Why HIV Medical Treatment Guidelines Matter

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

As with all chronic diseases and conditions the approved medical treatment guidelines serve as an important marker, not only for patients and the medical professionals who treat them, but also the payors. This is certainly no different with HIV/AIDS. That is why the ADAP Advocacy Association is calling on the Health Resources and Services Administration ("HRSA") at the U.S. Department of Health & Human Services to update its treatment guidelines for HIV-associated lipodystrophy. HRSA's current guidelines need to correct a statement regarding growth hormone-releasing factor, because it does not accurately reflect the available treatment to patients suffering from lipodystrophy disease.

According to WebMD, "Lipodystrophy is a problem with the way the body produces, uses, and stores fat. It is also called fat redistribution. Since the widespread use of antiretroviral therapy began, the numbers of HIV-positive people with lipodystrophy has increased. Today, lipodystrophy occurs in 30% to 50% of people who are infected with HIV (human immunodeficiency virus)."[1]

The ADAP Advocacy Association has increasingly supported educational initiatives aimed at tackling HIV-related co-mordibities, as well as HIV-related stigma. Combatting lipodystrophy falls under both categories. Researchers have concluded lipodystrophy is associated with increased rates of hypertension, diabetes, and lipids for patients experiencing lipodystrophy. Furthermore, long term psychological affects are present among patients, especially among those patients age 65 and older.[2]

Lipodystrophy is more than a cosmetic issue, especially for the HIV-positive patients living with the disease. For example, people living with HIV often believe the doughy fat around their midsection can be addressed by a healthy diet and exercise alone. But diet and exercise may not be enough to combat the challenges associated with visceral adipose tissue ("VAT"). The "Don’t Take VAT" website – www.DontTakeVAT.com – includes fact sheets about VAT and healthy living with HIV, as well as a video that provides a deeper look at VAT and tips about what to ask your doctor.

[Editor's Note: Read our related blog, "HIV-Related Belly Fat: More Than Just an Appearance Issue"]

But more needs to be done, frankly!

In 2010, the U.S. Food & Drug Administration ("FDA") approved Tesamorelin (trade name Egrifta) as treatment for lipodystrophy. Whereas some private health insurance plans cover this treatment option, public payors mostly don't cover it. Only three State AIDS Drug Assistance Programs ("ADAP") include Tesamorelin on its approved drug formulary, including Minnesota (though it requires a prior authorization), New Jersey, and Washington State. Not a single Medicaid program includes Tesamorelin on its Preferred Drug List ("PDL"). By restricting access to an FDA-approved treatment represents a disservice to the patients suffering from HIV-associated lipodystrophy.

Ironically, some states cite "cost" as the prohibitive factor for the reason lipodystrophy treatment isn't added to their approved drug formulary or PDL. Yet, other costly (and still needed) supports and services are covered -- such as counseling, physical therapy, and in some cases, surgery.

Photo Source: GLAD

That is why HRSA should update its "Guide for HIV/AIDS Clinical Care." It would provide better guidance for ADAPs nationwide seeking the necessary budgetary justification for adding Tesamorelin to its approved drug formulary. It is the only treatment available to these patients, and they are crying out for help! To read the draft letter to HRSA requesting an update to the medical treatment guidelines, CLICK HERE.

This effort shouldn't be interpreted as an endorsement of the particular product, Tesamorelin. The simple fact is Tesamorelin is the only product on the market approved by the FDA used in the treatment of HIV-associated lipodystrophy. Talk to patients who are living with HIV-associated lipodystrophy, and listen to their stories about the physical discomfort associated with the disease, or the stigma that they encounter on a daily basis living with the physical disformity caused by the disease.

Massachusetts is already leading the way to improve access to care and treatment 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 be done with public payors, such as ADAP and Medicaid.

Summarized Carl Sciortino, executive director for the AIDS Action Committee, and former representative in the Massachusetts Legislature who introduced the aforementioned legislation: "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."

To endorse this effort by adding your organization to the ADAP Advocacy Association's national sign-on letter, CLICK HERE. The deadline for signing on to the letter is COB on Monday, November 7, 2016.

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[1] WebMD, "Lipodystrophy and HIV," 2016; available online at http://www.webmd.com/hiv-aids/guide/lipodystrophy_and_hiv.
[2] Mascolini, Mark, "HIV Drug Therapy, Glasgow Oct 23-26 2016," NATAP, 2016; available online at http://www.natap.org/2016/GLASGOW/GLASGOW_18.htm. 

Mandating Treatment for HIV-Related Lipodystrophy: The Massachusetts experience and a call for national action

By: Ben Klein, Senior Attorney and AIDS Law Project Director, GLBTQ Legal Advocates & Defenders

There is a debilitating and disfiguring side effect of early HIV medications that causes profound suffering among our longest-term survivors of the HIV epidemic. For some, it is so severe that they do not leave their homes and become shut-ins, depressed, and suicidal. For others it causes chronic physical pain and structural damage, including spine and neck problems. And for many it is an involuntary public disclosure of HIV, still the most stigmatized health condition in America. Most public and private insurers refuse to cover the simple, inexpensive, and effective medical treatments available to remedy it.

