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Buprenorphine for opiate addiction: potential economic impact
Drug and Alcohol Dependence 63 (2001) 253– 262 www.elsevier.com/locate/drugalcdep
Buprenorphine for opiate addiction: potential economic impact Robert Rosenheck a,b,c,*, Thomas Kosten a,c a Department of Psychiatry, Yale School of Medicine, New Ha6en, CT 06519, USA Department of Epidemiology and Public Health, Yale School of Medicine, New Ha6en, CT 06519, USA c New England Mental Illness, Research and Education and Clinical Center (MIRECC), West Ha6en, CT 06516, USA b
Received in revised form 27 September 2000
Abstract This study evaluated the potential economic impact of the buprenorphine/naloxone combination in the context of practice in the United States of America. In comparison to treatment provided through methadone clinics, buprenorphine/naloxone therapy in office practice may be associated with increased medication, physician, and nursing costs, but reduced costs for dispensing, toxicology screens, counseling and administration. It may also result in markedly reduced costs for patients, especially travel costs, resulting in net savings for society as a whole. A review of controlled studies suggest that buprenorphine/naloxone is not likely to be any more or less effective than methadone, but since it will be less expensive in the long run, it may be more cost-effective than methadone when provided to comparable groups of patients. Because of the convenience of office-based treatment, buprenorphine/naloxone may increase access to opiate substitution for some addicts. To the extent that treatment is provided to additional high-cost patients who are involved in extensive criminal activity or who undergo multiple detoxifications each year, net cost savings could be substantial. To the extent that treatment is extended to better adjusted addicts who are employed, married and experience fewer adverse effects from their addiction, costs could increase. The total cost impact will depend on which addict sub-populations make greatest use of the treatment opportunity presented by buprenorphine/naloxone. © 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Opiate addiction; Methadone maintenance; Buprenorphine; Cost-effectiveness
1. Introduction: a new type of opiate agonist stabilization treatment Heroin addiction is one of the most devastating and expensive of public health problems, affecting an estimated 810 000 addicted persons, their families, and their communities each year at an estimated annual cost of $21 billion (Mark et al., 2000). While both psychosocial and pharmacologic treatments have been available for heroin addiction for many decades, various constraints have limited the delivery of the most effective treatment for this disorder — opiate agonist stabilization with medications such as methadone and L-a-acetyl methadol (LAAM; Lowinson et al., 1997). In
* Corresponding author. Present address: Northeast Program Evaluation Center, VA Connecticut Health System, VA Medical Center, Yale School of Medicine, West Haven, CT 06516, USA. Tel: +1203-9373850; fax: + 1-203-9373433. E-mail address: [email protected] (R. Rosenheck).
opiate agonist stabilization treatment, legal, long-acting, medically managed medications are used to block both the painful withdrawal syndrome and craving as well as the subjective ‘drug high’ that motivate continued use. It is currently estimated that only 124 000 US addicts (15% of the total) receive this treatment annually (Mark et al., 2000). Use of opiate agonist stabilization treatment has been politically controversial and is subject to tight government regulation. The number of addicts who can receive treatment is restricted by limited public funding, local opposition to establishment of new methadone clinics, state licensing restrictions, and stringent Federal regulations designed to prevent the medication from being diverted from its medical use and resold as a substance of abuse on the street. During the past two decades, however, a new opiate agent, buprenorphine, has been developed as an experimental treatment and may soon be approved for more widespread use in USA. Buprenorphine has three major
0376-8716/01/$ - see front matter © 2001 Elsevier Science Ireland Ltd. All rights reserved. PII: S0376-8716(00)00214-3
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advantages. First, because it is only a partial opiate agonist, the associated withdrawal syndrome should be milder than with methadone or LAAM and eventual tapering of the medication may be easier to accomplish. Second, because it is long lasting, dosing can be daily or possibly limited to 2– 3 days intervals necessitating less frequent clinic visits, even without take-home doses. Third, since it is deactivated when ingested it must be taken sublingually. As a result, it can be combined with the opiate antagonist naloxone at levels, which are virtually not absorbed sublingually. While harmless, if taken sublingually as prescribed, when the combined buprenorphine/naloxone preparation is injected into an opiate dependent person, it precipitates immediate and painful withdrawal and thus is not likely to be diverted for abuse. Because the risk of diversion is likely to be sharply reduced by the combined buprenorphine/naloxone preparation, it is likely that either Congress will pass legislation allowing the combined agent, which will be marketed under the brand name Suboxone®, to be used in office practice, or its use will be approved by a federal regulatory agency such as the Food and Drug Administration (FDA) or the Center for Substance Abuse Treatment (CSAT). Although the exact regulations are unknown at this time, this will be an important development with potentially far-reaching consequences. One of the two major characteristics of current opiate agonist stabilization therapy in USA is that, by law, it must be delivered through specially licensed methadone clinics. These clinics are required to meet three regulative requirements that add to treatment costs. First, they must dispense medication on-site on a 6 day-per-week basis for the first 3 months of treatment with a potential reduction to weekly treatment only after 3 years have passed, and only among a select group of patients who maintain sustained abstinence (typically fewer than 20% of patients). Second, they must follow extensive and costly security procedures to prevent diversion, and third, they must provide counseling at a ratio of no less than one counselor per fifty clients. Published studies suggest annual costs for methadone maintenance range in USA from $3500 to 5000 per patient per year depending on the amount of counseling offered (Bradley et al., 1994; French et al., 1997; Kraft, et al., 1997; Avants et al., 1999). As a result of these requirements, methadone clinics serve large numbers of clients, mixing stable clients with unstable clients (frequently generating substantial distress for the former) and typically become stigmatizing settings at which large numbers of addicts ‘hang out’, often in undesirable neighborhoods, waiting in line for their medications. Although the regulatory details that will guide the delivery of buprenorphine/naloxone in standard office-based medical practice are unknown, this change promises to increase the accessibility, convenience, and acceptability of opiate agonist stabiliza-
tion therapy because treatment can be provided in less stigmatizing environments, requires less frequent visits, and because medications may be prescribed in a physician’s office and purchased at a local pharmacy, rather than being dispensed directly by a central clinic. Exposure to drug dealing may also be reduced when treatment is received in settings without high concentrations of addicts. Recent studies have demonstrated the feasibility of delivering buprenorphine/naloxone in office practice (O’Connor et al., 1998) and meta-analysis of an extensive series of field trials has shown that, like methadone, it is an effective treatment for opiate addiction (Barnett, personal communication). The major advantage of buprenorphine/naloxone, thus, is not greater pharmacologic efficacy, but rather in its greater safety and acceptability to society as a medication that can be used in office practice. While the feasibility and efficacy of buprenorphine has been well studied, its potential economic impact has received little consideration and virtually no empirical study. If buprenorphine/naloxone is more accessible and available than methadone or LAAM, increasing numbers of addicts may enter treatment, and overall treatment costs could increase substantially. On the other hand, if treatment results in reduced expenditures on repeated detoxifications due to lower relapse rates; lower medical costs because of reduced medical illnesses such as HIV, and hepatitis C (Cooper, 1989; French et al., 1996); and lower criminal justice costs (Gerstein et al., 1994), overall societal costs could be reduced. Such savings could offset potentially the additional cost of medication, even if buprenorphine/naloxone is priced at $4–8 per day for a 12-mg daily dose ($1500– 3000 per year). Although the ultimate pharmacoeconomic evaluation of buprenorphine/naloxone will have to await the determination of the final regulations and will require empirical study through controlled trials, it is possible at present to identify three central issues that will affect its economic impact. First, we consider the direct costs that are likely to be incurred in providing the combined buprenorphine/ naloxone treatment in office settings as compared with providing methadone treatment in federally regulated clinics. We compare resource use, heuristically, for a hypothetical episode of uninterrupted treatment that includes both the more intensive treatment initiation stage (first year) and the less intensive maintenance stage of care (subsequent years). Although the final regulations have not been specified it is possible to estimate plausible ranges of resource consumption based on recent clinical and research experience in the context of practice in United States of America. Second, we review available literature on the efficacy and effectiveness of buprenorphine/naloxone as compared with standard opiate agonist stabilization therapy with
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methadone. Third, and finally, we identify clinical subgroups of opiate addicts and consider the potential differences in the cost-impact of buprenorphine/naloxone on these subgroups. One of the important lessons of recent cost-effectiveness research in mental health is that the cost-effectiveness of treatments varies widely across different clinical subgroups and that potential cost savings are greatest in high-cost populations (Rosenheck, 2000; Rosenheck and Neale, 1998; Rosenheck and Leslie, 2000; Rosenheck et al., 1993, 1999). If a treatment is highly cost-effective among criminal recidivists because it reduces the risk of arrest and incarceration, and has limited cost-effectiveness in stable outpatients, its net economic impact will be determined by whether it is used more frequently by criminal recidivists or stable outpatients. Consideration of the differential cost-effectiveness of treatments across clinical sub-groups and the impact of this variability on net economic impact has recently been described and termed ‘systems cost-effectiveness’ (Frank et al., 1999). We thus provide an economic logic model of how buprenorphine may perform in office practice whose empirical details can be filled in over the coming years.
