Aging and Living with HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Since the beginning of the HIV/AIDS epidemic forty-two years ago, medical advancements in HIV prevention and treatment have come a long way. As a result, there is a growing population of older people living with HIV (OPWH). In 2020, about half of all people in the United States living with HIV were age 50 or older. It is estimated that by 2030, that percentage will be over seventy percent.[1] Aging for the general population is challenging. However, emerging evidence indicates specific challenges unique to aging people living with HIV. OPWH are dealing with health care system issues, specific medical challenges, social determinants of health hurdles, and even social stigma.

Photo Source: IDSE.net

Isolation and loneliness are pervasive challenges OPWH reportedly face.[2,3] Many have survived the early years of the HIV/AIDS pandemic. As such, they have seen many of their friends and relatives die from the disease. Living in isolation, among many things, means not having anyone to call on in case of emergency, having no one to care for them when they become ill, and not having any outlet for social interaction. Jim Clay, program lead with Cascade AIDS Project in Portland, Oregon, created several social groups for OPWH under the umbrella of a program called Aging Well.[4] The groups enable OPWH with shared living experiences, such as those who are LGBTQ, to find a sense of community and support. Social integration and support lower the actual and perceived stigma that many OPWH experience.[3] Quality of life challenges regarding psychological well-being directly affect medical outcomes.

Regarding medical outcomes, OPWH are challenged with unique problems. HealthHIV highlighted some of these in their third annual State of Living with HIV National Survey.[1] To be considered for the survey, subjects had to be aged 50 or older or have been living with HIV for at least 15 years. Of those who qualified to be included, 93% were aged 50 or older, with one-third of those older than age 65. Most of the respondents living with HIV for 15 or more years were over the age of 50.

According to HealthHIV, polypharmacy was a medical issue reported by nearly all the included respondents. OPWH have higher rates of multiple comorbidities than the general population.[6] Polypharmacy means taking five or more medications to treat numerous non-HIV comorbidities and HIV. Multiple medications increase the chances of drug interactions with antiretrovirals or other drugs. The different simultaneous medications also cause wear on organs such as the liver and kidneys. Additionally, twenty-five percent of the respondents reported having current antiretroviral side effects, with the majority having had side effects on previous regimens.[1] Moreover, the survey also highlighted that OPWH are more likely to be diagnosed at later stages than younger people with HIV. Half of the respondents were. This is troubling because data shows OPWH have poorer CD4 cell recovery after initiating antiretroviral therapy.[5]

Photo Source: HealthHIV

Evolving research is revealing specific medical challenges for women aging with HIV. Data shows that HIV can cause women to go into early menopause up to 5 years earlier than HIV-negative women.[7] This is due to HIV infection causing chronic infection, immunodeficiency, lower estrogen levels, and metabolic changes due to long-term medication use.[7] Early menopause increases the risk of osteoporosis. This is compounded by the fact that HIV is a known risk factor for osteoporosis.[7] Women with HIV are also three times as likely to have absent periods going into menopause.[7] Instead of gradually easing into menstrual changes, their periods stop abruptly. Women universally deal with the psychological and social stigma of aging. Older women living with HIV have their lived experiences negatively compounded by these medical challenges.

Predominantly, society associates aging with security and being established in life. Unfortunately, social determinants of health are challenging for many aging adults, especially OPWH. Housing, income, food insecurity, and transportation are just a few challenges reported by respondents of the HealthHIV survey. Affordable housing is a problem for OPWH on fixed incomes and those without much or any savings for retirement. One respondent explained that aging adults with HIV have to live where they can afford to.[1] That is the most basic tenet of survival, which influences everything else. Where one lives affects what kind of transportation they need, what sustenance they can afford, and even access to HIV care. If OPWH, out of necessity, have to live far away from their medical care, their medical outcomes are negatively affected. Not being able to access health services results in untimely doctor visits or complete omission, lack of medication adherence, and inadequate treatment of comorbidities. Sixty-eight percent of the respondents were concerned about the lack of permanent housing, and thirty percent worried about the condition of where they lived.[1]

Prevention of new HIV infections among the young and treatment of those under 50 is essential. However, OPWH are being left behind, and they feel it. It is vital to develop geriatric practices and policies to support OPWH. The aging HIV-positive population needs options for care that are more cooperative and convenient instead of fragmented. Their whole being needs to be addressed on a physical, mental, medical, and social service level. Most importantly, their humanity needs to be acknowledged and supported. OPWH are still sexual beings, and there are still cases of people over 50 newly acquiring HIV. Screening for HIV and other STDs/STIs in older adults must be integrated into all aging population care paradigms. The long-term effect of living with HIV is new territory. OPWH should not be left unsupported to deal with it alone.

[1] HealthHIV. (2023, May). State of Aging with HIV Third Annual National Survey. Retrieved from https://healthhiv.org/stateof/agingwithhiv/

[2] McCarty, A. (2023, July 18). 'Fought like hell to get here': Portland group helps long-term survivors of HIV 'age well' through connection and community. Retrieved from https://www.kgw.com/article/news/local/pride/portland-group-long-term-survivors-hiv/283-a110d2ca-af2c-4463-94dc-474c2db2dab3

[3] Petrullo, J. (2023, July 12). Older people with HIV face stigmas, struggles that require action. Retrieved from https://www.ajmc.com/view/older-people-with-hiv-face-stigmas-struggles-that-require-action

[4] Cascade AIDS Project. (2023). Aging Well: About Us. Retrieved from https://www.agingwellnw.org/about

[5] Means, A. R., Risher, K. A., Ujeneza, E. L., Maposa, I., Nondi, J., & Bellan, S. E. (2016). Impact of Age and Sex on CD4+ Cell Count Trajectories Following Treatment Initiation: An Analysis of the Tanzanian HIV Treatment Database. PLOS ONE, 11(10), e0164148. https://doi.org/10.1371/journal.pone.0164148

[6] Lerner, A. M., Eisinger, R. W., & Fauci, A. S. (2020). Comorbidities in Persons With HIV: The Lingering Challenge. JAMA, 323(1), 19–20. https://doi.org/10.1001/jama.2019.19775

[7] Mulcahy, L. (2023, July 27). Menopause may start earlier for aging women with HIV. Retrieved from https://www.webmd.com/hiv-aids/news/20230627/menopause-may-start-earlier-aging-women-hiv

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

The State of Long-Acting Injectable Medicaid Coverage

By: Marcus J. Hopkins, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)

A review of state Medicaid programs has revealed that coverage of recently approved Long-Acting Injectable (LAI) drugs used for the treatment of HIV is mixed, with several key states making access to these drugs difficult for patients. Currently, such products include Cabenuva (cabotegravir; rilpivirine| ViiV Healthcare), Sunlenca (lenacapavir | Gilead Sciences), and Trogarzo (ibalizumab | Theratechnologies).

Cabenuva received full approval from the U.S. Food and Drug Administration (FDA) in 2021 and is used to treat patients who have already proven to be adherent to daily pill regimens and have achieved undetectable viral suppression, meaning that they have fewer than 50 copies of the HIV virus per milliliter of blood. Cabenuva is a series of two injections (200mg cabotegravir; 200mg rilpivirine) administered to patients by a healthcare provider once every month or every other month.

Sunlenca is a salvage therapy—a treatment option utilized in patients who have multi-drug-resistant strains of HIV or who have experienced drug toxicity—that is administered twice a year and used in combination with other antiretroviral drugs.

Trogarzo is also a salvage therapy — a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. The drug is approved, in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.

