AIDS Healthcare Foundation (AHF), the largest global AIDS organization which operates free AIDS treatment clinics in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe, including 18 healthcare centers in California, Florida, and Washington, DC, has banned pharmaceutical sales representatives from Merck and Co. Pharmaceuticals, from calling on AHF’s medical providers and staff in its US healthcare centers.
“The fact that Merck recently obtained FDA-approval for wider use of Isentress as a first line treatment, but kept it priced as if it were a salvage drug is reprehensible”
The action came in response to AHF’s concerns over Merck’s steep and unwarranted pricing for its key AIDS drug Isentress—at nearly $13,000 per patient yearly, believed to be the most expensive first line AIDS therapy on the US market today. Isentress was originally approved in October 2007 by the Food and Drug Administration (FDA) as a salvage therapy for treatment experienced patients who are resistant to other AIDS drugs. When it first came to market, Merck set the average wholesale price (AWP) of Isentress at $12,150 per patient yearly. Merck has since raised the AWP of Isentress to $12,868—5%—since its introduction to market.
However, in July, 2009, the FDA expanded its approval of Isentress for use as a first line course of treatment of HIV/AIDS, meaning newly-diagnosed, treatment naïve patients who have never been on any AIDS drug regimens could also begin being prescribed the drug. The move vastly expands the US market for the Merck’s Isentress and also made the drug the most expensive first line treatment available here.
“The fact that Merck recently obtained FDA-approval for wider use of Isentress as a first line treatment, but kept it priced as if it were a salvage drug is reprehensible,” said Michael Weinstein, President of AIDS Healthcare Foundation. “When it first introduced Isentress in 2007, Merck described Isentress as a ‘prescribed therapy for treatment experienced HIV patients.’ In essence, Merck thought of, compared it to—and priced—Isentress as a salvage therapy, yet now as a first line treatment, Merck prices Isentress as much as three times more than certain other first line AIDS treatments.”
AHF recently sent a letter instituting the ban on Merck sales representatives in AHF healthcare centers to Richard C. Clark, Merck’s CEO. The letter, which was signed by Dr. Homayoon Khanlou, Chief of Medicine/US and Michael Weinstein, AHF President, stated:
This letter is to inform you that effective immediately, Merck sales representatives are no longer granted access to these [AHF Healthcare] centers.
This decision is based on Merck’s refusal to price its AIDS drug Isentress equal to the prices of other first-line AIDS treatments. As AHF has repeatedly pointed out to Merck regarding this issue, there is no justification for Isentress to be priced as a salvage drug now that the FDA has approved it for first-line use, vastly increasing its market. It is pure greed.
Your refusal to lower the unwarranted price charged for Isentress is causing great harm to State AIDS Drug Assistance Programs (ADAP), and to people with HIV/AIDS who rely on them. The limited funding available for these programs is being exhausted by the high cost of Isentress and other newer AIDS drugs. Because of this, State ADAPs are unable to provide treatment to additional people who need it. Moreover, several States have been forced to make cuts to ADAP services and enrollment as a result of budget shortfalls. These States can no longer afford to provide treatment to many of their current ADAP clients, and as costs increase, more people will be put at risk of losing access to services. This means that the more people who go on high-priced Isentress, the fewer who can receive services.