Gilead’s once-daily ‘Quad’ pill — expected to get FDA approval within the next two weeks — is expected to be priced thousands of dollars higher than current drugs purchased by state programs without representing a significant clinical and safety improvement over existing medications

In response, advocates from AHF call on state government programs and private insurers to place cost-prohibitive AIDS drug on ‘Prior Authorization’ status in order to “… ensure the Quad is only prescribed to patients when there is a documented need for it, and also will help ensure access for people with HIV/AIDS to these safety net programs”

WASHINGTON--(BUSINESS WIRE)-- In what may be an unprecedented move on drug pricing and access, advocates from AIDS Healthcare Foundation, are calling on state AIDS and Medicaid directors as well as a number of private medical insurers nationwide asking them to place Gilead Science’s new ‘Quad’ pill — a four-in-one, once-daily HIV/AIDS combination tablet — on ‘Prior Authorization’ status on their respective drug formularies. In general, ‘Prior Authorization’ requires that a particular prescription must be reviewed by a second medical provider for assessment of medical necessity before being filled for a particular drug, and the process may add a day to the timeline of a filling a prescription.

It is widely expected that Gilead will get FDA approval for the ‘Quad’ sometime within the next two weeks — and also expected that it will likely then price the combination therapy at thousands of dollars more than drugs that state AIDS Drug Assistance Programs (ADAP) currently purchase.

In response, AHF this week began sending letters asking leaders of state government programs and private insurers to place the potentially cost-prohibitive AIDS drug on prior authorization status once it has been FDA-approved and comes to market in order, “…ensure access for people with HIV/AIDS to these safety net programs.”

“We request that your state place the Quad on Prior Authorization in your ADAP and Medicaid programs. This will ensure the Quad is only prescribed to patients when there is a documented need for it, and also will help ensure access for people with HIV/AIDS to these safety net programs.”

Later in the letter, AHF wrote:

“…clinical studies have shown that the Quad does not provide a substantial medical improvement over existing HIV drugs. For example, a recent study found the Quad only to be medically ‘non-inferior’ to (i.e., it was not worse than) Atripla (the most popular HIV treatment on the market), in terms of controlling the virus and keeping patients healthy.”

The letter adds:

“…the use of prior authorization is warranted to control unnecessary cost while not unduly restricting access.In situations where there is not a documented need for the Quad to be prescribed, patients will still have access to numerous other effective treatment options. In addition, patients can already access the same medication classes available in the Quad by taking its components in separate tablets. Taken separately, these medications are equally effective, and safer.”

Over the past months, AIDS advocates from AHF and other groups have spearheaded a campaign urging John C. Martin, CEO of Gilead,not to decimate ADAP and other drug programs by pricing its latest HIV/AIDS drug combination, the ‘Quad,’ higher than Gilead’s Atripla, currently the most prescribed HIV/AIDS medication. Earlier this week, a group of U.S. Congress members wrote to Mr. Martin telling him that they are “troubled” by media reports indicating Gilead may charge may charge thousands more than existing AIDS drugs for the ‘Quad.’ In the letter, the Congress members also urged Gilead “…to consider sustainable pricing strategies for its products that would help allow ADAPto provide treatment to as many individuals as possible.”

“Gilead’s excessive pricing of it AIDS drugs has generated record profits for it, and $53 million in annual pay for its CEO, John Martin (making him the 10^th highest paid executive in the nation),” wrote AHF’s President, Michael Weinstein. “However, this has come at the expense of state ADAP and Medicaid programs, the largest purchasers of Gilead’s products, and the people living with HIV/AIDS that rely on these programs but cannot access them due to funding constraints. To save lives, curb the spread of HIV, and lower long-term care expenses, it is imperative to get more patients tested and into antiretroviral treatment. This will be impossible if we continue to introduce new HIV drugs, like the Quad, at prices higher than the drugs they replace.”

Previous ‘Prior Authorization’ Requests

In California, advocates from AHF previously — and successfully — asked for ‘Prior Authorization’ status for Serono’s drug, Serostim (somatropin), a drug used to combat AIDS wasting and weight loss in HIV/AIDS patients. AHF sought ‘Prior Authorization’ status for Serostim because many doctors and providers believed it was medically unnecessary if patients faithfully followed their antiretroviral (ARV) drug regimens — and because the drug has a price tag of over $7,000per month. It is widely believed that AHF’s request to have Gilead’s ‘Quad’ placed on ‘Prior Authorization’ status is the first such request for any antiretroviral therapy used to treat HIV/AIDS.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 176,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean the Asia/Pacific region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

AIDS Healthcare Foundation
Ged Kenslea, Communications Director
Office: 323-308-1833
Cell: 323-791-5526
gedk@aidshealth.org

Source: AIDS Healthcare Foundation