Protease Inhibitors and Integrase Inhibitors Show Early Promise in Protecting Against Covid-19

By: Ranier Simons, ADAP Blog Guest Contributor

The scientific and medical world is still actively researching and learning about Covid-19. This is especially true regarding how Covid-19 affects the populations of people living with HIV. Generally, HIV-positive people are more susceptible to community-spread diseases or opportunistic infections. However, current research indicates that people living with HIV are not at increased risk for severe COVID-19 illness or hospitalization.[1] This realization is only valid for HIV -positive people who have healthy CD4 counts greater than 200 and are on a consistent, stable medication regimen. Those with advanced HIV disease and low CD4 counts do not fare as well. Ongoing research also shows that unvaccinated HIV-positive people are more likely to develop long Covid.[2] 

Photo Source: AIDSmap

Not only are otherwise healthy HIV-positive individuals not at a higher risk for Covid-19, but small early studies suggest that they may be at a lower risk due to their antiretroviral therapy (ART). Specifically, protease inhibitors and integrase inhibitors show early promise in protecting against Covid-19.

One such study, presented at the European Congress of Clinical Microbiology & Infectious Diseases this week in Lisbon, Portugal, shows promise in protease inhibitors. Protease inhibitors work by blocking a critical enzyme viruses, like HIV, need for replication which allows infection of more cells.[1] This study was a multicenter cohort study that examined how long-term usage of protease inhibitors (PI) influenced the incidence of Covid-19. The study group was 169 people with HIV on ART with PI and 338 HIV patients on ART without PI. None of the patients had ever contracted Covid-19. They had been on PI treatment for at least a year.

Seventy-seven percent of the PI group was treated with darunavir/ritonavir, 8 percent with atazanavir/ritonavir, and the remainder used other PI’s. After being followed for a year, 12 percent of those treated with PI’s contracted Covid-19 compared to 22 percent of those in the non-PI group.[1] This is an observational study and cannot be used to imply direct proven clinical causality. Yet, it is a promising step of initial inquiry.

Photo Source: Viral Zone

Integrase Inhibitors are the focus of another recent study. In a study recently published in the International Journal of Molecular Sciences, researchers report two drugs that prevent SARS-CoV-2 (Covid-19) from entering host cells. SARS-CoV-2 enters cells via a pathway involving its spike protein (S) and the angiotensin-converting enzyme 2 (ACE2) receptor on host cells. Utilizing an assay they developed to detect the interaction between S and ACE2; scientists selected a library of drugs to screen in regards to possibly preventing the interaction.[3] Out of the 1068 integrase inhibitors considered, Dolutegravir and Etravirine were the most successful at prohibiting SARS-CoV-2 into host cells.[3] They were both also found to be effective at neutralizing the Omicron variant as well as wild-type virus and other variants of concern. 

Investigating the possible Covid-19 protection offered by protease and integrase inhibitors may lead to additional weapons in the arsenal against Covid-19. Utilizing these drugs’ off-label effects could lead to new pre/post-exposure prophylactic treatments for Covid-19 infection.

[1] Henderson, E. (2022, March 27). HIV patients on antiretroviral treatment with protease inhibitors may have lower COVID-19 risk. Retrieved from https://www.news-medical.net/news/20220327/HIV-patients-on-antiretroviral-treatment-with-protease-inhibitors-may-have-lower-COVID-19-risk.aspx
[2] Alcorn, K. (2022, March). COVID-19 and coronavirus in people living with HIV. Retrieved from  https://www.aidsmap.com/about-hiv/covid-19-and-coronavirus-people-living-hiv
[3] Lee, R. et al. (2022) "Identification of Entry Inhibitors against Delta and Omicron Variants of SARS-CoV-2", International Journal of Molecular Sciences, 23(7), p. 4050. doi: 10.3390/ijms23074050.https://www.mdpi.com/1422-0067/23/7/4050

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. 

Medical Debt is a Severe Financial Burden in the United States

By: Ranier Simons, ADAP Blog Guest Contributor

Medical debt is a major financial crisis in the United States. It is a major barrier to financial health and even physical health. Studies show that medical debt is negatively correlated with health issues. People who have problems paying their medical bills have a shorter life expectancy, poorer mental health, health issues like hypertension, and lower self-reported health status.[1] 

Photo Source: The Sycamore Institute

Even though over 90 percent of the U.S population has some semblance of health insurance, medical debt is still a pervasive and debilitating issue.[2] Present-day medical insurance plans have many cost-sharing requirements that saddle patients with bills they cannot pay. With high monthly premiums, these requirements, such as high deductibles and co-payments, result in bad life decisions. People face juggling basic needs such as food, clothing, and housing with paying medical bills generated by necessary care. Moreover, people borrow from family or even financial institutions, going into even further debt to take care of their medical bills.

