An Inherent Value in Advocacy Partnerships

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

As we've witnessed our national dialogue boil over into "us versus them" or "red versus blue" or "urban versus rural" or the even more egregious "you're either with us or you're against us", it is important to remember there is an inherent value in advocacy partnerships. It is even more important for the HIV advocacy community to continue to leverage broad partnerships, rather than retreat into corners. Adopting the latter approach would surely result in less potent national and state-level advocacy, fewer programmatic outcomes, and far less access to care and treatment for the patients who need it.

The ADAP Advocacy Association has long boasted in its tag line that it "works with advocates, community, health care, government, patients, pharmaceutical companies and other stakeholders." Yet, all too often, some question why one group or another is invited to sit our communal table. Unfortunately, it is happening more so in recent years. It is a troubling trend, no doubt.

Our organization's primary audience is the patient. One of our core value statements is that the voice of individuals living with HIV/AIDS shall always be at the table and the center of the discussion. All too often the patient voice is pushed aside, or not even included in important conversations because they're characterized as "bitching and moaning" rather than proposing solutions. But haven't patients earned that right, because after all they're the ones living with the damn disease? That said, such an narrow attitude under-estimates the valuable contributions made by patients every single day!

Likewise, state health department employees aren't the enemy. They are our partners and if state agencies are doing something counterintuitive to promoting greater access to care and treatment, then it is the advocacy community's and patient community's role to engage them. Joey Wynn, who serves as a board member to this organization, routinely engages state agencies in Florida...including when those same agencies are doing something the local advocacy community finds potentially harmful. Joey's approach has served people living with HIV/AIDS in South Florida rather well, too. In fact, I've personally witnessed the effectiveness behind his approach at a town hall meeting in Miami (as seen above when Joey invited me to speak), as well as his past leadership with the Florida HIV/AIDS Advocacy Network ("FHAAN").

Beating up on pharmaceutical companies is easy, and it most certainly is a popular thing to do. Yet, it is indeed possible to push back on the high cost of prescription drug prices while simultaneously working with these same partners to fight harmful public policy proposals, such as federal budget cuts, or the dangerous idea of drug importation.

Photo Source: Wikipedia

Nashville, Tennessee-based advocate and social media guru Josh Robbins is prime example! Josh has partnered with numerous private entities — such as medical diagnostic companies and pharmaceutical companies — and various public agencies — including health departments — to promote a litany of public health initiatives ranging from National HIV Testing Day, U=U, and access to PrEP. His groundbreaking work in Tennessee could not have been achieved operating from a silo.

Wanda Brendle-Moss, who also serves as a board member to this organization, recently reflected on her HIV advocacy journey. Wanda has demonstrated that collaboration is an effective advocacy tool in North Carolina, evidenced by her relationships with the North Carolina AIDS Action Network, North Carolina Harm Reduction Coalition ("NCHRC"), and the Rev. William Barber II's Moral Mondays (as seen in the photo above). Wanda would work with anyone who will answer her phone call, email, or text!

Speaking of North Carolina and NCHRC, under the leadership of the former executive director, Robert Childs, progressive harm reduction policies were adopted in a conservative state with an even more conservative General Assembly. Such legislative victories in the state included achieving syringe exchange programs, expanded Naloxone access, Good Samaritan protections, prescription drug monitoring programs, among other things. How? It was the advocacy partnerships developed by NCHRC, including with some VERY unlikely allies.

Nationally, efforts such as the ongoing U=U campaign ("Undetectable = Untransmittable") to reduce HIV-related stigma could not have happened without Bruce Richman's steady leadership. It isn't surprising that Bruce has assembled an extremely broad coalition of community partners, representing all stakeholder groups.

The most effective advocacy is rooted in advocacy partnerships, and not rivalries. With the current occupant residing at 1600 Pennsylvania Avenue being so unfriendly to our community, such advocacy partnerships are even more important now!

