Thursday, April 19, 2018

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)

Two pills, one with a thumbs up and one with a thumbs down
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]

Treatment for Lipodystrophy - It's Now the Law!
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, " 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:


[1] Health Resources & Services Administration (2017, October). Part B: AIDS Drug Assistance Program. U.S. Department of Health & Human Services. Retrieved from
[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
[3] Health Resources & Services Administration (2017, October). Part B: AIDS Drug Assistance Program. U.S. Department of Health & Human Services. Retrieved from
[4] Macsata, Brandon M. (2016, October 28). ADAP Blog. Why HIV Medical Treatment Guidelines Matter. ADAP Advocacy Association. Retrieved from
[5] Macsata, Brandon M. (2016, October 28). ADAP Blog. Why HIV Medical Treatment Guidelines Matter. ADAP Advocacy Association. Retrieved from
[6] Yahoo Finance (2017, December 12). HIV With Diarrhea Often Suffer in Silence. Business Wire. Retrieved from
[7] Yahoo Finance (2017, April 10). Jaguar Subsidiary Napo Pharmaceuticals Signs Agreement with the ADAP Crisis Task Force for Mytesi. Business Wire. Retrieved from
[8] U.S. Centers for Disease Control and Prevention (2016, April 18). HIV Among Transgender People. Retrieved from
[9] Pund, Britten, Et al. (2016, August). CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH. National Alliance of State & Territorial AIDS Directors. Retrieved from
[10] U.S. Centers for Disease Control and Prevention (2016, April 18). HIV Among Transgender People. Retrieved from
[11] U.S. Centers for Disease Control and Prevention (2016, April 18). HIV Among Transgender People. Retrieved from
[12] Pund, Britten, Et al. (2016, August). CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH. National Alliance of State & Territorial AIDS Directors. Retrieved from
[13] Pund, Britten, Et al. (2016, August). CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH. National Alliance of State & Territorial AIDS Directors. Retrieved from

Friday, April 13, 2018

Grindr Fuels HIV Stigma & Fails the Most Basic Privacy Test

Guest Blog By: Marcus J. Hopkins, Blogger

Just last month, in March 2018, Grindr’s Director for Equality, Jack Harrison-Quintana, announced that the app would roll out a new feature: men who opted in would receive a reminder every three to six months to get tested for HIV, as well as receive the location information of the nearest testing site (McNeil, 2018).  “…few men will download health-oriented apps that make them feel shamed for missing a test,” Harrison-Quintana claimed. For the uninitiated, Grindr is a gay male hookup app that allows users to connect with others via their mobile devices. Users have the ability to include as much or as little personal information as they wish when creating and editing their profiles, including their HIV status and “last tested date.”

What he failed to mention, however, was that users’ HIV status with not one, but two other outside companies.

Grindr Privacy Statement
Photo Source:

The two companies – Apptimize and Localytics – have been receiving some of the information that Grindr users choose to include in their profiles, including their HIV status and “last tested date” (Ghorayshi & Ray, 2018). BuzzFeed, who broke the story on April 02, 2018, independently verified a data analysis conducted by an outside research firm, SINTEF, who was commissioned to produce the report by Swedish public broadcaster, SVT, which first published the findings (Ghorayyshi & Ray).

This is just the latest HIV status-related debacle in recent years. In August 2017, the Community Access National Network’s HEAL Blog wrote about the inadvertent exposure of clients’ HIV status by insurance giants, Aetna and CVS/Caremark (Hopkins, 2017). Aetna, in January 2018, agreed to pay $17 million for their data breach that exposed that as many as 12,000 clients were taking HIV medications (Gordon, 2018). A Federal lawsuit was recently filed over CVS/Caremark’s release of protected client information when the company created a program identification number for each client with the letters ‘HIV’ in the number (Snell, 2018).

