The Use of Non-Opioid Pharmacotherapies. for the Treatment of Alcohol Dependence

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2 M00K02 Alcohol and Drug Abuse Administration Department of Health and Mental Hygiene The Use of Non-Opioid Pharmacotherapies for the Treatment of Alcohol Dependence Introduction The 2011 Joint Chairmen s Report (page 70, budget code M00K02.01) directed the Department of Health and Mental Hygiene (DHMH), in conjunction with the Department of Public Safety and Correctional Services (DPSCS), to submit a report on the usage of non-opioid pharmacotherapies for the treatment of alcohol dependence in those incarcerated in DPSCS facilities. The Budget Committees requested that DHMH and DPSCS report on the current utilization of non-opioid pharmacotherapies to treat alcohol dependence, State and local spending on non-opioid pharmacotherapies, and the cost-effectiveness of using non-opioid pharmacotherapies to reduce alcohol recidivism. The Budget Committees also requested that DHMH report on where non-opioid pharmacotherapies are currently being used within the general population and any potential plans to expand the use of non-opioid pharmacotherapies to other populations, including the Medicaid and Primary Adult Care population. Background on Non-Opioid Pharmacotherapies Alcohol abuse is a major public health problem. Excessive alcohol use has immediate and longterm effects that increase the risk of many harmful health conditions, including the development of chronic diseases. This impacts the somatic and behavioral healthcare system, resulting in a significant number of hospitalizations and emergency room visits for alcohol-related conditions, as well as taxing the law enforcement system, because of violence and unintentional injuries. Among adults, alcohol is the leading substance of abuse in Maryland; approximately 55% of admissions for substance abuse treatment cite alcohol use as a problem. 1 1 Outlook and Outcomes FY 2010, Alcohol and Drug Abuse Administration, 1

3 Naltrexone is a non-opioid pharmacotherapy that was first approved for the treatment of alcoholism in Naltrexone is an opiate receptor antagonist that blocks the pleasurable effects of alcohol and reduces cravings. The original formulation of oral naltrexone requires a daily dosage and has a half-life of four hours. In addition to the drawback of daily dosing, the blood levels of naltrexone vary during the day, leading to a less consistent reduction of craving. There is anecdotal evidence that the use of oral medications for alcohol dependence is minimal in ADAA supported programs, due to the limitations of the oral medications. In April 2006, the U.S. Food and Drug Administration (FDA) approved an extended release injectable formulation of naltrexone referred to as extended-release naltrexone (also known as NTX-XR or naltrexone XR) which is marketed under the trade name Vivitrol. This is a nonaddictive medication which uses pharmacologic means to improve the likelihood of successful treatment for alcohol dependence, by increasing adherence and steady state blood levels. In contrast to the oral formulation, Vivitrol requires an injection every four weeks on average and has a half-life of five to ten days. Vivitrol is also indicated for the prevention of relapse to opioid dependence, following opioid detoxification. Of note, the FDA-approved label recommends that treatment with Vivitrol should be part of a comprehensive management program that includes psychosocial support. According to the FDA-approved label, controlled clinical trials have found that Vivitrol is associated with reductions in the number of drinking days and heavy drinking days, although treatment effects were not as substantial among the 92% of patients who were actively drinking at the time the treatment began. Vivitrol for patients with opiate addiction improved the percentage of opioid-free weeks, compared to placebo. There are a variety of potential adverse effects from Vivitrol, including hepatitis, psychiatric adverse reactions (including depression and suicidality), injection site reactions, eosinophilic pneumonia, and hypersensitivity. Several published studies have found that treatment with Vivitrol may be cost-effective. One large scale study compared Vivitrol to all existing medication treatments for alcohol dependence and for psychosocial therapy only. Its analysis of healthcare insurance data reported that patients persisted with treatment longer than patients receiving the oral alcohol use disorder medications or psychosocial therapy only, and had decreased inpatient and emergency healthcare costs and utilization compared with those receiving other medications. All treatments were equal in increasing outpatient behavioral health visits. The oral medications were disulfiram (Antabuse), oral naltrexone (Revia), and acamprosate (Campral). A second large scale study reported that patients who received Vivitrol, versus no medication or the same medications mentioned above, had lower healthcare utilization and total costs. Vivitrol showed an advantage over the oral 2

4 medications in treatment length of stay and healthcare utilization, at comparable or lower total cost. 2 Another recent large scale study compared the medications for opioid dependence using Vivitrol versus the following medications, all in oral formulations: naltrexone, buprenorphine, and methadone. This study also reported positive outcomes for the use of any of these medications and Vivitrol in particular. Despite the higher costs for medications, the total healthcare costs, including inpatient, outpatient and pharmacy costs, were 29% lower for patients who received any medication for opioid dependence versus those who did not. Patients given Vivitrol had fewer opioid-related and -unrelated inpatient hospitalizations than those receiving any of the oral medications. In this study, despite higher costs for Vivitrol, total healthcare costs were not significantly different from those for oral naltrexone or buprenorphine and were 49% lower than those for methadone. 3 Department of Public Safety and Correctional Services and Use of Non-Opioid Pharmacotherapies The Department of Public Safety and Correctional Services (DPSCS) does not currently have Federal or state funds within its budget to provide non-opioid pharmacotherapies for the treatment of alcoholism within its prison facilities. Because the purpose of treatment is to sustain abstinence upon discharge from facilities, DPSCS is tracking studies that address soon-to-be released or recently released prisoners. DPSCS is aware of two Vivitrol studies conducted by Friends Research for the criminal justice population. The first study uses Vivitrol in a community-based setting, by recruiting Department of Parole and Probation (DPP) inmates residing in the Gaudenzia treatment programs. DPP is not involved in the study. The second study was recently granted approval from the DPSCS Research Committee and will treat inmates at the Maryland Correctional Institute for Women and the Metropolitan Transition Center. The inclusionary criteria of this study are opiate 2 Basur O et al. Alcohol Dependence Treatments: Comprehensive Healthcare Costs, Utilization Outcomes, and Pharmacotherapy Persistence, Volume 17, Volume 8 Supplement, , June Basur O et al. Cost and Utilization Outcomes of Opioid-Dependence Treatments, Volume 17, Volume 8 Supplement, , June

