HIV-infected individuals have a substantial burden of comorbid substance use disorders (SUD), and untreated licit and illicit drug dependencies among people living with HIV contribute to worse HIV care outcomes. Approximately 30–70% of people living with HIV are daily smokers, more than 2–3 times the rates of uninfected individuals,1–3 and mortality from cardiovascular diseases is increasing among HIV-infected individuals.4,5 Over half of HIV-infected individuals may have hazardous drinking6,7 and injection drug use remains a significant risk group for HIV transmission.8 SUD are associated with delays in seeking medical care, reduced adherence to HIV treatment, and increased HIV transmission through risky behaviors; and a few substances accelerate HIV progression.9
Clinical guidelines and policy recommendations support integrating SUD treatment into HIV medical care to improve patient outcomes and reduce disease transmission.10–13 Strategies include National Institute on Drug Abuse research grants to link individuals to SUD and HIV treatment,14 Substance Abuse and Mental Health Services Administration and Ryan White HIV/AIDS Program funding for rapid HIV testing in substance abuse facilities and other innovations to integrate SUD treatment for HIV-infected individuals,15,16 and state-specific clinical guidelines on managing comorbid HIV and substance abuse.17 In addition, the Institute of Medicine recently recommended measuring referrals for and receipt of SUD services as a core indicator of HIV care.18
The fragmented health care system is a barrier to providing access to SUD treatment and integrating HIV and SUD care.19 Most HIV-infected individuals do not have private insurance and must navigate a complex multipayer system (predominately Medicaid, Medicare, and Ryan White), in which program eligibility may change depending on shifts in income and disability status.20 Single state agencies that provide SUD services are funded through a conglomeration of Medicaid, Substance Abuse and Mental Health Services Administration block grants, and other local, state, and federal funds.21 Inadequate access is a major obstacle to integrating substance abuse and HIV treatment.14 A recent study found that very few publicly-funded substance abuse treatment clinics provide medication-assisted therapies for SUD, and providers and program administrators are frequently unaware of the these therapies included on their states’ publicly funded formularies.22 Providers in a multistate demonstration project of integrated buprenorphine and HIV care identified payment as a major barrier.13
State-administered AIDS Drug Assistance Programs (ADAPs), funded through Ryan White, could potentially provide access to medication-assisted therapies for SUD for a significant portion of HIV-infected individuals, thereby improving SUD and HIV care integration. ADAP is a critical source of drug coverage for HIV-infected individuals without private insurance or who do not yet meet disability requirements for Medicaid and Medicare,23 and one-quarter of HIV patients are enrolled in ADAP (authors’ calculation based on National Alliance of State and Territorial AIDS Directors23 and Kaiser Family Foundation24). Ryan White’s emphasis on interdisciplinary care gives it the ability to provide integrated primary care and SUD treatment.16 States have considerable flexibility in ADAP design and administration,25 allowing state ADAPs to respond to changing needs. For example, many states have expanded their formularies to include non-HIV medications such as those to treat mental health conditions and modifiable cardiovascular risk factors.4,26
Considering the policy emphasis and clinical importance of SUD treatment in HIV-infected individuals and ADAP’s potential ability to facilitate integrated care, we sought to assess the availability of medication-assisted therapies for SUD through state ADAPs over time. We reviewed state ADAP formularies from 1997 to 2009 to assess the availability of guideline-concordant medication-assisted therapies to manage alcohol, tobacco, and opioid dependence over time. Management of these conditions have been linked to improvement of HIV care,2,27,28 and there are national guidelines for their pharmacologic management.29–39 Although dependence to other drugs such as cocaine and methamphetamine are also important, there are no Food and Drug Administration (FDA)-approved medications to treat these conditions. We examined which medication-assisted therapies were most likely to be included on state ADAP formularies throughout the program’s history and documented variation in the coverage of these medications across states.
We collected ADAP formulary data for 50 states and the District of Columbia from 1997 to 2009 from the ADAP annual reports published by the National Alliance of State and Territorial AIDS Directors.40 Formulary data after 2010 were not compiled in annual reports and were not included due to inconsistent reporting. We systematically reviewed state drug formularies for the presence of medication-assisted therapies to treat alcohol, tobacco, and opioid dependence. National clinical guidelines during the study period were used to enumerate a list of relevant medications for each category of substance use. Table 1 displays the complete list of these medications considered in the analysis, changes over time, and the guidelines used to create the decision rules.
We created 2 summary variables for each SUD. First, we created a “complete formulary” variable for whether a state included all guideline-concordant medications in that year. In addition, we created a “partial formulary” variable that indicates whether a state included at least 1 recommended medication in that year. Recognizing that medications are added to and removed from the guidelines over time, decision rules were year specific. For example, varenicline for tobacco dependence was only considered from 2007 to 2009 because it was first available in 2006, and levo-alpha acetyl methadol was not counted as a recommended medication after 2003. We report the specific medications included by year for each state and descriptive statistics for the availability of medications in each year (“current adoption”) and the cumulative adoption over time (“ever adoption”).