The FDA approval of LAIs presents Persons Living with HIV/AIDS (PLWHA) with one of the most exciting opportunities to ever occur in the HIV treatment landscape: the chance to remain undetectable without having to remember to stop every day to take your HIV medications. Cabenuva is specifically designed for patients who have a proven track record of medication adherence, and the prospect of having to treat your HIV only once every month or every other month is both appealing and revolutionary—a sea change in a treatment landscape that has all too often been beset by horrific, painful, disfiguring, and/or sickening side effects and short medication half-lives that placed patients at risk of developing multi-drug-resistant strains of HIV after missing even a single dose.

LAIs still face several barriers they must overcome before they become the first-line standard of care, including (but not limited to) provider and patient awareness and acceptance of the regimens, payor Prior Authorization limits, and the requirement that the drugs be administered by clinicians rather than by patients, themselves. The latter barrier makes prescribing LAIs in rural and remote areas a difficult proposition, as patients in those regions often face their own barriers to accessing care and treatment, including geographic, transportation, and financial barriers.

The new review of state Medicaid programs in the United States found that 38 states provide coverage for Cabenuva, of which 20 states list it as a Preferred Drug, 7 as a Non-Preferred Drug, and 13 have Prior Authorization requirements restricting access to the drug. 13 states Medicaid Programs—AR, CO, DE, GA, IN, IA, KS, KY, MT, NE, SC, TN, WI—offer either no coverage or list the drug as non-formulary (Figure 1).

Figure 1 – State Medicaid Preferred Drug List Coverage of Cabenuva, July 2023

State Medicaid program coverage of Sunlenca is less robust, which is to be expected given that the drug only received FDA approval in January 2023. 30 states currently offer coverage for Sunlenca, of which 23 states list the drug as a Preferred Drug, 7 as a Non-Preferred Drug. 21 states offer either no coverage or list the drug as Non-Formulary (Figure 2).

Figure 2 – State Medicaid Preferred Drug List Coverage of Sunlenca, July 2023

State Medicaid program coverage of Trogarzo is even less robust. 30 states currently offer coverage for Trogarzo, of which 22 states list the drug as a Preferred Drug and 8 as a Non-Preferred Drug. 21 states offer either no coverage or list the drug as Non-Formulary (Figure 3).

Figure 3 – State Medicaid Preferred Drug List Coverage of Trogarzo, July 2023

Several states have restrictions against prescribing Cabenuva as a treatment regimen, including Delaware, which requires failure with two Preferred Agents before Prior Authorization requests will be approved, and Wisconsin, in which both Cabenuva and Sunlenca are considered “Non-Formulary” (Table 1).

This review of Medicaid PDL coverage was initiated after receiving a report from Positive Health Clinic in Morgantown, WV, that West Virginia’s state Medicaid program was denying virtually all prescriptions for Cabenuva. A Patient Care Navigator reported that West Virginia’s Medicaid program has essentially classified the drug as a salvage therapy through its Prior Authorization requirements.

To date, Positive Health Clinic has had all new prescriptions denied by the state’s Medical Director, even after multiple appeals and conversations with state Medicaid officials. Those appeals included copies of the FDA approval and treatment indication, highlighting that the state has misclassified the drug.

The one exception has been an approval as a result of medication continuation. A patient who moved to West Virginia from Pennsylvania and was already prescribed the regimen. In order to get their prescription approved, Positive Health Clinic had to submit multiple forms of proof that the patient was fit to continue therapy, including:

1. An active prescription for the drug
2. Evidence that the patient was 100% compliant with receiving each dose
3. Proof that the patient would continue to remain compliant.

We reviewed West Virginia’s state Medicaid PDL and Cabenuva Prior Authorization form in order to confirm this report and found the following guidance:

Cabenuva requires review by the Medical Director and is available only on appeal. Medical reasoning beyond convenience or enhanced compliance over preferred agents must be provided.

This approval guidance exists in direct opposition to the FDA’s approval and treatment indication guidance:

CABENUVA, a 2-drug co-packaged product of cabotegravir, a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

While Prior Authorization requirements for new (and often expensive) therapeutic drugs are not uncommon, the West Virginia Medicaid program’s blanket preemptive denial of a highly effective and proven HIV therapy appears to be an attempt to staunch what they believe will be an influx of prescriptions for an expensive drug. This approach is likely a response to increased efforts on the part of HIV and Harm Reduction advocates to utilize Cabenuva as the go-to therapy in West Virginia’s hard-to-reach, hard-to-treat patient populations.

Since 2018, West Virginia has endured two concurrent, unrelated (according to molecular surveillance), and unabated HIV outbreaks in Cabell and Kanawha Counties. These outbreaks, for which the state has received very limited funds from federal agencies to combat, have occurred primarily in populations of Persons Who Inject Drugs (PWIDs)—populations that are notoriously difficult to reach, treat, and retain in care.

Prior to 2018, West Virginia saw an annual average of just 67 new HIV diagnoses. Beginning in 2018, the state began seeing significant increases in new diagnoses, more than half of which were directly related to Injection Drug Use. This outbreak of new diagnoses among PWIDs was further exacerbated by the state’s increasing hostility toward comprehensive harm reduction measures, specifically Syringe Services Programs (SSPs). Even in 2020, when COVID-19-related shutdowns led to a 2/3 reduction in the number of HIV tests administered in the state of West Virginia, the state identified 135 new HIV infections, of which 108 (80%) were directly related to IDU.

Since 2020, the state has struggled significantly with increasing provider buy-in for proactive HIV testing, leaving the bulk of HIV testing to be done in hospital emergency rooms during overdose events (using an opt-out delivery method that requires informed denial of testing) and by a mere handful of non-profit agencies and the state’s overworked, but extremely dedicated, Director of HIV Care and Prevention. This Director is one of the very few in the United States who regularly goes into communities to conduct testing events. His efforts are, however, hampered by inadequate levels of state and federal funding and increased scrutiny from a state legislature that continues to grow more hostile to HIV testing and prevention efforts.

According to the most recent report, West Virginia identified 140 new cases of HIV in 2022, of which 98 (70%) were directly attributed to IDU. 2023 is likely to be an equally devastating year, with 25 of the 48 cases identified to date (52.1%) being directly related to IDU.

The thinking behind utilizing LAIs as the first-line treatment option in PWIDs is that it has the potential to increase treatment adherence in a population that often faces numerous barriers to care and treatment, including a potential lack of stable housing, a lack of safe places to store daily HIV regimens, a potential inability to remain consistent with treatment regimens.

Prior Authorization requirements for drugs that treat infectious diseases already create arguably unnecessary barriers to treatment for patients. West Virginia’s blanket refusal to cover an FDA-approved and highly effective HIV treatment regimen for patients who are already adherent and virally suppressed serves as an unacceptable and unconscionable barrier to care in a state that is in desperate need of more convenient treatment options.

While Cabenuva, Sunlenca, and Trogarzo are still relatively new drugs, state Medicaid programs should be jumping at the opportunity to decrease treatment abandonment rates and increase easy treatment options for qualifying patients. We hope that more programs will abandon unnecessary restrictions upon this vital tool in the HIV treatment toolkit.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Modern Antiretroviral Therapy is Less Toxic, but Not Free from Side Effects

By: Ranier Simons, ADAP Blog Guest Contributor

Antiretroviral therapy (ART) has indisputably improved the medical outcomes of people living with HIV/AIDS (PLWHA). ART increases life expectancy, prevents people with an HIV-positive diagnosis from reaching an AIDS diagnosis, brings many patients back from AIDS into healthier CD4 counts, and even renders many undetectable. Today’s current lines of defense are also increasingly less toxic than earlier drugs. 