2. Cost of office-based practice The direct cost of delivering opiate agonist stabilization therapy, whether in a regulated methadone clinic or in office practice, is determined by the use of six types of resources, (1) the direct cost of the medication; (2) the cost of dispensing medication; (3) medical and nursing personnel costs for providing direct clinical care; (4) counseling and case management services; (5) the cost of office space, equipment, and administration; and (6) patient costs.
2.1. Medication costs The cost of methadone, at an average dosage of 60 mg per day is about $0.66 per day or $241 per year (Medical Economics Company, 1999). The retail price of Suboxone® has yet to be finally established but is expected to range from $4 to 8 per day for a 12 mg per day dose ($1500–3000 per year) (personal communication from research office of the Schering Plough Corporation), 6– 11 times the cost of methadone.
2.2. Dispensing costs Because of concerns about medication diversion, the dispensing of methadone is strictly regulated. A typical methadone clinic treating 200– 250 patients per day is likely to require three LPNs to provide coverage 6 days per week and a quarter-time pharmacist on staff, at an estimated salary and fringe benefit cost of $170 000 per
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year or $2.15–2.68 per patient per day including the additional cost of automated dispensing equipment. In subsequent years, about three-fourths of patients are permitted take-home doses of methadone, reducing dispensing costs by about 40%. Dispensing costs for buprenorphine/naloxone are estimated at $2.50–5.00 per prescription with 14–20 prescriptions per year. Combining medication and dispensing costs allows a more complete estimate of the comparative cost of the two agents and indicates that considering only medication and dispensing costs, buprenorphine/naloxone will be 1.6– 2.8 times more expensive than methadone in the first year of treatment or $580–1900 more per patient per year.
2.3. Toxicology screens Methadone clinics are also currently required to perform urine toxicology screens on their patients at least monthly and most require such tests on a weekly basis. It is likely that there will be no toxicology requirement for buprenorphine/naloxone treatment, although clinical practice guidelines may recommend such screening on a periodic (e.g. monthly) basis. This may represent an additional cost saving of $300–600 per year for buprenorphine/naloxone at published cost estimates (Avants et al., 1999) if the lack of a requirement leads to reduced screening. However, it is also possible that clinical practice standards will be maintained, resulting in smaller reduction in the frequency of toxicology screening.
2.4. The cost of medical and nursing personnel There is no clinical reason to expect that the intensity of direct professional care related to medication would be any higher or lower in office-based practice than in a methadone clinic. Patients in either setting would initially be evaluated by a physician and seen perhaps briefly every week by a physician or nurse during the first month of treatment for visits ranging in length from 10 to 30 min. The intensity of such visits would be reduced after treatment is initiated and stabilized. Buprenorphine/naloxone may be administered in several different types of setting each with a somewhat differing style of practice. Patients seen in the office of a psychiatrist, internist or general medical practitioner are likely to have more extensive contact with medical personnel than patients seen in understaffed public health clinics or in methadone maintenance programs as they are currently structured. To the extent that treatment is delivered in private medical practices, to patients who expect more regular contact with their physician, these costs may tend to be higher than in methadone clinics. One recent study estimated medical costs in an ‘enhanced’ methadone program to be only
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$123 over a 12-week period, which included treatment initiation (i.e. about $40 per month) (Avants et al., 1999). During the maintenance phase of treatment, however, medical contacts for clinic-based buprenorphine/naloxone treatment may be limited to one brief contact per month. Medical costs for methadone maintenance are also likely to be declined after the first year because a single annual examination is all that is required. Heroin addicts often have significant physical health problems, which are more likely to be identified and treated in office-based medical practice. As a result, routine secondary medical costs may increase by a substantial amount in office practice, at least in the short run. Although medical services are provided in methadone clinics they are, in actual practice, typically minimal. It is also possible that early identification of medical and psychiatric problems may prevent vastly more expensive complications over the log run and that very expensive medical problems such as AIDS, hepatitis, hypertension, and suicidal behavior will be more effectively and efficiently managed if opiate agonist stabilization is available in office-based settings, although short-term costs may increase (Cooper, 1989; French et al., 1996). More empirical data are needed to estimate these costs, which can be quite extensive and could, therefore, swamp other costs considered here.
2.5. Counseling Methadone clinics are required by statute to provide on-site counselors with a ratio of no less that one counselor for 50 patients and typically provide weekly or more frequent counseling sessions. We, thus, project four to six sessions per month in the first year on average, with no change, in subsequent years, although there would be substantial variation in relation to client needs and local practice patterns. Since counseling may not be a required adjunct to buprenorphine/naloxone treatment, it is possible that, in some practices, patients will have no counseling other than their medical or nursing visits. One study of buprenorphine detoxification, however, found completion rates increased from 20 to 50% when an extensive behavioral intervention was included (Bickel et al., 1997), and the study of office-based treatment by O’Connor et al. (1998), cited above, included weekly nurse counseling with buprenorphine. It is thus likely that counseling will enhance the effectiveness of buprenorphine/naloxone, as it does methadone treatment (Kraft et al., 1997) and that forthcoming regulations will include a counseling requirement. We, thus, include an upper bound estimate of two sessions per month in the first year and 1.5 in subsequent years. This monthly average is based on the assumption that counseling may be weekly for the first few months of treatment and then taper off.
2.6. Office space, equipment and administration A free standing methadone clinic represents a substantial investment in office space, equipment, and administrative personnel devoted exclusively to serving methadone clients. Because of the risk of medication diversion, extensive documentation is required of all medication dispensed, and clinics are subject to numerous federal (FDA, CSAT), state, and professional site reviews. Substantial time is required by full-time administrators as well as by nurses, counselors and case managers to document medication dispensing and service delivery. For methadone clinics we estimate capital costs to be an additional 7–14% of all non-medication operational costs (Bradley et al., 1994) and methadone specific administration to be an additional 5–10% of all professional staff costs. We estimated capital and administrative costs to be an additional 7– 11% of nonmedication operational costs for buprenorphine/ naloxone in general medical clinics (Rosenheck et al., 1995).
2.7. Patient costs The final cost to be considered here is patient travel time and expense. If, in the first month of treatment, buprenorphine/naloxone patients must come to a clinic four to six times, as contrasted to 24 times for treatment in a methadone clinic, savings to patients in time and money are likely to be substantial. These differences will be even greater in the maintenance phase of treatment when buprenorphine/naloxone patients may be attending appointments no more than monthly, while methadone patients must still attend clinic several times each week. If one estimates 20 min of travel time to and from visits, and 20 min of treatment time per visit, costed at minimum wage plus transportation costs, buprenorphine/naloxone may yield a savings of $2400–2800 per year (Table 2). Travel costs per visit may be even further reduced for buprenorphine/naloxone patients because they can be treated closer to where they live and work. Patients who can go to a local doctor would be able to choose a practitioner near their home or place of work, and could thereby avoid extensive travel costs to the nearest methadone clinic, which are few in number and therefore, widely dispersed. These are important societal savings, although they do not accrue to insurance companies or health care systems.
2.8. Summary Table 1 presents a summary hypothetical clinical cost scenario with high- and low-range estimates for treatment with both buprenorphine/naloxone and methadone. The costs of medication and dispensing are
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estimated to be about $580– 1900 greater for buprenorphine/naloxone. However, while direct medical care costs are also expected to be higher for buprenorphine/ naloxone, the costs of counseling, toxicology screens, administrative and capital costs, and especially patient time and travel costs, are likely to be lower for buprenorphine/naloxone office practice, entirely because of the less strict regulatory requirements. Our sensitivity analysis suggests that, considering only provider costs (Table 1), buprenorphine/naloxone may be 92–114% as expensive as methadone in the first year (− $250 to +753); and 81– 97% as expensive in subsequent years (−$518 to − 158), assuming a simple primarily medical model approach to treatment with buprenorphine/naloxone. When patient costs and savings are included, buprenorphine/naloxone is only 54– 76% as extensive as methadone in the first year and 44–64% as expensive subsequently (Table 2).
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These results, it must be remembered, are hypothetical and are only as accurate as our assumptions and should be used for illustrative purposes only. To the extent that extensive psychosocial services are included with buprenorphine/naloxone treatment, provider savings could be substantially reduced. In addition, if our high estimate for buprenorphine/naloxone and our low estimates for methadone are the more accurate approximations, our results would change dramatically.
