Spike in Monkeypox Disease Among MSM Causes Alarm, Too

By: Ranier Simons, ADAP Blog Guest Contributor

On Saturday, July 23, 2022, the World Health Organization (WHO) declared monkeypox a PHEIC, public health emergency of international concern.[1] Internationally, the number of cases has reached over 16,000 in over 75 European countries, North and South America, the Middle East, South Asia, Australia, and other parts of Africa not previously exposed.[1] In the United States, there have been roughly 2,900 cases. 

It is important to note that anyone can contract monkeypox. Monkeypox was first identified in 1958 in a colony of research monkeys.[2] Since 1970 human outbreaks have been reported in 11 African countries. The first outbreak outside of Africa was in 2003 in the United States. It occurred in several midwestern states and was linked to infected prairie dogs that people had as pets. Those pets likely contracted the disease from being housed with infected rats and door mice shipped from Ghana.

Photo Source: National Institute for Communicable Diseases

Although anyone can contract the disease, the recent outbreak disproportionately affects gay, bisexual, and men who have sex with men (MSM).[2] The U.S. Centers for Disease Control & Prevention (CDC), the media, and health professionals have consciously not labeled monkeypox a gay disease. It indeed is not a gay disease. However, given that the current outbreak mainly affects gay men, it is essential to clarify that explicitly. The award-winning blogger Mark S. King points out, "Gay men are getting monkeypox and suffering greatly. When gay men understand the threat, we are more likely to take precautions, get vaccinated, or be informed about treatment”.[3]

Concerns about stigma are valid. Gay men historically have and continue to face stigma and apathy in the healthcare arena and public opinion regarding healthcare issues. But, King also points out that it is dangerous to bury facts with vague and evasive messaging.[3] Vague messaging leads the general public to think that their present odds of contracting the disease are higher than the reality of the numbers. Conversely, labeling monkeypox a gay illness would make the public complacent about being mindful of their activities and being tested when they should be. 

The Washington Post’s Benjamin Ryan points out that “…public health experts know well, epidemiology is less concerned with whether someone could contract an infection; instead, the much more vital questions focus on which groups of people are most likely to be exposed to a pathogen, to contract it and why.”[4] There need to be targeted education and prevention efforts aimed at gay men to emphasize the specifics that make them more susceptible to the spread of monkeypox. Facts show that the sexual and social networks of gay men are why it is hitting the population hard. There have been clusters of infections traced back to events such as large circuit parties, nightclub events, and pool parties. Bathhouses are the settings of some clustered outbreaks, as well. Gay men need to be informed of the statistical fact of gay men having an increased incidence of multiple sex partners, especially in combination with certain events and travel, which also increases the likelihood of the spread of monkeypox amidst their demographic.

Monkeypox is contracted through close skin-to-skin contact. Transmission comes from exposure to broken skin, mucus membranes, respiratory droplets, infected bodily fluids, and even contact with contaminated linens. It is not airborne like Covid-19. Rubbing, kissing, and physical contact are enough to cause infection. Sexual intercourse is not necessary. Seven to fourteen days after infection is when symptoms usually appear. Fever, chills, exhaustion, headaches, and muscle weakness are typically initial signs.[2] Progression includes the swelling of lymph nodes and widespread body rash that can include the mouth, hands, and feet. Then fluid-filled painful pox can appear on the body, surrounded by red circles. There is increased reporting that some infected individuals only see some rash and painful pox sores in the genital and anal regions instead of all over the body.

Photo Source: PBS

Over 190,000 doses of the two-dose Jynneos vaccine have been pulled from the Strategic National Stockpile. Jynneos is used for the prevention of monkeypox and smallpox. There is still not enough in circulation to meet the demand for vaccination nor to vaccinate all those in the highest risk categories. There is also an antiretroviral effective against monkeypox named TPOXX (tecovirimat), approved by the U.S. Food & Drug Administration (FDA) for use against smallpox in 2018.[5] Unfortunately, TPOXX was only authorized for smallpox because it is deadly and can be considered a possible bioterrorism weapon. Monkeypox is not fatal like smallpox. Thus obtaining TPOXX requires many pages of paperwork to get it from the Strategic National Stockpile. Additionally, protocol requires doctors to submit pictures of a patient's lesions to the local health department or CDC and a folio of pages of detailed information to get TPOXX. After getting the drug, patients are required to keep a daily journal while they are taking it.[5]

Presently, monkeypox prevention is paramount as vaccination and treatment options are scarce. Effectively educating gay, bisexual, and men who have sex with men with the unadulterated details of their demographics’ statistically documented behaviors put them at high risk is the best weapon against the spread of the disease. Targeted explicit information delivered with respect and dignity is the best way to avoid stigma while undergirding the importance of the information.

