, smoking cessationservices have been referred to as the "gold standard"forcomparing the cost effectiveness of other healthcareinterventions.8
Multiple evidence-based guidelines, particularly theupdated 2000 Public Health Service Smoking CessationGuidelines, emphasize the importance of advisingsmokers to quit smoking at every clinical visit.9-11Although some studies have shown high costs fromincreased healthcare utilization after quitting smoking(due to quitting because of illness),12-14 most studiesdemonstrate that smokers who quit eventually have significantlylower healthcare utilization than continuingsmokers.15-17 Thus, healthcare organizations that implementsmoking cessation services will realize a relativelyquick return on this investment. Few, if any, interventionsaimed at improving the health of the populationserved offer better value than providing and improvingaccess to smoking cessation aids (SCAs).
Despite knowledge of the health benefits of tobaccouse cessation and availability of cost-effective treatments, many healthcare providers and healthcare systemsfail to treat tobacco use adequately. Smoking cessationhas one of the lowest delivery rates of allpreventive services.6,18-20 Even though unaided quitattempts are less likely to be successful than aided quitattempts, most quit attempts are undertaken withouttreatment.19,20 To address this problem, current clinicalguidelines recommend that every smoker who is interestedin quitting be offered treatment for tobaccodependence that includes a combination of counselingand pharmacotherapy.9,10 Counseling can range frombrief interventions provided by the patient's primarycare provider to enrollment in intensive smoking cessationprograms. Even brief cessation counseling providedon a regular basis for all tobacco users can significantlyincrease overall abstinence, with both low-and high-intensityinterventions being cost effective.7,10,21
Pharmacotherapy is an effective means of treatingtobacco dependence. Recent studies of health planshave shown that providing coverage for tobaccodependence treatments, including pharmacotherapy,increases the use of pharmacotherapy, the number ofquit attempts, and quit rates.10,21-25 Current recommendedfirst-line agents include the nicotine patch,nicotine gum, nicotine nasal spray, nicotine inhaler,nicotine lozenge, and bupropion sustained-release(SR).26-28 Meta-analyses show long-term abstinencerates of 17.7% for the patch to 30.5% for bupropion SR.21Compared with placebo, nicotine replacement therapy(NRT) and bupropion SR successfully double long-termquit rates.21,25,27,28
Whereas the nicotine patch, nicotine gum, and thenicotine lozenge are available over-the-counter, nicotinenasal spray, nicotine inhaler, and bupropion SR arecurrently available only by prescription. If health insuranceplans include SCAs on their formularies and supportSCAs as a prescription benefit, copayments forprescriptions are generally lower than over-the-counterprices for SCAs.23,26,29
Some healthcare systems restrict access to smokingcessation medications. Restrictions may take the form oflimiting the number and type of smoking cessation medicationsincluded on formularies and requiring patientsto attend behavioral treatment (counseling) in order tobe eligible for prescriptions. The justifications for thispractice are both financial and practical. As pharmaciesstruggle to reduce drug expenditures, smoking cessationmedications are often inappropriately targeted, perhapsbecause tobacco use is still regarded as a behavioral controlproblem rather than as a chronic, relapsing addictivedisorder. As stated above, the belief that behavioralcounseling will improve smoking cessation rates is supportedby data showing the effectiveness of intensivebehavioral counseling.7,10,21 However, medicationsincluding NRT have also been shown to be effective withoutspecific counseling.21,25,27,28 Thus, requirements forcounseling may act as a barrier for some patients whoare otherwise interested in quitting and can, in effect,reduce the number of smokers who make a quit attempt.
The purpose of this study was to evaluate the effectivenessof the Veterans Health Administration (VHA)in providing treatment for tobacco dependence. Thisanalysis documented trends in the utilization of SCAsby the VHA between fiscal years (FY) 1999 and 2002. Inaddition, we described the proportion of VHA nationalpharmacy costs that were attributable to SCAs andplaced these costs within the context of the nationalcosts of treating smoking-related diseases. The effect ofrestricting access to SCAs by requiring attendance atsmoking cessation programs on subsequent SCA utilizationand cost was also analyzed.
