Profiting From Misery Because They Can

By: Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative

Since the passage of the Affordable Care Act (ACA) in 2010, millions of Americans have gained access to health insurance and other forms of healthcare coverage which they were previously unable to afford. According to the U.S. Department of Health and Human Services (HHS), a record 31 million Americans have access to healthcare coverage through the ACA’s Marketplace or Medicaid Expansion coverage (HHS, 2021). And yet, for a significant percentage of Americans, healthcare has not become, despite the name of the law, “affordable.”

When we talk about “affordability,” we often speak in terms of average numbers—the average costs of services and prescriptions; the average costs of insurance premiums and deductibles. By those measures, the ACA has failed:

• The cost of services has increased at an average annual rate of 3.5% per year over the past 20 years (Peter G. Peterson Foundation, 2022). Several factors contribute to this increase in costs, including the introduction of new and innovative technologies leading to more expensive procedures and products, the complexity of the U.S.’s overly complex multi-payor healthcare system that naturally leads to administrative waste, and the decrease of competition as hospital systems consolidate and take over smaller hospitals.
• The cost of prescription drugs has increased on an annual average of around 5% (Keown, 2022). Two HIV drugs, Biktarvy and Descovy (Gilead Sciences), saw price increases of 5.6% in 2021 which, according to a Gilead spokesperson, are offset by rebates and other discount programs (Keown).
• The cost of premiums has increased on an annual average of 11.6% (Antos & Capretta, 2020). Deductibles have risen dramatically, as well, increasing from an average of $2,425 in 2014 to $4,500 in 2020 for Silver Plans offered on Healthcare.gov (Antos & Capretta).

While these costs have increased at a consistent rate, the Real Median Personal Income in the U.S. has largely stagnated since the late-1990s, hovering between $30,000 and $37,000 (U.S. Census Bureau, 2022). This translates to the reality that, while the costs associated with healthcare services and treatments have increased, median incomes have not increased in conjunction to support those increased expenditures.

According to a recent report released by Peterson Center on Healthcare and the Kaiser Family Foundation, although 90% of Americans now have access to some form of health insurance coverage (private, employer-sponsored, or public), medical debt remains a persistent problem for 23 million people—nearly 1 in 10. This is especially true for Americans with lower incomes, Black Americans, and patients with significant medical needs. In terms of age, patients aged 35-64 were more likely than any other demographic to have significant medical debt. In terms of geographic location, people living in the South or in states that have not expanded Medicaid were more likely to have significant medical debt (Rae, et al, 2022). 

Other aspects of the ACA—such as the 80/20 rule, requiring insurers to spend at least 80% of the premiums they collected on medical claims—were designed to limit the profits made by insurance companies. If insurers fail to meet that percentage, they are required to rebate the difference to policyholders. In the early years of the ACA, this resulted in billions in rebates to consumers. However, insurers have successfully devised numerous schemes to ensure that consumers pay more, and insurance provider profit margins stay high.

One such mechanism involves a practice referred to as “Co-Pay Accumulator Programs.”

What Are Co-Pay Accumulators and How Do They Work?

Co-Pay Accumulator Programs are stipulations included in many private and employer-sponsored health insurance plans, often hidden in the “fine print.” Under these programs, money paid to pharmacies and healthcare providers via coupons, assistance cards, discounts, product vouchers, and other third-party sources does not count towards patients’ deductibles or out-of-pocket maximums (OPMs). Since reaching a deductible or OPM makes the insurance company responsible for any further cost of treatment and services covered under a plan, delaying these benchmarks makes patients liable for more costs, increasing the amount they end up paying for prescriptions and other services.

Co-Pay Accumulator Programs save money for insurers by passing along higher costs to patients. For instance, a patient with hepatitis C might be prescribed a direct-acting antiviral (DAA) costing $28,000 per month. Even if an industry co-pay assistance program (CAP) only covers up to 25% of the drug’s cost, meaning $7,000, then just by paying for the first $3,500 dose, the CAP will already meet the patient’s $3,000 deductible. The patient only pays a token amount out of pocket, perhaps $5, while the CAP pays the other $3,495, and all future doses are billed to the insurer.

However, if the plan includes a co-pay accumulator program, that CAP payment will not count towards meeting the patient’s deductible. Instead, the patient uses the CAP for the second dose as well, hitting the CAP maximum of $7,000 yet even then still not meeting their plan’s deductible. With no more help from the CAP, the patient then has to spend $3,000 out of pocket for the next dose before finally hitting their deductible. This saves the insurance company $10,000 by costing the patient $3,000 and the CAP $7,000 before the insurance company even begins helping to pay for the drug. (Hopkins, 2021)

It is our belief that regardless of the source of payment—be it manufacturer coupon, AIDS Drug Assistance Program, or other patient assistance organization, such as the Patient Access Network (PAN) Foundation—all payments should count toward both deductibles and OPMs.

How Many Patients Are Impacted?

According to a 2018 analysis by Zitter Health Insights, 12% of patients with commercial plans were subject to Co-Pay Accumulator Programs in 2018, with 44% of commercial plans including Co-Pay Accumulator Programs. They predicted that 40% of patients would be impacted in 2019 with that number expected to grow annually (Schweitz, 2019). Many patients who are impacted, however, are unaware that their plans contain Co-Pay Accumulators Programs in no small part due to companies using seemingly innocuous language such as “Out-of-Pocket Protection Program” (Express Scripts), “True Accumulation” (Caremark), or “Coupon Adjustment: Benefit Plan Protection Program” (UnitedHealthcare) (Hopkins, 2021).

Photo Source: The Matrix Consulting, LLC

How Can We Address Co-Pay Accumulators?

At the end of 2021, only state-level action had been successfully undertaken to prohibit the inclusion of Co-Pay Accumulator Programs, with twelve states and Puerto Rico having passed such legislation:

• Arizona (HB 166)
• Arkansas (HB 569)
• Connecticut (SB 003)
• Georgia (HB 946)
• Illinois (HB 0465)
• Kentucky (SB 45)
• Louisiana (SB 94)
• North Carolina (SB 257)
• Oklahoma (HB 2678)
• Tennessee (HB 0619)
• Virginia (HB 2515)
• West Virginia (HB 2770)

In 2022, eleven states have introduced legislation to address Co-Pay Accumulators (that the author was able to find):

• District of Columbia (B24-0557)
• Florida (SB 1480) – FAILED; (HB 1063) – FAILED
• Iowa (H 2384)
• Maine (SP 621)
• Minnesota (SF 2136)
• Mississippi (HB 880) – FAILED; (SB 2470) – FAILED
• Missouri (SB 1031)
• New York (A1741); (SB 5299) – FAILED
• South Carolina (H 4987)
• Utah (SB 139) – FAILED
• Washington state (HB 1713) – FAILED; (SB 5610) – PASSED

In addition to state-level actions, Congress recently introduced the Help Ensure Lower Patient (HELP) Copays Act (H.R 5801). The HELP Copays Act, sponsored by Rep. A. Donald McEachin (D-VA-04), would ban co-pay accumulator programs by:

• Updating the Affordable Care Act’s (ACA) definition of cost-sharing to require that all out-of-pocket payments made by or on behalf of a patient count toward the patient’s deductible and out-of-pocket limit. This would end co-pay accumulator programs in marketplace exchange insurance plans. 
• Stipulating that any item or service covered by an employer health plan is part of the essential health benefits (EHB) package and therefore the plan must count any cost sharing toward patients’ annual limits. This would end the ACA’s EHB loophole that allows plans to deem certain categories of drugs as non-essential.