[1] Branswell, H. (2022, July 23). WHO declares monkeypox outbreak a public health emergency. Retrieved from https://www.statnews.com/2022/07/23/who-declares-monkeypox-outbreak-a-public-health-emergency/
[2] Howard, J. (2022, July 21). Monkeypox spreading in 'cluster events,' but vaccines can help stop it, local health officials say. Retrieved from https://www.cnn.com/2022/07/21/health/monkeypox-clusters-local-officials/index.html
[3] King, M. (2022, July 19). Monkeypox is a gay thing. We must say it. Retrieved from https://marksking.com/my-fabulous-disease/monkeypox-is-a-gay-thing-we-must-say-it/
[4] Ryan, B. (2022, July 18). You are being misled about monkeypox. Retrieved from https://www.washingtonpost.com/opinions/2022/07/18/monkeypox-gay-men-deserve-unvarnished-truth/
[5] Walsh, D. (2022, July 21). There Is a monkeypox antiviral. But try getting it. Retrieved from https://nymag.com/intelligencer/2022/07/tpoxx-is-a-monkeypox-antiviral-but-try-getting-it.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.   

Resurgence of Meningococcal Disease Among MSM Causes Alarm

By: Ranier Simons, ADAP Blog Guest Contributor

Amidst the myriad of present-day public health concerns, including Covid-19 and monkeypox, there is another to add to the list. The U.S. Centers for Disease Control & Prevention (CDC) has raised the alarm regarding a surge in meningococcal disease. There has been an unusual surge of meningococcal disease in Florida.[1] The outbreak has been deadly, with 26 reported cases and 7 deaths. The CDC describes this outbreak as one of the worst meningococcal disease outbreaks among gay and bisexual men in U.S. history.[2] Twenty-four of the 26 documented cases and 6 of the 7 deaths thus far have been MSM (men who have sex with men). Anyone can become infected with meningococcal disease. It just happens that this present outbreak has initially affected mainly MSM. Presently, the outbreak primarily affects people living in Florida but has affected people who have traveled to Florida.

There are two types of meningococcal disease: meningitis and bloodstream sepsis. The Neisseria meningitidis bacteria cause them.[3] Meningitis is an infection of the tissues surrounding the brain and spinal cord. Bloodstream sepsis is a bloodstream infection resulting from the body attempting to fight infection. The body releases chemicals into the bloodstream to fight the meningococcal bacteria. As a result, those chemicals cause inflammation throughout the body. That inflammation can negatively affect the body in many ways, including organ failure and death.[4]

Photo Source: CDC

The disease is respiratory with bacteria found in the back of the throat or nose. Spread generally requires close contact and can also be caused by coughing or kissing. This is why the CDC is very alarmed, given the many summer music events, Pride festivals, and other gatherings where people are in crowded areas for extended periods. Signs of meningitis are sudden high fever, neck stiffness, headache, nausea, sensitivity to light, and mental confusion.[5] Symptoms of meningococcal sepsis are fever, chills, unusual fatigue, and in some cases, a purplish rash on the hands and feet.[5]

Without treatment, both meningococcal diseases can kill within days.[3] There are multiple species or subgroups of meningococcal bacteria. Subgroups B and C have been detected in the Florida outbreaks. Strain C is affecting large numbers of gay, bisexual, and other MSM in the counties of Orange, Polk, Seminole, Miami-Dade, and Broward. A much smaller outbreak has been detected in Leon County of Florida, affecting primarily college students, caused by strain B.

Fortunately, vaccines against meningococcal disease have been around for a long time and are widely available. The most common one is the MenACWY vaccination which protects against subgroups  A, C, W, and Y. The MenB vaccine is for subgroup B. The CDC urges all those living with HIV to get vaccinated in addition to MSM. Even before this outbreak, doctors recommended vaccination for people living with HIV. In the U.S., healthcare providers have recommended the 2-does series of the MenACWY vaccine since 2016.[6] However, widespread adoption of vaccine adherence has historically not been accomplished. The effort to educate on the importance of vaccination needs to increase as there isn’t high vaccination uptake among those newly diagnosed with HIV. 

