Magellan Medication-Assisted Treatment Industry Validation Points

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1 Magellan Medication-Assisted Treatment Industry Validation Points The Magellan medication-assisted treatment (MAT) program focuses on increasing the appropriate use of proven medications to treat members with a primary alcohol and other drugs (AOD) diagnosis. Based on professional standards, such as those developed by the American Psychiatric Association's Physician Consortium for Performance Improvement(R), a taskforce of Magellan clinical leaders created the MAT program. This national intervention seeks to increase the use of medications in treatment of substance use disorders where clinically appropriate, monitors the number of cases in which physicians are prescribing medications and measures member readmission rates. Validation Points and References 1. Pharmacological treatment for substance use disorders is a proven, industry best practice. The American Psychiatric Association (APA) and National Committee for Quality Assurance (NCQA) have adopted performance measures for management of alcohol that include pharmacologic treatment. Pharmacological treatment is a best practice for the National Quality Forum and has been supported by and mandated by the Office of Veteran s Affairs (VA) for all of its facilities. 1 The Washington Circle, a policy group devoted to the improvement of care for substance use disorders, released performance measures to monitor the use of medications approved for the treatment of alcohol and opioid dependence. o o Development and pilot testing of these measures was conducted at Brandeis University s Institute for Behavioral Health, using data from private health plans, Medicaid, and the Veterans Health Administration. They represent the first standard set of measures for monitoring use of medications in substance use disorders. These measures build upon existing Washington Circle/HEDIS process performance measures for initiation and engagement of substance abuse treatment, now widely used to assess quality of care across a range of treatment settings Magellan Health Services 1

2 The U.S. Food and Drug Administration (FDA) has approved four medications to treat Alcohol Use Disorders (AUDs). These medications make treatment in primary care and other general medical settings a viable adjunct or alternative to specialty care with many potential advantages. The consensus panel for this the Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Improvement Protocol believes that direct intervention by healthcare practitioners to treat AUDs is both possible and practical. o Screening for and providing brief interventions to treat AUDs in general medical settings increases the likelihood of recovery, especially for patients who have not yet progressed to chronic alcohol dependence, those with comorbid medical disorders being treated in these settings, and those who otherwise would not seek or receive treatment for their AUDs. 5 The National Institute on Drug Abuse (NIDA) in its publication, Principles of Drug Addiction Treatment describes examples of treatment approaches and components that have an evidence base supporting their efficacy. These include pharmacotherapies such as buprenorphine and naltrexone for opioid treatment and naltrexone, acamprosate and topiramate for alcohol addiction. 27 The APA guidelines for substance abuse include descriptions of and research on use of naltrexone and acamprosate for alcohol and buprenorphine and naltrexone for opioids. 28 The use of psychopharmacy is a standard of care with strong organization support at the Veteran s Health Administration Buprenorphine is safe and effective in augmenting substance use treatment (especially opioid use) and can result in improved outcomes by increasing individuals ability to stay in treatment. Buprenorphine naloxone versus clonidine was the strongest predictor of treatment success. The ability of buprenorphine naloxone to reduce symptoms and retain subjects in the early phase of treatment may be a critical factor in understanding the better outcomes compared to clonidine. 9 Buprenorphine seems to be more effective as seen by a higher retention rate than methadone in patients affected by depressive traits and dysphoria. A significantly lower rate of opioid positive urines was found in buprenorphine patients than methadone on week Since 1996, buprenorphine has been available for office-based treatment of opioid addiction. 7 The Food and Drug Administration approved buprenorphine (Subutex and Suboxone) as medications for the treatment of opioid addiction in The Quick Guide for Physicians based on TIP 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction was developed to accompany Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction and is designed to meet the needs of the busy physician for concise, easily accessed how-to information. 12 Magellan Health Services 2