The Kaiser Family Foundation published a brief shining light on the burden of medical debt in the United States. The overall finding was that the burden of medical debt is stratified along racial and economic lines, age cohorts, strength of insurance coverage, and health status. The data source was the Survey of Income and Program Participation (SIPP). Significant medical debt was defined as people who owed more than $250 in unpaid medical bills as of December 2019.[2]  The survey shows that people in the United States owe, at the minimum, approximately $195 billion in medical debt. Roughly six percent of adults have over $1,000 in medical debt, and one percent (about 3 million people) owe over $10,000.[2]

Photo Source: KFF

Along racial lines, African-Americans are reported to be more likely to have significant medical debt. Of the 9 percent of adults surveyed who meet the study threshold of high debt, 16 percent of those are non-Hispanic African-American. This contrasts to 9 percent of non-Hispanic White Americans and 4 percent of non-Hispanic Asian-Americans. Regarding gender, more women report having high medical debt than men; 11 percent and 8 percent, respectively. Part of this discrepancy could be attributed to women having lower incomes and increased healthcare expenditures associated with childbirth.

Unsurprisingly, older adults are more likely to have significant medical debt than younger people. However, there is a distinction apparent among those later in life. The report shows that the percentages decrease when older adults reach Medicare age. Twelve percent of adults aged 50-64 report significant medical debt, in contrast to 6 percent of those aged 65-79.[2] 

In terms of income, those with lower or moderate incomes are more likely to have high medical debt. Twelve percent of adults with incomes below 400% of the federal poverty level have such debt. Income is essential because some do not have liquid assets to pay out of pocket maximums, deductibles, and co-insurances, even with insurance. Sixteen percent of adults stated they would need to take on credit card debt to meet an unexpected $400 expense.[2] Four hundred dollars could easily be an emergency room visit co-pay for a privately insured person or even an urgent care visit for someone who was not insured.

Health status in combination with income is another relationship leading to medical debt. Those with more medical issues, by definition, have more medical expenditures due to chronic health maintenance needs, and higher utilization of services generates more bills that accumulate over time. Those with more serious medical issues cannot earn as much income being hindered physically by their medical problems in both ability and maintaining consistent employment.

Geography was also shown to be a factor by the report. People living in rural states in the South reported as being 12% of those reporting high medical debt, as opposed to 10% in the Midwest, 6% in the West, and 8% in the northeast. Related to this geographical distribution is Medicaid. Twelve states that have not expanded Medicaid under the Affordable Care Act are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.[3]

The KFF report is proof that expanding coverage is not a panacea to alleviating the financial burden associated with medical debt. Effective change will come with restructuring healthcare finance, socioeconomic infrastructure, wholistic population needs assessment, and re-examining the country’s value system.

[1] Pellegrin, M. (2021, May 19). How medical debt affects health. Retrieved from https://www.sycamoreinstitutetn.org/how-medical-debt-affects-health/
[2] Rae, M., Claxton, G., Amin, K., Wager, E., Ortaliza, J., & Cox, Cynthia. (2022, March 10). The burden of medical debt in the United States. Retrieved from https://www.healthsystemtracker.org/brief/the-burden-of-medical-debt-in-the-united-states/
[3] Holahan, J., Buettgens, M., Banthin, J., & Simpson,M. (2021, June 30). Filling in the gap in states that have not expanded Medicaid eligibility. Retrieved from https://www.commonwealthfund.org/publications/issue-briefs/2021/jun/filling-gap-states-not-expanded-medicaid

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. 

Industry’s Changes to 340B Drug Discount Program

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

The Community Access National Network (CANN) and ADAP Advocacy Association, back in October 2020, issued a Dear Colleague letter to our industry partners in the pharmaceutical manufacturing space surrounding HIV therapies. We detailed our concerns regarding the 340B Discount Drug Program and the necessity to ensure safety-net public health programs do not “get caught in the crossfire between pharmaceutical companies and contract pharmacies.” Our efforts led to constructive conversation, as well as a commitment to protect patients access to timely, appropriate care and treatment. Essentially, we sought a “carve out” for certain Covered Entities, namely the Ryan White Grantees (“Grantees”) serving clients living with HIV/AIDS. 

Photo Source: CANN

In the time since, considering our collective concerns for the sustainability, stability, and honest efforts to provide necessary services to PLWAHA, many of our industry partners have ensured additional efforts at transparency and accountability do not add to already existing reporting burdens of the Grantees. We still contend that the carve-out is essential to avoiding possible damaging effects on the safety-net programs crucial to the HIV-positive community.

Unfortunately, a few of our industry partners have express concerns about “bad actors” trying to encroach on the federal grantee carve-outs industry partners have thus far offered in requesting additional reporting of 340B Covered Entities. It has been our earnest position that solving the problems facing the 340B Drug Discount Program are achieved in a way that preserves benefit to patients and intent of the program while protecting against bad actors. However, any effort requires a scalpel, not a hatchet. The carve-out of these additional reporting requirements, in light of the oversight already offered by being federal grantees, has helped our industry partners align their values with their actions in working to ensure program integrity and minimize risks to patient benefit. 