3. Efficacy/effectiveness In addition to costs, pharmacoeconomic evaluation must also address medication effectiveness — the longterm improvement in health attributable to an agent as used in typical practice. Effectiveness must be distin-
Table 1 Comparison of projected costs of buprenorphine/naloxone and methadone treatment with sensitivity analysis (high and low estimates) Unit cost
Year 1 Medicationa Dispensingb Tox screensc Medical/nursingd Secondary medicale Counselingf Capital/administrationg Total Bup–nal/methadone ratioh Subsequent years Medicationa Dispensingi Tox screensj Medical/nursingk Secondary medicall Counselingm Capital/administrationg Total Bup-nal/methadone ratioh a
Buprenorphine/naloxone
Methadone
Low
High
Low
High
$4–8; $0.66 (See below)b $23.7/Screen $92/Visit $92/Visit $25/Visit
$1460 $30 $284 $518 $184 $300 $92 $2869 92.0%
$2920 $100 $616 $852 $460 $900 $322 $6170 113.9%
$241 $673 $616 $138 $0 $1200 $251 $3119
$241 $839 $1232 $276 $0 $1800 $1029 $5417
$4–8; $0.70 (See below)b $23.7/Screen $92/Visit $92/Visit $25/Visit
$1460 $30 $142 $334 $92 $150 $52 $2261 81.3%
$2920 $100 $284 $668 $230 $450 $191 $4843 96.8%
$241 $404 $616 $92 $0 $1200 $226 $2779
$241 $503 $1232 $276 $0 $1800 $949 $5001
Buprenorphine–naloxone@$4.00 vs. 8.00 per day; methadone@$0.66 per day. $2.50–5.00 per prescription for buprenorphine–naloxone vs. $2.15–2.66 per day for methadone based on expert consensus estimate of 3 RN FTEE+0.25 pharmacist and cost for 200–500 methadone patients. c Monthly vs. bimonthly for buprenorphine–naloxone; bimonthly vs. weekly for methadone. d Two 1-h admission visits for buprenorphine/naloxone plus monthly 20 min contact; admission physical for methadone plus occasional visits. e Additional medical visits (two to five for buprenorphine/naloxone). f Low estimate of monthly counseling vs. high estimate of bi-monthly counseling (buprenorphine/naloxone) vs. counseling four to six times per month for methadone. g For buprenorphine/naloxone estimated capital and administration costs are 7–11% of all non-medication costs; for methadone capital costs are estimated at 7–14% of all non-medication costs; administration is estimated to be an additional 5–10% of professional costs. h Total buprenorphine/naloxone costs as a percent of total methadone costs. i Methadone dispensing costs are estimated to decline by 50% for 75% of clients, or by 38% overall. j Buprenorphine–naloxone only shows reduced tox screens from year 1 to subsequent years. k Initial medical assessments excluded in year 2 for buprenorphine/naloxone. l Secondary medical services reduced by 50% for buprenorphine/naloxone. m Counseling reduced by 50% in subsequent years for buprenorphine/naloxone. b
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Table 2 Hypothetical costs of buprenorphine/naloxone and methadone treatment with sensitivity analysis (high and low estimates) (including patient travel) Buprenorphine/naloxo Methadone ne
Year 1 Clinic costsa Patient travelb Visits per year Cost@$9–11 per visit vs. $11–13 per visitc Total Bup–nal/methadone ratiod Subsequent years Clinic costsa Patient travelb Visits per year Cost@$5–6 per visit vs. $6–7 per visitc Total Bup–nal/methadone ratiod
Low
High
Low
High
$2869
$6170
$3119
$5417
38 $342
52 $572
312 $2808
312 $3432
$3211 54.2%
$6742 76.2%
$5927
$8849
$2261
$4843
$2779
$5001
24 $216
52 $572
312 $2808
312 $3432
$2477 44.3%
$5415 64.2%
$5587
$8433
a
From Table 2. Patient travel including transportation costs and time. c Costs of travel are assumed to be lower for buprenorphine/naloxone because office is likely to be closer to place of residence or employment. d Total buprenorphine/naloxone costs as a percent of total methadone costs. b
guished from efficacy, which is the value of a treatment under highly controlled conditions in which patient characteristics that affect outcomes are held constant and in which any differences in improvement can, therefore, be attributed to the pharmacologic agent itself and not to differences in patient characteristics (Wells, 1999). Efficacy studies are needed initially to determine whether pharmacologic agents are beneficial and safe, and to establish optimum dosages. Once efficacy is demonstrated, however, effectiveness studies are needed to determine whether those benefits are realized in actual practice, especially when the treatment context of actual practice differs from that of clinical trials. Most studies of buprenorphine treatment of opiate dependence have been efficacy studies in which buprenorphine (alone, rather than combined with naloxone) is compared with the best currently available treatment, methadone maintenance, and provided under similar treatment conditions. However, because buprenorphine/naloxone can be delivered in office settings, effectiveness studies, which take this contextual difference into consideration are needed to assess its ‘real-world’ impact. Such studies have been initiated only recently and results from many such studies will be needed before the cost-effectiveness of buprenorphine/
naloxone in various subpopulations can be confidently assessed. Barnett and colleagues (personal communication) recently completed a meta-analysis of five efficacy studies that compared buprenorphine (8–16 mg per day) to methadone (60 mg per day) under similar treatment conditions, in conventional methadone clinics (Johnson et al., 1992; Kosten et al., 1993; Strain et al., 1994; Ling et al., 1996; Schottenfeld et al., 1997). Across these five studies, measures of treatment retention and rates of negative urine toxicologies for illicit opiates were significantly poorer among patients treated with buprenorphine, but the magnitudes of these differences from methadone were small and the authors concluded that differences in outcomes were probably not clinically significant across the five randomized clinical trials. More recently, O’Connor conducted the first study that evaluated the effectiveness of buprenorphine in office-based practice. In a 12-week experimental comparison of buprenorphine given three times per week at a primary care clinic (which included regular counseling by nurse practitioners) versus being provided in methadone maintenance setting (n= 46), both treatment retention and urine toxicology results were better for patients treated at the primary care site (O’Connor et al., 1998). In the office-based buprenorphine group, 78% of patients were retained for 12 weeks and 37% of urine toxicologies were opiate free. In comparison, in the methadone clinic buprenorphine group, only 52% of patients were retained for 12 weeks and only 15% of urines were opiate free. During the last 3 weeks of the trial, 43% of office-based patients were drug free, but it was only 13% in case of methadone clinic-based patients. Thus, while efficacy appears to be equivalent for methadone and buprenorphine in conventional methadone clinics, buprenorphine treatment in an officebased setting may be more effective than in a methadone clinic setting, presumably because the treatment environment is less stigmatizing and more acceptable and because more stable patients are not as exposed to the problems of less stable patients. The studies reviewed above focus on the comparison of buprenorphine and the current standard of care for opiate agonist stabilization treatment, methadone maintenance. Numerous studies have demonstrated the superiority of opiate agonist stabilization to simple detoxification (Lowinson et al., 1997; Sees et al., 1999), and the superiority of buprenorphine to either placebo or to subtherapeutic doses of buprenorphine. Among daily heroin users in the TOPS national survey, for example, reduction in heroin use was observed in over 85% of patients in methadone maintenance and in less than 50% of patients in drug free outpatient care (Hubbard et al., 1984). Furthermore, during the first few months of treatment, only 7% of methadone patients continued weekly or more frequent use of heroin. More
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recently, the drug abuse treatment outcome study (DATOS) also reported substantial reductions in heroin use and other problem behavior for individuals in opiate agonist stabilization treatment, with greater improvement for those retained in treatment for longer periods of time (Hubbard et al., 1997; Simpson et al., 1997). There have been no experimental cost-effectiveness studies comparing opiate agonist stabilization treatment and outpatient drug-free treatment, but some observational studies show substantial cost reductions following treatment entry (Gerstein et al., 1994), although others have not (Fischer et al., 1999). Although cost reductions in observational studies cannot be attributed entirely to treatment effects, entry into opiate agonist stabilization treatment may be associated some reduction in the use of health care and criminal justice resources, and increased productivity, although they may also result in receipt of much needed additional medical care. Experimental cost-effectiveness studies are much needed to evaluate these potential cost consequences.
