Opiate Treatment with Agonists Including Methadone, Buprenorphine, and Suboxone

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1. Treatment of Opioid Use Disorder Among Commercially Insured Adults in the US

"First, we confirmed that the rate of diagnosed OUD has increased steadily among commercially insured adults, and we documented how the age distribution of OUD has changed. In 2008 diagnosed OUD among the youngest age group (ages 18–24) was more than double that among the oldest group (ages 55–64). However, in 2017 diagnosis rates exhibited a hump-shaped pattern in age, with the highest rate (4.75 per 1,000 enrollees) among the middle-aged (people ages 35–44) and the greatest increase among the near-elderly (ages 55–64).

"Second, even as diagnosed OUD rates have increased and overdose deaths have soared, the likelihood that patients would receive any treatment has plunged. This decrease was driven by a reduction in MAT rates, coupled with relatively steady rates of medication-free treatment (except for the youngest age group, which experienced a surge in this treatment modality). In 2008, 60 percent of those diagnosed with OUD in our primary sample had at least one claim for OUD medication, but that rate had declined to 50 percent by 2017. Notably, there has been a course reversal: The nadir of 43 percent occurred in 2016, and the subsequent surge in MAT among patients with OUD has coincided with a sharp increase (27 percent) in the number of practitioners who completed the training required to prescribe buprenorphine.5,6 However, the aggregate time-series trend in treatment rates is deeply concerning in light of the high and increasing reported prevalence of OUD and its life-threatening sequelae.

"Third, our analysis of medical spending for commercially insured patients with OUD revealed several new facts and points to areas for future research. We documented high average spending for patients with OUD, both before and after diagnosis (around $30,000 per person during the twelve-month period spanning a diagnosis). We found that receiving an OUD diagnosis was followed by a sizable increase in medical spending, but that increase was much larger for patients who chose medication-free treatment than for those who chose medication or no treatment. However, we also found significant differences in prediagnosis spending across these groups, which implies that selection effects must be addressed before a causal link between treatment modality and spending is inferred."

Karen Shen, Eric Barrette, and Leemore S. Dafny. Treatment Of Opioid Use Disorder Among Commercially Insured US Adults, 2008–17. Health Affairs 2020 39:6, 993-1001.
https://www.healthaffairs.org/...

2. Effectiveness of Methadone Treatment

"For more than 45 years, research has confirmed that opioid agonist therapy (ie, methadone hydrochloride) is a highly effective treatment for opioid addiction provided outside primary care.4-6"

Alford, Daniel P., et al., "Collaborative Care of Opioid-Addicted Patients in Primary Care Using Buprenorphine - Five-Year Experience," Archives of Internal Medicine, 2011;171(5):425-431.
http://archinte.jamanetwork.co...

3. NIH Consensus Statement on the Safety And Effectiveness Of Methadone And Opioid Substitution Treatment

"The safety and efficacy of narcotic agonist (methadone) maintenance treatment has been unequivocally established."

Effective Medical Treatment of Opiate Addiction. NIH Consensus Statement 1997 Nov. 17-19; 15(6): 4.
http://consensus.nih.gov/1997/...

4. NIH Consensus Statement on Methadone and Opioid Substitution Treatment

"Prolonged oral treatment with this medicine [methadone] diminishes and often eliminates opiate use, reduces transmission of many infections, including HIV and hepatitis B and C, and reduces criminal activity."

National Institutes of Health, Office of the Director, "NIH Consensus Statement: Effective Medical Treatment of Opiate Addiction," (U.S. Department of Health: Bethesda, MD, November 1997) Vol. 15, No. 6., p. 16.
http://consensus.nih.gov/1997/...

5. Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder

"In a national cohort of 40,885 insured individuals between 2015 and 2017, MOUD [Medication for Opioid Use Disorder] treatment with buprenorphine or methadone was associated with a 76% reduction in overdose at 3 months and a 59% reduction in overdose at 12 months. To our knowledge, this was the largest cohort of commercially insured or MA individuals with OUD [Opioid Use Disorder] studied in a real-world environment with complete medical, pharmacy, and behavioral health administrative claims.

"Treatment with buprenorphine or methadone was associated with a 32% relative rate of reduction in serious opioid-related acute care use at 3 months and a 26% relative rate of reduction at 12 months compared with no treatment. In contrast, detoxification, intensive behavioral health, and naltrexone treatment were not associated with reduced overdose or serious opioid-related acute care use at 3 or 12 months.

"Despite the known benefit of MOUD treatment with buprenorphine or methadone, only 12.5% initiated these evidence-based treatments. Most individuals in this cohort initiated treatment with psychosocial services alone or inpatient detoxification, both of which are less effective than MOUD. It is possible that individuals accessed public sector treatments that were not captured in our data, particularly for methadone, which was not covered by Medicare and may not have been covered without co-payment for all commercial plans during this time. Low rates of MOUD use among an insured population highlight the need for strategies to improve access to and coverage for MOUD treatment."

Wakeman SE, Larochelle MR, Ameli O, et al. Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder. JAMA Netw Open. 2020;3(2):e1920622. doi:10.1001/jamanetworkopen.2019.20622
https://jamanetwork.com/journa...