These kinds of breaches of privacy and public confidence should be easily avoidable. In 2018, it is so rare for other Western countries to inadvertently expose others’ HIV status, that it almost never occurs. When we hear of these stories, they frequently involve companies based in the United States, in no small part because of how lax are the repercussions for this kind of exposure. On the part of Aetna, sheer laziness led to the exposure of clients; with CVS, stupidity seems to be the cause. With Grindr, however, there are more pernicious factors at play, and honestly, there are likely to be few legal repercussions for the company in the U.S., because of our extremely lax privacy laws.

In 2017, the U.S. House of Representatives voted to repeal an Obama-era law that demanded ISPs obtain permission to share users’ personal information (Lee, 2017). While this law pertained only to ISPs and not other companies like Facebook or Google, the sentiment is clear: your personal information is up for grabs. Many European nations have incredibly strict privacy laws that require explicit informed consent before sharing any data with third parties; the U.S., however, favors a stupidly “free market,” where the sentiment is “Caveat Emptor” – “Let the buyer beware.”

Stop Stigma (with HIV/AIDS Red Ribbon)
Photo Source: Pinterest - AIDS/HIV HISTORY

This latest revelation that Grindr was sharing data likely isn’t illegal, in the same way that Facebook sharing data with Cambridge Analytica likely isn’t illegal. For people living with HIV, these kinds of data sharing arrangements help to create and perpetuate fears that their private information will be exposed to others without their direct knowledge. Our laws and system allow companies like Grindr and Facebook to post miles-long user agreements filled with legalese that is barely comprehensible to people with college education, much less those who just want to hop on an app and hook up with the nearest person they consider hot.

It’s time for a rethink in our country of how our personal information is protected, because right now, the deck is wholly stacked against us.

  • Ghorayshi, A. & Ray, Sri. (2018, April 02). Grindr Is Letting Other Companies See User HIV Status And Location Data. New York, NY: BuzzFeed, Inc.: BuzzFeed News. Retrieved from:
  • Gordon, E. (2018, January 17). Aetna Agrees To Pay $17 Million In HIV Privacy Breach. Philadelphia, PA: National Public Radio: WHYY Philadelphia: Shots. Retrieved from:
  • Hopkins, M.J. (2017, August 28). HIPAA: Healthcare mailers violate privacy rights of people living with HIV. Washington, DC: The Community Access National Network: HEAL Blog. Retrieved from:
  • Lee, D. (2017, March 29). Anger as US internet privacy law scrapped. Los Angeles, CA: BBC News: Technology. Retrieved from:
  • McNeil, D.G., Jr. (2018, March 26). Grindr App to Offer H.I.V. Test Reminders. New York, NY: The New York Times: Health: Global Health. Retrieved from:
  • Snell, E. (2018, April 03). Federal Lawsuit Filed Following Alleged CVS Health Data Breach. Danvers, MA: Xtelligent Medica, LLC: HealthIT Security: News. Retrieved from:

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.

Thursday, April 5, 2018

Rhode Island Advocates Score 'YUGE' Victory Against Insurance Company Gimmicks

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

Last month, advocates in the Ocean State fought back against proposed legislation in the Rhode Island General Assembly that would have prohibited patients from utilizing manufacturer coupons and drug discount cards to lower their out-of-pocket drug costs. S.2532 was a thinly veiled threat orchestrated by the insurance companies and other private health plan payers, which would have resulted in patients paying more for their prescription drugs. Such gimmicks disproportionately impact people living with chronic health conditions who rely on specialty drugs, such as HIV/AIDS or Hepatitis C.

Welcome to Rhode Island, The Ocean State

In early March the legislation was introduced in the Rhode Island General Assembly and referred to the Senate Health and Human Services Committee. The Committee, however, ultimately recommended the measure be held for further study after strong pushback from the HIV community (and others).

On March 27th, opponents testified against S.2532 during a hearing convened by the Committee. The HIV Health Care Access Working Group (HHCAWG)  which is part of the Federal AIDS Policy Partnership (FAPP)  also sent a letter opposing S.2532, and the state legislators took notice.