4. Differential impact across clinical subgroups In the previous sections of this review, we observed that buprenorphine/naloxone may be modestly less expensive than methadone maintenance and that it is likely to have similar efficacy. It is thus probable, although not empirically demonstrated, that successful entry into buprenorphine/naloxone treatment will be associated with reductions in health service use and criminal justice system involvement, with some resultant savings. Buprenorphine/naloxone has the potential to expand the overall supply of opiate agonist stabilization treatment, because the treatment will be provided in more locations by more practitioners. But it also may enhance the convenience and acceptability of this treatment to patients and families because it will be provided in mainstream practices that offer greater privacy and comfort. The end result is likely to be that greater numbers of opiate addicts will take advantage of an effective treatment, and that some addicts who would have been reluctant to seek help from traditional methadone clinics will be willing to seek help. In this section, we consider various subgroups of heroin addicts, and reflect on the differential potential economic impact of buprenorphine/naloxone treatment for each of them. The epidemiology of opiate addiction has received limited study and is complicated by the low overall prevalence of the disorder (B 0.5%) and by the understandable under-reporting of illegal behavior in surveys (Anthony and Helzer, 1995). Studies consistently show,
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however, that heroin addiction is more common among men than women, among people between the ages of 15 and 45 than among people under 15 or over 45, and among people living in urban rather than rural areas. Past studies had not reported an independent relationship between racial groups and heroin addiction (Anthony and Helzer, 1995). Little is known, however, about variability in the intensity and duration of heroin addiction in USA or about either treatment rates, service use, or exit rates from addiction within various subgroups. Recent studies of the cost-effectiveness of both pharmacotherapies and behavioral interventions have shown that the cost impact of an intervention can vary substantially across subgroups (Rosenheck, 2000; Rosenheck and Neale, 1998; Rosenheck and Leslie, 2000; Rosenheck et al., 1993, 1999). An effective treatment can sharply reduce costs among patients with high pre-treatment resource consumption but has little chance of reducing costs among patients who consume few services to begin with, even if it is medically effective (Rosenheck et al., 1993). Candidates for buprenorphine/naloxone therapy can be divided into two broad polar groups with gradations in between those who currently consume substantial health care and/or criminal justice resources and those who do not. The potential cost impact of buprenorphine/naloxone will vary substantially across these two groups.
4.1. Current ser6ice users Cost savings with buprenorphine/naloxone are likely to be greatest among patients who currently consume substantial resources from the health care and criminal justice systems. These patients fall into three groups, (1) recidivist addicts with repeated cycles of detoxification and relapse; (2) incarcerated addicts nearing release from prison; and (3) current methadone patients.
4.1.1. Detoxification recidi6ists Substantial savings with buprenorphine/naloxone may be realized by more effective treatment of recidivist heroin addicts, addicts who undergo repeated detoxifications, often in costly inpatient settings, and have only occasional aftercare visits, but who are never engaged in sustained treatment. Some of these people seek treatment only when they run out of money. It is, therefore, possible that the greater accessibility of buprenorphine/ naloxone on an outpatient basis will lessen the severity and cost of such crises. The average cost of an episode of outpatient detoxification has been estimated at $3100 (Hartz et al., 1999). Examination of national administrative data from the Department of Veterans Affairs showed that, in fiscal year 1999, 1359 veterans out of 3.4 million system users were hospitalized for opiate
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dependence for an average of 10.6 days during the year at an estimated average annual cost of $6135. Similar data from the Market Scan® data base, a compilation of private insurance claims primarily from the employees of large corporations (Leslie and Rosenheck, 1999), shows that, in 1997, only 488 people out of 2.8 million were hospitalized with an ICD 9 diagnosis of opiate dependence at an average cost of $4264 per year, although others may have been coded with alternate, more reimbursable, diagnoses. There is virtually no information available on the size of this group of addicts nationally, although the data presented above suggest that, among low income men, 40/100 000 receive inpatient detoxification as compared with 17/ 100 000 in the private sector. While these are relatively small numbers, it is unknown how many potential patients of this type currently seek opiate agonist stabilization therapy and the likely increase in that number as buprenorphine/naloxone becomes available.
mine whether these large cost reductions are attributable to methadone treatment. In addition, they did not include the growing costs for treatment of HIV and hepatitis C.
4.1.2. Incarcerated addicts A second population that may benefit from the availability of buprenorphine/naloxone is incarcerated addicts. Over the past two decades, stricter sentencing laws for drug addicts have resulted in a vast and costly expansion of the US prison system. General Barry McCaffrey, the White House director of national drug control policy, recently estimated that, of the 1.8 million inmates in American prisons, 400 000 (22%) are current or former addicts or chronic drug users (New York Times, 1999). The availability of substance abuse treatment for inmates, however, has been limited. Criminal justice related costs, most often based on self report data, are among the largest costs associated with opiate addiction, especially when one includes the costs to victims. In the 1980s, the TOPS study found that savings in criminal justice costs during methadone treatment were equal to the cost of the treatment itself, regardless of post-treatment developments (Harwood et al., 1988). More recently, the CALDATA study (Gerstein et al., 1994) reported that average criminal justice system costs were between $6645 and 8672 during the year before entry into methadone treatment while average victim and theft costs were between $7036 and 10 229. Annual total health care costs, in contrast, only averaged $2975–3373. Furthermore, CALDATA found that criminal justice system costs dropped by 18% after entry into methadone treatment and that costs of victimization and theft were reduced by 52%, resulting in savings of almost $7000 per treated patient for taxpaying citizens. Other studies have reported somewhat lower cost estimates (French et al., 1993). Health care cost savings, in contrast, were reduced by only 19% ($639) in CALDATA. It must be emphasized, however, that both TOPS and CALDATA used prepost designs and it is, therefore, not possible to deter-
4.2. Low-ser6ice users
4.1.3. Current methadone patients Because of their extensive experience in the treatment of drug addiction, current methadone clinics may offer buprenorphine/naloxone treatment as an alternative to methadone for both new patients and for long-term stabilized patients. Since, as noted in the first section of this review, medication costs for buprenorphine/naloxone are likely to be substantially greater than for methadone, provider costs may increase in the transition from methadone to buprenorphine/naloxone unless psychosocial services are substantially scaled back. Substantial savings, however, may be realized among patients whose transportation costs would decline as a result of less frequent treatment visits.
4.2.1. ‘Functional’ heroin abusers Although evidence is limited, it is widely suspected that there are substantial numbers of heroin users who manage to keep their opiate use and/or periodic addiction from disrupting their lives in major ways. Although married and employed, these addicts may be able to keep their drug use concealed from close intimates, although it may still be a drain on their lives and finances when their addiction becomes more severe. For ‘functional’ users such as these, the availability of office-based opiate agonist stabilization therapy may be very appealing. However, since these heroin users do not currently incur substantial costs, there may be little room for savings. Treatment of these patients may thus generate a net increase in health care costs, but may result in important benefits to quality of life and productivity that warrant such expenditures. It is also possible that, even in these patients, reduced exposure to HIV, cellulitis and more severe addiction will result in net cost savings in the long term. 4.2.2. Chronic pain patients A final group of patients who may benefit from buprenorphine/naloxone are patients with chronic medical problems who have become addicted to opiate analgesics that sometimes are prescribed by physicians and/or sometimes are purchased in the illegal drug market. The size and precise clinical characteristics of this population are largely unknown. A recent study suggested that only 3.8% of all emergency room visits related to addiction involved patients on opioid analgesics (Joranson et al., 2000), although this may be an underestimate of the true size of the population. Virtually no information is available on either the clinical
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value of buprenorphine/naloxone for these patients nor its economic impact. This subgroup deserves mention because the availability of buprenorphine/naloxone in office practice will provide them with a hitherto unavailable treatment option. Furthermore, since some of these patients may be very high consumers of diverse health care services, buprenorphine/naloxone treatment may yet yield significant savings.
5. Conclusions This study identified factors that will determine the ultimate economic impact of buprenorphine/naloxone in the treatment of opiate dependence and presented ranges of estimates relevant to its use in the United States of America. Given a common treatment population, buprenorphine/naloxone may be more cost-effective than methadone since it may be less expensive to administer, incurs lower patient travel costs, and is comparable in its effectiveness. In addition, we used the perspective of ‘systems cost-effectiveness’ to consider not only differences in cost-effectiveness when buprenorphine/naloxone is applied to a common clinical subgroup; but also differences in cost-effectiveness for different clinical subgroups. The ultimate economic impact of buprenorphine/naloxone will be determined by whether it fosters expanded use of opiate agonist stabilization among high cost recidivists (in whom the savings potential is large) or among lower cost, higher functioning opiate users with lower potential for savings. In a recent review of the costs of opiate addiction to society, Mark et al. (2000) concluded that available data are insufficient to make predictions about the economic impact of expanding the availability of current models of opiate agonist stabilization therapy. The issues we have identified, however, may serve as a framework for the empirical evaluation of these issues in the future and suggest that, as a result of relaxed regulations, office-based use of buprenorphine/naloxone may have cost advantages over current opiate agonist treatment, although it may not be any more clinically effective. Data from controlled studies are needed to demonstrate the ultimate economic consequences of this promising new approach.
Acknowledgements This study was supported, in part, by a grant from Schering-Plough Corporation to the Advanced Behavioral Research Institute. We would like to thank the participants in an expert panel on the use of buprenorphine in office-based practice convened at the Annual Meeting of the American Academy of Addiction Psy-
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chiatry, Nassau, Bahamas, December 5– 6, 1999. We would like to thank Kathleen Carroll, Ph.D. and Allison Olivetto, Ph.D. for their helpful comments and suggestions.