Photo Source: 4Life4Me+

AZT, the first antiretroviral (ARV) used alone against HIV, was so toxic that it caused a faster health decline than HIV would have in people left untreated. The side effects, including damage to bone marrow, made people feel worse than they did without it. Although ART has evolved significantly, it is not perfect. Current ARVs have fewer serious or unbearable adverse issues; however, many PLWHA still deal with side effects.

Some side effects are short term lasting only a few days or weeks. Conversely, some can be much more long-term. It is important to remember that the side effects of one medication can vary from person to person in type, severity, and number. Additionally, some drugs take months to years to develop side effects. PLWHA are living longer and thus are on ART for more extended periods. Researchers are concerned about the potential cumulative toxicity that can develop from long-term use.[1] 

Diarrhea, depression, other mood changes, and hypertension are three common side effects of ART.[2] Diarrhea is one of the most prevailing side effects and causes some people to stop taking their medications. Commonly, it is a side effect of protease inhibitors like ritonavir which may damage the intestinal lining.[3] Immodium (loperamide) is a common over-the-counter remedy used to help PLWHA deal with diarrhea. There are frequently prescribed solutions such as Mytesi (Crofelemer) as well. Derived from the red sap of the Croton lechleri plant, it is just the second botanical prescription drug approved by the U.S. Food & Drug Administration (FDA).[2] Unfortunately, while effective, some State AIDS Drug Assistance Program (ADAP) drug formularies do not offer it.

Depression in PLWHA can have many causes. For some, it can be the psychological result of dealing with having the disease. It can also be caused by the penetration of HIV across the blood-brain barrier and infection of the central nervous system.[4] However, it can also be a side effect of some ARVs. In fact, many list depression or strange dreams as a side effect.[4] Efavirenz, which is in drugs like Atripla, is known for causing nightmares, vivid dreams, or depression.[5] While being a comorbidity among PLWH, hypertension is also shown to be a side effect of some ARVs. Studies show that the chronic inflammation associated with HIV and ART is a significant factor in the high prevalence of PLWHA with high blood pressure.[2]

Photo Source: Ivan Toms Centre

A side effect of ART not well-known by many is Diabetes. Some older nucleoside reverse transcriptase inhibitors and older protease inhibitors that are no longer used as much, such as zidovudine and lopinavir, respectively, cause pancreatic damage.[2,6] Newer treatments, such as integrase inhibitors like dolutegravir and bictegravir, have been correlated with weight gain.[6] Unhealthy weight gain increases the risk of developing Diabetes as well. Integrase inhibitors have been shown to lead to faster viral suppression than some other ARVs.[6] Thus, eating well and exercising when using them is essential to mitigate any possible weight gain.

Fortunately, with the breadth of current options available, PLWHA are not stuck dealing with lifestyle challenges or unpleasant and possibly severe side effects to maintain viral suppression. Suffering from adverse effects results in poor medication adherence or complete abandonment. PLWHA are encouraged to communicate with their care team when a medication switch may be necessary. Sometimes PLWHA feel as if too many medications are becoming toxic in their body. In this case, their physician may be able to switch them from a three-drug regimen to a one or two-drug regimen.[7] 

Some ARVs have to be taken with food or even specific types of food. When that becomes a problem, there are options for those who have specific dietary restrictions by choice or necessity. HIV-positive pregnant women must beware of birth defects some ARVs can cause. For them, dolutegravir-based regimens are recommended.[7] PLWHA at risk of kidney problems are directed not to use regimens like Stribild and Truvada, which contain tenofovir disopoxil fumarate (TDF), which can cause them harm.[7] Regimens containing tenofovir alafenamide (TAF), such as Biktarvy or Descovy, better serve that population.[7] Even novel options exist for those who do not wish to take pills. The FDA approved Cabenuva, a two-shot injectable regimen containing rilpivirine and cabotegravir, in 2021. The two injections are administered in a doctor’s office every two months.[7]

All drugs cause side effects, even essential established medications like aspirin. Although newer ARVs don’t have the number or severity of side effects as ones from the past, it is misleading to describe newer regimens as “free from side effects.” Knowledge of possible side effects of regimens enables PLWHA and their doctors to make informed decisions about their care. Moreover, awareness empowers patients to distinguish between side effects and adverse outcomes caused by other issues. Being educated is empowering as well as informs realistic expectations.

[1] Chawla, A., Wang, C., Patton, C., Murray, M., Punekar, Y., de Ruiter, A., & Steinhart, C. (2018). A Review of Long-Term Toxicity of Antiretroviral Treatment Regimens and Implications for an Aging Population. Infectious diseases and therapy, 7(2), 183–195. https://doi.org/10.1007/s40121-018-0201-6

[2] Yahoo News. (2023, July 3). 2023 Treatment Guide: Dealing With HIV Med Side Effects? Retrieved from https://news.yahoo.com/2023-treatment-guide-dealing-hiv-134944629.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

[3] MacArthur, R. D., & DuPont, H. L. (2012). Etiology and pharmacologic management of noninfectious diarrhea in HIV-infected individuals in the highly active antiretroviral therapy era. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 55(6), 860–867. https://doi.org/10.1093/cid/cis544

[4] Rapid Response Service. (2009, March). HIV medication and depression. Retrieved from https://www.ohtn.on.ca/rapid-response-hiv-medication-and-depression/

[5] Cairns, G.(2012, October). Efavirenz and the brain: are we nearer to solving a mysterious side-effect?.Retrieved from https://www.aidsmap.com/news/oct-2012/efavirenz-and-brain-are-we-nearer-solving-mysterious-side-effect

[6] Haynes, R. (2021, January).Type 2 diabetes and HIV. Retrieved from https://www.aidsmap.com/about-hiv/type-2-diabetes-and-hiv#:~:text=Some%20anti%2DHIV%20medications%20may,taken%20them%20in%20the%20past

[7] Yahoo News. (2023, June 29). 2023 Treatment Guide: Is it Time to Change Your HIV Regimen? Retrieved from https://www.yahoo.com/entertainment/2023-treatment-guide-time-change-203031820.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Viral Suppression Linked to Access to Timely, Appropriate Care and Treatment

By: Ranier Simons, ADAP Blog Guest Contributor

One of the most critical factors influencing positive health outcomes of people living with HIV/AIDS (PLWHA) is viral suppression. Viral suppression means that the HIV viral load in the blood is so low that it cannot be detected or measured by laboratory tests. Viral suppression is officially defined as having less than 200 copies of HIV per milliliter of blood.[1] Antiretroviral drug therapy (ART) is the current scientifically established most effective way to achieve undetectable viral load status. Studies have routinely shown that viral suppression is a directly associated with PLWHA having access to timely, appropriate care and treatment.

Photo Source: Ideal Healthcare

ART is as vital for prevention as it is for treatment. Maintaining an undetectable viral load means the virus cannot be transmitted to an HIV-negative person through sexual contact.[2] Maintaining undetectable status requires consistent adherence to ART regimens. Unfortunately, many PLWHA face barriers which make medication adherence a challenge. Two significant barriers are affordability and access to ART regimens. 

AIDS Drug Assistance Programs (ADAPs) were created in 1987, and then incorporated under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act in 1990 to provide HIV-related prescription drugs to low-income PLWHA who have limited or no prescription drug coverage.[3] The state-administered programs pay for insurance and medical care for 20% of PLWHA in the United States.[4] The Ryan White law states that the purpose of ADAPs is to "provide therapeutics to treat HIV disease or prevent the serious deterioration of health arising from HIV disease in eligible individuals, including measures for the prevention and treatment of opportunistic infections."[5] ADAPs achieve this goal for low-income PLWHA by providing antiretroviral medications and paying for health insurance that covers HIV-related treatments.

