What you need to know to obtain financial assistance for your HIV and HCV medications.

I have been working with the Fair Pricing Coalition (FPC) since it was founded by Martin Delaney and Linda Grinberg in 1999. Murray Penner of the National Alliance of State and Territorial AIDS Directors (NASTAD) and I currently serve as co-chairs of the FPC.

The FPC is a national coalition of activists who work on HIV and hepatitis C (HCV) drug pricing issues, and negotiate prices of new drugs with HIV and HCV drug manufacturers. We advocate to try to prevent drug price increases and ensure that pharmaceutical companies make their HIV and HCV treatment medications available to those who cannot afford them through out of pocket (OOP) expense reimbursement programs for people with insufficient insurance coverage. The FPC has recently concentrated on co-pay costs and all other OOP costs, including deductibles and co-insurance levied by insurance companies since the

enactment of the Affordable Care Act (ACA), also known as Obamacare. For many years, the FPC concentrated heavily on advocacy for programs like US state AIDS Drug Assistance Programs, known as MADAP in Maryland. ADAPs cover prescription costs and even insurance premiums for the working poor. Because of onerous ACA OOP costs that so many people cannot afford, the FPC has now expanded its focus to include ACA network clients and private insurance clients.

The FPC worked to ensure that all HIV and HCV drug companies cover at least the ACA maximum ($6,800 per individual, $13,600 for families) annually for all prescription OOP costs, including co-pays, deductibles and co-insurance costs. Currently very generous OOP reimbursement programs are in place for all HIV and HCV treatment medications for people whose medical expenses are not covered by Medicare and Medicaid. Detailed contact and eligibility information on HIV and HCV drug company OOP reimbursement programs can be found on the FPC’s website: http://fairpricingcoalition.org/projects. Company OOP reimbursement programs are a direct result of several years of intense negotiations between the FPC and representatives from the pharmaceutical industry.

We also advocate for free drugs through patient assistance programs for people with no insurance and coordinate our work with the ADAP Crisis Task Force, urging manufacturers to continue to work with the Task Force so that Ryan White ADAPs that provide access to prescriptions for the uninsured and working poor across the nation have special pricing agreements in place. Our work helps to control drug costs, thereby helping to ensure access for recipients of state ADAPs, Medicare, and Medicaid, as well as those who are privately insured, underinsured, and uninsured. This type of advocacy is rare in most other disease fields.

We have worked very hard for many years to ensure generous uniform industry free patient assistance programs (PAPs) for people with HIV and HCV who do not have insurance. The FPC has advocated for an income eligibility criterion of 500% of the federal poverty level (FPL) for people with HIV, ($58,350 for individuals in 2015), and over $100,000 for more expensive HCV drugs. All but one HIV drug company use the 500% FPL criterion for HIV PAPs. Janssen’s PAP criterion is 200% of the FPL, but they will make exceptions for people whose income is over their 200% cap. HCV drug manufacturers Gilead, AbbVie and Vertex use the over $100,000 annual income standard for individuals for their HCV PAPs. The criterion for Janssen’s and Merck’s HCV PAPs is 500% of the FPL. You can also find more PAP contact and eligibility information at: http://fairpricingcoalition.org/projects/.

As drugs for HIV and HCV become more expensive, PAP and OOP reimbursement program advocacy is more necessary than ever. It is critical that people living with HIV and HCV know these programs are available. Please share this access program information with your friends and communities.

We have also convinced most major HIV and HCV drug companies to make generous contributions to nonprofit groups like the Patient Access Network Foundation (PAN) so that OOP reimbursement benefits will also be available to Medicare and Medicaid patients who are currently not eligible for OOP reimbursement programs from drug companies under federal law. 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.

We continue to advocate that HIV drug companies institute a price freeze. Increases in HIV drug prices post-approval are disconcerting and are much higher than the medical consumer price index rate of inflation. 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 FPC presentation made at a meeting of the Federal AIDS Policy Partnership in DC.

http://www.aidsactionbaltimore.org/wordpress/wp-content/uploads/2014/12/FAPP.pdf, as well as the FPC recent press release (LINK) in this issue.

In the last year, the FPC has spent a great deal of time and effort on price and patient access to the new curative treatments for HCV. These new direct acting antivirals (DAAs) have better outcomes (cure rates of 90-100%), fewer side effects, and shorter treatment durations than previous treatment regimens that relied on interferon and ribavirin. Many people with HIV are also co-infected with HCV. The approval of new DAAs offered great hope for people with HCV and the promise of eliminating HCV in the United States. Unfortunately, Gilead Sciences’ astronomical pricing of Sovaldi (sofosbuvir) at $1000 per pill has resulted in wide-spread, onerous prior authorization requirements and restrictions from both public and private payers throughout the country.

Gilead’s Harvoni (sofosbuvir/ledipasvir) was approved on October 10, 2014 and is the first one pill once a day, interferon/ribavirin free, 8 or 12 week treatment for most HCV genotypes. Congressional investigations, lawsuits, negative press and FPC advocacy Gilead has experienced since Sovaldi was approved seems to have impacted the pricing of Harvoni. Harvoni was priced at $63,000 for 8 weeks of treatment, $94,500 for 12 weeks of treatment (WAC), and $189,000 for 24 weeks of treatment. While this price is still an unsustainable budget buster, especially for many federal programs with limited resources, the variable treatment durations average to less than the $100,000+ price tag forecasters were predicting.

These outrageous prices have severely limited patient access to Sovaldi and Harvoni, especially for Medicaid patients who are, of course, among the poorest citizens in America. Medicaid coverage is dictated on a state-by-state basis. Many state Medicaid programs have placed prior authorization restrictions on Sovaldi and Harvoni, including requirements that only people with advanced fibrosis or cirrhosis (equivalent to Fibrosis scores of F3-F4) are eligible to access these expensive drugs and limiting prescribers to certain specialists who are often inadequate in numbers and geographic distribution to serve many patients. Onerous drug abstinence and drug treatment restrictions are also often required. These restrictions subject people to the very real potential of progressing to cirrhosis and liver cancer before they can access a lifesaving curative treatment. Thus, the FPC’s work with Gilead on their access programs has been crucial.

AbbVie’s 3D HCV regimen was approved on December 19, 2014. While AbbVie priced Viekera Pak at a Wholesale Acquisition Cost of $83,300, it also began efforts to negotiate with payers for easing of restrictions that many payers have instituted because of the high price of Sovaldi and Harvoni. The FPC has been pushing AbbVie to price their new HCV regimen much lower than the Gilead regimen. As a result of AbbVie’s lower pricing, Gilead also lowered their prices, resulting in lower costs and possibly the easing of some access requirements. Other new HCV regimens in the pipeline will hopefully decrease these prices even more in the near future.

For more information on HIV and HCV patient access programs, contact AIDS Action Baltimore at 410-837-2437.

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