Photo Source: TNS; The Atlanta-Journal Constitution

Since anyone can become infected, everyone must be mindful of the danger of meningococcal disease. Those in high-risk groups, including college students and MSM, should vaccinate and maintain vaccination over time. People can survive if providers administer antibiotics early. However, there can be long-term issues after contracting the bacteria, such as hearing or vision loss, amputation of affected limbs, and even memory and concentration issues.

Diseases spread quickly. Thus, it is important for people all over the country to take meningococcal vaccination seriously, not just people living in Florida. People travel to and from Florida regularly, especially as travel contiuously  increases in the direction of pre-Covid pandemic numbers.

[1] Thomas, D. (2022, June 30). Georgia health officials report no cases here, but issue cautions for men who have sex with men and travel to Florida. Retrieved from https://www.ajc.com/news/coronavirus/unusual-surge-of-meningococcal-disease-cases-in-florida-alarms-the-cdc/KHCYT7D46VFLLJIWVYS67WIPJA/
[2] Freeman, L. (2022, June 30). Meningococcal outbreak in Florida; Lee County has second highest case count with four cases. Retrieved from https://news.yahoo.com/meningococcal-outbreak-florida-lee-county-151840797.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr&guccounter=1/
[3] Thomson, J. (2022, June 24). Florida Meningococcal Disease Outbreak: CDC Urges Gay Men To Get Vaccine. Retrieved from https://www.newsweek.com/gay-men-florida-outbreak-meningococcal-disease-meningitis-sepsis-vaccine-1718797
[4] CDC. (2021, August). What is sepsis? Retrieved from https://cdc.gov/sepsis/what-is-sepsis.html
[5] Padgett, D. (2022, July 7). CDC Encourages Meningococcal Vaccine For At-Risk Florida Visitors. Retrieved from https://news.yahoo.com/cdc-encourages-meningococcal-vaccine-risk-193000372.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr
[6] Shaw, M. (2022, June 23). Meningococcal vaccine uptake lagging among people living with HIV. Retrieved from https://www.ajmc.com/view/meningococcal-vaccine-uptake-lagging-among-people-living-with-hiv

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

HRSA Releases Annual ADAP Client-Level Report, 2019 - Program Enrollment Way Up

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

The Health Resources and Services Administration (HRSA) has released the AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report, 2019. These data reflect the demographic characteristics of clients served by the ADAP program from 2015-2019. This is the first such data report since September 2020 (HRSA, 2022) as a result of the onset of the COVID-19 global pandemic.

Increasing ADAP Enrollment

In 2019, 296,930 clients were served by state ADAP programs across the United States—an increase of more than 37,000 clients from 2015. While this represents a 14.4% increase in national enrollment numbers from 2015 to 2019, 24 states saw enrollment increases or decreases of greater than 25% (Figure 1).

Two states—Arkansas and Nevada—saw increases of greater than 100%, with Arkansas seeing a 122.8% increase and Nevada seeing a 168.8% increase. Comparatively, three states—Alaska, Louisiana, and Minnesota—saw decreases in enrollment of greater than 30%. Nineteen states saw enrollment increases between 25% - 99.9%.

Client enrollment regularly decreases and increases based on a number of factors, including but not limited to:

• Clients becoming newly eligible or ineligible based upon their income
• Clients moving from state ADAP programs to state Medicaid programs
• An increase in new HIV diagnoses and, with the delivery of competent case management services, being enrolled in the program
• Clients moving into or out of states
• Clients passing away

Because no one state’s ADAP program is identical to another, the reasons for enrollment increases and decreases are highly specific to each state. That said, significant increases and decreases should be carefully examined to identify service disparities, particularly in states where patients face numerous barriers to accessing care and treatment.

Figure 1. Change in State AIDS Drug Assistance Programs (ADAPs) Enrollment, 2015 to 2019

Photo Source: HRSA, 2022

The Demographics of ADAP

77.7% of ADAP clients are male—a figure that has remained unchanged since 2015. Similarly, the racial and ethnic demographics of ADAP clients have remained largely unchanged since 2015, with an average of roughly 40% of enrollees being Black Americans, 26% being Hispanic/Latino, and 30% being White from 2015 to 2019. Of the women who are clients of ADAP, over half (57.0%) are Black. Additionally, ADAP enrollees have continued to overwhelmingly be at the lowest end of the income eligibility scale with 43.5% of clients earning between 0% - 100% of the Federal Poverty Level (FPL)—$12,490/year for an individual.