To participate in ADAPs, recipients are required to regularly recertify their eligibility for the programs. People are eligible when they meet the criteria of having a documented diagnosis of HIV, fall within the program parameters that define low-income, and meet a particular ADAP’s residency criteria within its service area.[6] Data has shown that many PLWHA struggle to complete the recertification requirements and thus become dis-enrolled. For an in-depth description of the burdensome recertification process, please see a previous ADAP Advocacy blog discussion on the topic here. In an effort to examine the effects of dis-enrollment on viral suppression, a group of researchers performed a study of ADAP clients in Washington state who failed to re-certify and were dis-enrolled.

Photo Source: Washington State

A retrospective cohort study published in May 2023 was performed on 5238 clients in Washington State's ADAP from 2017 to 2019.[4] The researchers used various quantitative and statistical analyses to determine the risk difference of viral suppression before and after dis-enrollment. Several factors, or what are statistically known as unmeasured confounders, overlap in regard to causing dis-enrollment and medication discontinuation. Those confounders include housing instability, poor mental health, binge drinking, and illicit drug use.[4] Stringent statistical efforts were used to isolate the influence of dis-enrollment from those confounders.

A total of 1336 study subjects were dis-enrolled at least once or more than once within the time parameters examined. Results showed that overall, 12 out of every 100 PLWHA lost viral suppression due to dis-enrollment. Disenrollment had an exceedingly harmful effect on those with dual Medicaid/Medicare insurance (22/100) compared to those with private insurance (8/100).[4] Having dual Medicaid/Medicare coverage means that a person has a disability.

During the 2017-2019 window of the cohort study, ADAP clients were required to recertify every six months. Researchers found that those who failed to recertify lost viral suppression almost immediately afterward.[4] Around 83% were virally suppressed before dis-enrollment versus 69% after. This indicates that changes need to be made in the re-certification process to make it less complicated for enrollees to complete and reduce the administrative burden on providers.

In October 2021, Health Resources & Services Administration (HRSA) removed the six-month re-certification requirement. Given that the six-month requirement has deleterious effects on enrollment, it is recommended that ADAPs end the practice of using the six-month default and adopt the newer flexibility in the re-certification policy. The study also noted that Washington state ADAP offers a more extensive breadth of services than most other states. Thus, some Washington state clients who are ADAP enrollees use it for other services and obtain their medications by other means. Therefore, dis-enrollment could have a much more significant impact on viral suppression in other states where every person enrolled in ADAP is dependent on it for their ART.

[1] Centers for Disease Control. (2022, July 21). HIV Treatment as Prevention. Retrieved from https://www.cdc.gov/hiv/risk/art/index.html

[2] World Health Organization. (2018, July 20).Viral suppression for HIV treatment success and prevention of sexual transmission of HIV. Retrieved from  https://www.who.int/news/item/20-07-2018-viral-suppression-for-hiv-treatment-success-and-prevention-of-sexual-transmission-of-hiv

[3] Kaiser Family Foundation. (2017, August 16). AIDS Drug Assistance Programs (ADAPs). Retrieved from https://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.

[4] Erly SJ, Khosropour CM, Hajat A, Sharma M, Reuer JR, Dombrowski JC (2023) AIDS Drug Assistance Program disenrollment is associated with loss of viral suppression beyond differences in homelessness, mental health, and substance use disorders: An evaluation in Washington state 2017–2019. PLoS ONE 18(5): e0285326. https://doi.org/10.1371/journal.pone.0285326

[5] Penner, M. (2008, October 1). AIDS Drug Assistance Programs: A Lifeline for People With HIV. Retrieved fromhttps://www.thebodypro.com/article/aids-drug-assistance-programs-lifeline-people-hiv#1

[5] Resources Health and Administration Service. (2021, August). Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program. Report No.: PCN 21–02. Retrieved from https://hab.hrsa.gov/sites

[6] Feller, S. (2023, May 13). Monoclonal antibody speeds time to HIV viral suppression, study finds. Retrieved from https://www.healio.com/news/infectious-disease/20230512/monoclonal-antibody-speeds-time-to-hiv-viral-suppression-study-finds?utm_medium=social&utm_source=twitter&utm_campaign=sociallinks

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Walmart’s Expanded HIV Services Promise Increased Access

By: Marcus J. Hopkins, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)

Editor's Note: The Blogger platform classifies any use of the word "p(h)armacy" as being a sales promotion. As a result of this erroneous classification, the word and its derivations will be typed using that format in order to avoid being flagged as a sales promotion.

In December 2022, Walmart announced that it would be expanding its Special P(h)armacies of the Community (SPOCs) to support communities with high rates of HIV to include stores in North Brunswick and North Bergen, NJ, Monticello, NY, and Hartford, CT. Those locations joined the initial three locations opened as part of their pilot program.

Since then, Walmart has opened an additional 70 locations, totaling 77 SPOCs located in Colorado, Connecticut, Florida, Georgia, New Jersey, New York, North Carolina, Texas, and Virginia. By the end of 2023, Walmart has promised more than 80 locations across eleven states.

According to their initial press release, Walmart claims that these SPOCs:

will help with all aspects of care, including industry-leading clinical programs, p(h)armacy services provided by HIV-trained p(h)armacists, enhanced care coordination, healthy lifestyle recommendations, and finding emotional support services from our Community Health Workers.

Walmart's SPOCs are located inside of individual p(h)armacies within the stores, ostensibly making the locations convenient to patients and those seeking HIV preventative care.

There are, it should be said, significant benefits to Walmart beyond just the good press.  Walmart has enormous opportunities to earn profits by accessing the 340B Drug Pricing Program’s inclusion of HIV medications. According to a 2019 report by Drug Channels, an estimated 25,000 p(h)armacies acted as contract p(h)armacies for hospitals and other covered entities that participate in the 340B program, and six large retail chains—Walgreens, CVS, Walmart, Rite Aid, Kroger, and Albertsons—account for two-thirds of 340B contract p(h)armacy locations.

In recent years, 340B program profits have soared with little to no oversight or enforcement, and we would be remiss if we didn't mention that Walmart stands to earn significant profits from serving as the contract p(h)armacy for People Living with HIV/AIDS (PLWHA), particularly in the markets they've chosen.

Which brings me to the next point:

As Walmart pointed out in its December 2022 statement, roughly 90% of the U.S. population lives within 10 miles of a Walmart location. They also state that these SPOCs provide “…an opportunity to reach people who might not otherwise have access to or seek out HIV care.”

And yet…the locations of these SPOCs are in areas of the country that already receive the bulk of federal funding for HIV testing, services, and treatment. Almost every location is in an urban or suburban population center—areas that often already have p(h)armacies specializing in HIV treatment and care.

It is obvious that these locations were chosen in accordance with the Ending the HIV Epidemic's (EHE) Phase 1 jurisdictions, which resulted in federal HIV funds being directed to the counties and cities where HIV incidence is highest. This methodology is all well and good, but it misses the larger scope of the HIV epidemic and fails to fill the gaps left by this federal funding "plan".

It is curious, then, that Walmart argues that these locations will "…reach people who might not otherwise have access to or seek out HIV care," when those areas are already glutted with services compared to other areas of the country. Looking at Orlando alone, there are 25 providers of care, and four dedicated p(h)macies dedicated to providing services to PLWHA.