Why Our Annual ADAP Leadership Awards Are More Than a Shiny Plaque

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

The ADAP Advocacy Association earlier this week announced the Call for Nominations for its 2018 Annual ADAP Leadership Awards. The awards recognize individual, community, government and corporate leaders who are working to improve access to care and treatment for people living with HIV/AIDS - notably under the AIDS Drug Assistance Program (ADAP). Whereas the honorees are awarded a shiny plaque, more importantly they receive the acknowledgment and appreciation for their meaningful contributions to ending the epidemic impacting the 1.1 million people in the United States who are living with HIV/AIDS.

Submit a nomination at https://www.surveymonkey.com/r/F52YKT3.

Nominations are solicited annually from the community, and honorees are selected by an Awards Committee comprised of our board members, as well as other ADAP stakeholders (including former award honorees). The awards are presented to the honorees during our Annual ADAP Leadership Awards Dinner, which is held at the conclusion of our Annual AIDS Drug Assistance Program Conference in Washington, DC. This year's awards dinner is slated for Friday, September 21st and it will be headlined by the one-and-only Josh Robbins, who is "one of the coolest HIV-positive patient advocates in the history of the world."

The award categories focus on community-based advocacy, social media advocacy, and grassroots advocacy. Additionally, individuals are recognized for their contributions with the "William E. Arnold" ADAP Champion award, Emerging Leader award, and Lawmaker award. Other awards are also part of the annual celebration of the grit, grind, satisfaction, and tribulations associated with fighting the epidemic.

2018 represents the eleventh year that the ADAP Advocacy Association has publicly thanked honorees for their leadership, and since 2010, it has been done at our awards dinner. We invite you to nominate someone today at https://www.surveymonkey.com/r/F52YKT3.

ADAP Open Drug Formulary Programs Improve Access to Care & Treatment; So why are there so few?

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

Each State AIDS Drug Assistance Program ("ADAP") is unique in that "it decides which medications will be included in its drug formulary, and how those medications will be distributed to eligible consumers."[1] It clearly presents a conundrum between payers and consumers. Ask any payer of health benefits, and controlling costs is probably paramount to them. Ask any consumer of health benefits, and most important is the unrestricted access to all the supports, services and/or therapies that should be afforded to them. Therein is the divide between closed and open drug formulary programs, including ADAP.

(Editor's Note: This blog is not intended to be an endorsement of any product made by any pharmaceutical company but rather acknowledge the unique health needs experienced by people living with HIV/AIDS, as they attempt to access care and treatment that is appropriate, culturally competent, and timely)

Photo Source: COMP Blog

In March 2015, Managed Healthcare Executive published an article, Closed formularies hold the line on costs, which accurately summed up the challenges faced by health plans. Though health plans are quite different from State AIDS Drug Assistance Programs, in general, they nonetheless do share an important thing in common. They often employ cost containment strategies in an effort to not only control costs, but also ensure plan sustainability. It provides little comfort, however, for consumers living with chronic health conditions, such as HIV/AIDS, who require access to numerous drug therapies.

According to the National Alliance of State & Territorial AIDS Directors ("NASTAD"), only approximately one in five (1:5) ADAPs employ an open drug formulary program. The Online AIDS Drug Assistance Program Formulary Database (2018 version) reports the following states offer open drug formularies: Illinois, Iowa, Massachusetts, Minnesota, Nebraska, New Hampshire, New Jersey, Ohio, Oregon, and Washington State. Only Washington State reports no drug exclusions under its open drug formulary program.[2]

To be fair, ADAPs aren't unique in this area. ADAPs mirror private health plans (and many other public health plans) in that they have closed drug formularies. Yet, open drug formulary programs are advantageous to consumers because they provide additional coverage for medications. So why are there so few?

The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) dictates that "each ADAP must cover at least one drug from each class of HIV antiretroviral medications ("ARVs") on their ADAP formulary. RWHAP funds may only be used to purchase FDA-approved medications."[3] Otherwise, State ADAPs are pretty much left to their own fruition on which ARVs to include on their formularies, as well as non-ARV medications to treat other conditions and medication side effects.

