National Hepatitis Awareness Month

By: Kevin Maloney, Deputy Director, Community Access National Network (CANN)

This month is National Hepatitis Awareness month, and Tomorrow, May 19th has been designated by the U.S. Centers for Disease Control & Prevention (CDC) as National Hepatitis testing day.

It is estimated by the CDC that 1.2 million Americans are living with HIV-infection and it is estimated that 1 in 3 living with HIV-infection are also co-infected with Hepatitis B (HBV) or Hepatitis C (HCV). There is both acute and chronic Hepatitis C. Acute HCV is caught within the first 6 months of becoming infected, while chronic Hepatitis C can persist for as long as 20 + years, and both can be asymptomatic. Viral hepatitis progresses faster among persons with HIV-infection and persons who are infected with both viruses experience greater liver-related health problems than those who do not have HIV-infection. Although antiretroviral therapy has extended the life expectancy of persons with HIV-infection, liver disease—much of which is related to Hepatitis B and Hepatitis C infection—has become the leading cause of non-AIDS-related deaths among this population.

People living with HIV-infection who are co-infected with either Hepatitis B or Hepatitis C are at increased risk for serious, life-threatening complications. As a result, all persons living with HIV-infection should be tested for Hepatitis B and Hepatitis C by their doctors.

Hepatitis C increases the risk of death for patients with AIDS by 50%, according to the results of a large study published in the online edition of Clinical Infectious Diseases this month. A fifth of these deaths were attributable to liver-related causes, five times the rate seen in people with AIDS who were not co-infected. The investigators also found that a third of co-infected patients were unaware of their hepatitis C infection.

Below are some more facts from the CDC:

About 25% of individuals infected with HIV in the US are also infected with HCV, and an estimated 10% of individuals infected with HIV are coinfected with HBV.

About 80% of injection drug users (IDUs) with HIV infection also have HCV.

HIV coinfection more than triples the risk for liver disease, liver failure, and liver-related death from HCV.

About 20% of all new HBV infections and 10% of all new Hepatitis A (HAV) infections in the US are among MSM. For MSM not infected with HBV or HAV, any sexual activity with an infected person increases their risk. In particular, unprotected anal sex increases the risk for both HBV and HIV among MSM, and direct anal-oral contact increases the risk for HAV.

Compared with other age groups, a greater proportion (about 1 in 33) of persons aged 46–64 years are infected with HCV.

Chronic HCV is often "silent," and many persons can have the infection for 20 to 30 years without having symptoms or feeling sick.

In the US, HCV is twice as prevalent among blacks as among whites.

The following is some general information about Hepatitis C.

What are the symptoms of acute Hepatitis C?

Approximately 70%–80% of people with acute Hepatitis C do not have any symptoms. Some people, however, can have mild to severe symptoms soon after being infected, including:

Abnormal liver function tests (ALT/AST numbers)

Fever

Fatigue

Loss of appetite

Nausea

Vomiting

Abdominal pain

Dark urine

Clay-colored bowel movements

Joint pain

Jaundice (yellow color in the skin or eyes)

How is Hepatitis C spread?

Hepatitis C is spread when blood from a person infected with the Hepatitis C virus enters the body of someone who is not infected. Today, most people become infected with the Hepatitis C virus by sharing needles or other equipment to inject drugs. Before 1992, when widespread screening of the blood supply began in the United States, Hepatitis C was also commonly spread through blood transfusions and organ transplants.

People can become infected with the Hepatitis C virus during such activities as:

Sharing needles, syringes, or other equipment to inject drugs

Needle stick injuries in health care settings

Being born to a mother who has Hepatitis C

Particularly increasing and alarming is sexual transmission of HCV in large urban areas..ie..NYC, San Francisco, Washington D.C.

Less commonly, a person can also get Hepatitis C virus infection through sharing personal care items that may have come in contact with another person’s blood, such as razors or toothbrushes.

Treatment Options:

Hepatitis B and C can be cured. The earlier the infection is diagnosed the better there is a chance at curing it. Though, with new medicines and much more in the pipeline – chronic Hepatitis C sufferers are also finding it easier to cure Hepatitis C. Many clinics have the capability of doing rapid HCV screenings, much like the HIV test where a patient's status can be determined in 20 minutes. Treatment options for Hepatitis C are becoming more effective and less toxic to the body. !