If the purpose is to expand access, Walmart would be better suited to open SPOCs in farther-flung areas of those states, where patients are already required to travel more than 30 minutes to access HIV services. Opening a SPOC in Florida’s rural counties, such as Okeechobee, Hardee, DeSoto, Highlands, or Glades, would provide patients living outside of urban areas better access to care and services.

Beyond just the nine current and two potential states where Walmart's SPOCs have or will be opened, there are significant gaps in care and p(h)armacy services in states like Alabama, Kentucky, Mississippi, Tennessee, central and western Virginia, and West Virginia—areas that are largely rural, but have either significant existing populations of PLWHA or face increased risks of HIV transmission either through sexual contact or through Injection Drug Use.

To be clear, I am not being critical of Walmart for expanding services to be inclusive of PLWHA and those seeking preventative services. I am absolutely in favor of a "Yes, And" approach to HIV services provision. The addition of more providers has the potential to provide patients with more choices of where to receive care, and additional opportunities and points of care may allow patients to access services in places that are convenient to them. Additionally, increasing the number of providers has the potential to break HIV care outside of the longstanding monopolistic service provision models that exist both locally and nationally, where patients have been essentially forced to access care, treatment, and supportive services from providers because there hasn’t been anywhere else to go, even if those providers have treated them poorly, engaged in unethical practices, or provided services that aren't culturally competent or sufficient to meet the needs of their patient populations.

That said, Walmart, CVS, and Walgreens haven't really managed to make their locations places where patients—particularly those attempting to access sexual or reproductive healthcare services—feel safe accessing those services or openly discussing concerns with staff p(h)armacists. There’s a distinct lack of personal connection in highly corporate locations, and when you're dealing with fraught issues such as those presented with HIV care and treatment (or other chronic conditions), the last place you want to be if you're having a tough time dealing with issues is in the middle of a large shopping center surrounded by random people trying to find the potato chip aisle.

Overall, however, the expansion of Walmart's SPOC locations seems like a good thing, even if the locations they've chosen don’t really provide services that are novel to those areas. Time will tell whether or not they have any real impact.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Monoclonal Antibodies Reveal Promise for Viral Suppression Failure

By: Ranier Simons, ADAP Blog Guest Contributor

There are multiple treatment goals of HIV antiretroviral therapy (ART): “maximally and durably suppress plasma HIV RNA, restore and preserve immunologic function, reduce HIV-associated morbidity and prolong the duration and quality of survival, and prevent HIV transmission.”[1] Suppressing the HIV viral load to an undetectable status means reducing the levels of HIV in the blood so low that it cannot be detectable by blood assay tests. Usually, after starting ART, patients achieve viral suppression after 12-24 weeks of therapy.[1]

However, viral suppression is sometimes not maintained or achieved at all. Virological suppression failure happens in patients who initially contract drug-resistant strains of HIV, patients who have inadequate adherence to treatment regimens, those who acquire resistance over time after long-term treatment, and by nature of the pharmacokinetics and pharmacodynamics of the drugs in some patients’ bodies based on their genetics.[2] ART consists of drug cocktails of antiretroviral medications. Advancements in HIV research have resulted in many different ART medicines for patients. Thus, patients have other options to switch to when one regimen is unsuccessful. 

Unfortunately, there are patients who have exhausted many available avenues of therapy without achieving viral suppression. Ongoing research is looking into means by which to augment the current library of drug options as well as create new drugs. A recent study presented in May at the 2023 American Conference for the Treatment of HIV™ (ACTHIV™) is a promising development. ACTHIV™ is a conference dedicated to those on the frontline of treating HIV patients. The conference presents research and developments that can be directly integrated into the clinical setting.[3] 

Photo Source: New England AETC

The study involved the use of monoclonal antibodies as part of ART. Monoclonal antibodies are proteins synthesized in a lab that act like the antibodies we already produce. The monoclonal antibodies stimulate your immune system by binding to foreign invaders, such as viruses, to help your body attack them.[4] The subject of the study was a monoclonal antibody called ibalizumab, marketed by Theratechnologies as Trogarzo. Trogarzo is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor.[5] The FDA initially approved it in 2018 for treating adults with multi-drug resistant HIV with unsuccessful ART regimens.

This study was novel because it was the first one directly comparing ibalizumab with non-ibalizumab regimens. The clinical trials cohort data was compared to real-world population data of appropriately matched patients on non-ibalizumab-containing regimens. The non-ibalizumab control group was taken from a database called OPERA, an extensive electronic health record database with deidentified patient-level data encompassing around 14% of the total United States' HIV population collected at the point of care.[6] Results from 76 ibalizumab-treated patients from clinical trials were compared to 65 comparable non-ibalizumab-regimen patients from OPERA. 

Photo Source: POZ

Using ibalizumab sped up the time period to viral suppression compared to the control group. The data showed a doubling in the likelihood of viral suppression compared to the non-ibalizumab group.[6] Additionally, viral suppression was more robust. About 95% of the ibalizumab group stayed undetectable through the completion of the study, compared to 27% of those who achieved undetectable status without ibalizumab. The odds of losing viral suppression were 16 to 18 times higher in those in the non-ibalizumab group.[6] The most remarkable aspect of the results is that those in the ibalizumab group had more severe disease progression at the start of the study than those in the control group.[5] Yet they still had better outcomes.

The study solidified the clinical efficacy of using ibalizumab. This is promising because it legitimizes a pathway to develop similar ART tools in the future. It also proves the effectiveness of using databases like OPERA to comparatively study present and future innovations.

[1] NIH Office of AIDS Research. (2016, January 28). Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Retrieved from https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/treatment-goals

[2] Bessong, P.O., Matume, N.D. & Tebit, D.M. Potential challenges to sustained viral load suppression in the HIV treatment programme in South Africa: a narrative overview. AIDS Res Ther 18, 1 (2021). https://doi.org/10.1186/s12981-020-00324-w

[3] American Conference for the Treatment of HIV. (2023). https://acthiv.org/

[4] Cleveland Clinic. (2023). Monoclonal Antibodies. Retrieved from https://my.clevelandclinic.org/health/treatments/22246-monoclonal-antibodies

[5] Theratechnologies. (2023, May 4). Theratechnologies’ Trogarzo® (Ibalizumab-uiyk) Shortens Time to HIV Undetectability and Extends Durability of Undetectability and Viral Suppression in a Matched Treatment Comparison. Retrieved from https://www.theratech.com/news-releases/news-release-details/theratechnologies-trogarzor-ibalizumab-uiyk-shortens-time-hiv

[6] Feller, S. (2023, May 13). Monoclonal antibody speeds time to HIV viral suppression, study finds. Retrieved from https://www.healio.com/news/infectious-disease/20230512/monoclonal-antibody-speeds-time-to-hiv-viral-suppression-study-finds?utm_medium=social&utm_source=twitter&utm_campaign=sociallinks

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

What’s Needed to Fix a Vital Drug Discount Program

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Guy Anthony, Founder & President, Black, Gifted & Whole Foundation

****Reprinted with permission from POZ****

Thirty years ago, when Congress passed the Public Health Service Act, no one could have imagined that section 340B of the law would become the lightning rod that it is today. The little-known provision created a program to help America’s safety net health care providers bring affordable care and discounted medicines to vulnerable, low-income patients. 

Photo Source: POZ | iStock

The initial concept was simple and effective. Pharmaceutical manufacturers provide steeply discounted drugs to hospitals, providers, and clinics that serve uninsured and underinsured patients living with HIV/AIDS, and safety net providers dedicated to reaching the most vulnerable and underserved communities. The support that the 340B program provided to Ryan White Clinics and hemophilia treatment centers was critical in addressing the HIV/AIDS crisis through the 1990s. Today, when people living with HIV can successfully manage the disease with highly effective therapies, it remains essential.