Eddie Hamilton, founder of the Ohio-based ADAP Educational Initiative, summarized his support for open drug formulary programs:

“One of the leading barriers to care is the lack of access to the non-ARV medications for various reasons, such as co-pays or non-covered medications. Open formularies enhance ARV regimen compliance as it enables people living with HIV/AIDS to deal with the various side effects and co-morbidities associated with HIV. While the Ryan White program covers mostly HIV related services, it is counter-intuitive to fix only one medical issue while leaving other potential life threatening medical issues that would be preventable on the table. One may have a undetectable viral load but succumb to a heart attack because of the lack of access to a statin!”

It is disheartening when people living with HIV/AIDS are denied access to numerous non-ARV medications, especially when the medications could treat a litany of other health-related conditions. Some of the conditions commonly identified by consumers are lipodystrophy, diarrhea, hormone therapy, and co-infection with Hepatitis C ("HCV").

For example, HIV-related lipodystrophy remains an important health issue confronted by consumers yet often it is characterized by payers as cosmetic. Research has shown that between 20% and 30% of HIV-positive patients are experiencing excess visceral adipose tissue ("VAT"). For years, there's been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments — something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

An ADAP Blog posted in late 2016 highlighted the success by Massachusetts in expanding treatment options for people living with HIV-associated lipodystrophy. The Treat Lipodystrophy Coalition fought tirelessly for the law to require insurance coverage for treatment of a debilitating and disfiguring side effect of HIV medications. Patients living with HIV-associated lipodystrophy are now demanding the same is done with public payers, such as ADAP and Medicaid.[4]

Photo Source: Treat Lipodystrophy Coalition

Carl Sciortino, executive director for the AIDS Action Committee, and former representative in the Massachusetts Legislature who introduced the aforementioned legislation, then summarized the effort to expand treatment access: "Some of our long-term survivors carrying the physical scars of earlier life-saving treatments have been denied the dignity and medical treatment they are entitled to for far too long. Lipodystrophy affects our veterans, and as a country we have effectively turned our backs on their need to treat their epidemic-inflicted wounds. I'm proud of our step forward in providing insurance coverage in Massachusetts, and I'm grateful for any interest it sparks in providing care to people living with HIV across the country."[5]

Tesamorelin (common brand name: Egrifta) is the only FDA-approved therapy to combat HIV-related lipodystrophy. Yet, as of December 31, 2017, only 11 ADAPs reported that they do include Tesamorelin on their drug formularies, including: Colorado, District of Columbia, Illinois, Louisiana, Massachusetts, New Hampshire, New Jersey, North Carolina, North Dakota, South Carolina, and Washington. Thanks to the ADAP Crisis Task Force, that soon could be changing after a discounted drug pricing agreement for ADAPs was reached with the drug's manufacturer.

One of the most common side effects causing angst for people living with HIV/AIDS is diarrhea. It is a widely held opinion that HIV-related diarrhea is a thing of the past with the advent of the newer ARVs. The "runs" impact long-term survivors quite often, according to a patient survey released in December 2017.[6]

Josh Robbins, Founder of the HIV Scoop, isn't known for being shy, and as such he become a vocal spokesman on how this common HIV-related side effect personally impacted his life. His advocacy on the issue has given hope to others like him. Robbins characterized the struggle as follows:

“Before I found the drug to help normalize my gastro issues related to living with HIV, I was at a crossroads with HIV treatment. Everyone preached the importance of adherence to ARVs and staying in care, but I was exhausted of the process because of diarrhea and me not finding relief from it or support medically. When I saw the information on the drug, I knew I wanted to give it a try. What could I lose as I tried everything else? After starting it, there wasn’t a magic moment that I knew it was working for me—but I did notice that I didn’t dread taking my ARVs anymore and I stopped missing doses because they made me feel bloated and the diarrhea was brutal. All of that slowed down to where I don’t even think about it anymore. Can I give all the credit to this drug? Maybe not, but I can say that I finally feel normal in my stomach, I don’t spend tons of time in the bathroom anymore, and I’m finally adherent to my HIV meds. At least for me, this drug makes my journey living undetectable possible, because it normalized my gastro issues. So, yea, this drug changed my journey living with HIV.”