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Buprenorphine for opiate addiction: potential economic impact Robert Rosenheck a,b,c,*, Thomas Kosten a,c a Department of Psychiatry, Yale School of Medicine, New Ha6en, CT 06519, USA Department of Epidemiology and Public Health, Yale School of Medicine, New Ha6en, CT 06519, USA c New England Mental Illness, Research and Education and Clinical Center (MIRECC), West Ha6en, CT 06516, USA b
Received in revised form 27 September 2000
Abstract This study evaluated the potential economic impact of the buprenorphine/naloxone combination in the context of practice in the United States of America. In comparison to treatment provided through methadone clinics, buprenorphine/naloxone therapy in office practice may be associated with increased medication, physician, and nursing costs, but reduced costs for dispensing, toxicology screens, counseling and administration. It may also result in markedly reduced costs for patients, especially travel costs, resulting in net savings for society as a whole. A review of controlled studies suggest that buprenorphine/naloxone is not likely to be any more or less effective than methadone, but since it will be less expensive in the long run, it may be more cost-effective than methadone when provided to comparable groups of patients. Because of the convenience of office-based treatment, buprenorphine/naloxone may increase access to opiate substitution for some addicts. To the extent that treatment is provided to additional high-cost patients who are involved in extensive criminal activity or who undergo multiple detoxifications each year, net cost savings could be substantial. To the extent that treatment is extended to better adjusted addicts who are employed, married and experience fewer adverse effects from their addiction, costs could increase. The total cost impact will depend on which addict sub-populations make greatest use of the treatment opportunity presented by buprenorphine/naloxone. © 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Opiate addiction; Methadone maintenance; Buprenorphine; Cost-effectiveness
1. Introduction: a new type of opiate agonist stabilization treatment Heroin addiction is one of the most devastating and expensive of public health problems, affecting an estimated 810 000 addicted persons, their families, and their communities each year at an estimated annual cost of $21 billion (Mark et al., 2000). While both psychosocial and pharmacologic treatments have been available for heroin addiction for many decades, various constraints have limited the delivery of the most effective treatment for this disorder — opiate agonist stabilization with medications such as methadone and L-a-acetyl methadol (LAAM; Lowinson et al., 1997). In
* Corresponding author. Present address: Northeast Program Evaluation Center, VA Connecticut Health System, VA Medical Center, Yale School of Medicine, West Haven, CT 06516, USA. Tel: +1203-9373850; fax: + 1-203-9373433. E-mail address: [email protected] (R. Rosenheck).
opiate agonist stabilization treatment, legal, long-acting, medically managed medications are used to block both the painful withdrawal syndrome and craving as well as the subjective ‘drug high’ that motivate continued use. It is currently estimated that only 124 000 US addicts (15% of the total) receive this treatment annually (Mark et al., 2000). Use of opiate agonist stabilization treatment has been politically controversial and is subject to tight government regulation. The number of addicts who can receive treatment is restricted by limited public funding, local opposition to establishment of new methadone clinics, state licensing restrictions, and stringent Federal regulations designed to prevent the medication from being diverted from its medical use and resold as a substance of abuse on the street. During the past two decades, however, a new opiate agent, buprenorphine, has been developed as an experimental treatment and may soon be approved for more widespread use in USA. Buprenorphine has three major
0376-8716/01/$ - see front matter © 2001 Elsevier Science Ireland Ltd. All rights reserved. PII: S0376-8716(00)00214-3
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advantages. First, because it is only a partial opiate agonist, the associated withdrawal syndrome should be milder than with methadone or LAAM and eventual tapering of the medication may be easier to accomplish. Second, because it is long lasting, dosing can be daily or possibly limited to 2– 3 days intervals necessitating less frequent clinic visits, even without take-home doses. Third, since it is deactivated when ingested it must be taken sublingually. As a result, it can be combined with the opiate antagonist naloxone at levels, which are virtually not absorbed sublingually. While harmless, if taken sublingually as prescribed, when the combined buprenorphine/naloxone preparation is injected into an opiate dependent person, it precipitates immediate and painful withdrawal and thus is not likely to be diverted for abuse. Because the risk of diversion is likely to be sharply reduced by the combined buprenorphine/naloxone preparation, it is likely that either Congress will pass legislation allowing the combined agent, which will be marketed under the brand name Suboxone®, to be used in office practice, or its use will be approved by a federal regulatory agency such as the Food and Drug Administration (FDA) or the Center for Substance Abuse Treatment (CSAT). Although the exact regulations are unknown at this time, this will be an important development with potentially far-reaching consequences. One of the two major characteristics of current opiate agonist stabilization therapy in USA is that, by law, it must be delivered through specially licensed methadone clinics. These clinics are required to meet three regulative requirements that add to treatment costs. First, they must dispense medication on-site on a 6 day-per-week basis for the first 3 months of treatment with a potential reduction to weekly treatment only after 3 years have passed, and only among a select group of patients who maintain sustained abstinence (typically fewer than 20% of patients). Second, they must follow extensive and costly security procedures to prevent diversion, and third, they must provide counseling at a ratio of no less than one counselor per fifty clients. Published studies suggest annual costs for methadone maintenance range in USA from $3500 to 5000 per patient per year depending on the amount of counseling offered (Bradley et al., 1994; French et al., 1997; Kraft, et al., 1997; Avants et al., 1999). As a result of these requirements, methadone clinics serve large numbers of clients, mixing stable clients with unstable clients (frequently generating substantial distress for the former) and typically become stigmatizing settings at which large numbers of addicts ‘hang out’, often in undesirable neighborhoods, waiting in line for their medications. Although the regulatory details that will guide the delivery of buprenorphine/naloxone in standard office-based medical practice are unknown, this change promises to increase the accessibility, convenience, and acceptability of opiate agonist stabiliza-
tion therapy because treatment can be provided in less stigmatizing environments, requires less frequent visits, and because medications may be prescribed in a physician’s office and purchased at a local pharmacy, rather than being dispensed directly by a central clinic. Exposure to drug dealing may also be reduced when treatment is received in settings without high concentrations of addicts. Recent studies have demonstrated the feasibility of delivering buprenorphine/naloxone in office practice (O’Connor et al., 1998) and meta-analysis of an extensive series of field trials has shown that, like methadone, it is an effective treatment for opiate addiction (Barnett, personal communication). The major advantage of buprenorphine/naloxone, thus, is not greater pharmacologic efficacy, but rather in its greater safety and acceptability to society as a medication that can be used in office practice. While the feasibility and efficacy of buprenorphine has been well studied, its potential economic impact has received little consideration and virtually no empirical study. If buprenorphine/naloxone is more accessible and available than methadone or LAAM, increasing numbers of addicts may enter treatment, and overall treatment costs could increase substantially. On the other hand, if treatment results in reduced expenditures on repeated detoxifications due to lower relapse rates; lower medical costs because of reduced medical illnesses such as HIV, and hepatitis C (Cooper, 1989; French et al., 1996); and lower criminal justice costs (Gerstein et al., 1994), overall societal costs could be reduced. Such savings could offset potentially the additional cost of medication, even if buprenorphine/naloxone is priced at $4–8 per day for a 12-mg daily dose ($1500– 3000 per year). Although the ultimate pharmacoeconomic evaluation of buprenorphine/naloxone will have to await the determination of the final regulations and will require empirical study through controlled trials, it is possible at present to identify three central issues that will affect its economic impact. First, we consider the direct costs that are likely to be incurred in providing the combined buprenorphine/ naloxone treatment in office settings as compared with providing methadone treatment in federally regulated clinics. We compare resource use, heuristically, for a hypothetical episode of uninterrupted treatment that includes both the more intensive treatment initiation stage (first year) and the less intensive maintenance stage of care (subsequent years). Although the final regulations have not been specified it is possible to estimate plausible ranges of resource consumption based on recent clinical and research experience in the context of practice in United States of America. Second, we review available literature on the efficacy and effectiveness of buprenorphine/naloxone as compared with standard opiate agonist stabilization therapy with
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methadone. Third, and finally, we identify clinical subgroups of opiate addicts and consider the potential differences in the cost-impact of buprenorphine/naloxone on these subgroups. One of the important lessons of recent cost-effectiveness research in mental health is that the cost-effectiveness of treatments varies widely across different clinical subgroups and that potential cost savings are greatest in high-cost populations (Rosenheck, 2000; Rosenheck and Neale, 1998; Rosenheck and Leslie, 2000; Rosenheck et al., 1993, 1999). If a treatment is highly cost-effective among criminal recidivists because it reduces the risk of arrest and incarceration, and has limited cost-effectiveness in stable outpatients, its net economic impact will be determined by whether it is used more frequently by criminal recidivists or stable outpatients. Consideration of the differential cost-effectiveness of treatments across clinical sub-groups and the impact of this variability on net economic impact has recently been described and termed ‘systems cost-effectiveness’ (Frank et al., 1999). We thus provide an economic logic model of how buprenorphine may perform in office practice whose empirical details can be filled in over the coming years.