These demographics have all remained largely unchanged over the past decade in no small part because they are reflective of the HIV epidemic, in and of itself. New HIV diagnoses continue to be disproportionately identified in Black, Brown, and lower-income communities. As a result, those clients compose the majority of ADAP clients.

In addition to gender, race, and income demographics, ADAP clients who are part of a racial or ethnic minority tend to be younger than their White counterparts. 58.6% of White ADAP clients are aged 50 or older.

Health Coverage of ADAP Clients

In 2019, nearly 40% of all ADAP clients had no healthcare coverage, whatsoever, including private and employer-sponsored insurance, Medicaid coverage, Medicare coverage, Veterans Administration coverage, Indian Health Services coverage, and other types of coverage. This varies by race, with just 22.0% of White clients lacking healthcare coverage compared with 49.3% of Hispanic clients and 43.8% of Black clients. It also varies by gender, with 38.5% of male clients lacking coverage and 37.3% for females. Trans folx and gender non-conforming individuals were disproportionately impacted by a lack of healthcare coverage, with 48.3% of transgender male clients, 50.2% of transgender female clients, and 60.4% of clients with different gender identities lacking coverage.

Services Utilization of ADAP Clients

The percentage of clients who received only full-pay medication assistance (where ADAP pays the full cost of medications) decreased from 52.6% in 2015 to 46.8% in 2019. This number is expected to decrease as more ADAP programs begin transitioning clients over to other payor models, such as insurance continuation programs, medication co-pay/deductible assistance, or insurance premium assistance. Each of these models represents cost savings for ADAP programs over the full-pay medication assistance service, as the ADAP programs are no longer paying the full cost of medications.

Breaking these services down by Health and Human Services (HHS) Region (Figure 2), Region 4, which comprises most of the American South, saw the highest percentage of ADAP clients receiving full-pay medication assistance (38.6%).

Figure 2. Map of United States Department of Health and Human Services Regions

Photo Source: HRSA, 2022

 Potential Concerns for ADAPs

There are some concerns being circulated that ADAP enrollment may begin increasing in the near future. The onset of the COVID-19 global pandemic resulted in the Secretary of HHS declaring quarterly national Public Health Emergencies (PHEs) beginning in January 2020 (Office of the Assistant Secretary for Preparedness and Response, 2022). One of the provisions of the PHE declarations required states to keep people enrolled in state Medicaid programs throughout the PHE in order to receive the temporary increase in the federal share of Medicaid costs. 

When the Secretary fails to renew the PHE, this provision, along with the increased federal funding, will end, meaning that state Medicaid programs will likely begin redetermining eligibility. This could result in an influx of clients moving off of Medicaid and back onto state ADAP programs, which are statutorily required to be the “payor of last resort.”

Additional concerns exist around the reauthorization of the Ryan White HIV/AIDS Program (RWHAP), which has not been reauthorized since 2009. Because the law has no sunset provision, meaning that it can be funded in perpetuity. There have been consistent concerns about reopening RWHAP for reauthorization for fear that Republicans in Congress will gut the program. These concerns have been voiced since at least 2013. As a result, there is little advocacy in favor of reauthorization.

Ultimately, the ADAP program is currently as “safe” as it’s ever been. Waitlists are virtually a thing of the past, meaning that eligible patients are able to gain access to the medications that they need. The ADAP Advocacy Association will continue to monitor the program for both successes and challenges.

References:

• Health Resources and Services Administration. (2020, September). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report 2019. Rockville, MD: United States Department of Health and Human Services: Health Resources and Services Administration: HIV/AIDS Bureau: Division of Policy and Data https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/hrsa-adr-data-report-2018.pdf
• Health Resources and Services Administration. (2022, June). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report 2019. Rockville, MD: United States Department of Health and Human Services: Health Resources and Services Administration: HIV/AIDS Bureau: Division of Policy and Data https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/hrsa-adr-data-report-2019.pdf
• Office of the Assistant Secretary for Preparedness and Response. (2022, April 12). Renewal of Determination That A Public Health Emergency Exists. Washington, DC: United States Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response: Public Health Emergency Declarations. https://aspr.hhs.gov/legal/PHE/Pages/COVID19-12Apr2022.aspx 

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. 

Copay assistance is a lifeline for patients. So why are insurers blocking it?

By: Stephen J. Ubl, President & Chief Executive Officer with the Pharmaceutical Research and Manufacturers of America (PhRMA)

****Reprinted with permission from the Pharmaceutical Research and Manufacturers of America****

In today’s broken insurance system, patients too often pay more for a medicine than what their insurance company pays.