But the program and the true safety-net clinics that rely on it is teetering on the brink of collapse due to statutory silence in key areas. It turns out that the attraction of using significant savings on medicines to boost profit margins has been irresistible to some for-profit entities, at the expense of the safety net. The for-profit entities dipping into the 340B program’s discounted prescription drugs now include, among others, well-resourced hospitals in wealthier zip codes, pharmacy benefit managers (PBMs), and a vast network of contracted pharmacies (also largely located in wealthier zip codes). The numbers on this point speak volumes: 340B discounted drug purchases amounted to $38 billion in 2020, more than 15 times what it was in 2005. As Congressman Bucshon noted, wouldn’t you expect a 15x increase in the amount of charity care that is available in this country?

The realities of how the 340B program is currently implemented is a clear indication that stronger accountability and transparency are urgently needed so that the program can begin to work as intended, and patients don’t continue to get left behind. Abuses of the program have been exhaustively documented by government watchdogs and others including analysis by an advocacy group for cancer patients that found that hospitals are overcharging patients for a common breast cancer drug. The research found that hospitals pay a discounted price of just over $43,000 for a year’s supply of the drug,   while charging patients over $217,000 for the same medicine, reaping a profit of more than $173,000 from just one patient, thanks to the program designed to help the nation’s poorest citizens. 

Patients are bearing serious consequences from the lack of clarity in the 340B program and the loss of critical resources safety-net providers depend on. As organizations that provide essential services and education for the HIV/AIDS community, we know this program must be better defined if it is to work as intended. We also know that Congress has a central role to play in making that happen. 

We can only achieve changes that work in the interest of the safety net if the diverse 340B community works together, rather than at odds with itself. That’s where the newly-formed Alliance to Save America’s 340B Program (ASAP 340B) comes into play. The Alliance’s 10 policy principles provide a critical foundation for Washington decision makers to change the trajectory of the program and improve administration and oversight at the federal level. The Principles are designed to ensure greater transparency and accountability; determine a “patient definition” with with stronger safeguards; establish clear criteria for 340B contract pharmacy arrangements to improve access; prevent middlemen and for-profit entities from profiting off the 340B program; and update and strengthen 340B hospital eligibility requirements.

Photo Source: ASAP 340B

Inaction will – not could but will – very soon have serious ramifications on the care that our community receives. Yet despite the diverse organizations that have come to the table to bring about change, not everyone agrees. A cacophony of voices – including some from the HIV community – has expressed concern or displeasure with the idea of bringing ideas to the table that would enhance transparency, accountability, and most importantly, deliver long-time certainty to the program. But notably, no comprehensive, viable alternatives have been offered. 

Congress and the administration have made it clear that making prescription drugs more affordable should be a major public health priority. Fixing the 340B program can move the needle on that goal, bringing health care affordability to our nation’s most underserved patients and communities.

This opinion piece was also published on June 7th in POZ.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

HRSA Offers Guidance on Buprenorphine

By: Ranier Simons, ADAP Blog Guest Contributor

There is a higher prevalence of substance use disorder (SUD) among people living with HIV/AIDS (PLWHA) compared to the population at large.[1] Among PLWHA, nearly 50 percent report a current or past history of substance use disorders (SUD).[2] As such, in May 2023, the HIV/AIDS Bureau of the Health Resources and Services Administration (HRSA) sent a letter to all Ryan White HIV/AIDS Program (RWHAP) Part B Aids Drug Assistance Program (ADAP) recipients encouraging them to include medications used to treat SUD in their formularies. HRSA additionally emphasized adding buprenorphine and naloxone.[3] 

Photo Source: HRSA

Buprenorphine is used to treat opioid addiction as an agonist treatment. It is a long-acting drug compared to the short-acting opioids to which people have addictions, such as heroin and oxycodone. Buprenorphine stays in the blood for 24-36 hours, in contrast to shorter-acting drugs people abuse that require consumption multiple times a day to prevent withdrawal symptoms.[4] Proper dosage of buprenorphine does not cause a euphoric high, and it allows substance abusers to stabilize their lives and gain control. Any drug can be abused and overdosed. However, an overdose of buprenorphine is less likely than an overdose of methadone, another medication used for agonist treatment. Naloxone is a drug that can temporarily reverse the effects of an opioid overdose giving a person time to allow medical assistance to arrive.

Roughly 40 percent of ADAPs do not have buprenorphine or naloxone on their formularies.[3] While most health insurance plans cover medications to treat SUD, 37.4 percent of ADAP patients have no health coverage.[3] Each ADAP determines the composition of its formulary. They use advisory boards of professionals to examine their populations and determine the cost/benefit analysis of including certain medications. ADAP clients without health insurance who also have SUD are left without the means to obtain SUD drugs that could drastically improve their lives.

PLWHA dealing with substance use addictions have poorer health outcomes than those without addictions. Drug abuse causes inconsistent antiretroviral adherence resulting in lower rates of viral suppression. SUD causes people to not engage in behaviors necessary for a productive, stable existence. Additionally, substance abuse can result in dangerous drug interactions between therapeutic medications and the drugs being abused, in addition to excessive wear on organs such as the liver and kidneys. To effectively fight the HIV/AIDS epidemic, it is vital to treat PLWHA wholistically. This means dealing with their mental and physical co-morbidities in addition to their HIV.

Photo Source: Baton Rouge Behavioral Hospital

The World Health Organization (WHO) also recognizes the importance of buprenorphine and naloxone. Both are listed on the 2021 22nd WHO model list of essential medicines, which is updated every two years. The essential medicine list are medicines: “that satisfy the priority health care needs of a population…selected with due regard to disease prevalence and public health relevance, evidence of efficacy and safety and comparative cost-effectiveness…intended to be available in functioning health systems at all times, in appropriate dosage forms, of assured quality and at prices individuals and health systems can afford…“[5] 

RWHAP's ADAP manual states that ADAPs may include medications used to treat chronic medical and mental health conditions in addition to some of the mandatory requirements, such as including at least one drug from each class of HIV antiretroviral medications.[6] If more ADAPs heed the suggestion of the HRSA letter, more PLWHA with substance addictions can get treatment and relief. Many ADAPs are facing funding challenges. However, including buprenorphine and naloxone would be worthwhile formulary additions as their usage is evidence-based.

[1] Shiau, S., Arpadi, S. M., Yin, M. T., & Martins, S. S. (2017). Patterns of drug use and HIV infection among adults in a nationally representative sample. Addictive behaviors, 68, 39–44. https://doi.org/10.1016/j.addbeh.2017.01.015

[2] Durvasula, R., & Miller, T. R. (2014). Substance abuse treatment in persons with HIV/AIDS: challenges in managing triple diagnosis. Behavioral medicine (Washington, D.C.), 40(2), 43–52. https://doi.org/10.1080/08964289.2013.866540

[3] HRSA. (2023, May 11). Ryan White Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/rwhap-partb-aids-drug-assistance.pdf

[4] Centre for Addiction and Mental Health. (2023). Buprenorphine. Retrieved from https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/buprenorphine#:~:text=Overview,pain%20relief%20for%20seven%20days

[5] World Health Organization. (2023). WHO model list of essential medicines - 22nd list, 2021. Retrieved from https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02

[6] HRSA. (2016). AIDS Drug Assistance Program Manual. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/resources/adap-manual.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Did South Carolina Just Weaken Patient Choice Protections for Specialty Drugs?