FDA Sets Eyes on OraQuick's In-Home HIV Test

On May 15, 2012, the U.S. Food & Drug Administration (FDA) will discuss the safety and effectiveness of the OraQuick In-Home HIV Test. This is a test which consumers would be able to purchase over the counter, take home and in 20 minutes find out their HIV status. Who’s Positive conducted a Nationwide Survey and gathered responses from 1,569 participants.

Overall, the survey findings demonstrate support for rapid OTC testing - particularly from the HIV community - with approximately half of the respondents identified as people living with HIV/AIDS.  It should be noted that the survey was conducted online, and thus its findings are not scientific.  However, it offers some interesting insights.

Seventy-four percent (74%) of respondents said that they would support an OTC rapid, oral swab HIV test that could be purchased in a retail store, if approved by the FDA.

Other key findings of the survey found:

66% of the respondents who identify as a HIV-positive consumer support an OTC HIV test;

80% of those aged to 30 support an OTC HIV test;

A majority or nearly 52% of those who identified as a paid member of an HIV/AIDS organization support an OTC HIV test; and

47% of those who identify as one who performs HIV testing support an HIV OTC test.

“Our survey demonstrates widespread support for additional testing options, especially among younger generations and those who are already living with HIV,” said Tom Donohue, Founding Director of Who’s Positive. "Over-the-counter testing has the potential to break down barriers and empower people who have never been tested before to learn their HIV status and, if positive, find the care and support they need."

How will an over the counter test affect already cash strapped AIDS Drug Assistance Programs? The jury is still out on that. As of May 10, 2012, there are 2,759 individuals on ADAP waiting lists in ten (10) states, according to the National Alliance of State & Territorial AIDS Directors (NASTAD) report. The number of states with waiting lists and individuals on them held relatively steady from last week’s update with a total increase of 55 individuals.

The Folly of Waiting for Godot

By Jeffrey Lewis

Like the protagonists in Waiting for Godot, the 1.2 million Americans who are HIV-positive are anxiously waiting. But unlike the gentlemen in Samuel Beckett’s classic play who wait in vain for someone who never shows up, the HIV community is awaiting something that almost certainly will arrive in June. That is when the U.S. Supreme Court will deliver its decision on the constitutionality of the Affordable Care Act.

If the Court upholds the ACA, it would mark a decisive turn in the fight against AIDS. First, the Act would expand Medicaid so that lower-income HIV sufferers can get earlier access to treatment. And second, it would eliminate the “pre-existing condition” limitations that have made it all but impossible for many HIV-positive people to obtain private insurance. According to the National Minority AIDS Council, these two provisions would “prolong life potentially by decades for literally hundreds of thousands of persons.”

With the Court’s decision just a month or so away, it is tempting to cross our fingers, sit on our hands ---and wait.

We must not succumb to that temptation.

For one thing, there’s no guarantee that the ACA will survive. And even if it does, most of the Act’s major provisions won’t take effect until 2014, or even later ---longer than many HIV-positive folks can afford to wait, in particular, the 3,079 individuals on waiting lists in 10 states to gain access to their life-saving medications under the AIDS Drug Assistance Program. More important yet, under the ACA, the federal government will effectively quit paying for health care in 2019. And when the feds turn off the spigot, we’ll still be left with the bills.

When that happens, the results are predictable. Programs will be cut. The needy will take yet another step backwards. Those with HIV and other chronic conditions will again fall victim to the long knives of congressional and state appropriators. And those of us on the front lines of the AIDS battle will once again be asking “what do we do now?”

One thing we can’t do is expect the pharmaceutical industry to shoulder the burden alone.

Like any business or industry, pharmaceutical companies need revenue, capital for new investments and shareholders who demand that they earn a profit. That means there is a limit to how much they can cut prices ---and a limit to how much we should expect them to.

One thing pharmaceutical companies can do, however, is drop their resistance to the creation of a single, common, and industry-wide Patient Assistant Program enrollment form. This step alone would simplify the process, eliminate confusion, and make it far easier for assistance to reach the people who need it most.