This addition to the ACA would require insurers to count co-pay assistance paid by any third party on behalf of the patient toward their insurance deductible or out-of-pocket maximum (Immune Deficiency Foundation, 2021). The bill has bipartisan support with 20 co-sponsors and 116 state and national organizations sent a sign-on letter via the All Copays Count Coalition to Secretary of Health and Human Services, Xavier Becerra, in support of the HELP Copays Act.

Whom Should We Contact?

While federal legislators continue to work on the HELP Copays Act, people can (and should) reach out to their state legislators to pass legislation at the state level to prohibit insurers from implementing Co-Pay Accumulators by any name. They may find their state legislators online.

At the federal level, the HELP Copays Act continues to sit in the House Committee on Energy and Commerce. People should reach out to their Congressional Representatives, which they may find here.

In addition to contacting members of the House, we urge patients to contact their Senators to ask for a companion bill to be introduced in the Senate. They may find their contact information here.

The ADAP Advocacy Association, Patient Access Network Foundation, and The Matrix Consulting, LLC, invite you to direct your elected representatives to the PAN Foundation’s excellent campaign:

End harmful co-pay accumulator programs online at https://www.panfoundation.org/end-copay-accumulators/.

References:

• Anton, J. R. & Capretta, J. C. (2020, April 10). The ACA: Trillions? Yes. A Revolution? No. Washington, DC: Health Affairs Blog: Health Affairs Forefront. https://www.healthaffairs.org/do/10.1377/forefront.20200406.93812/full/
• Keown, A. (2022, January 04). Drug Price Increases for 460 Drugs in 2022. Urbandale, IA: BioSpace. https://www.biospace.com/article/a-new-year-means-price-increases-for-many-prescription-drugs/
• Peter G. Peterson Foundation. (2022, February 16). WHY ARE AMERICANS PAYING MORE FOR HEALTHCARE? New York, NY: Peter G. Peterson Foundation: Blog. https://www.pgpf.org/blog/2022/02/why-are-americans-paying-more-for-healthcare
• Hopkins, M. J. (2021, April 07). How “Co-Pay Accumulators” Stifle Healthcare Access and Empty Patients’ Wallets. Lost River, WV: Community Education Group: Rural Health Service Providers Network: Publications. https://secureservercdn.net/198.12.144.78/m60.322.myftpupload.com/wp-content/uploads/CoPay_Accumulators-FINAL.pdf
• Immune Deficiency Foundation. (2021, December 02). Support the HELP Copays Act and fight unfair copay accumulators. Towson, MD: Immune Deficiency Foundation: News. https://primaryimmune.org/news/support-help-copays-act-and-fight-unfair-copay-accumulators
• Rae, M., Claxton, G., Amin, K., Wager, E., Ortaliza, J., & Cox, C. (2022, March 10). The burden of medical debt in the United States. Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/brief/the-burden-of-medical-debt-in-the-united-states/?_hsmi=206419781&_hsenc=p2ANqtz--ts2CCK83uE9bi6lOcPJxnqqO0KQG5tOHocn9uAhHCAiYGFqKj4-5sQwvC4s15sMUuMqmLSQsg_QORW4rajQjwpITJZg&utm_campaign=KFF-2022-Health-Costs&utm_medium=email&utm_content=206419781&utm_source=hs_email
• Schweitz, M. C. (2019, January 22). The Cost-Shift Conundrum of Copay Accumulator Programs. Thorofare, NJ: Healio: News: Rheumatology: Practice Management. https://www.healio.com/news/rheumatology/20190114/the-costshift-conundrum-of-copay-accumulator-programs
• United States Census Bureau. (2022, March 11). Real Median Personal Income in the United States [MEPAINUSA672N]. Retrieved from FRED, Federal Reserve Bank of St. Louis. https://fred.stlouisfed.org/series/MEPAINUSA672N
• United States Department of Health and Human Services. (2021, June 05). New HHS Data Show More Americans than Ever Have Health Coverage through the Affordable Care Act. Washington, DC: U.S. Department of Health and Human Services: About HHS: News. https://www.hhs.gov/about/news/2021/06/05/new-hhs-data-show-more-americans-than-ever-have-health-coverage-through-affordable-care-act.html

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.

Gilead Sciences Discovers $250 Million of Counterfeit Biktarvy and Descovy

By: Ranier Simons, ADAP Blog Guest Contributor

The selling of counterfeit goods is a lucrative market. Expensive, popular, and high-demand items are counterfeited globally. The quality of the fake goods ranges from high quality to poorly made. Counterfeiting doesn’t stop at goods. There is also a large market for counterfeit drugs. Studies estimate that the global illegal drug market has sales between $200 billion and $400 billion annually.[1] Additionally, data shows that 9%-41% of medication sold in low to middle-income countries are counterfeit. The percentage drops to about %1 in high-income countries like the United States.[2]

Irrespective of the lower percentage in the U.S., counterfeit drugs are a serious issue. Unfortunately, expensive HIV medicines are on the list of valuable targets. On August 5, 2021, Gilead Sciences released a press release stating that it had become aware of counterfeit and tampered versions of Biktarvy and Descovy in the supply chain in the U.S.[3] The press release resulted from a sealed lawsuit Gilead filed against the sources of the counterfeit in July of 2021. The U.S. District Court of the Eastern District of New York unsealed the documents on January 18, 2022, revealing the details. 

