AAB Advocacy

AIDS Action Baltimore is involved in many research and treatment advocacy campaigns on many fronts, including initiatives with government, industry and academia.  What follows are links to articles and press releases regarding some of our projects.  We have either taken the lead or been involved with other AIDS service organizations in regard to these projects.  If you have any questions or would like to help in any of these areas in any way, please feel free to contact us either by phone or e-mail.

AIDS Action Baltimore (AAB) has been a prominent member of the Fair Pricing Coalition (FPC) since it was founded by Martin Delaney and Linda Grinberg in 1999. I have been acting FPC chair since Martin Delaney died in 2009 and am now the FPC co-chair. Murray Penner from the National Alliance of State and Territorial AIDS Directors (NASTAD) is also a co-chair.

The FPC is a national coalition of activists who work on HIV and Hepatitis C (HCV) drug pricing issues and negotiate new drugs prices with HIV drug companies. We badger companies about drug price increases and ensure that they make their anti HIV and HCV drugs available to those who cannot afford them either through co-pay programs for people with insufficient insurance coverage or patient assistance programs for people with no insurance. We also work the AIDS Crisis Task Force to ensure that Ryan White AIDS Drug Assistance Programs (ADAPs) that provide access to prescriptions for the working poor across the nation receive generous rebates for all drugs purchased for people with HIV. Our work helps to control drug costs, thereby ensuring access for recipients of state ADAPs, Medicare, and Medicaid, as well as those who are privately insured, underinsured and uninsured. This type of advocacy does not happen in any other disease field.

We have worked very hard for many years to ensure generous uniform industry patient assistance programs (PAPs) for people with HIV and HCV who do not have insurance. The FPC has advocated for an income eligibility criteria of 500% of the federal poverty level (FPL) for people with HIV, ($58,350 for individuals in 2014), and over $100,000 for more expensive HCV drugs. All but one HIV drug company uses the 500% FPL criteria for HIV PAPs. Janssen’s PAP criteria is 200% of the FPL, but they will make exceptions for people whose income is over their 200% cap. HCV drug manufacturers Gilead and Vertex use the over $100,000 annual income for individuals for their HCV PAPs. The criteria for Janssen’s and Merck’s HCV PAPs is 500% of the FPL. You can find more PAP contact and eligibility information at: http://fairpricingcoalition.org/projects/.

Current company co-pay programs are a direct result of several years of intense work and negotiations between the FPC and representatives of the pharmaceutical industry. We almost lost our co-pay programs last year after a complicated government snafu. The community convinced former Secretary of Health and Human Services Kathleen Sebelius to rule that the Affordable Care Act (ACA) was not a “government program” for co-pays purposes in order to avoid federal prohibitions that do not permit co-pay programs for people in government programs. We feared that all our work in this arena would come to a screeching halt when the Centers for Medicare and Medicaid Services (CMS) issued an unclear ruling thereafter, indicating that co-pay programs were not favored and/or permissible for ACA patients, and also confused the co-pay playing field for Ryan White covered patients. The underlying issue is this. Both government and private insurance payers do not favor co-pay programs because they are seen as inducements for people to purchase more expensive brand name drugs when cheaper generic versions are available. While the drugs may be cheaper for the patient, the brand name drugs cost are much more expensive for the entity that has to foot the bill. This problem does not usually even apply to HIV and HCV because most of our drugs are still under patent protection which means there are no generic alternatives.

Some companies continued their co-pay programs after the CMS ruling, but some did not for fear of being sued by CMS. The landscape was confused to say the least. But the FPC finally convinced all HIV and HCV drug companies to keep their co-pay programs alive based on the Sebelius ruling. We were eventually successful after a long slog. Now very generous co-pay programs are in place for all anti-HIV and HCV drugs for people whose medical expenses are not covered by Medicare and Medicaid.

Detailed contact and eligibility information on HIV and HCV drug company co-pay programs can be found on the FPC’s web site. http://fairpricingcoalition.org/projects/. As drugs for HIV and HCV become more expensive, PAP and co-pay program advocacy is more necessary than ever. Please share this access program information with your friends. We need to get the word out to people that these programs are available. We need your help to let people know about free drug PAPs for people without insurance and co-pay programs that help defray the cost of really expensive ARV medications for people with insurance.

We have also convinced most major HIV and HCV drug companies to make generous contributions to non-profit groups like the Patient Access Network Foundation (PAN) so that co-pay benefits will also be available to Medicare and Medicaid patients. PAN HIV program co-pay information can be found at: http://www.panfoundation.org/hiv-aids. PAN HCV co-pay information can be found at: http://www.panfoundation.org/hepatitis-c.

Now that we have ironed out the “government program” co-pay snag, we are concentrating on co-pay costs as well as all out of pocket (OOP) costs occasioned by other costs levied by insurance companies after enactment of the ACA. For many years, the FPC concentrated heavily on advocacy for programs like ADAPs which covered prescription costs for the working poor. Because of onerous OOPs that so many people cannot afford, the FPC has now expanded its focus largely to ACA network clients and private insurance clients. The FPC is currently working to ensure that all HIV and HCV drug companies cover at least $6,350 annually for all prescription OOPS, including co-pays, deductibles and co-insurance costs. So far, we are about half way there. We are also trying to convince HIV drug companies to institute a price increase freeze. The increases in the price of HIV drugs since approval are unbelievable. As you can see, every year our work gets tougher and more complicated. There is always more to do to ensure that people actually have access to the drugs we worked so hard to get approved by the FDA. For more information on the work of the FPC as well as many facts and figures related to pricing challenges, including the percentage of price increases for HIV drugs since FDA approval, check out a recent presentation I made at a meeting of the Federal AIDS Policy Partnership in DC. https://www.aidsactionbaltimore.org/wordpress/wp-content/uploads/2014/12/FAPP.pdf.