3 SAMHSA s Medication-Assisted Treatment: for Opioid Addiction in Opioid Treatment Programs, TIP 43; incorporates the many changes in medication-assisted treatment for opioid addiction that have occurred over the most active decade of change since the inception of this treatment modality approximately 40 years ago. It presents consensus panel recommendations and evidence-based best practices for treatment of opioid addiction in opioid treatment programs Concerns about side-effects and the addictive properties of buprenorphine are not warranted when the medication is used with appropriate oversight. Illicit use of the opioid treatment drug buprenorphine is commonly believed by some to be driven by a desire for a euphoric high, but the much more common motivation behind illicit use of the drug is to self-treat for opioid withdrawal symptoms and cravings. 14 With regard of buprenorphine IV abuse, the combination product seems to have a less abuse potential than buprenorphine alone Studies support the use of naltrexone and acamprosate in treating alcohol dependence. Clinical evidence suggests that when naltrexone is combined with psychosocial treatment models, it reduces the percentage of days that the patient drinks, reduces the alcohol consumed when the patient does drink, and prevents the patient from relapsing and drinking excessively. 15 Since 1994, naltrexone has been used as an adjunct in the treatment of alcohol dependence with positive effects in increased duration of recovery, reduced cravings, and reduced intensity of relapse. 16 More depressed alcohol-dependent patients receiving the sertraline plus naltrexone combination achieved abstinence from alcohol, reported fewer serious adverse events, and tended to not be depressed by the end of treatment. 17 Clinical trials of acamprosate have shown that this medication helps in maintaining abstinence and is superior to placebo in alcohol dependent patients who had undergone inpatient detoxification. 18 Reviewed studies suggest that acamprosate can be safely used with patient with psychiatric symptoms and does not interact with psychiatric medications. Adverse outcome events are similar to placebo in patients taking concomitant medications. These studies indicate significant positive effect for acamprosate on anxiety symptoms particularly when combined with motivational therapy. 2 In two studies, neurophysiological data suggests two classes of drinkers: reward cravers and relief cravers. While naltrexone should work better in the first group, acamprosate is hypothesized to be efficacious in the second The use of addiction counseling, along with medication-assisted treatment, increases the likelihood of program retention and patient recovery. Magellan Health Services 3

4 Participants with opiate-positive toxicologies at week 1 were more likely to drop out of the program and had a significantly shorter retention time on average. Employment and addiction counseling during treatment were significantly associated with treatment retention. Abstinence during the first week of treatment and receipt of counseling were critical to patient retention. 19 Studies have demonstrated that medications can assist in the successful management of relapse and/or withdrawal symptoms related to alcohol and opioid abuse when used in 11, 22, 23, 24, 25 conjunction with traditional psychosocial interventions. 6. Studies demonstrate the effectiveness of medication-assisted treatment administered in a primary care or community-based setting. Users preferred treatment in community settings because they reportedly found it less stigmatizing and easier to access. The findings suggest that the community-based programs with very low staff investment from a community-based clinic can be initiated and replicated safely and effectively across the country. 20 Results indicate treatment retention rates for buprenorphine treatment in primary care settings was superior to services delivered in a drug treatment setting. 6 No significant differences in the effectiveness of treatment with buprenorphine were found when comparing the retention rate between the 3-week period at an addiction clinic and the 12-week treatment at general practitioners offices. 21 Magellan Health Services 4

