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.