Manufacturer coupons and drug discount cards, commonly known as accumulator adjustment programs, were highlighted in a recent ADAP Blog, "Rx Drug Coupon Concerns Pit Prices Against Patients." The smoke and mirrors being perpetrated against patients is fueled by the insurance industry's misinformation, as well as their hopes that most patients don't take the time to read, and let alone understand, their policy documents.

Have you heard of the copay accumulator?
Photo Source: Patients Rising

The AIDS Institute (TAI) has been actively monitoring efforts by insurance companies to restrict access to care and treatment for people living with HIV/AIDS  including efforts to limit accumulator adjustment programs. Carl Schmid, TAI's Deputy Executive Director, summarized concerns over limiting such programs:
“It is already difficult for people living with HIV and others who want to take PrEP to access their medications due to insurance benefit practices such as high co-insurance and deductibles, this will just compound the situation. It is time for us to be loud and strong, and fight back. People lives are on the line.”
What happened in Rhode Island was a victory for people living with HIV/AIDS, as well as patients in general. But this issue isn't going away any time soon.  The ADAP Advocacy Association has expressed strong concern over the ongoing gimmicks by the insurance industry and health plan payers on this policy issue.

Related articles of potential interest:

Friday, March 30, 2018

Controversial History with HIV Disqualifies Robert Redfield from CDC Service

Guest Blog By: Marcus J. Hopkins, Blogger

Robert Redfield, a 66-year-old virologist and physician, has been appointed to be the head of the U.S. Centers for Disease Control and Prevention (CDC) by U.S. Health and Human Services (HHS) Secretary Alex Azar (Sun, 2018b).  Redfield has replaced the acting head of the CDC, Principal Deputy Director Anne Schuchat, after the Trump Administration’s first pick, Brenda Fitzgerald, was forced to resign because she failed to divest from her “complex financial interests” “…in a definitive time period” (Sun, 2018).

Fitzgerald’s financial interests were so “complex” that she was essentially permanently recused from participating in the agencies activities and was unable to testify before Congress on public health issues.  Appointed by Trump’s first HHS Secretary, the disgraced Tom Price, Fitzgerald repeatedly dismissed concerns about her financial interests, and yet, had to cancel each appearance before Congress because of said interests.

Under Azar, Redfield is yet another controversial pick to head up the nation’s primary health organization.  Redfield has a long and storied history of controversial positions related to HIV and public health.

Photo Source: Gay Today

Beginning with his tenure within the Defense Department, Redfield helped create a disastrous and non-confidential policy of testing all troops for HIV beginning in October 1985 (Garrett, 2018).  Troops who tested Positive for HIV often found out after their entire chain of command, and anyone found to be HIV+ was immediately barred from service.  In addition, Active Duty personnel were also tested, and if found Positive, were often subjected to mistreatment, including isolating HIV+ personnel in isolated barracks colloquially referred to as “the leper colony,” where they were treated like prisoners until they fully developed AIDS or were dishonorably discharged.  By 1989, 5 million troops were tested, and roughly 6,000 testing Positive (Garrett). 

In the 1990s, Redfield was yet again embroiled in HIV chicanery when internal memos were obtained by Public Citizen, a left-leaning non-profit organization that represents patients, citizens, and consumer rights through advocacy and policy research.  These previously unrelease memoranda demonstrated clear evidence that Redfield led a: 
…systematic pattern of data manipulation, inappropriate statistical analyses, and misleading data presentation by Army researchers in an apparent attempt to promote the usefulness of the GP160 AIDS vaccine…which [was] intended to prevent the progression of disease in persons with HIV infection (Public Citizen, 1994).
In Phases I and II studies, researchers at the Walter Reed Army Institute of Research, led by then-Chief of the Department of Retroviral Research, Robert Redfield, and were published in many scientific fora (plural for “forum”), including the New England Journal of Medicine, AIDS Research and Human Retroviruses, and at the International AIDS Conference in 1992.  The fabricated results were also twice falsely presented before hearings of the House Subcommittee on Health and Environment.