But even if the industry gets on board, there would still be a host of legal and operational obstacles to creating a single, common and universally-accepted PAP form. Instead of asking the federal government to become involved, I believe there is a private sector solution.

EHIM ---the company for which I serve as Chief Operating Officer ---is currently reviewing every PAP form from every drug manufacturer. Our goal is to take the pharmaceutical industry a solution so excuse is not a four letter word.

Meanwhile, there is another major problem brewing that we need to get ahead of. An over-the-counter HIV test is on now the horizon. While this would be a major breakthrough in identifying people in need of help, it would also likely swamp already bloated AIDS ADAP waiting lists. At present, there are over three thousand people across 10 states who have received an HIV diagnosis ---and many more not yet ADAP-certified ---on these lists. Making them even longer isn’t an attractive option.

But that is exactly what will happen unless eligibility for ADAP is expanded and Congress agrees to a long term funding commitment. I hope the pharmaceutical industry will take the first step by agreeing to allow any person with HIV and without prescription drug insurance coverage to be eligible for the ADAP solution.

Committing ourselves to ensuring that anyone with HIV but no insurance gets help would stop a race to the bottom in which states steadily lower ADAP income eligibility requirements. And in the long run, it would actually save money by slowing the flood of patients going to ERs because they don’t have access to medication.

Finally, there is one more thing to which all of us must commit. And that is to bring civility, respect and the word compromise back into our politics and national discourse. Who among us is infallible or has all the answers? Today ---more than ever- -we need intelligent public policy, not blind partisanship. HIV has no political affiliation; everyone who suffers from it is a member of our family ---the human family.

Jeffrey Lewis is the Chief Operating Officer at EHIMRx and the former President of the Heinz Family Philanthropies. He can be reached at jeffrey13@ehimrx.com. This material was part of his keynote address at the recent HIV Summit in Washington, DC. Lewis is also the past recipient of the ADAP Advocacy Association's ADAP Champion Award.

ADAP Solutions: A Consumer Perspective

By Kevin Maloney

On April 2nd & 3rd, the ADAP Advocacy Association (aaa+) hosted its ADAP Solutions Summit to identify improvements and reforms that could enhance the AIDS Drug Assistance Program (ADAP). As a consumer of ADAP services, I found these 2 days -- which brought consumers, industry, advocates and other stakeholders to the same table for the first time -- to be very productive. I met many folks, some consumers, some not, but all with one commonality; all indebted to the cause of helping ensure that every American has access to the care and treatment they need to remain alive, healthy, and productive. At no point was anyone's intentions or commitment called into question, and that is the way it should be done!

As a consumer of ADAP services, I want to touch on the aspects of some of the proposed enhancements that I feel could have an immediate impact by bringing more people into care, coinciding with President Obama's goals set forth in the National AIDS Strategy (NAS). Before I do so, I feel obliged to share with you my brief personal story.

The date of March 3rd, 2010, will be etched into my mind for the rest of my life. My doctor called me, and said “Kevin, I need you to come into the office.” When I walked into his office, and the receptionist staff was dead silent, they couldn’t even look me in the eyes. My doctor laid a paper down in front of me and it read; PCR by DNA HIV – Reactive. I tested positive for HIV-infection. I was asked how I felt psychologically, and I said “fine” (even though I was scared), and then I left the office.

Immediately after leaving his office, I started to put an action plan into place. First, I called Callen-Lorde (a CBO in NYC), and was offered an appointment the very next day. Then I called my HR department where I was working, to find out about taking a leave of absence. I learned of the Family Medical Leave Act (FMLA), and under this federal law it allowed me the time off that I needed to get to my doctor appointments, begin my chosen Anti-Retroviral Therapy (ARV), seek out support, and to learn everything that I could about living with this disease.

A month later with follow up labs, I was then told I had Hepatitis C, genotype 1a. WHAT?!? I felt like someone punched me in the stomach, and I fell to the floor, because this diagnosis through me for a loop. My doctor said is mainly contracted by people who share needles; I wasn’t an intravenous drug user (IDU) in my instance it piggy backed onto the HIV-infection. Now I was angry; how could this happen to me? I knew nearly NOTHING about this disease. So, I went home to read more about it, and found out I could clear the virus. I found a doctor in NYC , and soon after I began the dreaded interferon + Ribavirin therapy. At the forth week, I had a sustained virologic response, and at the 6 month post-treatment, I still had an SVR, I have cured Hepatitis C.