This condition is called lipodystrophy. It is one of the most underappreciated and unattended challenges of the HIV epidemic. Massachusetts just became the first and only state in the nation to mandate insurance coverage for lipodystrophy. And we hope that the experience of the Treat Lipodystrophy Coalition in Massachusetts will become a national model for advocacy and legislation to end this unnecessary suffering.

The word “lipodystrophy” is unfamiliar to many people, even within the LGBT and HIV communities. Lipodystrophy is a consequence of the first wave of HIV medications in the late 1990s, which transformed HIV into a chronic and manageable disease. It is a metabolic disorder characterized by the abnormal distribution of fat in the body. People with lipodystrophy experience a range of disfiguring body shape changes with colloquial names like “buffalo hump” (an abnormal fat pad on the back of the neck) and “horse collar” (abnormal fat growth in the front and side of the neck and under the chin). It also causes severe wasting in the face and limbs. The effects can be devastating.

Several years ago, my organization - GLBTQ Legal Advocates & Defenders (GLAD), a legal group that fights discrimination on the basis of sexual orientation, gender identity and expression, and HIV status - began to hear from people who had been unfairly denied medical care by insurers on the specious grounds that treatment for lipodystrophy is “cosmetic.” It was through representing these individuals in their insurance appeals that I came to fully appreciate the profound physical and psychological harm caused by lipodystrophy – and to understand advocating for treatment as a true life and death matter. What we discovered was that the few people who had the capacity to lawyer up, get letters from physicians and psychologists, file an appeal citing the established medical literature about lipodystrophy, and threaten to sue, were often able to get the medical care they needed. But the very nature of the disease meant that the majority of people suffering from lipodystrophy were unlikely to be able to take on this kind of self-advocacy. It became clear that systemic change was needed.

The path to successful legislation in Massachusetts began with a conversation about the challenge of untreated lipodystrophy with Carl Sciortino, then a state representative and now the Executive Director of the AIDS Action Committee. He first raised the idea of introducing a bill and stepped up to be the original sponsor. At that time, no other legislator had heard of lipodystrophy. Most people in the HIV community, and many physicians treating them, simply assumed that coverage was impossible. Few people even bothered to try.

GLAD formed the Treat Lipodystrophy Coalition, which was made up of people living with HIV, physicians, and HIV advocacy and service organizations. We knew that to have a chance at passing an insurance mandate, we would need to find and present the stories of people whose experience living with untreated lipodystrophy would shock legislators in Massachusetts into understanding this as a critical health care issue. It was a daunting task. The shame and stigma of lipodystrophy is so powerful that many people would not meet with us and still others were not able to come forward publicly.

But with painstaking work, we were able to find a number of courageous individuals who allowed us to share their stories in the form of a book we produced called “Treatment for Lipodystrophy Denied: Sound and Compassionate Healthcare for People with HIV.” Those stories galvanized both legislators and our own community into action. We met a man named John Wallace from South Boston, whose lipodystrophy was so severe that he became hopeless and depressed and never left his home. He told us: “I’ve thought about suicide many times. But it goes against my Catholic faith.” We told the story of Mark S., who described being called “freak” and “monster” just steps from the Massachusetts State House. There is George Hastie, who recounted being denied coverage for a three-pound pad on the back of his neck that resulted in permanent spinal damage. And Andrew Fullem, who described being a “walking advertisement for HIV.”

Our first legislative hearing in March 2014 was a transformative moment. Legislators who had never before heard about lipodystrophy were close to tears. With the storybook and that powerful initial testimony as a springboard, we continued to gain traction throughout 2015 and 2016 - organizing community members, enlisting the support and expertise of respected medical professionals and healthcare agencies, engaging local and statewide media coverage, developing compelling messages and disseminating clear, concise fact sheets to legislators. We had three main messages we hammered away at:

• Cost is the foremost legislative concern with insurance mandates. We countered by demonstrating that lipodystrophy not only affects a very small number of long-term survivors, but also is a fixed and shrinking population. It is an historic problem. And the treatments, generally liposuction to remove excess fat and facial fillers to remedy wasting, are inexpensive. Here’s a postcard we delivered to all legislators:

• We always referred to lipodystrophy as a “disease” that requires medical care to counter the fallacy that treatments are “cosmetic.” Since when do we not treat a diagnosed disease? 

• Refusal to cover lipodystrophy treatments is discrimination. Insurance companies cover restorative procedures for the consequences of other diseases, such as breast reconstruction and testicular replacement for cancer patients. We don’t let insurance companies say that’s cosmetic! Refusing to treat the consequences of lipodystrophy disease is unfair discrimination against people with HIV.

When we began this process, nobody believed we had a chance at passing this bill. We were fortunate to have champions in the legislature, Representative Sarah Peake and Senator Mark Montigny, who took up the cause and pushed for passage. The law will go into effect November 9 (“An Act Relative to HIV-Associated Lipodystrophy Syndrome Treatment,” Chapter 233 of the Acts of 2016).
To be sure, HIV/AIDS advocacy and service organizations have had unrelenting and crucial battles to fight over the decades: access to testing and treatment; prevention, including PrEP and clean needles; discrimination and stigma; and the shameful criminalization statutes that still exist in a majority of states, to name just a few.  But I hope we can all agree that it is intolerable to let our longest term survivors of the HIV epidemic suffer from untreated medication side effects. Here’s hoping that the Massachusetts experience begins a national call to action to address this indefensible insurance discrimination.

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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.