The VHA is the largest integrated healthcare systemin the United States, providing care to more than 4.1million veterans in FY2002.30 As one of the branches ofthe Department of Veteran's Affairs (VA), the VHA providesmedical care services to veterans who have servedon active duty in the military. The VHA provides medicalcare services free of charge to veterans who haveservice-connected disabilities or whose incomes fallbelow means test thresholds.31,32 Although the VHAdoes not bill enrollees for services provided, veteranswith no service-connected disabilities whose incomesfall above means test thresholds pay copayments foroffice visits and prescription medications.
In 1999, adjusting for age and sex, the prevalence ofsmoking was higher among VHA enrollees (33%) thanthe general population (23%).7,33-35 As such, tobacco usedisproportionately affected VHA enrollees.
The study sample included all patients receiving anoutpatient SCA prescription as recorded within the VAPharmacy Benefits Management (PBM) database duringa 4-year period, October 1, 1998, to September 30,2002 (n = 61 968; 66 047; 73 173; and 76 641, respectivelyat the end of each fiscal year). The study methodologywas reviewed and approved by the InstitutionalReview Board at the Minneapolis VA Medical Center.
Outpatient prescription drug data were obtainedfrom the VA's national PBM database. As of October1998, this centralized database provides a comprehensivereview of prescription information for descriptionof national, regional, and local facility trends in drugtherapy. Each VA facility electronically transferspatient-specific data on a monthly basis to the PBMbased in Hines, Illinois. Data originate from the VA'scomputerized databases known as the VeteransInformation Systems and Technology Architecture,within each of the VA's Veterans Integrated ServiceNetworks, and include the outpatient pharmacy, inpatientmedications, controlled substances, and laboratorypackages at each VA station. The PBM periodicallyvalidates the extracted data to assure accuracy and todetect deficiencies.
For the current database search, the number of prescriptionsand the number of unique patients receivingprescriptions for NRT (which includes nicotine patchesand nicotine polacrilex gum) and bupropion SR on anoutpatient basis, as well as the cost of each prescription,were extracted for FY1999 through FY2002. Outpatientprescriptions included preparations dispensed at a site'spharmacy either as a new fill or a refill, as well as prescriptionsobtained through the VA's mail order pharmacy.Thus, the dataset provides a detailed profile ofthe types of medications, quantities, cost (direct), anddosing for each patient in the database.
Smoking prevalence was based on data from the VA's1999 Large Health Survey.34 Trends in the number ofpatients treated within VA medical care facilities werebased on the VA's online national enrollment datasets.30
To assess the effect of restrictions on the use ofSCAs, we used a survey of the structure of care forsmoking cessation treatment to classify 41 VA sites forwhich detailed information on smoking cessation serviceswas available. These sites completed in-depth surveysas part of two randomized control trials. Sitesincluded those where SCAs were restricted to patientsattending a smoking cessation program and sites whereSCA use was unrestricted through FY1999 and FY2000.Of the 41 sites, those not found in either the PBM or VAenrollment databases were excluded from the analyses(n = 8), as they could not be matched to the PBM's utilizationand cost data, and the number of veterans usingVHA services (and thus the number of smokers) couldnot be determined for these sites. As sites whose restrictionstatus changed during FY1999 and FY2000 may nothave fully adjusted to the change in restriction status,their inclusion would dampen any of the observed differencesin utilization and cost of care received at therestricted and unrestricted sites. Thus, they were alsoexcluded from the analyses (n = 11). Sites that did notreport their restriction status for either or both FY1999and FY2000 were also excluded from the analyses, asthe stability of their restriction status could not beassessed (n = 4). Thus, the final sample consisted of 18sites whose restriction status remained stable duringFY1999 and FY2000. The analysis represents an upperbound on differences in utilization and cost for restricted(n = 8) and unrestricted sites (n = 10).
Finally, because the sample of restricted and unrestrictedsites was not selected randomly, we conducted ananalysis of possible confounders influencing treatmentrates across the restricted and unrestricted sites.Differences in general treatment characteristics, including(inpatient) admissions per thousand and (outpatient)provider visits per thousand, number of enrollees, numberof hospital beds available and types of providers (ie, physiciansand nonphysicians) were assessed using tests for differencesin proportions and means. Physicians includedprimary care, specialty/surgical care, and mental healthcareproviders as well as residents. Nonphysicians includednurses, nurse practitioners, physician's assistants,pharmacists, and an "other"category for social workers,for example.