By: Ranier Simons, ADAP Blog Guest Contributor

An undeniable fact with largely universal consensus is that the United States needs healthcare reform. Healthcare reform is an overhauling of the healthcare system to achieve what the Institute for Healthcare Improvement describes as the Triple Aim: “improving the patient experience of care (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of health care.”[1] The Affordable Care Act (ACA) is the most recent attempt to reach the Triple Aim by increasing insurance access, mandating levels of quality, and trying to make healthcare more affordable. The challenge of healthcare reform is that healthcare is a system. By definition, a system has moving components that not only move independently but also are interdependent upon other parts of the system. Regarding healthcare, the moving parts of the system are smaller systems. South Carolina recently attempted to make some positive changes to the healthcare infrastructure in that state, though it is unclear if all the changes will actually benefit patients.

Photo Source: Greenville Legal

It is important to remember that regulation is one tool used to attempt the improvement of the many U.S. healthcare system components. Through legislative regulation, lawmakers try to create frameworks to optimize how various healthcare system component’s function. A significant component of healthcare is prescription medication. Pharmacies, pharmacy benefit managers (PBMs), and insurance plans are several players in the prescription medication system. Presently, the costs and availability of drugs are primarily controlled by PBMs. Insurance companies employ pharmacy benefit managers who control which drugs appear on plan formularies, negotiate the prices insurance plans pay for prescriptions, decide which pharmacies can participate in a plan’s network, and more.[3,5]

While many components within the U.S. healthcare system operate under detailed and enforced regulation, PBMs do not. They are largely unregulated. To maximize their profits, they participate in multiple practices that create challenges for insurance plans, pharmacies, and ultimately patients, driving up costs and creating inefficiencies in patient care.[3,5] South Carolina has been working through legislation to curtail and regulate the activity of PBMs - including Senate Bill 520 (SB520), part of the Pharmacy Audit Protection Act - which was recently passed by the state legislature.[2]

One of many excessive practices by PBMs to drive profit is pharmacy audit. A pharmacist with over 30 years experience providing care to patients living with HIV/AIDS summarized, “Pharmacists are constantly being audited by strong-arm PBMs. They often go after the high-cost drugs and deny claims for minor infractions. It’s a bullying tactic.” SB520 aims to protect pharmacies from unjust audits by PBMs. The bill defines explicitly the structure of what entity can be designated a PBM; it explains what PBMs operationally can and cannot do, defines the rights of pharmacies in general and in the face of a PBM audit, gives patients freedom of choice in utilizing in-network pharmacies, and much more. PBMs use numerous abusive audit practices to drive profit, including audit fees, denying claims for minor clerical errors forcing pharmacies to pay back money for drugs they were reimbursed, and making it difficult for pharmacies to re-bill PBMs after winning audit appeals.

Photo Source: Framework LTC

The bill is essentially a step in the right direction. However, multiple payers lobbied to add verbiage potentially adversely affecting HIV patients and others. Section 38-71-2245, subsection (A) states: “A pharmacy benefits manager may neither limit an insured from selecting an in-network pharmacy or pharmacist of the insured's choice nor deny the right of a pharmacy or pharmacist to participate in a network if the pharmacy or pharmacist meets the requirements for network participation set forth by the pharmacy benefits manager, and the pharmacy or pharmacist agrees to the contract terms, conditions, and rates of reimbursements.”[2]  This section protects patient choice of pharmacists. 

Payers asked for the following verbiage added to the section: 

“Notwithstanding subsection (A), a pharmacy benefits manager may, for specialized delivery drugs, specify requirements for network participation that: (1) directly relate to the ability of the pharmacy or pharmacist to store, handle, or deliver a prescription drug in a manner that ensures the quality, integrity, or safety of the drug, its delivery, or its use; or  (2) relate to quality metrics that affect a pharmacy's or pharmacist's ability to participate, provided that the pharmacy benefits manager applies such terms equally to all network participants. (C) For prescription drugs that qualify as a high-cost prescription drug, subsection (A) of this section does not apply to a pharmacy benefits manager. A high-cost prescription drug is defined as a prescription drug whose current or prior year's annual average wholesale price exceeded 300 percent of the Federal Poverty Level for a single-member household. (D) A pharmacy benefits manager must provide notification of any changes to all applicable specialized delivery drug lists and high-cost prescription drug lists and must make such lists available on a website and upon request to participating pharmacies. A pharmacy may appeal a classification determination to the Department of Insurance.”[2]

The verbiage states that patient choice protections do not apply to specialty or high-cost prescription drugs. In section 38-71-2200, the bill defines specialized delivery drugs as “a prescription drug that meets a majority of the following criteria, as set forth by the manufacturer, FDA, or other applicable law or regulatory body and: (a) requires special handling or storage; (b) requires complex and extended patient education or counseling; (c) requires intensive monitoring; (d) requires clinical oversight; or (e) requires product support services; and the drug is used to treat chronic and complex, or rare medical conditions  (i) that can be progressive; or (ii) that can be debilitating or fatal if left untreated or under-treated.”[2]

Given the broad definition of specialty and high-cost prescription drugs, the bill allows PBMs to manipulate how HIV antiretrovirals and related treatments are filled. The pharmacist consulted on this issue also explains, "It’s a way for PBMs to mandate that these prescriptions need to be filled from their central mail pharmacies. Since most HIV ARVs are oral and do not require special handling, access has commonly been allowed at retail. The high cost is what’s driving this change. Also, most independent pharmacies don’t mind not having to fill these drugs because of the high cost. For HIV-focused pharmacies, these prescriptions and patients will no longer have access to trained pharmacists and relationships with providers… will all go to mail and automation.” 

He further explains that: “In exchange for fewer audits on specialty drugs, since the retail pharmacies won't be filling them anymore, the managed care organizations will allow more access to more regular prescriptions at retail pharmacies, a move that a lot of non-specialty pharmacies like because it allows them to serve more patients. They’re trading away HIV patients for more ‘non-specialty’ patients.”

Photo Source: SNF Solutions

The bill's definition of “specialized delivery” drugs affects other types of drugs as well. Using the example of antibiotics for a UTI for an elderly person, Jen Laws, President & CEO of Community Access National Network (CANN), explains: “Under the requirements set forth, most antibiotics lose efficacy when exposed to high heat, might require education as to contraindications for patients with other co-occurring conditions, will require monitoring for clearance of infection, and these types of infections can be progressive or debilitating in elderly patients. And while this is an extreme example, it is possible under the bill as written. Given payer willingness to abuse carve-outs and loopholes in laws, it's egregious to define ‘specialty’ so broadly, especially as medicine becomes more and more personalized.”

Increased financial burden on HIV patients and providers is another bill outcome. ARVs are not always defined as specialty drugs on formularies, and thus, many times, they are on lower tiers of formularies that only require cost-sharing of fixed lower copays. Since the bill allows PBMs to define all ARVs as specialty drugs, they can move them to higher formulary tiers, which have much higher cost-sharing practices, such as significantly higher copays and coinsurance. This creates a significantly increased out-of-pocket financial burden on patients and covered entities that are covering the 340B patient copay cost.  

Compounding the increased financial burden is the usage of copay accumulators. Patients in the past who used manufacturer copay assistance programs could apply the copay card payments to their insurance deductible and out-of-pocket costs. Presently, many insurers use copay accumulators, which allow the copay assistance programs to pay the copays but do not allow the payments to count towards deductibles or out-of-pocket expense limits. Thus, the insurance companies are essentially being paid twice by requiring the insured to still must pay their deductibles and out-of-pocket limits after exhausting copay assistance cards. Additionally, patients are in danger of being unable to afford their medication since they would be responsible for paying the full price of their medications after the copay assistance was exhausted up until the limits of completely paying their deductibles.[4]

This bill is an example of the challenges of healthcare reform. It is easy for well-intentioned legislation to be tainted by opposing interests. It is imperative to be vigilant about whom we select as legislative representation and stay informed about legislation being written that affects our daily lives.