Photo Source: IP Watch

Gilead reported that at a value of $250 million, about 85,247 bottles of counterfeit Biktarvy and Descovy were sold to pharmacies and patients over two years. The drugs entered the supply chain via distributors not authorized by Gilead, who sold to pharmacies and patients. The counterfeit versions were sold in genuine Gilead bottles. The tampered bottles had fake foil induction seals, fake caps, or improper labels.[4] Some of the bottles contained genuine Gilead pills. Others included other drugs, painkillers, and a powerful anti-psychotic drug with serious side effects. Since the bottles were sealed, pharmacists were not physically filling them. Thus, they were unaware of the contents. The majority of the counterfeit drugs were sold by an organized counterfeit ring that used shell companies to advertise and sell the fake drugs to pharmacies. Several licensed pharmaceutical distributors were a part of the scheme.[4] Some of the drugs were even bought off of homeless people or HIV patients before being resold.[5]

The dangers of counterfeit drugs are catastrophic. Results are poisoning, death, treatment failure, disease progression, and even drug resistance. Improper dosages of unneeded medications poison patients ingesting pills of the incorrect medications. Taking the wrong medications can also cause adverse interactions with other medications people are already taking. Fake drugs affect treatment regimens since physicians base treatment on the outcomes they see from care. If patients take counterfeit medication, their disease progression will not change or worsen. As a result, doctors would change medication or make other decisions based on false results. Improper counterfeit drugs also do not contain adequate levels of medications. In the case of antiretrovirals, that could result in drug resistance lowering a patient's options for treatment pathways. 

Photo Source: YouTube

The dangers surrounding counterfeit drugs was recently addressed in a 90-second public service announcement (PSA). Brandon M. Macsata, CEO of the ADAP Advocacy Association and a long-term survivor living with HIV, shared some important steps patients can take to combat counterfeit drugs. The PSA can be viewed online at https://www.youtube.com/watch?v=VWGUW1AAr_w. 

It is imperative that pharmacists source medications from reliable sources. Pharmacists sometimes seek out alternative suppliers to buy drugs cheaper. Scarcity also steers pharmacists into the hands of counterfeiters when legitimate suppliers of high-demand, expensive medication are unable to supply the market needs.[6] Actively examining medication bottles for suspicious appearances and informing patients about the dangers of buying medicines over the internet are effective ways to combat counterfeit medications. Moreover, pharmacists need to confirm that supplies were purchased directly from manufacturers or reputable sources with their distributors. Unfortunately, this due diligence is sometimes thwarted since source documentation is also faked, as it was, in the Gilead counterfeit case.

[1] Miller, H., Winegarden, W. (2020, October). Fraud in Your Pill Bottle: The Unacceptable Cost of Counterfeit Medicines. Retrieved from  https://medecon.org/wp-content/uploads/2020/10/CounterfeitMed_F.pdf
[2] CDC. (2021, July). Counterfeit medicines. Retrieved from )https://wwwnc.cdc.gov/travel/page/counterfeit-medicine
[3] Gilead. (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved from https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states
[4] IPWatchdog. (2022, January 19). Court unseals documents in Gilead lawsuit alleging massive counterfeit HIV drug scheme. Retrieved from https://www.ipwatchdog.com/2022/01/19/court-unseals-documents-gilead-lawsuit-alleging-massive-counterfeit-hiv-drug-scheme/id=144591/
[5] Lonas, L. (2022, January 18). Drugmaker says counterfeit versions of its HIV medicines ended up in patients’ hands. Retrieved from https://foxlexington.com/news/health-wellness/drugmaker-says-counterfeit-versions-of-its-hiv-medicines-ended-up-in-patients-hands/
[6] Chambliss, W, Carroll, W., Kennedy, D., Levine, D., Mone, M., Ried, D., Shepherd, M., & Yevligi, M. (2012). Role of the pharmacist in preventing distribution of counterfeit medications. Journal of the American Pharmacists Association. 2012(52), 195-199. doi: 10.1331/JAPhA.2012.11085

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.

Better Together: A Collaborative Model to Address Health Equity

By: Alan Richardson, Executive Vice President of Strategic Patient Solutions, Patient Advocate Foundation

Since our inception 25 years ago, Patient Advocate Foundation (PAF) has been the voice for the voiceless, navigating the complex healthcare and insurance coverage systems to enable patients to gain access to life changing treatments. We have helped more than 1.7 million people access, and as importantly, afford the care needed to sustain life and, in many cases, improve quality of life. Our firsthand experience helping patients and their families remove the barriers keeping them from appropriate care or causing financial and practical hardships in their homes has been humbling and insightful. As an organization, we have witnessed firsthand the disproportionate long-term consequences of unaddressed social determinants of health and the social needs gaps caused by them. It is through this realization that PAF established longstanding commitment to develop programs based in demonstrated patient need and intentionally bring our programs and services to these communities in an effort to refortify the financial and social needs foundation on which many families found was crumbling beneath them. Patient Advocate Foundation’s focus on health equity is intentionally designed to address the intersectionality of health and the social, financial, and logistical challenges that impact one’s ability to access healthcare and adhere to treatment recommendations. In some communities across the country, left unaddressed, the impact of this intersectionality manifests in late-stage diagnosis, decreased quality of life and/or premature mortality.

PAF has had a long-standing goal of reaching all communities, not just those who are fortunate enough to have an education, employment, insurance, access to a healthcare system or supported by a system of family and friends who advocate for them. We have sought and continue to establish pipelines from limited resourced communities to the platform of free services and resources available through PAF, developing many programs over the years that have enabled us to bring services, education, and support to underserved communities, often partnering with community and national organizations to amplify impact.  

We want to further expand our reach into the communities that continue to experience healthcare inequities. Our goal is to expand the degree to which PAF programs and services effectively reach and serve diverse patients in a way that facilitates their opportunity to attain the highest level of health, produces data and patient stories that enable advocacy and policy activities to address social needs gaps. We realize that our work to solve insurance issues, access issues, and affordability of patient treatments across all disease areas represents only some of the needs patients and their families have. 

One of the programs currently providing services is our HIV, AIDS and Prevention CareLine which provides individualized, sustained assistance to patients diagnosed with HIV, AIDS or are currently being treated with a medication to prevent HIV infection. The CareLine Case Managers provide help to patients across the country to resolve health care access and insurance issues at no charge to the patient. The HIV, AIDS and Prevention CareLine can be accessed by phone at 844-737-6674 M-F from 8:30 a.m. to 5:00 p.m. EST or at hivoraids.careline.org

Through the PAF Co-Pay Relief (CPR) program, insured patients can apply for direct financial assistance to cover treatment related expenses connected to their HIV/AIDS treatment and may include insurance co-payments, co-insurance and deductibles, office visits and administration charges related to treatment and medical insurance premiums. CPR is available for any insurance type including Medicare and Medicaid. Patients are approved for a 12-month period and can reapply in future years in co-pay assistance is still necessary. CPR can be accessed by phone at 866-512-3861 and CPR fund details and application documents can be found at copays.org/diseases. 