This repeated demonstration of a lack of ethics, moral fortitude, and integrity make him clearly unfit to head that nation’s leading health organization.  Dr. Peter Lurie, President of the Center for Science in the Public Interest (CSPI), goes further in his full-throated opposition to Redfield, stating that, as the head of the CDC, we would get “…a sloppy scientist with a long history of scientific misconduct and an extreme religious agenda” (Lurie, 2018).  We at ADAP Advocacy Association could not agree more with this assessment.

The Trump Administration has repeatedly displayed a unprecedented lack of integrity on several front, but perhaps its worst offenses exist with its appointments – Betsy DeVos, Scott Pruitt, Mick Mulvaney, Tom Price, Mike Pompeo, Rex Tillerson and Ryan Zinke.  Each of these appointments stands on their own in terms of their unpreparedness, lack of candor, and incompetence within their positions, rife with conflicts of interest, unacceptable levels of spending on personal travel and completely unnecessary “security upgrades,” and serving not the interests of the American public, but either the interests of corporations who have long derided the wings of government they now lead, or their own.  Robert Redfield is just the latest example of this failure to understand either the complexities of the positions to which they are appointed, or the roles of this organizations in American governance.

Enough is enough.  Redfield must, as his predecessor before him, be flushed out of the CDC before we become the laughing stock of the world.

  • Garrett, L. (2018, March 23). Meet Trump’s New, Homophobic Public Health Quack. Washington, DC: Foreign Policy. Retrieved from:
  • Lurie, P. (2018, March 21). CSPI Urges Administration Not to Appoint Dr. Robert Redfield, with History of Scientific Misconduct, as CDC Director. Washington, DC: Center for Science in the Public Interest: News. Retrived from:
  • Public Citizen. (1994, June 07). Washington, DC: Public Citizen. Retrieved from:
  • Sun, L.H. (2018a, January 31). CDC director resigns because of conflicts over financial interests. Washington, DC: The Washington Post: News: To Your Health. Retrieved from: 
  • Sun, L.H. (2018b, March 21). Longtime AIDS researcher Robert Redfield picked to lead CDC. Washington, DC: The Washington Post: News: To Your Health. Retrieved from:

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.

Thursday, March 22, 2018

Kudos to Janssen for its 2017 U.S. Transparency Report

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

On March 20th, Janssen Pharmaceutical Companies of Johnson & Johnson hosted a stakeholder meeting in Washington, DC to unveil its "2017 Janssen U.S. Transparency Report" and also promote a dialogue on value, access, and pricing transparency. It is the second time the company has released the comprehensive report, and as such the ADAP Advocacy Association extends its kudos to them for doing so. Patient advocacy groups are often left out of these conversations, yet patients are the people who have the most to gain from transparency. Numerous disease patient advocacy groups were also in attendance, including groups representing people living with diabetes, rheumatoid arthritis, and various mental health conditions.

(Editor's Note: This blog is not intended to be an endorsement of any product made by Janssen Pharmaceutical Companies of Johnson & Johnson but rather acknowledge their efforts to educate stakeholders on their corporate responsibility)

The transparency report highlights four key areas, including Janssen's ongoing investments in new medicines, value assessments, pricing and patient access, and resources for patients. An increasing amount of the public policy discussion has focused on drug pricing, so the information conveyed by Janssen in the report helps patient advocacy groups like ours (and others) refine their areas of interest. It is also important to gain insight into Janssen's work to develop new medicines considering the complexities of the current health care system.