2. Cost of office-based practice The direct cost of delivering opiate agonist stabilization therapy, whether in a regulated methadone clinic or in office practice, is determined by the use of six types of resources, (1) the direct cost of the medication; (2) the cost of dispensing medication; (3) medical and nursing personnel costs for providing direct clinical care; (4) counseling and case management services; (5) the cost of office space, equipment, and administration; and (6) patient costs.
2.1. Medication costs The cost of methadone, at an average dosage of 60 mg per day is about $0.66 per day or $241 per year (Medical Economics Company, 1999). The retail price of Suboxone® has yet to be finally established but is expected to range from $4 to 8 per day for a 12 mg per day dose ($1500–3000 per year) (personal communication from research office of the Schering Plough Corporation), 6– 11 times the cost of methadone.
2.2. Dispensing costs Because of concerns about medication diversion, the dispensing of methadone is strictly regulated. A typical methadone clinic treating 200– 250 patients per day is likely to require three LPNs to provide coverage 6 days per week and a quarter-time pharmacist on staff, at an estimated salary and fringe benefit cost of $170 000 per
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year or $2.15–2.68 per patient per day including the additional cost of automated dispensing equipment. In subsequent years, about three-fourths of patients are permitted take-home doses of methadone, reducing dispensing costs by about 40%. Dispensing costs for buprenorphine/naloxone are estimated at $2.50–5.00 per prescription with 14–20 prescriptions per year. Combining medication and dispensing costs allows a more complete estimate of the comparative cost of the two agents and indicates that considering only medication and dispensing costs, buprenorphine/naloxone will be 1.6– 2.8 times more expensive than methadone in the first year of treatment or $580–1900 more per patient per year.
2.3. Toxicology screens Methadone clinics are also currently required to perform urine toxicology screens on their patients at least monthly and most require such tests on a weekly basis. It is likely that there will be no toxicology requirement for buprenorphine/naloxone treatment, although clinical practice guidelines may recommend such screening on a periodic (e.g. monthly) basis. This may represent an additional cost saving of $300–600 per year for buprenorphine/naloxone at published cost estimates (Avants et al., 1999) if the lack of a requirement leads to reduced screening. However, it is also possible that clinical practice standards will be maintained, resulting in smaller reduction in the frequency of toxicology screening.
2.4. The cost of medical and nursing personnel There is no clinical reason to expect that the intensity of direct professional care related to medication would be any higher or lower in office-based practice than in a methadone clinic. Patients in either setting would initially be evaluated by a physician and seen perhaps briefly every week by a physician or nurse during the first month of treatment for visits ranging in length from 10 to 30 min. The intensity of such visits would be reduced after treatment is initiated and stabilized. Buprenorphine/naloxone may be administered in several different types of setting each with a somewhat differing style of practice. Patients seen in the office of a psychiatrist, internist or general medical practitioner are likely to have more extensive contact with medical personnel than patients seen in understaffed public health clinics or in methadone maintenance programs as they are currently structured. To the extent that treatment is delivered in private medical practices, to patients who expect more regular contact with their physician, these costs may tend to be higher than in methadone clinics. One recent study estimated medical costs in an ‘enhanced’ methadone program to be only
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$123 over a 12-week period, which included treatment initiation (i.e. about $40 per month) (Avants et al., 1999). During the maintenance phase of treatment, however, medical contacts for clinic-based buprenorphine/naloxone treatment may be limited to one brief contact per month. Medical costs for methadone maintenance are also likely to be declined after the first year because a single annual examination is all that is required. Heroin addicts often have significant physical health problems, which are more likely to be identified and treated in office-based medical practice. As a result, routine secondary medical costs may increase by a substantial amount in office practice, at least in the short run. Although medical services are provided in methadone clinics they are, in actual practice, typically minimal. It is also possible that early identification of medical and psychiatric problems may prevent vastly more expensive complications over the log run and that very expensive medical problems such as AIDS, hepatitis, hypertension, and suicidal behavior will be more effectively and efficiently managed if opiate agonist stabilization is available in office-based settings, although short-term costs may increase (Cooper, 1989; French et al., 1996). More empirical data are needed to estimate these costs, which can be quite extensive and could, therefore, swamp other costs considered here.
2.5. Counseling Methadone clinics are required by statute to provide on-site counselors with a ratio of no less that one counselor for 50 patients and typically provide weekly or more frequent counseling sessions. We, thus, project four to six sessions per month in the first year on average, with no change, in subsequent years, although there would be substantial variation in relation to client needs and local practice patterns. Since counseling may not be a required adjunct to buprenorphine/naloxone treatment, it is possible that, in some practices, patients will have no counseling other than their medical or nursing visits. One study of buprenorphine detoxification, however, found completion rates increased from 20 to 50% when an extensive behavioral intervention was included (Bickel et al., 1997), and the study of office-based treatment by O’Connor et al. (1998), cited above, included weekly nurse counseling with buprenorphine. It is thus likely that counseling will enhance the effectiveness of buprenorphine/naloxone, as it does methadone treatment (Kraft et al., 1997) and that forthcoming regulations will include a counseling requirement. We, thus, include an upper bound estimate of two sessions per month in the first year and 1.5 in subsequent years. This monthly average is based on the assumption that counseling may be weekly for the first few months of treatment and then taper off.
2.6. Office space, equipment and administration A free standing methadone clinic represents a substantial investment in office space, equipment, and administrative personnel devoted exclusively to serving methadone clients. Because of the risk of medication diversion, extensive documentation is required of all medication dispensed, and clinics are subject to numerous federal (FDA, CSAT), state, and professional site reviews. Substantial time is required by full-time administrators as well as by nurses, counselors and case managers to document medication dispensing and service delivery. For methadone clinics we estimate capital costs to be an additional 7–14% of all non-medication operational costs (Bradley et al., 1994) and methadone specific administration to be an additional 5–10% of all professional staff costs. We estimated capital and administrative costs to be an additional 7– 11% of nonmedication operational costs for buprenorphine/ naloxone in general medical clinics (Rosenheck et al., 1995).
2.7. Patient costs The final cost to be considered here is patient travel time and expense. If, in the first month of treatment, buprenorphine/naloxone patients must come to a clinic four to six times, as contrasted to 24 times for treatment in a methadone clinic, savings to patients in time and money are likely to be substantial. These differences will be even greater in the maintenance phase of treatment when buprenorphine/naloxone patients may be attending appointments no more than monthly, while methadone patients must still attend clinic several times each week. If one estimates 20 min of travel time to and from visits, and 20 min of treatment time per visit, costed at minimum wage plus transportation costs, buprenorphine/naloxone may yield a savings of $2400–2800 per year (Table 2). Travel costs per visit may be even further reduced for buprenorphine/naloxone patients because they can be treated closer to where they live and work. Patients who can go to a local doctor would be able to choose a practitioner near their home or place of work, and could thereby avoid extensive travel costs to the nearest methadone clinic, which are few in number and therefore, widely dispersed. These are important societal savings, although they do not accrue to insurance companies or health care systems.
2.8. Summary Table 1 presents a summary hypothetical clinical cost scenario with high- and low-range estimates for treatment with both buprenorphine/naloxone and methadone. The costs of medication and dispensing are
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estimated to be about $580– 1900 greater for buprenorphine/naloxone. However, while direct medical care costs are also expected to be higher for buprenorphine/ naloxone, the costs of counseling, toxicology screens, administrative and capital costs, and especially patient time and travel costs, are likely to be lower for buprenorphine/naloxone office practice, entirely because of the less strict regulatory requirements. Our sensitivity analysis suggests that, considering only provider costs (Table 1), buprenorphine/naloxone may be 92–114% as expensive as methadone in the first year (− $250 to +753); and 81– 97% as expensive in subsequent years (−$518 to − 158), assuming a simple primarily medical model approach to treatment with buprenorphine/naloxone. When patient costs and savings are included, buprenorphine/naloxone is only 54– 76% as extensive as methadone in the first year and 44–64% as expensive subsequently (Table 2).
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These results, it must be remembered, are hypothetical and are only as accurate as our assumptions and should be used for illustrative purposes only. To the extent that extensive psychosocial services are included with buprenorphine/naloxone treatment, provider savings could be substantially reduced. In addition, if our high estimate for buprenorphine/naloxone and our low estimates for methadone are the more accurate approximations, our results would change dramatically.