During this time of personal distress I coined the phrase “Rise up To HIV.” It started out as a personal platform to tell my story, and has since morphed into a personal AND advocacy platform. At a time when I could have given up, I chose to rise up, stand out, and speak up about my dual diagnosis, and about issues facing the community of 1.2 million people living with HIV/AIDS, including those who are co-infected with Hepatitis C that I belong to.

I can say that I am alive today; equally important, I am healthy because of the AIDS Drug Assistance Program granted me access to the life-saving medications that I needed to survive. As ACT UP celebrates its 25th anniversary, it is hard not to see ADAPs existing today. Many individuals and leaders got fed-up with watching dozens upon dozens of their friends and loved ones die. They themselves -- some of them on the brink of death -- started a movement to recognize AIDS and to demand treatment and services for those infected with the disease. To them, I say "thank you." We have you to thank for the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, as well as the AIDS Drug Assistance Program was formed.

There are thousands more PLWHAs who share similar stories, or ones even more dire.

Today, ADAP is facing the "Perfect Storm" and some would even suggest that it is in grave danger. If full funding for ADAP and other vital HIV/AIDS services is not restored to the levels of the law's legislative intent, and increased to keep up with the demand, then we WILL have flashbacks to the 1980s and 1990s; people will be dying. This time, not because we have no medicine to treat the disease, but because we don’t have the funding to provide it to everyone who needs it.>p> Currently, there are over 3,000 people across 10 states on ADAP wait-lists. Though this number does not reflect individuals in states that have reduced financial eligibility, or capped enrollment, it provides a very public face for the crisis. I’ll share with you some scary statistics:

1.2 million Americans (believed to be much higher) are living with HIV/AIDS;

Of these 1.2 million, it is estimated that only 20 percent of PLWHAs are receiving care and treatment;

Approximately 20 percent of HIV-infected Americans do not know they are infected;

Only 28 percent of PLWHAs have undetectable viral loads in the United States; and

1 in 3 PLWHAs are co-infected with Hepatitis C.

We are facing a public health crisis, unseen since the epidemic began. The weak economy has crippled state budgets that pay into ADAP, and the federal government's commitment as a share of total spending on the program has declined over the last 5-6 years. In addition, prevention initiatives and other supportive services such as HOPWA funds have dried up in communities across the nation.

Further, many states have employed cost containment strategies, such as reduced formularies, lowered financial eligibility levels, implemented client cost sharing, or program enrollment caps. These strategies have disqualified individuals who would have previously qualified for ADAP.

Without reliable access to the medications, which cost patients under the AIDS Drug Assistance Program an average of less than $10,000 a year, PLWHAs are more likely to acquire opportunistic infections, develop full-blown AIDS, transmit the virus and require expensive hospitalizations, and even die.

On May 12th, 2011, the University of North Carolina at Chapel Hill led an international study that showed early treatment with antiretroviral therapy prevents HIV transmission. The result of the study (HPTN05) was that those taking ARV were 96 percent less likely to pass on the disease than those who didn’t take ARV. This critical new finding convincingly demonstrates that early treatment of infected individuals can have a major impact on the spread of the epidemic.

Combined, the advanced scientific studies, new treatment guidelines, and new prevention messages/campaigns at the national, state, and local level are increasing the demand on ADAPs. That demand is far outpacing the required funding to meet the needs of PLWHA. It is fueling this crisis, but it has to stop now! HIV/AIDS is still a communicable and deadly disease, and our government must continually remind themselves of these facts and provide the adequate funding to provide proper treatment to those already infected, while also preventing the spread of the virus to others.

As a consumer who has self-maneuvered the complexities of the ADAP system, I want to highlight the enhancements talked about during the ADAP Solutions Summit. I believe that they will be most beneficial to bring more people into care, and retain those already receiving ARVs.

