AIDS Healthcare Foundation criticizes Etravirine's pricing

AIDS Healthcare Foundation (AHF) has urged Tibotec Pharmaceuticals Ltd., a division of Johnson & Johnson, to reconsider and reduce its steep price for its newest AIDS drug, etravirine (TMC 125), a non-nucleoside reverse transcriptase inhibitor, (NNRTI), which received Food and Drug Administration (FDA) approval on Friday after a fast track or 'priority review' and approval process granted to companies for medications and therapies intended to treat life-threatening illnesses such as AIDS.

Immediately following FDA approval of the drug, which Tibotec will sell under the brand name Intelence, Reuters reported that the drug's wholesale cost will be US$5.45 per tablet. At the approved dose of two tablets twice per day, a 30-day supply would be US$654-or close to US$8,000 per patient, per year (PPY) wholesale cost.

"We commend Tibotec for the development of this promising new HIV/AIDS drug, but strongly urge them to immediately reconsider and price this life-saving AIDS medicine more fairly," said Michael Weinstein, AIDS Healthcare Foundation President. "As with many AIDS drugs before it, the cost of Intelence will simply be out of the price range for most AIDS patients and threatens to further stress Medicaid and AIDS Drug Assistance Programs nationwide. Just last week, Governor Arnold Schwarzenegger announced plans to cut US$7 million dollars from California's ADAP, a program that helps low-income Californians living with HIV/AIDS access such lifesaving drugs. AIDS drugs are priced at the maximum the market will bear, regardless of production costs. It appears Tibotec is once again following suit with the steep price of its newest AIDS drug."

Tibotec drew earlier criticism from AIDS advocates back in June 2006 after it received FDA approval for its Protease Inhibitor, Prezista (darunavir, or TMC 114) and began marketing that HIV/AIDS drug at a price well above other drugs in its class -- close to US$10,000 per patient per year. According to Tibotec's own website at the time, Prezista had been found to be, " ... highly-active in vitro against HIV with Protease Inhibitor resistance mutations...," and was found to be particularly effective as part of a second or third line 'salvage' therapy used in combination with Roche and Trimeris' drug, Fuzeon (US$20,000 per patient per year) and Abbott's Norvir (US$7,800). Taken together -- as these medications are usually prescribed as part of a lifesaving AIDS drug cocktail or regimen -- the cost for these drugs for one HIV/AIDS patient runs between US$35,000 and US$40,000 per patient per year.

In clinical trials, Tibotec's latest drug, Intelence, has been found to be effective for many HIV-infected patients who are NNRTI-resistant and whose infections are not responding to currently available medications. It is widely expected to be prescribed and used in conjunction with other AIDS drugs as part of salvage regimens for patients whose previous drug combinations have failed them.

"As many states and the federal government also face significant budget constraints and are drastically cutting budgets and services, we question Tibotec's judgment and timing in pricing this latest AIDS drug so high," added AHF's Weinstein. "When Governor Schwarzenegger proposed eliminating US$7 million in drugs for co-morbidities and opportunistic infections from the ADAP formulary last week, AIDS Healthcare Foundation said that instead of cutting any drugs from the ADAP formulary, the Governor and state lawmakers should instead reduce reimbursements to drug companies and try to purchase drugs for ADAP and other crucial state programs at federal pricing levels such as those that the Department of Veterans Affairs has successfully negotiated with the industry. We vow to work in Sacramento and in Washington to ensure that ADAP and other similar government programs do not continue to become glorified corporate welfare programs that boost the coffers and bottom lines of drug companies while the state and the nation's voiceless, poor and disabled are being forced to endure drastic cuts to the very programs that help keep them alive."