5 addiction or opiate and alcohol addiction. The study is funded by Alkermes, the manufacturer of Vivitrol. Alcohol and Drug Abuse Administration and Current Funding for the Use of Non-Opioid Pharmacotherapies The Alcohol and Drug Abuse Administration (ADAA) provides funding to localities, which develop strategies for substance abuse treatment tailored to local needs. Four jurisdictions in Maryland are now using or planning to use Vivitrol for alcohol dependence. - Carroll County provides Vivitrol for patients chronically relapsing on alcohol or for those patients that also have a co-occurring alcohol and opioid dependence. Vivitrol has only been spent on alcohol dependence to date. Funds to be spent on Vivitrol come from the ADAA grant to the jurisdiction. In FY 2011, the county budgeted $14,000 from the ADAA grant for the use of Vivitrol. In FY 2012, the county again budgeted $14,000 from the ADAA grant. So far, $7,000 has been spent in FY Beginning in January, 2012, Carroll County will have additional funds for Vivitrol through a Drug Court grant: $35,000 in CY 2012 and $45,000 for CY Montgomery County provides Vivitrol for outpatient services alcohol dependence treatment. Funds spent on Vivitrol came from multiple sources in FY 2011: $30,000 in County General Funds; $10,000 from a SAMHSA Drug Court grant; and $12,000 from an ADAA year end supplement. For FY 2012, the County has $30,000 in County General Funds to be spent on Vivitrol, $9,750 of which has been spent to date. - Washington County provides Vivitrol for jail based, outpatient and residentially placed patients for alcohol dependence treatment. The County has budgeted $120,000 in funds from the ADAA grant to the jurisdiction to be spent on Vivitrol in FY In addition, the County has budgeted $5,000 from the Federal Second Chance Grant to treat jail-based patients for alcohol or opioid dependence. The County can ask for a Federal budget modification if there is more need in the jail for Vivitrol. - Baltimore Substance Abuse Systems (bsas) is planning to use Vivitrol in Baltimore City for alcohol-dependent only patients. The populations that will receive the medication are DPSCS incarcerated pre-trial detainees and patients in residential programs with each receiving subsequent linkage to outpatient treatment. This use is distinct from the Friends Research studies described previously in this report. bsas plans to spend $500,000 on Vivitrol in FY 2012 from the annual ADAA grant to the jurisdiction. 4

6 ADAA is collaborating with these jurisdictions to conduct an evaluation on the implementation of this medication to determine the following outcomes: adherence with treatment, side effects causing discontinued treatment, hospitalizations since treatment, criminality, continued substance use, employment and treatment availability. As of September, 2011, Montgomery, Carroll and Washington Counties have reported that approximately 30 individuals have received Vivitrol through county treatment services. Medicaid and Primary Adult Care - Current Use of Non-Opioid Pharmacotherapies, and Upcoming Model Program Medicaid and the Primary Adult Care Program (PAC) support pharmacotherapy for drug addiction, largely through Managed Care Organizations (MCOs). The MCOs have the authority to set their formulary and to decide how and when to cover medications such as Vivitrol and other non-opioid pharmacotherapies. To date, there has been limited interest among MCOs in including Vivitrol on preferred drug lists. In the HealthChoice program, MCOs have stated that they are willing to authorize Vivitrol when other treatments are not effective for the target population, partly in recognition of the fact the MCOs financially would be responsible for any avoidable inpatient costs. In HealthChoice, the MCOs authorize Vivitrol consistent with the practices of other payers: not as a medication of first resort. In PAC, the MCOs have two main concerns about the use of Vivitrol: because inpatient services are not a covered benefit, the literature on the cost-effectiveness of Vivitrol (which relies heavily on the avoidance on inpatient costs) is not as persuasive; and because PAC enrollees may selfrefer to any prescribing provider, including out-of-network providers the MCOs might refuse to credential, the MCOs cannot engage the prescribing provider in any appropriate detailing or educational program. The Medicaid Program s assessment of the evidence is that additional data would be helpful to inform policy on the use of Vivitrol. Because of the potential value of Vivitrol to Medicaid and PAC enrollees, ADAA and Medicaid are collaborating on the development of a model program in two Maryland counties. This program focuses in on the patients most likely to benefit those leaving residential treatment programs and still receiving psychosocial support for addiction. The model program will include the initiation of Vivitrol for patients in residential programs for the treatment of alcohol abuse or the treatment of primary alcohol dependence. The patient will receive the injection prior to discharge with subsequent linkage to outpatient based treatment services that would provide Vivitrol for an additional 5 months. Data will be collected on 5

7 utilization, costs and outcomes, including rates on treatment, retention and abstinence, with interim results expected in approximately 1 year. The results from this program and the county-led initiatives described above will be shared with the MCOs and used to guide further decisions in Medicaid and PAC about the use of Vivitrol in Maryland. 6