Patient Partner for Equity

Despite reaching hundreds of thousands of people who are part of an underserved community, providing critical navigation and financial support to them that facilitated access to care and resolved daunting practical needs, we also know that there is still much work to do. Through our experience breaking down barriers to care and our understanding of the impact social determinants of health have on healthcare access and health outcomes; it is has become clear to us that the path to equity and access is through interconnectedness. Working together to connect these high-need patients who are often not connected to health and social services, with the resources they need to address medical and social needs is critical.  

The Patient Partners for Equity collaborative creates a one-to-one relationship between PAF and other nonprofit organizations for the purposes of connecting patients, specifically those from communities that are underserved and routinely experience health inequities, to PAF’s direct service programs and educational opportunities. This includes our case management navigation services, patient educational materials, our financial aid funds, and our Co-Pay Relief program. This bidirectional relationship allows organizations, and ours, the opportunity to close the gap of health inequities for some patients by connecting them to PAF case management, our financial assistance programs, and educational services, further enhancing the resources that your organization provides. Our intent is to provide organizations with the education and tools necessary to connect patients, families and caregivers to our patient support programs when appropriate, leveraging our services to amplify what you are able to do for those seeking your support. We believe that the path to achieving health equity is reliant upon the collective strengths that this type of partnership will afford. We need your help, and so do patients, their families, and caregivers. We have designed this collaborative with this as the motivating force.

Ready to be a Patient Partner for Equity?

Participation is simple. We ask for your commitment to participate through the completion of the Patient Partner for Equity profile form, allow us an opportunity to provide training to your team(s) about our patient support programs and agree to be included as a Patient Partners in Equity member on PAF’s websites. We have also created other touchpoints and opportunities to engage as you deem appropriate or possible for you and your organization.  

As a member of PAF’s Patient Partners for Equity program, your organization will receive the following benefits:

• Recognition of your organization as a Patient Partner in Equity on PAF’s websites including your logo, an organizational profile, and reciprocal links between our website and yours.
• Personalized education about PAF’s patient support and educational services delivered to your team(s) virtually in a live and recorded format.
• Regular partnership e-communications including the PAF Spotlight, NPAF Policy Dispatch Newsletter and other patient focused patient resources, public policy updates and events.
• Complimentary virtual membership for your organization to National Patient Advocate Foundation’s (NPAF) Policy Consortium. 
• Spotlight of your organization on PAF’s websites once per year
• Access to PAF’s Patient Partner Portal (Available 2022), a dedicated portal for nonprofit organizations to access PAF’s patient programs and educational resources in a centralized location.  This includes access to the PAF Case Management secure referral form, Financial Aid Fund application portals.  In addition, the portal will enable your organization to apply to our Co-Pay Relief Program (CPR) for financial assistance on behalf of patients who meet eligibility requirements, track activity of patient grants, assist with reapplications or submission of materials as needed and gather insights on how these grants impacted the lives of patients seeking your support.

As a member of PAF’s Patient Partners for Equity program, we request that you provide the following:

• A link to PAF’s websites, where appropriate (partner page, patient resource page or other content area)
• Allow PAF to provide training about PAF’s patient support programs annually to your staff working with patients, families, and caregivers 
• Participation in an annual survey or meeting to gain feedback on the program
• Provide a single point of contact for general partnership touchpoints

We appreciate your consideration of our invitation to participate in the Patient Partners in Equity program.  If you would like to be part of the Patient Partners for Equity collaborative, or if you would like to learn more, please contact Alan Richardson, EVP of Strategic Patient Solutions at alan.richardson@patientadvocate.org or 757-952-1372.

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.

Medicine Abandonment is a Barrier to Health Equity

By: Ranier Simons, ADAP Blog Guest Contributor

One of the most important developments in medical science is the evolution of pharmaceuticals. Prescription drugs are used to treat and cure disease, prevent disease, slow aging, govern family planning, and even enhance biomechanical functioning. The United States spends more on over-the-counter and prescription drugs than any other country. In 2020, the U.S. spent $348.4 billion on prescription drugs.[1] America's drug prices are 250% higher than 32 countries that are a part of the Organization for Economic Co-operation and Development known as the OECD.[2]

Researchers are increasingly focused on exploring the relationship between drug finance and care access. Inquiry shows that drug prices and the pathways in which patients pay for medications result in unequal access to care. Unequal access to care results in health inequities. Care disparity is the subject of a report recently published by the Pharmaceutical Research and Manufacturers of America, known as PhRMA. PhRMA is a non-profit advocacy group that lobbies on behalf of its member biopharmaceutical companies. It believes in advancing innovation, making medicines more affordable, and improving access for all. The report, entitled "Understanding Medicine Abandonment as a Barrier to Health Equity", uses real-world data to highlight health disparities.

Abandonment, in this report, is defined as when a patient does not fill a newly prescribed brand-name medication within 30 days of approval from their insurance. The report's 2020 IQVIA sourced data showed that African-Americans were disproportionately likely to abandon new prescriptions than their white counterparts. Additionally, the results indicated that people with lower incomes have a higher likelihood of medication abandonment than those with higher incomes.[3] Research has shown that regular adherence to medication regimens is almost more important than the medication itself.[5]

African-Americans were overall seven percent more apt to abandon new prescriptions. However, that percentage was higher regarding specific diseases. The rate increased to 20 percent for insulin usage, 31 percent for atypical antipsychotic drugs, and 41 percent for HIV Pre-Exposure Prophylaxis (PreP) usage.[3] Rates of abandonment, in regards to insurance cost-sharing, also followed the same trend among racial lines. African-Americans were 10 to 34 percent more likely to abandon medication when the out-of-pocket price was $125 or more after insurance than white patients.[3] Similar results were observed regarding income in the absence of race. Patients with commercial insurance who had an annual income of less than $50,000 were more likely to have medication abandonment than those making over $100,000. In general, those earning less than $50,000 were 16 percent more likely not to fill prescriptions than those annually earning $100,000 or more.

The report is an acceptable baseline of inquiry. However, it cannot prove direct causal relationships of inequality. The analysis compares differing rates of abandonment by race and income. It does not include the influence of confounding variables such as racism, health status, education, and social determinants of health.[3]

"Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks."[4] It is vital to explore how these things influence health inequalities and contribute to medicine abandonment.

Photo Source: Healthy Mendocino

One important SDOH is culture. The study showed that African-Americans had a 31 percent higher likelihood of medicine abandonment regarding atypical antipsychotic drugs. In addition to the cost factor, there is documented stigma African-Americans associate with mental issues. One such study showed that 63 percent of African-Americans surveyed believed that mental health issues are a sign of personal weakness.[6] This sentiment would indicate that an African-American patient would likely not fill a needed mental health prescription even if they were fearless enough to seek help. 