Outcome measures included 4-year trends in therate of medication use among smokers, VA nationalexpenditures on SCAs, SCAs'share of overall pharmacyexpenditures, and the cost per treated smoker. Costswere adjusted for inflation and presented in 2002 USdollars using the US Consumer Price Index for all prescriptiondrugs. The influence of our analytical assumptions(eg, smoking prevalence, choice of ConsumerPrice Index) on the results was tested using sensitivityanalyses.
The number of veterans enrolling and utilizing theVA's healthcare system has increased during the pastfew years. Based on results from the VA's Large HealthSurvey, we assumed the prevalence of smoking amongVHA enrollees to be 30%.34 The percent of smokersreceiving prescription SCAs has been fairly stable duringthe years, ranging from 6.5% to 7.1% (Figure 1). Thefinding that the proportion of smokers receiving SCAshas been fairly stable over the years was insensitive tothe assumed smoking prevalence rate (see Commentsection).
During the last 4 years, among patients who receivedmedications as part of their treatment, approximatelytwo thirds received prescriptions for the nicotine patch,a fourth received prescriptions for bupropion SR, andfewer than 10% received prescriptions for nicotine gum(Figure 2). The number of prescriptions per treatedsmoker remained fairly constant over the years analyzed,with treated smokers receiving an average of 2 to3 prescriptions for SCAs per year (data not shown).Although the number of prescriptions for bupropion SRper patient increased slightly from 2.4 per year inFY1999 to 2.8 per year in FY2002, this difference wasnot significant (data not shown).
Stated in 2002 dollars, although total VA outpatientpharmacy expenditures increased from $1.8 billion inFY1999 to $2.3 billion in FY2002, the share of totalexpenditures attributable to SCAs has been consistentlydecreasing. Whereas SCA expenditures accountedfor approximately 0.56% ($9.9 million in 2002 dollars)of the VA's total outpatient pharmacy budget inFY1999 ($1.8 billion in 2002 dollars), this sharedropped 33% during the 4-year period, to represent0.37% ($8.6 million in 2002 dollars) of total pharmacyexpenditures in FY2002 ($2.3 billion). The nicotinepatch consistently accounted for the majority of SCAexpenditures (Figure 3).
Following downward trends in the cost of a 30-daySCA prescription, SCA pharmacy expenditures per patientdecreased from $160 per patient treated in FY1999 to$112 per patient treated in FY2002 (Figure 4). Much ofthe observed decrease in pharmacy expenditures perpatient may be attributable to the VA's ability to negotiatelower prescription drug prices over time or SCAscoming off of patent and becoming less expensive.
Eighteen VA sites were classified into 2 groups: 8sites that restricted SCAs to patients attending a smokingcessation program and 10 that were unrestricted. Intesting for possible confounders influencing treatmentrates across the restricted and unrestricted sites, no significantdifferences were found in general treatmentcharacteristics, including (inpatient) admissions perthousand and (outpatient) provider visits per thousand.Although the unrestricted sites were generally larger interms of the number of enrollees and the number ofhospital beds available, no significant differences werefound in the distribution of the types of providersemployed across sites.
Averaging across individual sites, a lower percentageof smokers received SCAs in the restricted sites than inthe unrestricted sites in both FY1999 (5.4% and 9.6%,respectively) and in FY2000 (5.8% and 10.1%, respectively)(Table). Moreover, restricted sites spent approximatelyone half as much as the unrestricted sites onSCAs per treated smoker in FY1999 ($128.32 and$233.56 per treated smoker, respectively, a differenceof $105), and two-thirds as much as the unrestrictedsites in FY2000 ($109.45 and $174.40 per treated smoker,respectively, a difference of $65).