Uniform FPL eligibility at 500% for ALL ADAPs in all states, Territories, and Dependencies

Utilize peer navigators

Increased education in the community on ADAP, Patient Assistance Programs and co-pay assistance, as well as insurance continuation programs administered under ADAP

Utilize Social media at the federal, state, and local level to improve access to information

Face to face access to a pharmacist, instead of mail order, and pharmacy of choice

Development of a common portal with the ability to be client driven

Recertification to happen every year, instead of every 6 months and more user friendly

Co-Infected individuals should have access to Hepatitis C drugs through ADAP

ADAPs should help pay deductible spend down for people with private insurance

If a client moves to another state, the old state ADAP should provide 90 days’ worth of medications prior to termination to allow a smooth transition to the new state

ADAPs should take into consideration Net Income, NOT Gross Income to determine financial eligibility

Fortunately I now live in Washington, DC and I was living in NY prior; both places have a very robust ADAP program. If I were in the White House I would conduct a very thorough and comprehensive review on each state ADAP, and begin the discussion on how best to move forward with a uniform AIDS Drug Assistance Program that can serve everyone regardless of geographic location, or socio-economic status. Too many people are falling through the cracks.

Again I ask: "Why do I have access to the care and treatment needed to stay alive, remain healthy, and productive; while others are on wait-lists or who have been shut out of care because of cost containment strategies?" Of course, it is a rhetorical question. This is not right, and this is not the American way!

I encourage you to read the Final Report issued by the ADAP Advocacy Association after its ADAP Solutions Summit. It can be downloaded here: http://www.adapadvocacyassociation.org/publications.html

States rationing HIV treatment is DANGEROUS MEDICINE; Sick people get better, healthier people get sicker

As of March 29th, 2012, there are nearly 4,000 people living with HIV/AIDS (PLWAHs) across 11 states on wait-lists under the AIDS Drug Assistance Programs (ADAPs). Yet there is another ghostly number that exists because states have lowered financial eligibility -- and in some cases have introduced outdated medical criteria as a cost containment measure -- thus virtually shutting people out of care. This number is often referred to as the invisible waiting list. Some advocates have characterized these cost containment measures as “murder by proxy.”

The Health Resources & Services Administration (HRSA), under the U.S. Department of Health & Human Service (HHS), has stated unequivocally that using medical criteria in administering wait-lists in HRSA Programs is considered to be a discriminatory practice, and just recently the Institute of Medicine said ALL treatment naïve patients should be on anti-retroviral medication (ARV). Also, a study published last year (HPTN052) proved that those taking ARVs are 96 percent less likely to pass the virus onto their partner. Despite federal policy and the strong scientific evidence, medical criteria remains on the table in states like Ohio. The proposed rules give highest priority on the wait-list to PLWHA who are pregnant and who have CD4 counts lower than 201. The medical criterion makes no mention of an important aspect of HIV care, which is the Viral Load.

The rules proposed by the Ohio Department of Health (below) are oppressive for PLWHA, and they are indeed dangerous for public health. In essence, states implementing medical criteria result in creating a viscous cycle whereby "sick" patients are allowed to get better, and "healthy" patients are forced to get ill.

Medical criteria completely overlooks that as "healthier" patients get "sicker" the demand for medical care and treatment rises, and the cost benefit of treating someone with HIV-infection vs. not treating someone with HIV-infection has proven itself over the years. It is more cost effective to treat someone healthier, than to wait until they are sick. The Ohio proposed rules is not a cost-effective strategy for health officials, politicians and taxpayers.

Thirty 30 years after the HIV/AIDS epidemic began less toxic medicines are available to keep people alive and healthy, and to keep people productive so that they can provide for themselves and others. Many PLWHA can work, access health insurance, and lead normal productive lives. More importantly someone on medicine is less likely to transmit the virus.

Ohio HIV/AIDS advocates have decried against the proposed rules, arguing that the state is trying to implement these rules on the backs of the poor and vulnerable, especially those living with a potentially life threatening disease such as HIV/AIDS.

The Ohio Department of Health (ODH) has instituted the following medical criteria.

When OHDAP has a waiting list for program enrollment and subject to sufficient funding, applicants to the Ryan White Part B programs must meet one of the following medical guidelines to be eligible for expedited enrollment:

1. Pregnant women who meet all OHDAP eligibility criteria and who are not eligible for other programs which provide antiretroviral (ARV) medications.