Racism is another SDOH. Institutionalized racism in medicine contributes to a pervasive African-American distrust of doctors and medication.[7] Racial differences in medical care and inclusion or lack of inclusion in medical research are part of medical institutional racism. The Tuskegee Experiment, gynecology’s roots of torture in slavery, and the poor representation of African-Americans in clinical trials are just a few examples.

Outside of race, the issue of drug pricing is also not binary. The PhRMA report showed a correlation between the income of insured patients and the likelihood of medicine abandonment. However, price is complex. The way patients pay for medication is also a source of concern. Patients pay monthly premiums for their insurance that include differing drug coverages. However, in addition to their premiums, they must pay copays for their medications. Those copays are often part of a matrix, including high insurance deductibles. 

In an effort to help patients afford their medications, many drug manufacturers have copay assistance programs. These programs are supposed to pay for the patients’ copays to the insurance company to reduce the financial burden and increase adherence. However, copay accumulator programs presently are a challenge to those efforts.

The Hepatitis B Foundation defines copay accumulator as "a strategy used by insurance companies and Pharmacy Benefit Managers (PBMs) that stop manufacturer copay assistance coupons from counting towards two things: 1) the deductible and 2) the maximum out-of-pocket spending."[8] This results in patients paying even more for their medications, with the insurance companies paying less. This phenomenon is supported by the PhRMA report, which shows that medicine abandonment increases as the amount of out-of-pocket expenses to the patient increases.

The intersection of race, economics, healthcare finance, and SDOH is a complex web. PhRMA's report is a solid stepping stone on which to wade through the constantly moving stream of health equity reform discourse and change. The report is available online here.

[1] Centers for Medicare & Medicaid Services (2021, December 15). NHE Fact Sheet. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet#:~:text=Prescription%20drug%20spending%20increased%203.0,the%20households%20(26.1%20percent)
[2] Mulcahy, A. (2021, January 28). Prescription drug prices in the United States are 2.56 Times those in other countries. Retrieved from https://www.rand.org/news/press/2021/01/28.html
[3] Pharmaceutical Research and Manufacturers of America. (2022). Understanding Medicine Abandonment as a Barrier to Health Equity. Retrieved from  https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/S-U/Understanding-Medicine-Abandonment-as-a-Barrier-to-Health-Equity_2022.pdf
[4] Cherry, A. (2021, October 14). The social determinants of health: why they matter to improving health outcomes. Retrieved from https://maximus.com/article/social-determinants-health-why-they-matter-improving-health-outcomes
[5] DiMatteo MR, Giordani PJ, Lepper HS, et al. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002;40(9):794-811
[6] Ward, E. C., Wiltshire, J. C., Detry, M. A., & Brown, R. L. (2013). African American men and women's attitude toward mental illness, perceptions of stigma, and preferred coping behaviors. Nursing Research, 62(3), 185–194. https://doi.org/10.1097/NNR.0b013e31827bf533
[7] Institute of Medicine (U.S.) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care; Smedley BD, Stith AY, Nelson AR, editors. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington (D.C.): National Academies Press (U.S.); 2003. The Culture of Medicine and Racial, Ethnic and Class Disparities in Health Care. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK220349/
[8] Hepatitis B Foundation. (2020, March 4). Copay accumulators – What they are and what they mean for your prescriptions. Retrieved from https://www.hepb.org/blog/copay-accumulators-mean-prescriptions/

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.

Fighting Fake Online Pharmacies & Counterfeit Medicines

By: Shabbir J. Safdar, Executive Director of the Partnership for Safe Medicines

If law enforcement knows that criminals in another country are shipping illegal drugs to patients in the United States, how long should we let them traffic poison while we fight the problems of prosecuting foreign nationals? How long do we let them harm Americans while they sit outside our borders and refuse to come to the U.S.? Three weeks? Six weeks?

Right now, we’re operating at delays measured in years, and the cost to Americans in medical harm and fraud is not acceptable. New bipartisan legislation would help disrupt these criminals: the DRUGS Act (S.3399 / H.R. 6352)

Let me tell you a story about a “Canadian” pharmacy: A web pharmacy named CanadaDrugCenter.com shipped an anti-inflammatory and a blood thinner to the U.S. in 2014. Their website had Canada in its name, but the medicines they sold came from Mauritius and Turkey. They didn’t even pretend. The packages were drop shipped straight from Mauritius and Turkey to the buyer in Portland, Maine.

The recipient was a professor of pharmacy with access to a lab, so he tested them. The anti-inflammatory was sub-therapeutic (not enough active ingredient) and the blood thinner had a contaminant. (Cancer-causing agent, anyone?)

What do you think happened to the company, CanadaDrugCenter.com? 

Extradition, even from a friendly neighbor like Canada, is challenging. The criminals that ran
CanadaDrugCenter had an enormous network of over 200 fake pharmacy websites, but still
could not be easily extradited. It’s hard to negotiate a plea deal with someone who knows you
can’t force them into court to face charges.

Nothing. For years.

As the Maine Board of Pharmacy and the Maine Attorney General wondered how they might be able to protect their patients from Canada Drug Center’s predatory business, CanadaDrugCenter continued selling to Maine patients. The Internet Archive shows they ran the website for at least two more years. They also ran full page ads in the local Maine newspaper. And they continued selling their counterfeit medicines to Mainers.

Eventually, the feds finally got involved. They had to conduct a long investigation, convince a U.S. attorney to bring charges, and then deal with the fact that the executives from Canada Drug Center had no interest in showing up in U.S. courts. Eventually they pleaded guilty and settled the case. Nobody went to jail but they paid a fine of over four million dollars.

Why do we let these operations continue when law enforcement knows they are selling drugs illegally online? These criminals sell fake versions of therapeutics like blood thinners, but also controlled substances like the ones driving the current opioid crisis. They do it from outside U.S. borders because they know it’s really hard to extradite them. These aren’t the first counterfeiters to simply decline to show up in U.S. court.

There is a better way: When we have clear evidence that someone is running a business selling drugs illegally online without a state pharmacy license, we should suspend their website domain name. The Food and Drug Administration and the Department of Justice could have suspended CanadaDrugCenter.com once they had proof of the crime. And the “Canadian pharmacy” could have reclaimed the domain when they cleared themselves of the charge.

This isn’t a new concept: if the police discover you’ve turned your home into an open air heroin store and shooting gallery, you don’t get to keep the supply of drugs until you’ve won your trial. You’re lucky if you even get let out of jail. If you’re caught with a pill press with an illegal mold for opioids in it, you don’t get to keep using the pill press until the trial is over.