6. Effectiveness of Different Treatment Pathways for Opioid Use Disorder

"Our results demonstrate the importance of treatment retention with MOUD [Medication for Opioid Use Disorder]. Individuals who received methadone or buprenorphine for longer than 6 months experienced fewer overdose events and serious opioid-related acute care use compared with those who received shorter durations of treatment or no treatment. These findings are consistent with prior research11,15,27-29 demonstrating high rates of recurrent opioid use if MOUD treatment is discontinued prematurely. Despite the benefit of MOUD in our study, treatment duration was relatively short. Given the chronic nature of OUD and the evidence that longer treatment duration may be associated with improved outcomes, patient-centered MOUD treatment models explicitly focused on engagement and retention are needed. Low-threshold treatment, which aims to reduce barriers to entry and is tailored to the needs of high-risk populations,30 may be a strategy to improve retention; however, to our knowledge, no rigorous studies have evaluated these models to date.31,32 In addition, patient-centered MOUD care, which allows participants to determine the services they need rather than requirements, such as mandatory counseling, are noninferior to traditional treatment.32

"Numerous barriers limit sustained engagement in MOUD, including a lack of access to waivered practitioners, high co-payments, prior authorization requirements, and other restrictions on use. Previous studies33,34 have demonstrated that restrictions on use for MOUD are associated with limited access and harm. Addiction treatment programs in states that require Medicaid prior authorizations for buprenorphine are less likely to offer buprenorphine, and the more restrictions on use in state Medicaid programs, the fewer treatment programs that offer buprenorphine.33 Requiring prior authorization for higher doses of buprenorphine may also result in increased recurrence rates among patients.34 Our finding that MOUD treatment with buprenorphine or methadone was associated with lower overdose and serious opioid-related acute care use supports expanded coverage of these medications without restrictions on use.

"Our findings are also consistent with analyses showing that MOUD treatment with buprenorphine or methadone is significantly associated with reduced overdose and recurrence of opioid use compared with no treatment or non-MOUD treatment. A previous cohort study15 of individuals in Massachusetts demonstrated a reduction in overdose-related mortality associated with treatment with buprenorphine (AHR, 0.62; 95% CI, 0.41-0.92) or methadone (AHR, 0.41; 95% CI, 0.24-0.70), results that are similar to our finding of an AHR of 0.41 (95% CI, 0.31-0.55) for overdose at 12 months for methadone or buprenorphine. A large meta-analysis11 examining mortality when individuals were in or out of treatment with buprenorphine or methadone similarly showed decreased overdose mortality during treatment. A study12 examining proxies for recurrent OUD among Massachusetts Medicaid enrollees found that treatment with buprenorphine or methadone was associated with lower recurrence rates and costs. No studies, to our knowledge, have examined the effect of different OUD treatment pathways on overdose and serious opioid-related acute care use among a national sample of commercially insured and MA enrollees."

Wakeman SE, Larochelle MR, Ameli O, et al. Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder. JAMA Netw Open. 2020;3(2):e1920622. doi:10.1001/jamanetworkopen.2019.20622
https://jamanetwork.com/journa...

7. Effectiveness of Different Treatment Pathways for Opioid Use Disorder

"Our finding that MOUD [Medication for Opioid Use Disorder] treatment with naltrexone was not protective against overdose or serious opioid-related acute care use is consistent with other studies15,35 that found naltrexone to be less effective than MOUD treatment with buprenorphine. The mean (SD) treatment duration for naltrexone in this cohort was longer than prior observational studies at 74.41 (70.15) days.

"The findings that nonintensive behavioral health treatment was associated with a reduced risk of overdose at 12 months but not 3 months and a reduced risk of opioid-related acute care use was surprising. Although we attempted to control for differences among various treatment groups, individuals referred to nonintensive behavioral health may represent a less complex patient population than those who receive MOUD treatment or are referred to intensive behavioral health or inpatient treatment."

Wakeman SE, Larochelle MR, Ameli O, et al. Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder. JAMA Netw Open. 2020;3(2):e1920622. doi:10.1001/jamanetworkopen.2019.20622
https://jamanetwork.com/journa...

8. Methadone Treatment Associated with Reductions in Frequency of Opioid Use, Fewer Injections, and Lower Rates of HIV

"In summary, data from studies conducted in Australia, Europe, Asia and the United States have, with few exceptions, found strong associations between participation in methadone treatment and reductions in the frequency of opioid use, fewer injections and injection-related HIV risk behaviors, and lower rates of HIV prevalence and incidence. Few randomized controlled trials have been conducted due to ethical concerns regarding the random assignment of individuals to no treatment or other potentially less effective treatment modalities. Despite this fact, the consistency of findings from the observational and case-controlled studies cited here provide a preponderance of evidence suggesting that sustained treatment of opioid-dependent injection drug users with methadone is associated strongly with protection from HIV infection."

Sullivan, Lynn David S. Metzger, Paul J. Fudala & David A. Fiellin, "Decreasing International HIV Transmission: The Role of Expanding Access to Opioid Agonist Therapies for Injection Drug Users," Addiction, February 2005, Vol. 100, No. 2, p. 152.
http://www.ncbi.nlm.nih.gov/pu...

9. Methadone Maintenance And Opioid Substitution Treatment (MMT and OST) Have Highest Probability Of Effectiveness

"Of the various treatments available, Methadone Maintenance Treatment, combined with attention to medical, psychiatric and socioeconomic issues, as well as drug counseling, has the highest probability of being effective."

National Institutes of Health, Office of the Director, "NIH Consensus Statement: Effective Medical Treatment of Opiate Addiction," (U.S. Department of Health: Bethesda, MD, November 1997) Vol. 15, No. 6., p. 7.
http://consensus.nih.gov/1997/...

10. Methadone Dosing

"Methadone's half-life is approximately 24 hours and leads to a long duration of action and once-a-day dosing. This feature, coupled with its slow onset of action, blunts its euphoric effect, making it unattractive as a principal drug of abuse."

National Institutes of Health, Office of the Director, "NIH Consensus Statement: Effective Medical Treatment of Opiate Addiction," (U.S. Department of Health: Bethesda, MD, November 1997) Vol. 15, No. 6., p. 14.
http://consensus.nih.gov/1997/...

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