While the prices insurers pay for brand medicines increased just 1.0% last year, too many patients still face unaffordable costs for life-saving treatments. In fact, commercially insured patients with a deductible have seen their out-of-pocket costs for brand medicines increase 50% since 2014.

This erosion in insurance coverage may be discouraging patients from using the medicines prescribed by their doctors, and the consequences can be devastating. In 2021, 61% of commercially insured patients did not fill their new prescription when their out-of-pocket costs exceeded $250.

Photo Source: PhRMA

That is why PhRMA supports a holistic solution to lower drug costs for patients. Until we address the roles insurers and pharmacy benefit managers play in deciding how much people pay at the pharmacy, there will still be individuals who struggle to afford their medicines.

In the absence of these broader reforms, many drug manufacturers offer help through patient assistance programs. When insurance falls short, this assistance aims to help patients take their medicines as prescribed by their doctors.

Research has found that those who use patient assistance were up to 47% more likely to stick with their treatment for a year. This lifeline is especially critical for individuals with chronic conditions. In 2019, they helped patients taking brand HIV or oncology medicines save $1,600 on average. Patients taking multiple sclerosis medicines saved an average of $2,200.

How Insurers Are Actively Undermining Patient Assistance

Unfortunately, insurers are adopting tactics that can deny patients the benefit of this assistance. Not only are insurers reducing coverage, they are coming between patients who need help and the assistance available to them. For example, insurers use accumulator adjustment programs, which exclude patient assistance from counting toward a patient’s deductible and out-of-pocket maximum. This forces patient to pay more and more out of pocket before their insurance coverage begins.

The intent of insurers is clear. These programs attempt to steer patients towards medicines insurers prefer instead of those that doctors prescribe. Not surprisingly, steering patients away from their prescribed medicines can steer them toward worse health outcomes.

In a survey, more than half of insurance companies acknowledged that accumulator adjustment programs can negatively impact whether a patient uses their medication as prescribed. Evidence shows that patients impacted by accumulator adjustment programs are 13 times more likely to stop taking a treatment as compared to those with consistent copays.

In some ways, patient assistance is similar to the support hospitals provide when they waive a patient’s out-of-pocket expenses. Taxpayer-funded incentives encourage this kind of hospital assistance. Yet the patient assistance many rely on for life-saving medicines is under assault by insurers.

Pushing Forward Patient-Centered Solutions

In a win for patients, a federal district court judge recently struck down a rule that would have made it more difficult for manufacturers to offer patient assistance. The federal judge noted that patient assistance can help people “shoulder high out-of-pocket costs and obtain needed medications that their doctors have prescribed.” The judge also described accumulator adjustment programs as “schemes” devised by health insurers to “pocket for themselves at least some of the assistance” that’s meant for patients.

Fortunately for patients, lawmakers are also taking notice. Since 2019, 15 states have banned accumulator adjustment tactics in state-regulated markets. At the federal level, a bipartisan bill was introduced to ban accumulator adjustment programs in many commercial health plans. Congress should build on the recent federal judge’s decision and rein in the use of accumulator programs.

Patient assistance offers a lifeline, but if insurance worked like insurance – covering the sick when they need care – patients wouldn’t have to rely on this assistance to afford the out-of-pocket costs for their medicines.

We need to solve systemic flaws that are driving up costs for patients in the first place. For example, insurers and PBMs pocket billions of dollars in rebates and discounts that are provided by drug manufacturers. These savings should be shared with patients at the pharmacy, but instead, many patients are forced to pay more for medicines than their insurance company pays.

Whether it’s through high out-of-pocket costs or accumulator adjustment policies, insurers are getting in between patients and their medicines. We should be doing everything we can to remove these barriers so people can access the health care they need. And until then, let’s remove barriers to patient assistance to help make medicines more affordable for those in need.

Stephen J. Ubl Stephen J. Ubl is president and chief executive officer of PhRMA. Mr. Ubl leads PhRMA’s work preserving and strengthening a health care and economic environment that encourages medical innovation, new drug discovery and access to life-saving medicines. Ubl is recognized around the world as a leading health care advocate and policy expert who collaborates successfully with diverse stakeholder groups – including patient and physician groups, regulators, public and private payers, and global trade organizations – to help ensure timely patient access to innovative treatments and cures.

This opinion piece was also published in the June 29th edition of the Catalyst.

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.