The medication in reference is Mytesi. Unfortunately, currently only 22 State ADAP drug formulary programs cover Mytesi, and as such people living with HIV/AIDS suffering from diarrhea are forced to rely on less potent over-the-counter therapies. These therapies often provide little or no relief. Once again, thanks to the ADAP Crisis Task Force, that soon could be changing after a discounted drug pricing agreement for ADAPs was reached with the drug's manufacturer.[7]

Evidence suggests that HIV-infections disproportionately impact the transgender communities.[8] In its recent issue brief on transgender health, NASTAD acknowledged the need to adopt a holistic approach to providing health services to this underserved population. The issue brief reads, in part, "...it is imperative that ADAPs ensure that their interventions are informed by a robust understanding of the unique personal, societal, and structural barriers that impede access to care and treatment for transgender people."[9]

The Centers for Disease Control & Prevention (CDC) has documented the unique needs set facing the transgender communities in the United States. CDC data suggests there is a need for gender-variant, culturally competent awareness and guidelines designed to better serve this underserved community enrolled in public health programs, as well as those persons eligible, but not enrolled (including ADAP).[10]

The CDC concluded, “Insensitivity to transgender identity can be a barrier for those who are diagnosed with HIV and seek quality treatment and care services. Research shows transgender women with diagnosed HIV infection are less likely to be on antiretroviral therapy (ART) or achieve viral suppression. Furthermore, few health care providers receive adequate training or are knowledgeable about transgender health issues and their unique needs.”[11]

Furthermore, NASTAD echoed this concern in its issue brief, making a compelling case for open drug formulary programs that are more liberalized to serve transgender consumers: "ADAP formulary composition presents another opportunity to promote trans- inclusive care and treatment. Beyond the provision of ARVs, ADAPs play a critical role in supporting the availability of medications for many co-occurring needs of PLWH, including transgender transition-related medications."[12]

As of December 31, 2015, unfortunately only 16 ADAPs covered one or more FDA-approved transgender transition-related medications on their formulary.[13]

According to Marcus J. Hopkins, Project Director of the Community Access National Network's HIV/HCV Co-Infection Watch, there are 43 State ADAPs offering some form of coverage for HCV treatment. Of those programs, 36 have expanded their HCV coverage to include the regimens that serve as the current Standard of Care (SOC) for Hepatitis C treatment. Eight (8) programs offer only Basic Coverage and 13 programs offer No Coverage. Three (3) territories – American Samoa, Marshall Islands, and Northern Mariana Islands – are not accounted for in this data.

HCV is a common co-infection in people with HIV/AIDS. An estimated 200,000-300,000 people in the United States are co-infected with both HIV and HCV infections. Experts believe that about 25% of Americans with HIV also have HCV; conversely some 10% of people with HCV are thought to also have HIV.

In most states, people living with HIV/AIDS are well served by their ADAP but that doesn't mean consumers should settle on the status quo. According to Jen Laws, an independent policy consultant and an ADAP Advocacy Association board member, expanding the efficacy of the State AIDS Drug Assistance Programs requires both modernization in systems and expansive formularies to meet the health needs of target populations; from heart disease and diabetes to gender confirming hormone replacement therapies, ADAPs can help us close the gaps in care clients face else where and realize the true potential of the programs in working to end HIV.

Laws argued, "Today, we understand comprehensive approaches to chronic health needs result in greater client adherence and positive overall health outcomes, directly impacting efficacy of HIV specific treatment. We know meeting target population health needs is a necessary step in combating the epidemic, especially in an environment where these same populations are unlikely to get their health needs met in traditional markets. In the age of treatment as prevention, ADAPs have a unique opportunity to function at the corner of both prevention and patient care."

