Wide variation by state exists in ADAP prescription drug coverage for the management of type 2 diabetes, hypertension, hyperlipidemia, and tobacco use. In our systematic survey of ADAP formularies, we identified only four states that provided prescription drug coverage consistent with clinical practice guidelines (coverage for all first-line drugs) for all four modifiable cardiovascular risk factors. Thirteen states provided no coverage for the four surveyed conditions. ADAPs most often provided coverage consistent with guidelines for type 2 diabetes and least often for smoking cessation. ADAPs more often provided absolutely no first-line drug coverage for type 2 diabetes and hypertension compared with the other two conditions. Prescription drug coverage was partially consistent with clinical guidelines most commonly for hyperlipidemia and smoking cessation. Of all medication classes, statins were most often covered and nicotine replacement therapies least often. The reasons for variation in coverage for these four conditions are most likely multifactorial, including ADAP’s historical context, funding mechanism, diverse approaches to implementation, and complexities of formulary design.
The historical context out of which ADAPs developed may contribute to state differences in prescription drug coverage for cardiovascular risk factors. ADAPs began as “AZT Assistance Programs” in 1987 with the sole purpose of providing HIV drug coverage at a time when HIV was associated with a rapid clinical course and high mortality.23
Since the 2006 reauthorization of the Ryan White Program, ADAPs have been mandated to provide, at minimum, one medication in each HIV-medication class but are not required to provide any additional medications.23
A prior survey of ADAP formularies indicated that less than half of ADAPs provide hepatitis C treatment and that coverage for opportunistic infections varies.13
Although, historically, states with the highest number of AIDS cases have received a greater proportion of federal funding, the number of HIV/AIDS cases does not appear to explain the variability in ADAP prescription drug coverage. Among the ten state ADAPs with highest cumulative number of HIV/AIDS cases, three provided coverage consistent with guidelines for all four conditions, while four provided absolutely no coverage.24,25
Disparities in prescription drug coverage may stem from financial constraints facing ADAPs. While ADAP client enrollment has continued to increase, federal funding has reached a plateau, and state funding has declined substantially due, in large part, to the economic recession.13
Consequently, some ADAPs have taken cost-containment measures, such as implementing waiting lists or restricting prescription drug formularies.13,15
Despite non-HIV medications accounting for less than 10% of the prescription drug budget, several states have removed non-HIV prescription drugs from their formularies.13,15
Expanded HIV testing and changes in eligibility for HIV treatment will contribute to ADAPs rising caseload and expenditures.26–28
Differences in ADAP formularies may also be explained by the diverse approaches used by ADAPs to provide prescription drug coverage. ADAPs are considered “a payer of last resort” and are intended to provide a “safety net” for individuals who are uninsured or underinsured.13,23,29
Clients may have prescription drug coverage through programs such as Medicaid or Medicare Part D, which may complement state ADAP formularies.13
However, state ADAPs with restrictive criteria for eligibility and limited prescription drug coverage tend to exist in states with Medicaid programs with equally stringent enrollment criteria and minimal drug coverage.30
ADAPs may also purchase health insurance for clients which provides access to a particular insurance plan’s formulary and may offer short term prescription drug coverage for clients until ADAP enrollment.13,15
In these cases, ADAP formularies would not be expected to be particularly comprehensive. For medications not offered on ADAP formularies, clients may rely on pharmaceutical assistance programs which are limited in scope and have complex and time-consuming application processes.31
Lastly, state ADAPs may structure their formularies to offer a wide array of medications. For example, the four ADAPs (MA, NJ, NY, PA) that provide coverage consistent with clinical guidelines have created comprehensive formularies (Appendix
Variations may reflect a delay in adapting to clinical guidelines or even a lack of awareness about guidelines by each state’s ADAP advisory committee, which determines the composition of the formulary. For instance, thiazolidinediones, a relatively more expensive, second-tier class of type 2 diabetes treatment, were covered more frequently by ADAPs than insulin.18,32
The coverage of thiazolidinediones may reflect their use for the treatment of antiretroviral-associated lipoatrophy, though clinical trial results have been inconsistent.33,34
More concerning is that rosiglitazone, a thiazolidinedione associated with increased cardiovascular risk, was available on eleven formularies.35–37
Similarly, ezetimibe, a costly lipid-lowering medication without proven clinical benefit and with possible increased cardiovascular risk, was also covered on several ADAP formularies.38,39
In spite of high smoking rates among HIV-infected persons, only four states provided coverage consistent with clinical guidelines for smoking cessation.7
Though ADAPs frequently covered bupropion, it was usually included for depression treatment not smoking cessation.
In light of the economic constraints facing state ADAPs and the increasing numbers of persons requiring treatment for HIV/AIDS and chronic conditions, ADAPs may decrease expenditures with coverage of effective prescription drugs and additional price reductions of prescription drugs. Currently, among HIV-infected persons, the effect of drug coverage for cardiovascular risk factors on clinical outcomes and costs is unknown. However, covering effective treatment for the surveyed risk factors may be more cost-effective over time given the increasing longevity of HIV-infected persons. Additionally, most of the recommended medications are available as generics. ADAPs negotiate with pharmaceutical manufacturers and utilize the 340B pharmacy program for access to discounted prescription drugs.25
Further reductions in cost may be possible if drug discounts available to federal entities, such as the Department of Defense, were also available to all ADAPs.25,29
The most significant impact on ADAPs may occur with implementation of the Affordable Care Act (ACA). The expansion of Medicaid eligibility and provision of subsidies to low-income persons to purchase insurance will likely decrease the number of individuals requiring ADAPs, therefore lessening the burden on these programs. With cost-sharing between ADAPs and Medicare Part D during the Medicare coverage gap (or “doughnut hole”), ADAPs and individuals who depend on both programs will have decreased financial burden. Past and current economic hardships have shed light on our fragmented public health insurance system and its effect on persons who rely on ADAPs. The ACA may help to rectify this patchwork system in order to provide more comprehensive and stable health care coverage.
Our study has several limitations. First, we used clinical guidelines as standard of care to determine adequacy of ADAP drug coverage. Yet, there remains uncertainty regarding the impact of clinical guidelines on health outcomes and the efficacy of certain drugs in the prevention of cardiovascular disease.17
Second, the actual clinical impact of limited ADAP drug coverage for cardiovascular risk factors is unknown. Nonetheless, studies suggest that variation in the availability of needed prescription drugs can alter health outcomes, including life expectancy among HIV-infected persons.40
Third, as previously noted, some ADAP clients may have assistance from other programs which may provide prescription drug coverage for these co-morbidities. Lastly, although we verified the most updated formulary with each state ADAP, given the dynamic nature of ADAP formularies, it is possible that we did not have the most recent information for some states.
Our findings indicate that most ADAPs do not provide guideline-consistent prescription drug coverage for type 2 diabetes, hypertension, hyperlipidemia, or smoking cessation. Given that state ADAPs are under extreme financial constraints, we highlight this variation in coverage by state to bring attention to the challenges facing HIV-infected persons who have little or no access to certain prescription drugs. Policymakers should address the root causes of this variation, and, at minimum, in an effort to maximize value, provide a comprehensive ADAP formulary informed by clinical guidelines. Further research is needed to evaluate the factors associated with variation in prescription drug coverage, the potential effects of this variation, and the impact of reducing variation on health outcomes.