3. Efficacy/effectiveness In addition to costs, pharmacoeconomic evaluation must also address medication effectiveness — the longterm improvement in health attributable to an agent as used in typical practice. Effectiveness must be distin-
Table 1 Comparison of projected costs of buprenorphine/naloxone and methadone treatment with sensitivity analysis (high and low estimates) Unit cost
Year 1 Medicationa Dispensingb Tox screensc Medical/nursingd Secondary medicale Counselingf Capital/administrationg Total Bup–nal/methadone ratioh Subsequent years Medicationa Dispensingi Tox screensj Medical/nursingk Secondary medicall Counselingm Capital/administrationg Total Bup-nal/methadone ratioh a
Buprenorphine/naloxone
Methadone
Low
High
Low
High
$4–8; $0.66 (See below)b $23.7/Screen $92/Visit $92/Visit $25/Visit
$1460 $30 $284 $518 $184 $300 $92 $2869 92.0%
$2920 $100 $616 $852 $460 $900 $322 $6170 113.9%
$241 $673 $616 $138 $0 $1200 $251 $3119
$241 $839 $1232 $276 $0 $1800 $1029 $5417
$4–8; $0.70 (See below)b $23.7/Screen $92/Visit $92/Visit $25/Visit
$1460 $30 $142 $334 $92 $150 $52 $2261 81.3%
$2920 $100 $284 $668 $230 $450 $191 $4843 96.8%
$241 $404 $616 $92 $0 $1200 $226 $2779
$241 $503 $1232 $276 $0 $1800 $949 $5001
Buprenorphine–naloxone@$4.00 vs. 8.00 per day; methadone@$0.66 per day. $2.50–5.00 per prescription for buprenorphine–naloxone vs. $2.15–2.66 per day for methadone based on expert consensus estimate of 3 RN FTEE+0.25 pharmacist and cost for 200–500 methadone patients. c Monthly vs. bimonthly for buprenorphine–naloxone; bimonthly vs. weekly for methadone. d Two 1-h admission visits for buprenorphine/naloxone plus monthly 20 min contact; admission physical for methadone plus occasional visits. e Additional medical visits (two to five for buprenorphine/naloxone). f Low estimate of monthly counseling vs. high estimate of bi-monthly counseling (buprenorphine/naloxone) vs. counseling four to six times per month for methadone. g For buprenorphine/naloxone estimated capital and administration costs are 7–11% of all non-medication costs; for methadone capital costs are estimated at 7–14% of all non-medication costs; administration is estimated to be an additional 5–10% of professional costs. h Total buprenorphine/naloxone costs as a percent of total methadone costs. i Methadone dispensing costs are estimated to decline by 50% for 75% of clients, or by 38% overall. j Buprenorphine–naloxone only shows reduced tox screens from year 1 to subsequent years. k Initial medical assessments excluded in year 2 for buprenorphine/naloxone. l Secondary medical services reduced by 50% for buprenorphine/naloxone. m Counseling reduced by 50% in subsequent years for buprenorphine/naloxone. b
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Table 2 Hypothetical costs of buprenorphine/naloxone and methadone treatment with sensitivity analysis (high and low estimates) (including patient travel) Buprenorphine/naloxo Methadone ne
Year 1 Clinic costsa Patient travelb Visits per year Cost@$9–11 per visit vs. $11–13 per visitc Total Bup–nal/methadone ratiod Subsequent years Clinic costsa Patient travelb Visits per year Cost@$5–6 per visit vs. $6–7 per visitc Total Bup–nal/methadone ratiod
Low
High
Low
High
$2869
$6170
$3119
$5417
38 $342
52 $572
312 $2808
312 $3432
$3211 54.2%
$6742 76.2%
$5927
$8849
$2261
$4843
$2779
$5001
24 $216
52 $572
312 $2808
312 $3432
$2477 44.3%
$5415 64.2%
$5587
$8433
a
From Table 2. Patient travel including transportation costs and time. c Costs of travel are assumed to be lower for buprenorphine/naloxone because office is likely to be closer to place of residence or employment. d Total buprenorphine/naloxone costs as a percent of total methadone costs. b
guished from efficacy, which is the value of a treatment under highly controlled conditions in which patient characteristics that affect outcomes are held constant and in which any differences in improvement can, therefore, be attributed to the pharmacologic agent itself and not to differences in patient characteristics (Wells, 1999). Efficacy studies are needed initially to determine whether pharmacologic agents are beneficial and safe, and to establish optimum dosages. Once efficacy is demonstrated, however, effectiveness studies are needed to determine whether those benefits are realized in actual practice, especially when the treatment context of actual practice differs from that of clinical trials. Most studies of buprenorphine treatment of opiate dependence have been efficacy studies in which buprenorphine (alone, rather than combined with naloxone) is compared with the best currently available treatment, methadone maintenance, and provided under similar treatment conditions. However, because buprenorphine/naloxone can be delivered in office settings, effectiveness studies, which take this contextual difference into consideration are needed to assess its ‘real-world’ impact. Such studies have been initiated only recently and results from many such studies will be needed before the cost-effectiveness of buprenorphine/
naloxone in various subpopulations can be confidently assessed. Barnett and colleagues (personal communication) recently completed a meta-analysis of five efficacy studies that compared buprenorphine (8–16 mg per day) to methadone (60 mg per day) under similar treatment conditions, in conventional methadone clinics (Johnson et al., 1992; Kosten et al., 1993; Strain et al., 1994; Ling et al., 1996; Schottenfeld et al., 1997). Across these five studies, measures of treatment retention and rates of negative urine toxicologies for illicit opiates were significantly poorer among patients treated with buprenorphine, but the magnitudes of these differences from methadone were small and the authors concluded that differences in outcomes were probably not clinically significant across the five randomized clinical trials. More recently, O’Connor conducted the first study that evaluated the effectiveness of buprenorphine in office-based practice. In a 12-week experimental comparison of buprenorphine given three times per week at a primary care clinic (which included regular counseling by nurse practitioners) versus being provided in methadone maintenance setting (n= 46), both treatment retention and urine toxicology results were better for patients treated at the primary care site (O’Connor et al., 1998). In the office-based buprenorphine group, 78% of patients were retained for 12 weeks and 37% of urine toxicologies were opiate free. In comparison, in the methadone clinic buprenorphine group, only 52% of patients were retained for 12 weeks and only 15% of urines were opiate free. During the last 3 weeks of the trial, 43% of office-based patients were drug free, but it was only 13% in case of methadone clinic-based patients. Thus, while efficacy appears to be equivalent for methadone and buprenorphine in conventional methadone clinics, buprenorphine treatment in an officebased setting may be more effective than in a methadone clinic setting, presumably because the treatment environment is less stigmatizing and more acceptable and because more stable patients are not as exposed to the problems of less stable patients. The studies reviewed above focus on the comparison of buprenorphine and the current standard of care for opiate agonist stabilization treatment, methadone maintenance. Numerous studies have demonstrated the superiority of opiate agonist stabilization to simple detoxification (Lowinson et al., 1997; Sees et al., 1999), and the superiority of buprenorphine to either placebo or to subtherapeutic doses of buprenorphine. Among daily heroin users in the TOPS national survey, for example, reduction in heroin use was observed in over 85% of patients in methadone maintenance and in less than 50% of patients in drug free outpatient care (Hubbard et al., 1984). Furthermore, during the first few months of treatment, only 7% of methadone patients continued weekly or more frequent use of heroin. More
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recently, the drug abuse treatment outcome study (DATOS) also reported substantial reductions in heroin use and other problem behavior for individuals in opiate agonist stabilization treatment, with greater improvement for those retained in treatment for longer periods of time (Hubbard et al., 1997; Simpson et al., 1997). There have been no experimental cost-effectiveness studies comparing opiate agonist stabilization treatment and outpatient drug-free treatment, but some observational studies show substantial cost reductions following treatment entry (Gerstein et al., 1994), although others have not (Fischer et al., 1999). Although cost reductions in observational studies cannot be attributed entirely to treatment effects, entry into opiate agonist stabilization treatment may be associated some reduction in the use of health care and criminal justice resources, and increased productivity, although they may also result in receipt of much needed additional medical care. Experimental cost-effectiveness studies are much needed to evaluate these potential cost consequences.