Photo Source: Money Logue

A new law that would take these website domains away from criminals is called the DRUGS Act (HR 6352 / S 3399). It’s bipartisan, introduced by both Republicans and Democrats in the House and Senate, and would go a long way to protecting Americans from criminals who refuse to play by the rules while we go through the long process of adjudicating their cases.

To learn more about how you can support it, watch our video about this legislation and use this link to send a letter to your elected officials.

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.

Ending the HIV Epidemic Off to a Middling Start

By: Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative

The Health Resources and Services Administration (HRSA)’s HIV/AIDS Bureau (HAB) released its inaugural Ending the HIV Epidemic (EHE) triannual report—Ending the HIV Epidemic in the U.S. Initiative Data Report—in December 2021 (HRSA, 2021). The findings contained within present a limited, clouded, and admittedly complicated portrait of a program that has been beset by setbacks, complaints about the selection process, and a global pandemic.

What is EHE?

EHE was announced in 2019 by the Trump Administration as a plan to “…end the HIV epidemic in the United States by 2030. The plan “…leverages critical scientific advances in HIV prevention, diagnosis, treatment, and outbreak response by coordinating the highly successful programs, resources, and infrastructure of many HHS agencies and offices” (Office of Infectious Disease and HIV/AIDS Policy, 2021). To achieve this goal, those who worked to develop EHE as a strategy developed a four-pillar approach:

1. Diagnose – diagnose all people with HIV as early as possible
2. Treat – rapidly prescribe Antiretroviral Therapy (ART) to people living with HIV (PLWH) to reach sustained viral suppression.
3. Prevent – prevent new HIV infections from occurring by using proven interventions, including Pre-Exposure Prophylaxis (PrEP) and Syringe Services Programs (SSPs)
4. Respond – respond to potential HIV outbreaks to get needed prevention and treatment services to people who need them (Office of Infectious Disease and HIV/AIDS Policy)

Once these policy goals were developed, EHE went about selecting “priority jurisdictions”—48 counties, Washington, DC, San Juan, Puerto Rico, and seven states that have a substantial rural HIV burden (AL, AR, KY, MS, MO, OK, & SC) (Figure 1).

Figure 1 – Map of Ending the HIV Epidemic Phase 1 Jurisdictions

Note: Office of Infectious Disease and HIV/AIDS Policy, 2020

Phase I jurisdictions were selected based upon HIV reporting data from 2017, including incidence, prevalence, and racial and ethnic demographic makeup. Once those jurisdictions were chosen, the vast majority of federal HIV funding was redirected away from a national approach to confronting HIV and to these jurisdictions.

The key strategies for addressing HIV in these jurisdictions include the following:

• Implementing evidence-informed and emerging intervention strategies shown to increase linkage, engagement, and retention in care focused on those not yet diagnosed, those diagnosed but not in HIV care, and those who are in HIV care but not yet virally suppressed;
• Re-engaging people with HIV who were in care, but are no longer in ongoing care and are not virally suppressed.
• Providing technical assistance and systems coordination to support effective strategic plans and activities to successfully implement the new initiative; and
• Expanding workforce capacity through the efforts of the AIDS Education and Training Centers (AETCs).

The Findings of the Report

The data presented in the HRSA report cover March 2020 through December 2020, broken into two reporting periods—March 2020 through August 2020, and September 2020 through December 2020. This was selected because funding was awarded to Phase I jurisdictions in March 2020. It is noted that subsequent reports will represent a full calendar year. $63 million was released to the 47 HRSA HIV/AIDS Bureau (HAB), two technical assistance providers, and 11 Ryan White HIV/AIDS Program (RWHAP) AETCs. HRSA anticipated that the HAB EHE recipients would serve 18,000 new or re-engaged people with HIV during the initial year.

According to the HRSA report, HAB EHE-funded service providers served 11,139 new people and 8,282 re-engaged people, totaling 19,421 clients—meeting and exceeding the goal of 18,000 new or reengaged clients by 7.9%.

These data include all clients served by funded providers. When controlled for EHE initiative-specific services, 6,381 clients were served, of which 68.4% were new or re-engaged clients. In 2020, of the 45,880 total clients prescribed ART, just 21.5% were new or re-engaged in care and treatment (HRSA).

Limitations of the Data

First and foremost, it must be mentioned that the rollout of the EHE initiative was very heavily impacted by the onset of the COVID-19 pandemic. As the U.S. nears the end of two calendar years of pandemic-related service reductions, social distancing, remote services implementation, and temporary or permanent site closures. These conditions created a set of hurdles that required on-the-spot revisions and improvisations that potentially limited the ability of jurisdictions to plan and implement the programmatic offerings for which they were funded.

As to the report, itself, HRSA openly admits that these data are limited to just the EHE-funded jurisdictions and are not reflective of overall trends across the nation. Because these providers are already providing services, the data they provide includes all of their clients, not just those served using EHE funding. As such, the Triannual Module data cannot be used to estimate the specific costs associated with serving clients using 2020 EHE funding. 

Additionally, no demographic or other characteristic data are submitted, meaning that it will be difficult to try to determine how EHE is actually impacting PLWH at the demographic level (e.g., White, Black, Hispanic).

And, because the data are reported in aggregate, it is not possible to de-duplicate client counts, meaning that the report may overestimate the number of unique PLWH served.

Perhaps the most damning lack of evidence in this report is that none of these data are broken into funding jurisdictions. Essentially, there’s no way to see how each jurisdiction is performing. This means that it is entirely possible that these reports could potentially originate from just the metro regions that already see the bulk of new and re-entering PLWH. Without these detailed data breakdowns, we have no way to see whether or not jurisdictions are producing results.

Criticisms of the EHE Approach

One sentence that causes concern in the Comments section of the HRSA report is the following:

"Without this EHE initiative, new infections will continue and could increase, costing more lives and the U.S. government more than $200 billion in direct lifetime medical costs for HIV prevention and medication."

This statement is indicative of what many advocates feel to be the primary issue with EHE: its insistence that the EHE approach is the definitive approach to addressing HIV. To be fair, this type of hubris and “this is the only way” verbiage was a consistent feature of the Trump Administration: “Only I can fix America;” “Only this trade deal will fix our trade deficit.”

Since the launch of EHE, HIV advocates across the country have raised significant concerns about several aspects of the strategy:

• If the purpose of EHE is to increase testing and surveillance, why are the majority of resources going to jurisdictions that already received considerable federal HIV funding resources?
• If funding is released in phases, what happens to HIV funding for jurisdictions that are not included until later rounds?
• What measures are in place to determine if EHE funds are being properly and effectively used in the selected jurisdictions?
• Are new funding opportunities always going to be restricted to Phase I jurisdictions?
• Does the “Respond” pillar actually function?
• While data do show that HIV has disproportionately impacted minority communities, particularly Black and Hispanic communities, they also show that HIV disproportionately impacts people with lower incomes. With that in mind, why has “poverty” been eliminated as a criterion in favor of focusing almost entirely on racial and ethnic minority demographics?