The purpose behind the transparency report is spelled out in a letter from the company leaders, Jennifer Taubert, company group chairman, and Anastasia G. Daifotis, MD, chief scientific officer:
"We want this information to be useful to all our stakeholders: patients, families, caregivers, and advocates, who are asking questions about out-of-pocket costs for medicines and what resources are available to help them; health care professionals, who are increasingly being asked to consider the overall value of the medicines they prescribe; policymakers, who are working to make policy changes to help their constituents get the care they need; and others in the health care system, like payers, who consider value and price information when they make decisions about coverage and access."
The report can be downloaded online at

Report cover for the "2017 Janssen U.S. Transparency Report" available online at

The stakeholder meeting also featured an interactive panel discussion on Innovation, Pricing & Patient Access, as well as another one on Moving to a Value-Based Approach. Each included representatives from Janssen Pharmaceutical Companies, but also independent experts who were asked to share their insight. The two panels offered good analysis on the oddities of the current health care system, and some tough questions from the audience about what needs to change.

The panels discussed numerous issues, including medication adherence, rebates, insurance discriminatory design, valued-based contracting, importation, among others.

Adam Fein, CEO of the Drug Channels Institute, outlined the problem with the "gross-to-net bubble," as he phrased it. For example, whereas the average net prices offered by Janssen declined by 4.6% last year, it is unlikely the reductions were passed along to consumers. Interestingly too, Fein noted that 9 out of 10 drugs on the market are relatively inexpensive with low-cost generics available. However, it is the 1:10 specialty drugs that are the true cost-drivers.

Dan Leonard, President of the National Pharmaceutical Council, addressed the question over value by noting sick people are currently subsidizing the healthy people. Leonard's analysis echoed the recent remarks by U.S. Food & Drug Administration (FDA) Commissioner Dr. Scott Gottlieb. Leonard also touched on how most insurance benefits are valued from the point of sale, except for drug costs due to the complexities of the existing market (i.e., rebates).

One of the more notable  and troubling  observations was shared by Janssen's own, Dr. Anastasia Daifotis. Upon answering a question from a stakeholder in attendance at the event, she said transparency is important because it sheds light on the rise in non-medical switching and how these patient decisions are being driven by budget and not appropriate patient care.

The ADAP Advocacy Association recognizes that the cost of pharmaceuticals is an important part of the broader conversation about the current health care system. In fact, many of the specialty drugs mentioned earlier in this blog directly impact the HIV/AIDS community, and unfortunately we've witnessed patient cost-sharing for these therapies increase under many insurance exchanges. We encourage more conversations like the one hosted by Janssen, and also to reserve a seat at the table for the patient perspective. It is imperative!

Thursday, March 15, 2018

Shkreli's Cell Block Tango

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

In the acclaimed Broadway musical, Chicago, it was the "Cell Block Tango" that yielded the memorable line, "He had it coming." It now fittingly applies to disgraced former pharmaceutical executive, Martin Shkreli. The "Pharma Bro" (as Shkreli was notoriously dubbed) fraudster will be sitting in a cellblock for the next seven years, and most certainly he had it coming!

Martin Shkreli being arrested for securities fraud.
Photo Source: Daily Squat

On Friday, March 9th, U.S. District Judge Kiyo Matsumoto handed Shkreli a seven-year prison term for securities fraud, as well as ordered him to forfeit assets and pay fines. It is unlikely anyone in the HIV/AIDS advocacy community shed any tears about this news, though Shkreli's sentence reportedly brought him to tears (boo, hoo, hoo).

The discussion over drug pricing is nothing new to the HIV/AIDS community. In fact, it is a healthy discussion and one that needs to be had. But what Shkreli pulled several years ago...purchasing the rights to a popular HIV drug and then jacking-up the price more than 5000%...was unconscionable. Whereas Shkreli's sentence to do hard time had nothing to do with his actions on the drug Daraprim (pyrimethamine), it was nonetheless celebrated by our community. In fact, there was even quite a bit of humor at his expense  evidenced by the headline, "Prison commissary increases lube price by 5000% ahead of Martin Shkreli’s arrival."