4. Differential impact across clinical subgroups In the previous sections of this review, we observed that buprenorphine/naloxone may be modestly less expensive than methadone maintenance and that it is likely to have similar efficacy. It is thus probable, although not empirically demonstrated, that successful entry into buprenorphine/naloxone treatment will be associated with reductions in health service use and criminal justice system involvement, with some resultant savings. Buprenorphine/naloxone has the potential to expand the overall supply of opiate agonist stabilization treatment, because the treatment will be provided in more locations by more practitioners. But it also may enhance the convenience and acceptability of this treatment to patients and families because it will be provided in mainstream practices that offer greater privacy and comfort. The end result is likely to be that greater numbers of opiate addicts will take advantage of an effective treatment, and that some addicts who would have been reluctant to seek help from traditional methadone clinics will be willing to seek help. In this section, we consider various subgroups of heroin addicts, and reflect on the differential potential economic impact of buprenorphine/naloxone treatment for each of them. The epidemiology of opiate addiction has received limited study and is complicated by the low overall prevalence of the disorder (B 0.5%) and by the understandable under-reporting of illegal behavior in surveys (Anthony and Helzer, 1995). Studies consistently show,
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however, that heroin addiction is more common among men than women, among people between the ages of 15 and 45 than among people under 15 or over 45, and among people living in urban rather than rural areas. Past studies had not reported an independent relationship between racial groups and heroin addiction (Anthony and Helzer, 1995). Little is known, however, about variability in the intensity and duration of heroin addiction in USA or about either treatment rates, service use, or exit rates from addiction within various subgroups. Recent studies of the cost-effectiveness of both pharmacotherapies and behavioral interventions have shown that the cost impact of an intervention can vary substantially across subgroups (Rosenheck, 2000; Rosenheck and Neale, 1998; Rosenheck and Leslie, 2000; Rosenheck et al., 1993, 1999). An effective treatment can sharply reduce costs among patients with high pre-treatment resource consumption but has little chance of reducing costs among patients who consume few services to begin with, even if it is medically effective (Rosenheck et al., 1993). Candidates for buprenorphine/naloxone therapy can be divided into two broad polar groups with gradations in between those who currently consume substantial health care and/or criminal justice resources and those who do not. The potential cost impact of buprenorphine/naloxone will vary substantially across these two groups.
4.1. Current ser6ice users Cost savings with buprenorphine/naloxone are likely to be greatest among patients who currently consume substantial resources from the health care and criminal justice systems. These patients fall into three groups, (1) recidivist addicts with repeated cycles of detoxification and relapse; (2) incarcerated addicts nearing release from prison; and (3) current methadone patients.
4.1.1. Detoxification recidi6ists Substantial savings with buprenorphine/naloxone may be realized by more effective treatment of recidivist heroin addicts, addicts who undergo repeated detoxifications, often in costly inpatient settings, and have only occasional aftercare visits, but who are never engaged in sustained treatment. Some of these people seek treatment only when they run out of money. It is, therefore, possible that the greater accessibility of buprenorphine/ naloxone on an outpatient basis will lessen the severity and cost of such crises. The average cost of an episode of outpatient detoxification has been estimated at $3100 (Hartz et al., 1999). Examination of national administrative data from the Department of Veterans Affairs showed that, in fiscal year 1999, 1359 veterans out of 3.4 million system users were hospitalized for opiate
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dependence for an average of 10.6 days during the year at an estimated average annual cost of $6135. Similar data from the Market Scan® data base, a compilation of private insurance claims primarily from the employees of large corporations (Leslie and Rosenheck, 1999), shows that, in 1997, only 488 people out of 2.8 million were hospitalized with an ICD 9 diagnosis of opiate dependence at an average cost of $4264 per year, although others may have been coded with alternate, more reimbursable, diagnoses. There is virtually no information available on the size of this group of addicts nationally, although the data presented above suggest that, among low income men, 40/100 000 receive inpatient detoxification as compared with 17/ 100 000 in the private sector. While these are relatively small numbers, it is unknown how many potential patients of this type currently seek opiate agonist stabilization therapy and the likely increase in that number as buprenorphine/naloxone becomes available.
mine whether these large cost reductions are attributable to methadone treatment. In addition, they did not include the growing costs for treatment of HIV and hepatitis C.
4.1.2. Incarcerated addicts A second population that may benefit from the availability of buprenorphine/naloxone is incarcerated addicts. Over the past two decades, stricter sentencing laws for drug addicts have resulted in a vast and costly expansion of the US prison system. General Barry McCaffrey, the White House director of national drug control policy, recently estimated that, of the 1.8 million inmates in American prisons, 400 000 (22%) are current or former addicts or chronic drug users (New York Times, 1999). The availability of substance abuse treatment for inmates, however, has been limited. Criminal justice related costs, most often based on self report data, are among the largest costs associated with opiate addiction, especially when one includes the costs to victims. In the 1980s, the TOPS study found that savings in criminal justice costs during methadone treatment were equal to the cost of the treatment itself, regardless of post-treatment developments (Harwood et al., 1988). More recently, the CALDATA study (Gerstein et al., 1994) reported that average criminal justice system costs were between $6645 and 8672 during the year before entry into methadone treatment while average victim and theft costs were between $7036 and 10 229. Annual total health care costs, in contrast, only averaged $2975–3373. Furthermore, CALDATA found that criminal justice system costs dropped by 18% after entry into methadone treatment and that costs of victimization and theft were reduced by 52%, resulting in savings of almost $7000 per treated patient for taxpaying citizens. Other studies have reported somewhat lower cost estimates (French et al., 1993). Health care cost savings, in contrast, were reduced by only 19% ($639) in CALDATA. It must be emphasized, however, that both TOPS and CALDATA used prepost designs and it is, therefore, not possible to deter-
4.2. Low-ser6ice users
4.1.3. Current methadone patients Because of their extensive experience in the treatment of drug addiction, current methadone clinics may offer buprenorphine/naloxone treatment as an alternative to methadone for both new patients and for long-term stabilized patients. Since, as noted in the first section of this review, medication costs for buprenorphine/naloxone are likely to be substantially greater than for methadone, provider costs may increase in the transition from methadone to buprenorphine/naloxone unless psychosocial services are substantially scaled back. Substantial savings, however, may be realized among patients whose transportation costs would decline as a result of less frequent treatment visits.
4.2.1. ‘Functional’ heroin abusers Although evidence is limited, it is widely suspected that there are substantial numbers of heroin users who manage to keep their opiate use and/or periodic addiction from disrupting their lives in major ways. Although married and employed, these addicts may be able to keep their drug use concealed from close intimates, although it may still be a drain on their lives and finances when their addiction becomes more severe. For ‘functional’ users such as these, the availability of office-based opiate agonist stabilization therapy may be very appealing. However, since these heroin users do not currently incur substantial costs, there may be little room for savings. Treatment of these patients may thus generate a net increase in health care costs, but may result in important benefits to quality of life and productivity that warrant such expenditures. It is also possible that, even in these patients, reduced exposure to HIV, cellulitis and more severe addiction will result in net cost savings in the long term. 4.2.2. Chronic pain patients A final group of patients who may benefit from buprenorphine/naloxone are patients with chronic medical problems who have become addicted to opiate analgesics that sometimes are prescribed by physicians and/or sometimes are purchased in the illegal drug market. The size and precise clinical characteristics of this population are largely unknown. A recent study suggested that only 3.8% of all emergency room visits related to addiction involved patients on opioid analgesics (Joranson et al., 2000), although this may be an underestimate of the true size of the population. Virtually no information is available on either the clinical
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value of buprenorphine/naloxone for these patients nor its economic impact. This subgroup deserves mention because the availability of buprenorphine/naloxone in office practice will provide them with a hitherto unavailable treatment option. Furthermore, since some of these patients may be very high consumers of diverse health care services, buprenorphine/naloxone treatment may yet yield significant savings.
5. Conclusions This study identified factors that will determine the ultimate economic impact of buprenorphine/naloxone in the treatment of opiate dependence and presented ranges of estimates relevant to its use in the United States of America. Given a common treatment population, buprenorphine/naloxone may be more cost-effective than methadone since it may be less expensive to administer, incurs lower patient travel costs, and is comparable in its effectiveness. In addition, we used the perspective of ‘systems cost-effectiveness’ to consider not only differences in cost-effectiveness when buprenorphine/naloxone is applied to a common clinical subgroup; but also differences in cost-effectiveness for different clinical subgroups. The ultimate economic impact of buprenorphine/naloxone will be determined by whether it fosters expanded use of opiate agonist stabilization among high cost recidivists (in whom the savings potential is large) or among lower cost, higher functioning opiate users with lower potential for savings. In a recent review of the costs of opiate addiction to society, Mark et al. (2000) concluded that available data are insufficient to make predictions about the economic impact of expanding the availability of current models of opiate agonist stabilization therapy. The issues we have identified, however, may serve as a framework for the empirical evaluation of these issues in the future and suggest that, as a result of relaxed regulations, office-based use of buprenorphine/naloxone may have cost advantages over current opiate agonist treatment, although it may not be any more clinically effective. Data from controlled studies are needed to demonstrate the ultimate economic consequences of this promising new approach.
Acknowledgements This study was supported, in part, by a grant from Schering-Plough Corporation to the Advanced Behavioral Research Institute. We would like to thank the participants in an expert panel on the use of buprenorphine in office-based practice convened at the Annual Meeting of the American Academy of Addiction Psy-
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chiatry, Nassau, Bahamas, December 5– 6, 1999. We would like to thank Kathleen Carroll, Ph.D. and Allison Olivetto, Ph.D. for their helpful comments and suggestions.
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