Adoption of Classes of Substance Abuse Medications
Table 2 enumerates each state’s adoption of medication-assisted therapies to treat alcohol, tobacco, and opioid dependence and the years of adoption. Table 3 lists the states that had adopted the 3 classes of medication-assisted therapies for SUD on their formularies and their dates of initial adoption. As seen in Tables 2 and 3, these states did not consistently retain these drugs on their formularies after their initial adoption. Figure 1 displays graphically the fraction of states that currently and ever had these medications on their formularies from 1997 to 2009.
By 2009, 17.6% of states ever had a complete formulary for at least 1 of the 3 conditions and 7.8% ever had a complete formulary for all 3 conditions simultaneously. The most commonly included medication-assisted therapies were for the treatment of tobacco dependence (15.7% ever had a complete formulary), followed by opioid dependence (11.8%) and alcohol dependence (9.8%). Over half of states (60.8%) ever had a partial formulary for at least 1 of the 3 conditions, and 9.8% ever had a partial formulary for all 3 conditions simultaneously. Most states (58.8%) ever had a partial formulary for tobacco, followed by 35.3% for opioids and 9.8% for alcohol.
A handful of states were classified as offering all guideline-concordant medications because they had open formularies (rather than listing each medication explicitly). Two states had an open formulary in 2001, 3 states had an open formulary from 2002 to 2006 and 2008 to 2009, and 4 states had an open formulary in 2007.
Adoption of Specific Medications
Virtually no states (other than those with open formularies) included medication-assisted therapies for alcohol dependence on their formularies. The one exception was Indiana, which included disulfiram (2001) and naltrexone (1999 and 2001). Acamprosate was not included by any state other than states that were presumed to offer it via their open formulary. The only states meeting the complete formulary criteria were those with an open formulary. Among the tobacco medications, buproprion was the most commonly included medication (51.0% of states adopted by 2009), followed by varenicline (21.6% adoption by 2009). Only 9.8% of states ever adopted nicotine replacement therapy. Among opioid medications, methadone was the most commonly included medication (25.5% of states adopted by 2009), followed by buprenorphine and levo-alpha acetyl methadol (7.8% and 5.1%, respectively). One state (Oregon) adopted buprenorphine before it was FDA approved in 2002.
We examined state ADAP formularies to document the extent to which states covered medications to treat alcohol, tobacco, and opioid dependence over time. We found that the most frequently included medication-assisted therapies were those to treat tobacco dependence, followed by medications to treat opioid dependence. Few state ADAPs covered medications to treat alcohol dependence. No states covered acamprosate, and only 1 state included disulfiram and naltrexone. Only states with open formularies offered the complete list of recommended medications. In any given year, less than one-tenth of states covered the complete set of recommended medications for at least 1 condition and less than half of states covered a partial formulary for at least 1 condition.
Overall the small fraction of states including these medication-assisted therapies is consistent with recent research demonstrating that less than two-fifths of publicly funded substance abuse treatment programs self-reported having prescribed any medication-assisted therapies in the past year. Some of this variation in prescribing patterns may be attributable to differences in program administrators’ perceptions about the state policy environment, including their single state agencies’ perceived support for medications and awareness of their states’ funding policies for medication-assisted therapies.22
Having tobacco medications as the most commonly included medication-assisted therapy for SUD is consistent with data that tobacco use is the most prevalent SUD among HIV-infected individuals.1–3 This may also be a result of a federal policy that allows states to restrict smoking cessation medications from their Medicaid formularies.41 As a payer of last resort, state ADAPs may therefore prioritize placing tobacco cessation medications on their formularies to wrap around gaps in their states’ Medicaid coverage. However, this finding may also be due to bupropion being included to treat depression and not nicotine dependence.
It was notable that there was virtually no coverage of medication-assisted therapies for alcohol dependence, despite evidence of the importance of addressing alcohol dependence among HIV-infected individuals.6,7,27 It was also surprising that coverage of medications to treat opioid dependence was so low, given that opioid dependence is commonly discussed as a major risk factor for HIV infection and that it has such a strong documented relationship with HIV medication adherence and treatment outcomes.42 In particular, it is striking that although methadone is the most prevalent ADAP medication for opioid dependence, it is also the only medication-assisted therapy that cannot be provided in HIV primary care settings outside methadone clinics.34 Two medications (buprenorphine and varenicline) received FDA approval during the study period. After their approval, there was a modest uptick in the inclusion of varenicline (21.6% of states had ever adopted by 2009) but few states adopted buprenorphine (7.8% ever adopted). (These figures do not count the 4 states that included these medications as part of their open formularies.)
One possible explanation for the limited availability of medication-assisted therapies for SUD is that although clinical guidelines exist for the treatment of SUD, knowledge regarding the safety and efficacy of all these medications for HIV-infected individuals are not known. Only recently, a study determined the safety of naltrexone and continued efficacy of antiretroviral therapy in HIV-infected individuals,43 and HIV treating physicians are less likely to prescribe antiretroviral therapy if a patient has an active or recent SUD, irrespective of CD4 count or other indications for treatment.44 Other potential reasons for these findings are HIV providers’ inadequate training on addiction medicine and conceptual differences between HIV and SUD treatment,13 which may reduce the extent to which HIV providers advocate for the inclusion of medication-assisted therapies on their states’ ADAP formularies. The strong stigma attached to SUD affect diagnosis, treatment, public education, and funding.45 It is also likely contribute to incomplete data and training on integration of HIV and SUD clinical care and limited advocacy to include medication-assisted therapies on ADAP formularies.