In this author’s experience, whenever those responsible for putting together or running the EHE program are faced with these questions, they tend to fall back on their methodology, rather than addressing either the problems that exist with EHE or appropriately resourcing jurisdictions with emerging HIV outbreaks if they are not included.

The Failure of EHE—A Case Study

An excellent case study of this is the state of West Virginia. Since the beginning of the HIV epidemic in 1981, West Virginia has been considered a low-incidence state, averaging 77 new HIV diagnoses per year between 2013-2017. Beginning in 2018, West Virginia began experiencing a series of HIV outbreaks related to Injection Drug Use (IDU). By 2019, the number of new HIV diagnoses increased by 92% to 148 new diagnoses, of which 61.5% were directly related to IDU (Office of Epidemiology and Prevention Services, 2022).

By all accounts, West Virginia is the ideal jurisdiction for the EHE initiative. A primarily rural state, West Virginia has been the poster child for public health disasters: it has led the nation in drug overdose deaths, opioid addiction, Hepatitis A, B, and C diagnoses, and now has the highest rate of IDU-related HIV diagnoses in the United States. It also has virtually no statewide HIV testing and surveillance infrastructure. What complicates the situation is that West Virginia is one of the most chronically underfunded states. 

And yet, West Virginia was not chosen to be a Phase I jurisdiction. Because the data used were from 2017, when West Virginia was not yet experiencing an outbreak, the state was not considered. However, even by current standards for newer funding announcements, West Virginia meets neither the threshold for new diagnoses (200) nor the racial and ethnic minority demographics—minorities make up just 4% of West Virginia’s population— that these announcements require.

When it became clear that West Virginia was experiencing concurrent HIV outbreaks, a West Virginia public health advocacy organization, the Community Education Group (CEG), approached those in charge of EHE, Dr. Jonathan Mermin at the Centers for Disease Control and Prevention (CDC), Health and Human Services (HHS), and numerous other agencies to try to get resources for the state to address these outbreaks. What they discovered was that the problem was deemed not severe enough for intervention and that the “Respond” pillar of EHE applied only to current phase jurisdictions. Moreover, West Virginia was not expected to receive HIV funding from EHE until 2025, when Phase II funds will be released.

In the end, it took nearly three years of constant needling and finally national press attention to get the CDC to return to West Virginia. Even then, the solutions they recommended came with no funding attached and relied upon harm reduction responses, such as SSPs, that, thanks to a state statute passed in 2021, are under such intense scrutiny and regulations that a significant number of the health department-run SSPs are closing.

How to Address These Issues

West Virginia is just one example of how EHE fails to address the real-world needs of PLWH and the jurisdictions that serve them. One of the primary failings of EHE is that it directs funding to jurisdictions that have, over the course of the past forty years, received the bulk of federal and private HIV funding: Los Angeles, San Francisco, New York City, Atlanta, and other metropolitan areas—areas of the country where the majority of HIV infections have occurred over the past forty years.

This is not to say that PLWH in these areas are not deserving of funding and services; they absolutely are. However, the U.S. has spent countless millions in these areas building testing, treatment, and services infrastructures that, while not perfect, exist. The inclusion of the seven states with a rural HIV burden has always seemed a bit like an afterthought.

In response to this, supporters of EHE consistently argue, “We’re going where the data lead us.” This argument is hard to refute because it is true—they are going where there are available data to lead them. This was the case with West Virginia: in a state with no surveillance infrastructure, how do we identify and respond to emerging trends?

If the purpose of EHE is to build those infrastructures across the country and reach into areas with the existing social determinants of health that often predict the emergence of infectious disease outbreaks, such as HIV and Hepatitis C (HCV). In fact, it is this point that makes the selection of the EHE counties so confusing:

A 2016 report released in the Journal of Acquired Immune Deficiency Syndrome identified 220 counties that were “…vulnerable to a rapid spread of HIV if introduced, and new or continuing high rates of HCV” (Van Handel, et al., 2016). Of the 220 counties identified in that report, with the exception of the 7 entire states that were selected, none of those counties identified were targeted with EHE funds (HRSA).

This is a problem. The way to solve it is to begin directing a greater proportion of federal HIV resources to those counties in order to build infrastructures in order to begin laying the groundwork to prevent those worst-case scenarios.

This isn’t a new problem. It is one that has existed since the beginning of the HIV epidemic which, after forty years, is now just ‘endemic.’ We have always directed the majority of resources to where the majority of people are located because that is where the data lead.

In order to address this, we must decide to move away from the model of being reactive to one where we are proactive. When these smaller jurisdictions are handed large sums and expected to upscale without having a clear pathway or the long-term resources to do so, the infrastructure will never be solid. Even if they receive Phase I dollars, the majority are going to large jurisdictions to prop up their existing systems, rather than to those that need to build theirs from scratch.

Does this mean that we “rob Peter to pay Paul”? Sadly, the fiscal reality is that there aren’t a lot of great solutions. We can:

1. Massively increase total HIV funding at the federal level, give the new additional funds to these vulnerable jurisdictions, and leave HIV funding in the metro areas at their existing levels, or
2. Live with the reality that a massive increase is highly unlikely and redirect a percentage of the funds currently allocated and awarded to metro areas to vulnerable jurisdictions, essentially telling metro areas to do more with less.

Neither of these scenarios is perfect. Then, again, neither is the existing funding mechanism under EHE. What is clear, however, is that we need yet another rethink about how we’re approaching HIV in the United States, because EHE does not appear to be bearing the fruit it promises.

But maybe the critics are wrong. Maybe, if we give it time, the problems will self-correct. Perhaps, with targeted interventions to help those struggling Phase I jurisdictions, we can right this ship. Given the current political climate in Washington and the increasingly volatile climates in statehouses around federal-level responses to public health crises, it is unclear as to whether or not a rethink will even be possible.