2. Post-partum women (women who given birth within 180 days prior to applying to OHDAP) who meet all OHDAP eligibility criteria and who are not eligible for other programs which provide antiretroviral (ARV) medications.

If the OHDAP is able to enroll some but not all individuals from the waiting list (based on insufficient funds), applications from individuals who meet all OHDAP eligibility criteria and who are not eligible for other programs which provide ARV medications will be prioritized as follows:

Priority 1: Individuals with HIV and other extreme medical conditions such as, but not limited to, HIV-associated nephropathy or HIV related dementia. The applicant’s HIV-treating physician or nurse practitioner shall complete a medical waiver request
consistent with section 3701-44-04 of the Ohio Administrative Code.

Priority 2: Individuals with a history of AIDS-defining illness [see paragraph (C) of Appendix A to section 3701-3-12 of the Ohio Administrative Code for indicator diseases diagnosed definitively] and/or a nadir CD4 count of less than or equal to 200 cells/mm3 (or less than 14%). Documentation shall be provided by the HIV treating physician or nurse practitioner evidencing how the individual meets this priority.

Priority 3: Individuals with HIV and a nadir CD4 count between 201-350 cells/mm3. Documentation shall be provided by the HIV-treating physician or nurse practitioner evidencing how the individual meets this priority.

Priority 4: Individuals with HIV and a nadir CD4 count between 351-500 cells/mm3. Documentation shall be provided by the HIV-treating physician or nurse practitioner evidencing how the individual meets this priority.

Priority 5: Individuals with HIV and a nadir CD4 count above 500 cells/mm3. Documentation shall be provided by the HIV-treating physician or nurse practitioner evidencing how the individual meets this priority.

The motto of the Ohio Department of Health is "to protect and improve the health of all Ohioans"; but the unintended consequences that would result from the state implementing its proposed rules on medical criteria for ADAP would undermine that motto. Ironically, Ohio cannot afford to adopt this proposed rule because it will only cost the state more money in other health-related costs.

Not only has Ohio instituted the above medical criteria, they have also reduced financial eligibility from 500 percent of the Federal Poverty Level (FPL) to 300% FPL. Many other states have also reduced their FPL, thus shutting people out of care and treatment. The latest ADAP waiting list numbers, and states who have implemented other cost containment strategies, are made available by the National Alliance of State & Territorial AIDS Directors (NASTAD), and can be reviewed by downloading the ADAP WATCH!

Every person living with HIV/AIDS should have access to the care and treatment they need to remain alive, healthy and productive. PLWHAs seeking access to care and treatment should not be subjected to dangerous medicine!

ADAP Solutions Summit Seeks Answers

The ADAP Advocacy Association (aaa+), in partnership with the Community Access National Network (CANN), will host an "ADAP Solutions Summit" in Washington, DC on April 2-3, 2012. But why?

ADAP waiting lists are nothing new; in fact, they date back to the program's inception but the scope of the modern day ADAP waiting lists is something entirely new. Previously, ADAPs were plagued with hundreds of people living with HIV/AIDS (PLWHAs) being denied access to timely care and treatment in a few states. Since 2009, ADAPs have encountered the "Perfect Storm" that has led to THOUSANDS being placed on waiting lists nationwide, as well as denied treatment because other cost containment measures have also exploded at the state level.

According to the National Alliance of State & Territorial AIDS Directors (NASTAD), in Fiscal-Year 2011 the National ADAP budget increased by $100 million to $1.88 billion. State funding accounted for $299 million over the overall budget and drug rebates accounted for $619 million of the overall budget. As a percentage of the increase, once again the federal government’s share did not keep pace with the demand, evidenced by a record number of new patients accessing the program (there were 32,522 new clients enrolled throughout the year. This represents, on average, 2,710 new clients enrolled in ADAPs each month). [1]

The Summit will focus on identifying numerous short-term and long-term solutions, including – but not limited to – increased federal/state funding, access to patient assistance programs, drug pricing & drug rebates, program efficiencies (i.e., eligibility determination), access to generics, etc. It will be headlined by a day-and-a-half roundtable comprised of fifty panelists representing the various ADAP stakeholder groups, including consumers, AIDS Service Organizations, pharmaceutical companies, PBMs, pharmacies, advocates and advocacy organizations, state agencies (corrections), State ADAP Directors, federal agencies (CMS, HRSA), and physicians.