It is important to recognize the historical and current reality many Grantees face. Yet, should pharmaceutical manufacturers insist on blanket reporting requirements for all Covered Entities void of any carve-outs, it should be done by supporting these Grantees, and thus the services and medications their patients rely upon. We urge our industry partners to pair any new reporting requirements with funding for the following activities:

• necessary expertise to navigate the establishment of third-party administrator and contract pharmacy agreements.
• extend program initiation funding for the 3 years after qualification to meet the labor needs of fulfilling this reporting requirement.
• develop other programming clinics specifically identify to work collaboratively.

Whereas our two organizations have long-supported reforms to the 340B Drug Pricing Program, because they are overdue and opportunities exist to ensure every single penny squeezed out of the program directly benefits patients, let’s not throw the baby out with the bathwater. Provided our industry partners are genuine in their expression and desire to preserve 340B’s intent to benefit patients, the aforementioned steps are modest and support appropriate transparency and accountability.

Respectfully, we believe any genuine effort to introduce added reporting burden on Grantees, of which are already most closely monitored in the 340B space, must also include support to meet these burdens. Any adjustments to Grantees’ reporting supported by funding and programming designed for Grantees to be “set up for success” on all accounts. We believe our industry partners are up to the task at hand and maintain the integrity to align actions and values.

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.

A Rare Personal Appeal to My POZ Brothers & Sisters; Please Protect Yourself

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

For nearly 15 years, I've had the distinct honor of serving as the CEO of the ADAP Advocacy Association. The position has afforded me the opportunity to advocate for greater access to care and treatment for people living with HIV/AIDS, as well as to encourage patients to become stronger self-advocates, and also to mentor some new advocates along the way. And although it is a rare occurrence for me, today I'm making a personal appeal to my POZ brothers and sisters to protect themselves against Covid-19. Please get vaccinated, and boosted!

Over the weekend, and only after playing the "rona-dodge-ball" game for over two years, my luck finally ran out and I tested positive for Covid-19. Last year, I had received both series of the Pfizer–BioNTech Covid-19 vaccine, as well as the first booster shot. I did so to protect myself as an immunocompromised patient, but more importantly to protect my son, Sebastian, who is too young to be vaxx'd. In retrospect, it was the best thing that I could have done for both him and me. 

My ongoing recovery from Covid-19 has also been helped with a prescription for Merck's monoclonal antibody, called molnupiravir. That, and a lot of fluids and rest.

Although vaccines don't guarantee full protection against acquiring Covid-19, they most certainly do provide undeniable protection after testing positive. I have experienced 48-hours of severe Flu-like symptoms, but it could've been much worse if I had been unvaccinated.

Too many people living with HIV/AIDS remain unvaccinated, and it is concerning to me. We've witnessed enough needless suffering from this coronavirus, and far too many deaths. Please don't ignore the facts made available by the U.S. Centers for Disease Control & Prevention on the rates of Covid-19 cases, associated hospitalization, and deaths by vaccination status. The broader issue isn't about protecting you from SARS-CoV-2 infection, but rather what will happen if you do indeed get it. It is undeniable the full vaccine series and booster is very likely to keep you out of the hospital, and more importantly, out of the funeral home.

Photo Source: CDC

My personal appeal comes in response to recent troubling conversations about vaccination hesitancy; one was with an unvaccinated young, African-American male, and another with an unvaccinated middle-aged, white female. The former believed the Covid-19 vaccinations actually cause people to get the coronavirus, and not provide any protection. The latter argued the unvaccinated were actually faring better against Covid-19 than their vaccinated (and boosted) peers. Neither of these beliefs could be further from the truth, but they exist. Unfortunately, a lot of misinformation is fueled by certain cable news outlets, social media-fueled conspiracy theories, and ill-informed politicians with bad hair lusting over sound bites.

The intersection between the HIV/AIDS epidemic and the Covid-19 pandemic has become the new normal. A recent headline in Business Insider read, "Over the last four decades, HIV/AIDS has killed at least 700,000 Americans. COVID-19 has killed more in two years." We've previously been down this road, together. So let's learn from the past!

The science and technology behind the current vaccinations against Covid-19 are deeply rooted in the same life-saving therapies we rely on to keep us all healthy...and alive! Why not embrace the Covid-19 vaccination as an extension of your HIV-related care and treatment? Why not trust in the advent of the medical and treatment advances to keep you healthy? Why not take a leap of faith the same way we'd collectively do, if a cure for HIV is eventually discovered?

There could be numerous reasons why protecting yourself against Covid-19 is important. For me, especially as a single parent, it is my son. The mental health toll that this pandemic has placed on me cannot be understated with respect to him. I lay awake at night playing the what if game. If something happens to me, then who will care for him? If I test positive, then will I expose him to this terrible illness? If he gets sick, then will he end up in the pediatric intensive care unit? What I do know, getting that jab in my arm is my best line of defense.

In other words, our choices have consequences.

If you're HIV-positive and still unvaccinated, then please... please... please protect yourself by getting vaccinated against this potentially deadly virus. Talk to your physician. Talk to your pharmacist. Talk to your social worker. Talk to your clergy. Talk to your vaccinated peers. I invite you to email me and let's set-up a time to talk about why it is so important to protect yourself and the people important to you. You're important to me, and that's why I'm making this rare appeal.

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.

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.