These data, recalculated to reflect site pharmacybudgets for SCAs, show that unrestricted sites spenton average approximately $73 500 on SCAs per10 000 veterans using the VHA system in FY1999 and$56 000 per 10 000 veterans in FY2000. Comparatively,restricted sites spent approximately$19 600 per 10 000 veterans in FY1999 and $19 500per 10 000 veterans in FY2000.
In summary, these data show that approximately7% of veterans who smoke receive SCAs from the VA.The rate has been relatively stable between FY1999and FY2002, despite recent emphasis in the literatureand clinical practice guidelines on the importance ofpharmacologic treatment of tobacco dependence.Prescription patterns have also remained stable duringthis period. Approximately 70% of SCA prescriptionswere written for nicotine patches, 25% for bupropionSR, and less than 10% for nicotine gum. Despite trepidationabout thepotential cost of smokingcessation medications,all such aidscombined compriseless than 1% of VAannual direct outpatientpharmacyexpenditures (approximately$9 million outof $2 billion), andexpenditures actuallydecreased betweenFY1999 and FY2002.Prior to September2003, access to SCAswithin the VA wasoften restricted topatients who attendedreferral-based smokingcessation counselingprograms throughproviders who specializedin this area.36 Siteswith restrictions treateda smaller proportionof smokers and spentapproximately twothirds of the cost pertreated smoker compared to sites without restrictions.
The cost of medication treatment is low relative tothe cost of treating smoking-related diseases within theVA, such as chronic obstructive pulmonary disease,lung cancer, and ischemic heart disease. The datademonstrated that expenditures for treatment of tobaccodependence are low compared to the VA's cost oftreatment of other chronic medical disorders, such ashyperlipidemia, which was approximately $200 millionin FY2002.
This analysis has several important limitations. First,to calculate the percentage of smokers treated, we estimatedthe prevalence of smoking and assumed this ratewas a constant 30% during the 4-year period. To testwhether our conclusions were robust over differentassumptions, we performed sensitivity analyses in whichthe estimated prevalence ranged from 20% to 47%.Although varying the estimated prevalence changed thepercentage of smokers treated, that percentageremained below 10%, and our main conclusion—thatsmokers are undertreated—remained the same.
Second, we may have underestimated the rate oftreatment because veterans may obtain medicationsfrom sources outside the VHA, such as over-the-counter formulations or through private insuranceor Medicaid. However, because VHA prescriptioncopayments are relatively low, veterans are likely torely on VHA coverage for prescriptions and are lesslikely to obtain their prescriptions elsewhere.37-39 Inaddition, bupropion SR for smoking cessation ispharmacologically identical to bupropion SR fordepression (Wellbutrin). Some sites restrict access tobupropion SR for smoking cessation, but notWellbutrin for depression, and providers may haveprescribed Wellbutrin or bupropion IR for smokingcessation. For our analyses, when considering prescriptionswritten for bupropion SR, we did notinclude those prescriptions written for Wellbutrin orbupropion IR. Thus, we may not have captured somebupropion prescriptions.
Third, the sites considered in the analyses of theeffect of restricting SCAs were not randomly chosenfrom a national database of sites with and withoutrestrictions on SCAs, and sites may not be representativeof all VA sites. Because we did not have data on thedemographic characteristics of the sample populationor on the use of behavioral interventions in unrestrictedsites, we could not test for these potential differencesamong restricted and unrestricted sites. Futureefforts should control for these possible sources ofselection bias inherent in observational studies.However, we were able to test for differences in general(inpatient and outpatient) treatment patterns andrates across sites, and found none. As our national estimateof the percent of smokers treated (7%) fallsbetween that reported by the restricted (4%) and unrestrictedsites (10%), we believe our estimates of differencesin treatment rates by restriction status arereasonably robust.
As this study primarily relied on administrativedata, we were not able to address the outcomes associatedwith the use of SCAs, namely quit rates. If restrictedsites were highly successful, higher quit rates maypotentially offset the lower rate of treated smokers.Finally, these data are population based, and thereforecannot be directly compared with those of othersources that examine the rate of treatment of smokerswho are interested in treatment. Although we know thatfewer than 10% of smokers received treatment with medications,we do not have a concurrent measure of interestin smoking cessation treatment. Although theevidence suggests that few (approximately 10% of) smokersin a large HMO sought cessation treatment whensuch therapy was completely free,22 the VHA's patientpopulation is not directly comparable. The VHA patientstend to be older with more medical and psychiatriccomorbidities than the general population,35,40-42 suggestingthat veterans may be more invested in quitting.
