Management Options for Opioid Dependence: Policy Implications and Recommendations Dan Ollendorf, PhD Sarah Jane Reed, MSc
New England CEPAC Goal: To improve the application of evidence to guide practice and policy in New England Structure: Core program of Institute for Clinical and Economic Review (ICER) Evidence review from ICER Deliberation and voting by CEPAC: independent clinicians, scientific review experts, and public members from all six New England states Funding: State Medicaid programs Regional private payers Regional provider groups 2
New England CEPAC CEPAC recommendations designed to support aligned efforts to improve the application of evidence to: Practice Policy Patient/clinician education Quality improvement efforts Clinical guideline development Coverage and reimbursement Medical management policies Benefit design 3
REVIEW OF PUBLISHED EVIDENCE 4
Framing Questions Maintenance treatment with opioid replacement (e.g., methadone) vs. detox (and other drug-free treatment) Suboxone vs. methadone vs. naltrexone Dosing and duration considerations Other considerations (e.g., key treatment components, innovative delivery models) 5
Maintenance vs. Detox Systematic reviews and recent clinical studies have consistently shown superiority of maintenance treatment to detox and other shortterm strategies for stopping all opioid use: Greater retention in treatment programs Less use of illicit opioids like heroin 6
Suboxone vs. Methadone Maintenance treatment with methadone and Suboxone (buprenorphine/naloxone) appear to be comparably effective: No differences in mortality, criminal activity, or illicit drug use Somewhat better treatment retention with methadone In US settings, may be correlated with greater regulation and treatment oversight of methadone clinics vs. office-based Suboxone prescribing 7
Naltrexone Not an opioid replacement therapy: Used to block cravings in patients who have stopped opioid use Clinical trials of oral naltrexone suggest it is no better than placebo at keeping patients in treatment, controlling illicit drug use, etc. Possible compliance issues? Data on injectable or implantable forms suggest somewhat better compliance, but limited head-to-head evidence 8
Dosing and Duration Attempts to taper maintenance medication to opioid abstinence have been largely unsuccessful Observational studies suggest that longer and gradual tapers have better chance for success Recent RCT of 3 Suboxone taper durations followed by oral naltrexone in 70 patients showed promise for 4-week taper*: 50% abstinence in treatment after 12 weeks vs. 16% and 20% for 2- and 1-week tapers (p=.03) 9 *Sigmon et al., JAMA Psychiatry 2013
Dosing and Duration Data from Sigmon trial and other studies suggest a meaningful subset of patients who might benefit from tapering and other detox strategies: Relatively short duration of addiction Not an injectable drug user Employed, educated Good support system at home 10
Program Components Evidence is mixed on benefit of intensive counseling approaches Brief, clinician-led counseling may be sufficient in many circumstances Use of incentives appears to improve program compliance and retention in treatment: Positive: monetary rewards for clean urine tests Negative: reduced methadone dose for missed appointments 11
Innovative Delivery Models Pilot studies of office-based take-home methadone dosing result in comparable or better outcomes vs. standard facility-based treatment Conducted primarily in clinically-stable, employed patients with social supports Alternative methods to deliver counseling appear to provide comparable effectiveness to in-person approaches, e.g.: Telephonic coaching Group therapy by videoconference 12
ECONOMIC EVALUATION: POPULATION BUDGET IMPACT 13
Budget Impact Model: Methods Numbers of opioid-dependent persons estimated from state-based SAMHSA survey data: Stratified by whether in vs. out of treatment Two-year estimates of substance abuse-related deaths, health care costs, and total costs Evaluation of change in numbers of deaths and costs associated with moving alternative numbers of patients into Suboxone maintenance 14
Budget Impact Model: Substance Abuse-Related Deaths over 2 Years 15
Budget Impact Model: Change in Total Costs over 2 Years 16
Access to Treatment Availability of facility-based and office-based opioid dependence treatment falls far short of clinical need In New England, 133,000 individuals are abusing or dependent on opioids, of whom 70% meet criteria for treatment but are not currently receiving it DATA 2000 legislation sets prescribing limits for buprenorphine and Suboxone: Approximately one-third of licensed physicians have obtained a waiver to move from a patient cap of 30 100 patients
Access to treatment Highly regulated environment for methadone clinics Medication must be taken under observation unless take-home privileges are granted Long wait-lists are common at most facilities Treatment unavailable in most correctional facilities only 10% of individuals that require MAT receive it as part of their justice system supervision (SAMHSA, 2013)
Geographical barriers to care: Vermont example
Key CEPAC Votes Maintenance therapy with any medication has superior effectiveness to short-term detoxification and has high comparative value Expanding access to maintenance therapy has high comparative value to the status quo. Value judgment adopts Medicaid perspective and includes both societal and direct health care costs
Key Policy Recommendation #1 Coordinated efforts are needed to improve access to opioid dependence treatment. Key mechanisms to consider: Change regulations that isolate methadone treatment from the rest of clinical care Establish resources to support waivered physicians in increasing their capacity & willingness to serve more patients Relax limits on the number of patients that can be treated by qualified clinical teams Broaden the scope of DATA 2000 to allow qualified psychiatric nurse practitioners to prescribe buprenorphinecontaining medications
Example: Maryland Buprenorphine Telehealth pilot: Connects patients in rural areas w/limited licensed prescribers to DATA-waivered physicians in others parts of state using telehealth. Once patient is inducted and stabilized in substance abuse treatment program, patient is transferred to telehealth physician if living in remote area.
Example: Med-O-Wheel in Vermont: Using new technology to help patients on waiting lists access some level of MAT. Device dispenses a single dose of buprenorphine for a limited two-hour window each day, making it difficult for patients to abuse medication Patients using Med-O-Wheel also receive telephone-based monitoring & support
Key Policy Recommendation #2 Develop systems to triage patients to the level of care most appropriate for their individual needs. Mechanisms to consider: Coordinated care networks in which patients receive short-term intensive outpatient care until stabilized, and then are referred to lower levels of ongoing care and MAT in primary care settings or community-based practices.
Examples: Vermont Hub and Spoke: Patients initiate treatment at specialty treatment centers ( hubs ) and transition to communitybased care once stabilized ( spokes ) Stable patients receive ongoing care with Suboxone. Physician-led care teams monitor treatment adherence, provides counseling, support contingency management, & coordinate patient access to other recovery supports
Examples: Baltimore Buprenorphine initiative: Patients are inducted and stabilized into an outpatient addiction program, and either receive standard outpatient services or intensive services (both include buprenorphine + counseling) Case management services are provided to enroll patients in necessary services and benefits Patients who are compliant w/treatment and stabilized are transitioned to primary care prescriber