Related articles of potential interest:

• Don't Take VAT, sponsored by Theratechnologies
• Keep Your Pants On, sponsored by Napo Pharmaceuticals
• Talking to your Doctor About Symptoms, online survey of patients living with HIV conducted Oct 25-Nov 6, 2017, sponsored by Napo Pharmaceuticals
• TRANSGENDER HEALTH: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS under the AIDS Drug Assistance Program: Model Policy for Ryan White/ADAPs Serving Transgender Clients, published in April 2017 by the ADAP Advocacy Association
• INFOGRAPHIC: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS under the AIDS Drug Assistance Program, published in April 2017 by the ADAP Advocacy Association
• CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH, published in August 2016 by the National Alliance of State & Territorial AIDS Directors
• HIV/HCV Co-Infection Watch – March 2018, published in March 2018 by the Community Access National Network

__________

[1] Health Resources & Services Administration (2017, October). Part B: AIDS Drug Assistance Program. U.S. Department of Health & Human Services. Retrieved from https://hab.hrsa.gov/about-ryan-white-hivaids-program/part-b-aids-drug-assistance-program.
[2] National Alliance of State & Territorial AIDS Directors (2018, February 1); 2018 ADAP Formulary Database; National Alliance of State & Territorial AIDS Directors (NASTAD). Retrieved from https://www.nastad.org/adap-formulary-database.
[3] Health Resources & Services Administration (2017, October). Part B: AIDS Drug Assistance Program. U.S. Department of Health & Human Services. Retrieved from https://hab.hrsa.gov/about-ryan-white-hivaids-program/part-b-aids-drug-assistance-program.
[4] Macsata, Brandon M. (2016, October 28). ADAP Blog. Why HIV Medical Treatment Guidelines Matter. ADAP Advocacy Association. Retrieved from http://adapadvocacyassociation.blogspot.com/2016/10/why-hiv-medical-treatment-guidelines.html.
[5] Macsata, Brandon M. (2016, October 28). ADAP Blog. Why HIV Medical Treatment Guidelines Matter. ADAP Advocacy Association. Retrieved from http://adapadvocacyassociation.blogspot.com/2016/10/why-hiv-medical-treatment-guidelines.html.
[6] Yahoo Finance (2017, December 12). HIV With Diarrhea Often Suffer in Silence. Business Wire. Retrieved from https://finance.yahoo.com/news/survey-finds-people-living-hiv-140000800.html.
[7] Yahoo Finance (2017, April 10). Jaguar Subsidiary Napo Pharmaceuticals Signs Agreement with the ADAP Crisis Task Force for Mytesi. Business Wire. Retrieved from https://finance.yahoo.com/news/jaguar-subsidiary-napo-pharmaceuticals-signs-130000636.html.
[8] U.S. Centers for Disease Control and Prevention (2016, April 18). HIV Among Transgender People. Retrieved from http://www.thebody.com/content/63509/hiv-among-transgender-people.html?ap=1200.
[9] Pund, Britten, Et al. (2016, August). CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH. National Alliance of State & Territorial AIDS Directors. Retrieved from https://www.nastad.org/sites/default/files/Crossroads-Trans-Health.pdf.
[10] U.S. Centers for Disease Control and Prevention (2016, April 18). HIV Among Transgender People. Retrieved from http://www.thebody.com/content/63509/hiv-among-transgender-people.html?ap=1200.
[11] U.S. Centers for Disease Control and Prevention (2016, April 18). HIV Among Transgender People. Retrieved from http://www.thebody.com/content/63509/hiv-among-transgender-people.html?ap=1200.
[12] Pund, Britten, Et al. (2016, August). CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH. National Alliance of State & Territorial AIDS Directors. Retrieved from https://www.nastad.org/sites/default/files/Crossroads-Trans-Health.pdf.
[13] Pund, Britten, Et al. (2016, August). CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH. National Alliance of State & Territorial AIDS Directors. Retrieved from https://www.nastad.org/sites/default/files/Crossroads-Trans-Health.pdf.