The Summit is being moderated by Randy Russell, Lifelong AIDS Alliance. Confirmed panelists include: William Arnold, Community Access National Network (CANN); Paul Arons, MD, Fair Pricing Coalition; Fran Barnes-Melvin, ViiV Healthcare; Janine Brignola, Nebraska AIDS Project; Christine Campbell, Housing Works; Lynda Dee, Fair Pricing Coalition; Catherine Dratz, Abbott Laboratories; Jim Driscoll, AIDS Healthcare Foundation; Eric Flowers, Ramsell Holding Corp.; Darryl Fore, Cleveland Ryan White Part A Planning Council; Jesse Fry, Florida HIV/AIDS Advocacy Network (FHAAN); Jeff Graham, Georgia Equality; Edward Hamilton, ADAP Education Initiative; Dwayne Haught, Texas Department of Health, ADAP; Kathie Hiers, AIDS Alabama; James Howley, Abbott Laboratories; Brian Hujdich, HealthHIV; Michael Juhlin, Florida ADAP consumer, Jason King, AIDS Healthcare Foundation; Meeka Jackson, Centers for Medicare & Medicaid Services, Pre-Existing Condition Insurance Plans (PCIP); Diana Jordan, Virginia Department of Health, ADAP; Jeffrey Lewis, EHiM; Brandon Macsata, ADAP Advocacy Association; Ken McCormick, Janssen Therapeutics; Harold Orr, MD, Corizon; Deborah Parham-Hobson, U.S. Department of Health & Human Services, Health Resources & Services Administration (HRSA); Blaine Parrish, Georgetown University Medical Center, School of Public Health & Health Services; Murray Penner, National Alliance of State & Territorial AIDS Directors (NASTAD); Glen Pietrandoni, Walgreens; David Poole, Gilead Sciences; Christine Rivera, New York Department of Health, ADAP; Jessica Riviere, Bristol-Myers Squibb; Carl Schmid, The AIDS Institute; Elizabeth Shepherd, Monique's Hope for Cure; Corklin Steinhart, MD, Merck & Co.; Coy Stout, Gilead Sciences; Pritpal Virdee, Walgreens; Robin Webb, A Brave New Day; Andrea Weddle, HIV Medicine Association; Kimberly Williams, ViiV Healthcare; Joey Wynn, Broward House. Additional roundtable panelists are awaiting confirmation.

The Summit roundtable panelists will hear several "big sky" keynote speeches, as well as numerous smaller "concrete" presentations on how ADAPs can be improved to serve more PLWHAs in need. Keynote speakers include:

Jeff Lewis, EHiM

The Honorable Tommy Thompson, former Governor of Wisconsin & former HHS Secretary (invited)

The Honorable Donna Christensen, MD, Delegate, U.S. Virgin Islands (invited)

Other presentations will be delivered by Murray Penner of NASTAD on the ADAP Crisis Task Force, Jeff Lewis of EHiM on the Welvista Solution, Eric Flowers of Ramsell Holding Corp. on the Practicality of a Common Portal, Joey Wynn of Broward House on an Ideal ADAP Model, Eric Flowers of Ramsell Holding Corp. on Inmate Transition Serives, and Glen Pietrandoni of Walgreens on HIV Centers of Excellence.

Panelists will be charged with assisting aaa+ to identify 3-5 short-term and long-term systemic reforms, which will be included in a Final Report made available to policy-makers on Capitol Hill. The Final Report will reflect the views of aaa+.

The Summit is open to the public registration is only $99 for non-pharmaceutical attendees, and $199 for pharmaceutical company attendees. To register, or learn more about the Summit please visit http://www.adapadvocacyassociation.org/events.html.

[1] Source: 2012 National ADAP Monitoring Project Annual Report

Tell GILEAD Pharmaceuticals to reduce the cost of HIV medications now!