According to someone who closely followed the case, "...critically, during Judge Matsumoto’s sentencing rationale, she specifically referenced receipt of correspondence from organizations working with HIV/AIDS patients as balancing off letters written in support of Shkreli." The observation was in reference to a community-led effort by Housing Works to send a strong message to Judge Matsumoto that Shkreli should forfeit his remaining shares in Vyera Pharmaceuticals (formerly Turing Pharmaceuticals), which owns the rights to Daraprim.

The community letter argued that allowing Shkreli to maintain ownership of his shares "will have a devastating impact on innocent people — including current Vyera employees, current Vyera shareholders and countless waiting for Vyera's anticipated treatments for certain orphan and rare diseases." Read the letter signed by 22 organizations, including the ADAP Advocacy Association.

Shkreli will undoubtedly appeal, but the HIV/AIDS community sent a message that such behavior moving forward will not go unnoticed, nor will it be tolerated! With respect to the Shkreli, additional advocacy on the issue is underway.

For now, Pharma Bro can be left to do the Cell Block Tango.

Cell Block Tango scene from the movie, Chicago.
Photo Source: Chicago

Thursday, March 8, 2018

Rx Drug Coupon Concerns Pit Prices Against Patients

Guest Blog By: Marcus J. Hopkins, Blogger

Drug manufacturer coupons have increasingly become a popular method of reducing the price consumers pay for their medications. Insurers, Pharmacy Benefits Managers (PBMs), and other payors, however, argue that these cost saving tools actually drive prices upward and result in patients choosing expensive brand name drugs over less expensive generic alternatives, essentially costing the payors more money, in the long run. As a result, some payors are taking the extraordinary step of no longer counting drug coupons toward patients’ out-of-pocket costs and deductibles, meaning that once patients use a coupon, they’ll be left to pay the remaining cost of the drug out-of-pocket.

When looking at how and when these coupons are used, however, Health Affairs = a leading journal in health policy thought and research – found that just 21% of coupons used in the 200 highest expenditure drugs of 2014 had a direct generic substitute, while another 28% had an “imperfect substitute.” The remaining 51% of drug had either no generic substitute or only branded alternatives (Van Nuys et al., 2018).

Januvia Rx Drug Coupon

For patients living with HIV (and, more recently, Hepatitis C), the past decade has been revolutionary in terms of the medications that have been made available to treat the disease. In 2007, most patients began treatment using a two- or three-pill regimen with various storage requirements. A year earlier, the first single-pill regimen, Atripla (Gilead), was approved by the FDA for the treatment of HIV.  In 2017, virtually patients begin HIV treatment with a single-pill regimen. The sad reality, however, is that there are no generic substitutes available in the United States for HIV drugs, and manufacturer coupons that reduce co-pays for them play a vital role in determining whether or not patients can afford the lifesaving medications they need.

“Consumers with life-threatening conditions are caught in the crossfire of an ongoing battle between insurers and drug companies over drug pricing. No matter who wins the battle, the casualties will be the patients, taxpayers, and the general public,” says Eddie Hamilton of the Columbus, Ohio-based ADAP Educational Initiative.

Rx pharmacy receipt
Photo Source: Consumer Reports

He is correct. In the rush to lower expenditures in the post-Affordable Care Act (ACA) market, insurers have increasingly begun weaponizing their drug formularies – the list of drugs payors will cover and for how much – against manufacturers to force lower pricing agreements, all of which are confidential under existing Trade Secrets laws. Placing brand name drugs in higher-cost tiers has been a relatively ineffective weapon when it comes to lowering overall prices, but has been an effective barrier to treatment for many patients living with HIV and other chronic illnesses for which there are few, if any, generic and/or effective alternatives.

This latest salvo against drug manufacturers will ultimately end up hurting consumers more than it will lower expenditures for insurers.

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.