5 References 1. Harris, A., Kivlahan, D., Bowe, T., & Humphreys, K. (2010). Pharmacotherapy of alcohol use disorders in the veterans health administration. Psychiatric Services, 61(4), Mason, B., & Lehert, P. (2010). The effects of current subsyndromal psychiatric symptoms or past psychopathology on alcohol dependence treatment outcomes and acamprosate efficacy. The American Journal On Addictions / American Academy Of Psychiatrists In Alcoholism And Addictions, 19(2), Mann, K., Kiefer, F., Spanagel, R., & Littleton, J. (2008). Acamprosate: Recent Findings and Future Research Directions. Alcoholism: Clinical & Experimental Research, 32(7), and Mann, K., Kiefer, F., Smolka, M., Gann, H., Wellek, S., & Heinz, A. (2009). Searching for Responders to Acamprosate and Naltrexone in Alcoholism Treatment: Rationale and Design of the Predict Study. Alcoholism: Clinical & Experimental Research, 33(4), The Washington Circle, January Incorporating Alcohol Pharmacotherapies into Medical Practice, TIP 49; SAMHSA Complete guide to use of MAT medications 6. O'Connor, P., Oliveto, A., Shi, J., Triffleman, E., Carroll, K., Kosten, T., et al. (1998). A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic; American Journal of Medicine, 105(2), Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: Treatment Improvement Protocol no 40. Rockville, Md, US Department of Health and Human Services, Public Health Service, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, Simojoki, K., Vorma, H., & Alho, H. (2008). A retrospective evaluation of patients switched from buprenorphine (Subutex) to the buprenorphine/naloxone combination (Suboxone). Substance Abuse Treatment, Prevention, And Policy, Ziedonis, D., Amass, L., Steinberg, M., Woody, G., Krejci, J., Annon, J., et al. (2009). Predictors of outcome for short-term medically supervised opioid withdrawal during a randomized, multicenter trial of buprenorphine naloxone and clonidine in the NIDA clinical trials network drug and alcohol dependence. Drug & Alcohol Dependence, 99(1-3), Gerra, G., Borella, F., Zaimovic, A., Moi, G., Bussandri, M., Bubici, C., et al. (2004). Buprenorphine versus methadone for opioid dependence: predictor variables for treatment outcome. Drug And Alcohol Dependence, 75(1), Anton RF, Naltrexone for the Management of Alcohol Dependence. New England Journal of Medicine 2008; 359: Quick Guide for Physicians based on TIP 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, QGP 40; SAMHSA. 13. Medication-Assisted Treatment: for Opioid Addiction in Opioid Treatment Programs, TIP 43; SAMHSA resource guide. 14. Melville, N., (2009). Alleviation of Opioid Withdrawal Symptoms Primary Driver of Illicit Buprenorphine Use; American Academy of Addiction Psychiatry (AAAP) 20th Annual Meeting & Symposium. 15. Harris, K. M., DeVries, A., Dimidjian, K., Pincus, H., & Tanielian, T. (2004). Trends in Naltrexone Use Among Members of a Large Private Health Plan. Psychiatric Services, 55(3), 221. Magellan Health Services 5

6 16. Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, Collins J, Raisch D, Casadonte P, Goldsmith RJ, Ling W, Malkerneker U, McNicholas L, Renner J, Stine S, Tusel D; Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med 2003 Sep 4;349(10): Pettinati, H., Oslin, D., Kampman, K., Dundon, W., Xie, H., Gallis, T., &... O'Brien, C. (2010). A doubleblind, placebo-controlled trial combining sertraline and naltrexone for treating co-occurring depression and alcohol dependence. American Journal of Psychiatry, 167(6), Sass H, Soyka M, Mann K, Zieglgansberger W; Relapse Prevention by Acamprosate: Results from a Placebo-Controlled Study on Alcohol dependence. Archives of General Psychiatry 53: , Stein, M., & Cioe, P. (2005). Brief report: Buprenorphine retention in primary care. Journal of General Internal Medicine, 20(11), Mohan, D., Dhawan, A., Chopra, A., & Sethi, H. (2006). A 24-week outcome following buprenorphine maintenance among opiate users in India. Journal of Substance Use, 11(6), Ortner, R., Jagsch, R., Schindler, S., Primorac, A., & Fischer, G. (2004). Buprenorphine Maintenance: Office- Based Treatment with Addiction Clinic Support. European Addiction Research, 10(3), Anton RF, O Malley SS, Ciraulo DA, et al. Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence: the COMBINE study: a randomized controlled trial. JAMA 2006; 295: Treatment Improvement Protocol (TIP) series. Rockville, MD: Department of Health and Human Services, Practice Guideline for the Treatment of Patients with Substance Use Disorders. 2 nd ed. American Journal of Psychiatry 2006; 164; Suppl:A5-A Harris AHS, Kivlahan D, Bowe T, Humphreys KN. Pharmacotherapy of Alcohol use Disorders in the Veterans Health Administration. Psychiatric Services; April 2010: Subutex and Suboxone Approved to Treat Opiate Dependence; Oct. 8, Principles of Drug Addiction treatment: A Research Based Guide, HIH publication # , April The American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Substance Use Disorders, Second Edition, May Harris Ales, Kivlahan Daniel, Bowe Thomas, Humphrys Keith, Pharmocotherapy of Alcohol Use Disorders, Psychiatric Services, Vol 61 #4, April Magellan Health Services 6

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