References:

• Health Resources and Services Administration. (2021, December). Ending the HIV Epidemic in the U.S. Initiative Data Report 2020. Rockville, MD: United States Department of Health and Human Services: Health Resources and Services Administration: Data: Data Reports and Slide Decks. https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/2020-hrsa-ehe-data-report.pdf
• Office of Epidemiology and Prevention Services. (2022, February 10). HIV Diagnoses by County, West Virginia, 2019-2022. Charleston, WV: West Virginia Department of Health and Human Resources: Office of Epidemiology and Preventions Services. https://oeps.wv.gov/hiv-aids/Documents/Data/WV_HIV_2019-2022.pdf
• Office of Infectious Disease and HIV/AIDS Policy. (2020, November 03). Priority Jurisdictions: Phase I. Washington, DC: United States Department of Health and Human Services: Office of Infectious Disease and HIV/AIDS Policy: HIV [dot] gov: Federal Response. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one
• Office of Infectious Disease and HIV/AIDS Policy. (2021, June 02). What Is Ending the HIV Epidemic in the U.S.?. Washington, DC: United States Department of Health and Human Services: Office of Infectious Disease and HIV/AIDS Policy: HIV [dot] gov: Federal Response. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview
• Van Handel, M. M., Rose, C. E., Hallisey, E. J., Kolling, J. L., Zibbell, J. E., Lewis, B., Bohm, M. K., Jones, C. M., Flanagan, B. E., Siddiqi, A. -E. -A, Iqbal, K., Dent, A. L., Mermin, J. H., McCray, E., Ward, J., & Brooks, J. T. (2016, November 01). County-Level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections Among Persons Who Inject Drugs, United States. Journal of Acquired Immune Deficiency Syndromes, 73(3), 323-331. https://doi.org/10.1097/QAI.0000000000001098

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.

FDA Extends Cabenuva Approval to Every Two Months

By: Ranier Simons, ADAP Blog Guest Contributor

The primary weapons in the fight against HIV are anti-retroviral drugs, commonly referred to as ARVs. ARVs work by lowering the levels of HIV, known as viral load, in the body to stop HIV’s damage to the immune system. Viral load is measured by the number of copies of HIV RNA in a milliliter of blood.[1] The goal of ARV’s is to decrease the viral load to the point that standard tests cannot detect it. This level of viral suppression is commonly known as ‘undetectable’, and with it comes the important  'undetectable equals untransmissible' (#UequalsU) treatment goal.[2] Moreover, viral suppression means a significant reduction in the damage HIV can do to the body. This fight recently gained a new weapon, with two-month dosing of the injectable HIV therapy, Cabenuva.

Effective treatment means maintaining the levels of the medications in the body. This requires adherence to daily dosing. Not keeping the drugs at appropriate levels in the blood can increase viral load, damage immune cells such as CD4’s, and even drug resistance.[3] Drug resistance means that mutations of HIV could develop that are not responsive to a person's treatment regimen rendering that regimen ineffective and making it harder to find other medications that will work. 

Photo Source: Very Well Health

Early in the fight against HIV, drug regimens consisted of multiple pills several times a day. Toxicity issues, as well as issues keeping dosage schedules, were significant barriers to treatment. Modern-day once-daily one pill regimens were developed to combat both of those issues. However, some patients still experience difficulties with adherence. The most reported adherence challenges are forgetfulness, stigma, health perception, and digestive side effects.[4]

Some patients report having issues remembering to take their medication daily, especially those who have been on long-term therapy. Stigma is a concern by those who do not want family members to know they are living with HIV or to see them take medications. They do not want coworkers to know they are on medication and are psychologically harmed by the daily reminder of their health status. Health perception is an issue for long-term ARV patients because they feel healthy; thus, they become inconsistent with their dosing. Some patients also are inconsistent with their regimens due to perceived and experienced side-effects they experience from the drugs.

The evolution of ARV drug development has led to recent innovations to battle adherence issues. In January 2021, the U.S. Food & Drug Administration (FDA) approved a once-a-month injectable HIV treatment called Cabenuva. It is an extended-release injectable of cabotegravir and rilpivirine. The drug is a collaboration between Janssen Pharmaceuticals of Johnson & Johnson and ViiV Healthcare. Cabenuva is two separate injections into the buttock muscles, with the extended-release rilpivirine having been developed by Janssen and the extended-release cabotegravir from ViiV Healthcare.[5]

Photo Source: The New York Times

Cabenuva is meant for those who are virologically suppressed on a stable regimen and who have no history of treatment failure or known resistance to cabotegravir or rilpivirine. Proper administration requires one month of daily administration of rilpivirine and cabotegravir in pill form to assess tolerance before beginning the monthly injections of Cabenuva. 

Continued research into daily Cabenuva proved that it is effective. Its efficacy has proven to be so positive that on February 1, 2022, the FDA approved it for two-month injectable treatment. Therefore, some patients can be treated with only six sets of injections annually instead of twelve. The extended label approval of Cabenuva from one to two months is based on the ATLAS-2M phase IIIb trial results. An ongoing clinical trial shows that in terms of virologic suppression, every two-month dosing is not inferior to monthly dosing. ATLAS-2M is being conducted in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the United States.[6]

The most common adverse reactions were fever, injection site reactions, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The type and frequency of experienced adverse reactions were similar in those receiving the injection monthly or every two months. Additionally, the rates of serious adverse events or withdrawal due to adverse events were similar between the two groups.

This new FDA approval has the potential to be life-changing for those where Cabenuva treatment is appropriate. For further information on ATLAS-2M, please see https://clinicaltrials.gov/ct2/show/NCT03299049.

[1] Peabody, R. (2017, May). Viral load. Retrieved from https://www.aidsmap.com/about-hiv/viral-load#:~:text=The%20results%20of%20a%20viral,100%2C000%20would%20be%20considered%20high
[2] NIH. (2020, June 12). 10 Things to know about HIV suppression. Retrieved from https://www.niaid.nih.gov/diseases-conditions/10-things-know-about-hiv-suppression#:~:text=Daily%20antiretroviral%20therapy%20can%20reduce,to%20keep%20the%20virus%20suppressed
[3] Peabody, R. (2019, July). Adherence to HIV treatment. Retrieved from https://www.aidsmap.com/about-hiv/adherence-hiv-treatment
[4] Genberg, B. L., Lee, Y., Rogers, W. H., & Wilson, I. B. (2015). Four types of barriers to adherence of antiretroviral therapy are associated with decreased adherence over time. AIDS and behavior, 19(1), 85–92. https://doi.org/10.1007/s10461-014-0775-2
[5] Janssen Pharmaceuticals. (2022, February 1). U.S. FDA approves CABENUVA (rilpivirine and cabotegravir) for use every two months, expanding the label of the first and only long-acting HIV treatment. Retrieved from https://www.janssen.com/us/sites/www_janssen_com_usa/files/us_fda_approves_cabenuva_rilpivirine_and_cabotegravir_for_use_every_two_months_expanding_the_label_of_the_first_and_only_long_acting_hiv_treatment.pdf
[6] ViiV Healthcare. (2022, February 1). ViiV Healthcare announces us FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting hiv treatment. Retrieved from https://viivhealthcare.com/en-us/media-center/news/press-releases/2022/january/viiv-healthcare-announces-us-fda-approval-of-cabenuva/

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.