[1] Institute for Healthcare Improvement. (2023). The IHI Triple Aim. Retrieved from https://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx

[2] South Carolina State House. (2023). S0520. Retrieved from https://www.scstatehouse.gov/sess125_2023-2024/bills/520.htm

[3] Royce, T., Schenkel, C., Kirkwood, K., Levit, L., Levit, K., Kircher, S. (2020). Impact of pharmacy benefit managers on oncology practices and patients. JCO Oncology Practice 16(5) 276-284. DOI: 10.1200/JOP.19.00606

[4] National Conference of State Legislatures. (2023, February 23). Copayment Adjustment Programs. Retrieved from https://www.ncsl.org/health/copayment-adjustment-programs#:~:text=When%20a%20patient's%20health%20plan,out%2Dof%2Dpocket%20maximums

[5] Healthcare Value Hub. (2018, January). Pharmacy benefit managers: Can they return to their client-centered origins? Retrieved from https://www.healthcarevaluehub.org/advocate-resources/publications/pharmacy-benefit-managers-can-they-return-their-client-centered-origins

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

An Expression of Support for Basic Human Decency

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Jen Laws, President & CEO, Community Access National Network

Earlier this week, ADAP Advocacy Association and Community Access National Network (CANN) issued a joint statement announcing an embargo of each respective organization’s patient advocacy and education activities within the state of Florida. Both organizations also cited a need to protect advocates and patients from outside of the state from the very real dangers associated with traveling to the state, while also emphasizing that both organizations will continue to support local advocates in the state as they work to create positive public policy changes for Floridians living with HIV. The decision to adjoin both the ADAP Advocacy Association and the Community Access National Network to the previously issued formal travel advisory by the NAACP wasn’t taken lightly because maintaining strong ties to the community is important in generating effective advocacy. The move was not a political statement either, but rather an expression of support for basic human decency.

The announcement comes after the state’s governor, Ron DeSantis, signed into law a series of bills targeted toward harming Black, Brown, LGBTQ+, and immigrant people. The transgender community was probably singled out more viciously than any of the marginalized communities throughout this hate-inspired Florida Legislative Session. Make no mistake about it why this effort to enflame a “culture war” is an issue of organizational values and something quite personal to both of us. The non-trans guy here taking issue with the fact that the trans guy here now cannot take “a leak” without fear of being charged with a felony has nothing to do with politics and everything to do with basic human rights.

The fact is we both previously lived in the state for many years – it’s where we started our HIV policy work, even before we knew one another. It is where we met over a decade ago. Upon reflection, we still can regularly be found discussing mutual friends from Florida, those still living and those who have passed on, in different phases of their lives.  

From recalling Bishop S.F. Makalani-MaHee's testimony to the Florida Legislature in 2016, against a bathroom bill (which failed that year), to his death on Transgender Day of Remembrance in 2017, part of this internal discussion was a reflection on the deep history he had with advocates serving both the Transgender and HIV communities of the state. What we’re witnessing right now in Florida is challenging for us, personally and professionally, but state-sponsored discrimination, hate, and stigma drew a line that cannot be ignored.

In 2017, Human Rights Watch published an important report, Living At Risk: Transgender Women, HIV, and Human Rights in South Florida, and the very same year ADAP Advocacy Association published it’s issue paper, Transgender Health: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS Under the AIDS Drug Assistance Program. Both of us worked on the ADAP project, and it was important for a transgender advocate (Jen) with lived experience to lead in writing model policies meant to serve Transgender People Living with HIV. The decision to issue a travel advisory in Florida for people living with HIV is rooted in disparities and areas of improvement emphasized in those two reports.

Photo Source: ADAP Advocacy Association

Much of our hearts belong to Florida for the dedication and innovation the people of this state can and do offer, despite every unnecessary public policy challenge they face. People like Mick Sullivan and Donna Sabatino (formerly with Tibotec Therapeutics), Connie Reese and her amazing work with Simply Amazing You Are (SAYA) in Miami-Dade County, Riley Johnson promoting trans equality in accessing medical care via RAD Remedy, Michael Ruppal’s leadership with The AIDS Institute, and the late Tiffany Marrero, who served to voice the experiences of vertical transmission patients and Black Women and only recently left us. Heck, Trelvis Randolph and Maria Mejia both reside in South Florida, and they serve on CANN’s board of directors. These folks not only are colleagues, but they are friends and expressing concern over traveling to a place once call “home” saddens us.

But some things are larger than us. Recognizing the inherent roots of racism, which has prompted the NAACP to issue a travel advisory, our joint statement read, in part:

The state of Florida's moves to harm Transgender people, Black and Brown communities, and immigrant families undermines the exceptional work the state's Health Department has done in the last several years and only serves to further existing health disparities affecting these communities, particularly as it relates to HIV. For example, according to Florida's own data, while Black and Hispanic/Latino communities make up about 15.6% and 26.7% of the state's population, respectively, these same communities represent 37.7% and 39.6% of HIV diagnoses. Put another way, in Florida, while white people experience a rate of HIV diagnoses of 8.5 per 100,000 people, that rate among Black communities is 51.8 and for Hispanic/Latino communities it's 31.7.

Similarly, Florida has, in years past, made extraordinary strides in ensuring transgender people can access HIV related care, specifically by integrating best practices and guidance from the Health Resources and Services Administration (HRSA) on integrating gender affirming care into HIV care provision. Indeed, as a result of these moves, transgender women represent some of the greatest successes in linkage to care, retention in care, and viral load suppression of any demographic in the state. Recently signed bills prohibiting state contracted clinics from providing gender affirming care will have a dramatic affect in reversing these long sought after wins. 

Make no mistake, we are frustrated with an apparent lack of involvement from the federal agency charged with implementing the Ryan White HIV/AIDS Program. Because Ryan White program dollars are passed through the state and then contracted with counties, local areas, or directly with a provider, and because other health initiatives of the state are also part of how providers in Florida acquire funding to provide public health services, they may be prohibited from providing gender affirming care at all - regardless of where those dollars originate (state or Federal).

It is incumbent upon HRSA to provide guidance beyond ‘allowable’ uses and inform that state it has contractual, fiduciary responsibilities associated with its grant and subrecipient contracts to ensure these dollars serve these communities. HRSA must move beyond the language of ‘allowable’ uses to ‘expected integration of best practices.’

In many situations, we have been willing and able to confront harsh environments. Indeed, we recognize the need to be present in the spaces where political forces wish to silence us. However, Florida has crossed a line in becoming hostile to the very existence of Black and Brown and Immigrant and Transgender people, those same communities most affected by HIV. The people who enacted these hateful laws were motivated by hateful politics; our response is motivated by concern for the people we’re charged with representing in our community…many of whom feel silenced. This is a line which we cannot cross and still consider ourselves as living the values we espouse.

We came to the difficult decision that neither the ADAP Advocacy Association or Community Access National Network will host any advocacy or educational event in the state of Florida. We will continue to support local advocates and people living with HIV residing in the state, including scholarship support for intrastate travel by local advocates. We will continue to offer analysis on the state's activities. But we will not ask advocates from outside of the state to risk their mental health or physical safety to travel to the state.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.