Given the strong interrelationship between SUD and HIV, integrating SUD treatment into HIV care will be necessary to meet the National HIV/AIDS Strategy’s goals to increase access to care, improve health outcomes, and reduce new infections.46 President Obama’s proposed 2013 budget includes additional funding for Ryan White, including an increase of $67 million above 2012 levels for ADAP. This reinforces the Administration’s stated political commitment to addressing the HIV epidemic and supporting ADAP.47 By including medication-assisted therapies for SUD on their formularies, state ADAPs can play an important role in expanding access to SUD treatment among HIV-infected individuals. This is especially important for vulnerable populations such as HIV-infected individuals who are transitioning from criminal justice settings to communities because HIV treatment outcomes are commonly disrupted during the postrelease period due to relapse to drug and alcohol use.48,49 New data suggest that SUD treatment at the time of release leads to sustained HIV treatment outcomes.50 Because most prisoners lose their Medicaid coverage during incarceration, ADAP is a critical source of medications on release.
Moving forward, there are several upcoming policy changes that may facilitate the integration of substance abuse treatment into HIV care. As part of the Affordable Care Act, in 2014, there will be a major Medicaid expansion and also the availability of state-administered health insurance exchanges with sliding scale subsidies.51 SUD treatment must be included in health insurance plans offered on the exchange and also in Medicaid.52 These changes should improve access to these medications. In 2009, the longstanding ban on using federal funding for syringe exchange programs was temporarily lifted. The ban has been reinstated, and the effect of the ban’s temporary repeal was primarily symbolic because no new funds were committed.53 However, this policy change could signal changing attitudes among federal policymakers about the importance of addressing SUD as an important component of HIV care and prevention.
On the other hand, there are several policy challenges to increasing HIV patients’ access to medication-assisted therapies through state ADAPs. Ongoing state budget shortfalls that have resulted in formulary restrictions, waiting lists, and other cost containment strategies40 may limit further expansion of ADAP formularies and the availability of state funding for treatment facilities. ADAP has an uncertain future, as the program’s reauthorization is scheduled for 2013, 1 year before the major provisions of the Affordable Care Act are implemented.51 The recent elections will have consequences for the implementation of the Affordable Care Act.54 Although the Medicaid expansion should improve access to care among low-income individuals, this effect may not be uniform across states. Medicaid programs are required to offer all FDA-approved medications, although tobacco cessation and benzodiazepines are major exceptions. In addition, some states limit medications through mechanisms such as caps on the number of prescriptions per month, not reimbursing for brand name or over-the-counter medications, requiring prior authorization for certain medications, and imposing cost-sharing requirements.55 In addition, the Supreme Court’s recent ruling that the Medicaid expansion cannot be mandated by the Federal government may result in some states not electing to expand coverage.56 Because Ryan White is a payer of last resort, ADAPs in states with less generous Medicaid programs need to cover a larger portion of low-income HIV patients. Cost constraints may make it nearly impossible to add non-HIV medications to their formularies.
This analysis has some limitations that suggest future areas of research. First, because there were few states that adopted these medication-assisted therapies for SUD over time, there was not enough variation in the outcome to perform more extensive regression analysis to untangle why some states were more likely to adopt than others. Future qualitative research could be used to understand the factors that led to these decisions. For example, Oregon adopted buprenorphine starting in 1998, 4 years before FDA approval. Second, in addition to qualitative research to understand why states made these formulary decisions, it would be useful to understand the mix of payers for SUD treatment among HIV patients, and how this varies across states. States could use this information to identify strategies to improve resource allocation and coordination among payers. Third, the nature of the data (drug formulary lists) makes it impossible to measure intent. For example, it is unclear whether bupropion was included to treat depression or tobacco cessation, or whether methadone was included for pain management or opioid dependence. It is also difficult to synthesize the extent to which the medications were used in practice. These published formularies may not be the most accurate representation of medications available to patients because the formularies may be updated throughout the year.
In summary, although state ADAPs have the potential to provide access to medication-assisted therapies for SUD to a significant number of HIV patients, these medications have not been widely covered throughout the program’s history. In particular, alcohol medications are largely excluded, and few states routinely offer medications to treat opioid dependence. Where an HIV patient lives affects his or her coverage for SUD treatment, which has important implications for medical outcomes and also HIV prevention. Increased availability of medication-assisted therapies through state ADAPs could facilitate integrated HIV and SUD care. Recognizing that state APAPs are facing extreme budgetary constraints, adding additional medications to their formularies may be difficult, particularly in states that do not choose to expand their Medicaid programs as part of the Affordable Care Act.
The authors are grateful to Taryn Couture for research assistance.
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