Referencing the latest figure from the National Alliance of State and Territorial AIDS Directors (NASTAD), as of March 8th, 2012, there are 3,949 individuals across 11 states on the AIDS Drug Assistance Program (ADAP) waiting lists. These individuals -- who are uninsured or underinsured -- have received an HIV + diagnosis, and are unable to properly access the drugs they need to remain alive, healthy, and productive.

In support of the following letter sent to GILEAD from the Fair Pricing Coalition, and signed by individual members, the FPC outlines it's concerns, and requests specific actions be taken by Gilead. Any interested individual or organization is welcomed, and encouraged to sign on. Please share WIDELY across your networks.

SIGN THE PETITION

It is essential that GILEAD understand the negative impact of their actions on people living with HIV/AIDS (PLWHAs). Since 2009, Gilead has raised prices three times each for Viread and Truvada for a total of 22.1% and 24.5% respectively; twice for Emtriva for a total of 15.3%,and agreed to four price increases on for Atripla, totaling 21%, and agreed to a 7.3% price increase for Complera. These increases are dramatically higher than the rate of inflation. They also come at a time when many people with HIV have lost their jobs, their employer-based insurance coverage and, in many instances, their ADAP coverage, all resulting in desperate patients attempting to access HIV drugs on the open market, a market plagued with constantly increasing drug prices.

As U. S. economic stagnation persists PLWHAs continue to lose jobs, income, health care benefits and ADAP coverage. At the same time, third party payers are imposing higher premiums as a direct result of escalating drug prices. Some patients have abruptly stopped treatment because they can no longer afford their medications. Although PAPs exist to help people who cannot afford medication, barriers to access are significant. Many people are unaware of the existence of PAPs. Others cannot cope with the labyrinth of multiple forms and requirements. Even with Gilead’s PAP eligibility at 500% of the Federal Poverty Level, a PLWHA earning $56,000.00 annually is not PAP eligible and will have to pay $20,000.00 or more to purchase Atripla at retail prices. This figure represents at least two-thirds of their net income.

The pharmaceutical industry’s extravagant price increases reverberate throughout the healthcare industry. They come at a time when many ADAPs are covering private insurance payments for their clients and result in ADAPs paying significantly increased premiums as a result of exorbitant price increases. This policy also results in higher premiums for people with HIV who are insured at a time when more and more people have less and less income due to unemployment, underemployment, reduced wages and reduced hours. Moreover, higher healthcare costs mean higher co-pays and pharmacy deductibles for people with private insurance and high share-of-cost plans, which also result in increased costs to patients as well as decreased benefits. More restrictive access within insurance plans affects the cost of drugs, but also ancillary services, such as mental health, prevention healthcare, rehabilitation and substance abuse services.

Escalating costs for private and employee healthcare plans occasioned by continuous drug pricing increases will undoubtedly have a deleterious effect on the states as they design their health care exchanges in preparation for the 2014 implementation of the Affordable Care Act (ACA). Many states are likely to set a minimum standard for drug coverage for their “essential health benefits” package that requires only limited coverage of antiretrovirals and other higher cost drug classes. Additionally, with non-preferred generic antiretrovirals entering the marketplace we are concerned that higher drug prices will increasingly result in key coverage decisions being driven by cost rather than the standard of care for HIV treatment.

Much of this crisis is occasioned by irresponsible pharmaceutical industry behavior. We firmly believe that Gilead’s price increases are particularly egregious because Gilead currently has the lion’s share of the antiretroviral market.

We believe that the best way to begin to address these issues is for industry to change its price increase practices and agree to the following:

- Gilead must agree to take no more than one CPI consistent price increase annually.

- Gilead must use its sales force to disseminate information regarding its PAP and co-pay programs.

- Gilead must contribute to foundations that provide co-pay program access to Medicare Part D clients.

- Gilead must cooperate with the FPC and other stakeholders in designing and implementing a seamless, industry-wide standardized PAP criteria and enrollment process.

Now is the time for Gilead to reconsider its price increase policy and rescind its latest unreasonable price increases. The FPC, it members and the undersigned sincerely hope that Gilead will agree to the above and we look forward to your immediate response.

Sign the Petition: http://www.change.org/petitions/tell-gilead-pharmaceuticals-to-reduce-the-cost-of-hiv-medications-now?utm_medium=facebook&utm_source=share_petition&utm_term=autopublish