AIDS Healthcare Foundation Urges Merck To Reduce Price On Anti-HIV Drug, Isentress

The AIDS Healthcare Foundation (AHF), a Los Angeles based advocacy and treatment organization, continues to express concern over the high pricing for Merck’s anti-HIV drug, Isentress.

Isentress is an antiretroviral drug in the class known as integrase inhibitors. It was first approved by the United States Food and Drug Administration (FDA) in October 2007 for use in patients resistant to other HIV drugs, which is known as salvage therapy.

In July 2009, Isentress received FDA approval for use as first-line treatment, meaning that physicians can prescribe it for newly diagnosed patients who have not received prior HIV treatment.

When Isentress was first launched as a salvage therapy, the wholesale price to pharmacies averaged $12,150 per year per patient. In the two years since, the price has increased to $12,868.

Additionally, Isentress must be taken with at least two other HIV treatments, which means that the total Isentress regimen can cost $20,000 to $30,000 per year.

Although Isentress is currently the most expensive first-line therapy, other branded first-line medications are similar in cost. For instance, Prezista (darunavir), is listed at $12,332. However, generics can be a third of the price of Isentress.

AIDS drug assistance programs receive a reduced price of $8,088 for Isentress, but this is still significantly more expensive than generic drugs that are commonly prescribed first-line for HIV-positive patients.

Salvage therapies are last-resort drugs used by a small population of patients. Now that Isentress is approved for first-line treatment and may be prescribed to a much larger number of patients, AHF is particularly concerned about the price of Isentress.

Two of the nation’s largest public pension funds, the California State Teachers’ Retirement System and the California Public Employees’ Retirement System, recently sent letters to Merck urging the company to meet with AHF representatives to discuss Isentress pricing and its availability to uninsured patients in California and other states.

In return, AHF commended both pension funds for expressing their concerns and welcomed the opportunity to speak with Merck representatives.

On February 17, AHF staged a protest outside the 17th Conference of Retroviruses and Opportunistic Infections in San Francisco, where several Merck officials were speaking about vicriviroc, another HIV salvage therapy that Merck is developing (see related Beacon news).

In addition, AHF placed vinyl train station banners stating ‘Merck: ‘Do the Right Thing’ at train stations near Merck headquarters in Whitehouse Station, New Jersey.

AHF has also contacted state AIDS drug assistance programs and Medicaid directors urging them to place “prior authorization” requirements on Isentress. These requirements would force physicians to fill out and submit request forms to the patient’s insurance provider if they deem that a patient needs Isentress, thereby restricting prescribing of the drug. AHF claims that “prior authorization” procedures would help control costs without preventing a patient who needs the drug from being able to receive it.

AHF’s disappointment with Merck over Isentress pricing began when Isentress was first introduced in 2007. At that time, AHF representatives asked Merck to lower the price of Isentress, to which Merck responded that the drug was priced according to the investment that was made while researching and developing it.

When Isentress was later approved for first-line therapy in 2009, AHF officials once again raised the issue of high pricing. They urged Merck to lower Isentress pricing to match the pricing of other first-line therapies, citing the fact that Merck had now expanded its market by broadening its patient base.

AHF has also protested other highly priced HIV drugs. In October 2009, the FDA advisory committee recommended approval of Pfizer’s Selzentry (maraviroc) as first-line therapy (see related Beacon news). The annual cost of Selzentry is $13,767, which would make it the most expensive first-line AIDS treatment if it receives final FDA approval. AHF has called on Pfizer officials to reconsider the pricing for Selzentry as well.

For patients who are unable to pay for Isentress, Merck offers assistance to patients through its Support program, which provides reimbursement support and patient assistance services.

For more information, please see the AIDS Healthcare Foundation press releases about the AHF and California pension fund campaigns as well as the Isentress Web sites for their support program.

- The AIDS Beacon
http://www.aidsbeacon.com/news/2010/03/03/aids-healthcare-foundation-urges-merck-to-reduce-price-on-anti-hiv-drug-isentress/