Thus, despite these limitations, we concluded thatonly a small minority of smokers received smoking cessationtreatment. The number of smokers treated andthe proportion treated remained stable over a periodwhen increased adoption of evidence-based practicewould be expected to increase treatment. Restrictedaccess to prescriptions to aid quit attempts may be animportant barrier to increasing delivery of services.The advisability of medication use without intensivebehavioral counseling is controversial but the evidencesuggests pharmacologic treatment is effective with evenbrief behavioral treatment, albeit more successful withmore intensive treatment.7,10,21
The need to develop effective smoking cessationstrategies that combine intensive behavioral andpharmacologic treatments in various healthcare settings remains an important issue.43 A recent VHANational Directive from the Under Secretary forHealth, intended to address this barrier, specified thataccess to smoking cessation medication should not berestricted, as it is an important part of evidence-basedtreatment in smoking and tobacco use cessation.36Data from this analysis suggest that removing restrictionswould likely increase pharmacy expenditures forSCAs to 3 or 4 times their previous levels, but thatbecause such expenditures are a very minor portion oftotal pharmacy expenditures, the absolute increase inthe total pharmacy budget would be small.
The reluctance to expend funds for smoking cessationin comparison with other chronic disorders such asdiabetes or hyperlipidemia is perhaps due to perceivedeffectiveness problems and the fact that many regardtobacco dependency as self-inflicted and under greaterbehavioral control. Smoking cessation treatment, however,is of comparable or greater benefit than treatmentof other chronic conditions, and is highly cost effectivein terms of cost per life-year saved.44
The fact that smoking remains the leading cause ofmortality in the United States, that the prevalence ofsmoking among the veteran population is higher thanamong the general population, and that smoking cessationtherapy is highly cost effective, justifies increasingexpenditures for smoking cessation treatment andimproving access to state-of-the-science treatment forall veterans. Although continuing to monitor pharmacycosts is appropriate for any healthcare institution, theaging veteran population and escalating healthcarecosts presents a persuasive argument for establishing amore preventive orientation in the public and privatehealthcare systems. Recent increases in the prevalenceof smoking in the military are of great concern.45-47 Tohave a long-lasting impact on reducing healthcare coststhe VHA should take a more aggressive role in reducingthe disparities in smoking rates between the veteranand nonveteran populations.
In closing, VHA restrictions on SCAs have beenrecently liberalized. This reinforces VHA's commitmentto increasing access to evidence-based smoking cessationinterventions. Monitoring the use of SCAs byquerying national pharmacy databases is an efficientmeans of assessing the efficacy of lifting SCA restrictionpolicies as well as assessing organizational progress inimproving access to cost-effective care.
From the Center for Chronic Disease Outcomes Research, Minneapolis VA MedicalCenter, Minneapolis, Minn (YCJ, AMJ, SSF); the Division of Health Services Research andPolicy, School of Public Health, University of Minnesota, Minneapolis (YCJ); theDepartment of Medicine, University of Minnesota Medical School, Minneapolis (AMJ, SSF);VA Center for the Study of Healthcare Provider Behavior, VA Greater Los AngelesHealthcare System and Department of Medicine, University of California at Los Angeles(SES); the Public Health National Prevention Program, Public Health Strategic HealthcareGroup (KWH-B), and the Pharmacy Benefits Management Strategic Healthcare Group(MCG), Department of Veterans Affairs, Veterans Health Administration, Washington, DC.
Dr. Fu is supported by a Research Career Development Award from VA HSR&D.
The views expressed in this article are those of the authors and do not necessarily representthe views of the Department of Veterans Affairs.
Address correspondence to: Yvonne C. Jonk, PhD, Center for Chronic DiseaseOutcomes Research, Minneapolis VA Medical Center, One Veterans Drive 1110,Minneapolis, MN 55417. E-mail: email@example.com.
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