The FPC has also been inundated with work surrounding the launch of new drugs which can actually cure HCV without the devastating side effects caused by older HCV drugs, namely interferon and ribaviran. Many people with HIV are also co-infected with HCV. This is especially true in the Baltimore metropolitan area. Most of the major HIV drug companies also have new HCV drugs, called Direct Acting Antivirals (DAAs). The new DAAs were supposed to usher in a new day for people with HCV. The HCV community worked very hard to ensure that HCV testing would be covered by advocating with the US Preventive Services Task Force (USPSTF) to give HCV testing the grade necessary to ensure that insurance companies will pay for HCV testing. The USPSTF has a history of waiting inordinately long periods of time to give their imprimatur to many tests and vaccines. It was a major undertaking to move this often out of touch body into the 21st Century in this regard.

HCV testing will now be reimbursed. Hundreds of thousands of people who were never able to obtain and/or afford health insurance would now be able to access these amazing new DAAs as a result of the ACA. The new DAAs have amazing 90 to 100% cure rates with much shorter courses of therapy. Some DDA regimens cure HCV in 12 weeks, instead of having to take old 48 week interferon containing regimens with horrible side-effects and often abysmal cure rates for more advanced patients and patients with the most prevalent and hard to treat genotype (GT) HCV GT 1a.

Hurrah, right! Not quite… Gilead Sciences’ pricing of Sovaldi, its highly effective new HCV drug is unconscionable, resulting in wide-spread onerous national prior authorization requirements and restrictions from both public and private payers.

Sovaldi is arguable the most effective new HCV DAA, and also requires the shortest treatment duration. Sovaldi was first approved by the FDA in December of 2013 for use with interferon and ribavirin and priced at an exorbitant price of $84,000 for a 12 week regimen or $1,000 per pill. The price of Sovaldi has sparked unprecedented outrage from all quarters, resulting in Congressional investigations in both the Senate and the House of Representatives, suits against Gilead and relentless unfavorable press and public relations. In all my years with the FPC, I have never seen such furor over any one drug price.   Nevertheless, Gilead’s Sovaldi launch has been the most successful in the history of drug marketing. Gilead has realized over 8.5 BILLION dollars in Sovaldi sales in the first three quarters of 2014 alone. When is enough, enough? Here’s what the FPC thinks of the price of Solvaldi: https://www.aidsactionbaltimore.org/wordpress/wp-content/uploads/2014/12/Sovaldi.pdf.

Gilead’s newest HCV drug Harvoni is what is known as a fixed dose combination (FDC) or single tablet regimen (STR). This means there is more than one drug in one pill, like Gilead’s HIV four drugs in one pill FDC Stribild which was also priced astronomically. https://www.aidsactionbaltimore.org/wordpress/wp-content/uploads/2014/12/Stribild.pdf.

Gilead’s Harvoni was approved on October 10, 2014 and is the first one pill once a day, interferon/ribavirin free, 12 week treatment for most HCV genotypes. The Congressional investigations, law suits and endless bad press Gilead has experienced since Sovaldi was approved seems to be hitting home. Harvoni was priced at $94,500 for 12 weeks of treatment. While this price is still an unsustainable budget buster, especially for many federal programs with limited resources, it is less than the $100,000+ price tag forecasters were predicting. Later stage patients with cirrhosis may need to take as much as 24 weeks of Harvoni with a price tag of $189,000. Again, when is enough, enough? https://www.aidsactionbaltimore.org/wordpress/wp-content/uploads/2014/12/Harvoni.pdf

These outrageous prices have severely limited patient access to Sovaldi and Harvoni, especially for Medicaid patients who are, of course, the poorest of the poor. Medicaid coverage is dictated on a state by state basis. Many state Medicaids have placed prior authorization restrictions on Sovaldi and Harvoni, including requirements that only patients with HCV Stage F3 and F4 are eligible to access these expensive drugs and that prescriptions can only be written by certain specialists who are often inaccessible to many patients. These restrictions subject people to the very real potential of progressing to cirrhosis and liver cancer before they can access a life-saving regimen that can cure HCV. So much for the dream of a widely accessible cure for HCV.

The FPC will continue to beat on Gilead about the overpricing of its HIV and HCV drugs. We will also work with other drug companies with new HCV DAA regimens in order to spark competition with Gilead. AbbVie’s 3D HCV regimen is due to be approved by the FDA no later than December of 2014. AbbVie has the chance to change this unfortunate dynamic. The FPC hopes that AbbVie will use this opportunity to reset the HCV payer landscape and price its new regimen in a manner that will result in a reversal of these horrible restrictions caused by the original price of Sovaldi and the subsequent price of Harvoni. We will continue to do this work until life-saving HCV drugs are widely available to people with HCV.