segunda-feira, junho 26, 2006
Médicos e activistas americanos aplaudam preço do TMC114
The Fair Pricing Coalition, an ad hoc coalition of hundreds of community AIDS organizations, medical facilities and concerned individuals, today applauded the pricing of Tibotec Therapeutics new protease inhibitor for the treatment of people with advance AIDS and resistant virus. The Food and Drug Administration announced approval of the drug, called Prezista, late on Friday, June 23, 2006. A spokesperson for the Coalition, Martin Delaney of Project Inform (a nationally known HIV treatment information and advocacy organization), said “We are very pleased with this drug for two reasons. First, it is a very important addition to the arsenal of drugs for treating HIV, perhaps the most potent drug yet for people who have developed resistance to other therapies. But just as importantly, we are pleased that Tibotec Therapeutics has reversed a years-long trend toward ever higher prices by the pharmaceutical industry. The last three drugs approved for HIV each set new and dramatically higher pricing thresholds, making it more and more difficult for public and private payers to keep up with the demands for care. After lengthy discussions, Tibotec finally priced their drug within pennies of the cost of the least expensive of the other new drugs and far below the most expensive. It has finally reversed the juggernaut of higher pricing and acted as a responsible corporate citizen.”
The Fair Pricing Coalition, which organized a series of meetings between the company and representatives of community organizations to discuss pricing, still emphasized that prices should be lower still, even as Tibotec has taken a major step in the right direction. Mark Milano, another Coalition member, stressed "There is plenty of room for profit and for additional research at even lower price levels. Now that Tibotec has reversed the awful trend of ever-increasing prices, their action needs to be the standard for other new drugs. Each new drug should further step back from the obscene prices that have been reached in recent years."
Lynda Dee, of AIDS Action Baltimore and the AIDS Treatment Activists Coalition (ATAC) said, “This successful outcome proves that it is worth making our needs known to pharmaceutical companies. Had we not made the effort and gotten so many people involved and speaking out, I don’t doubt we’d be seeing another jump in prices today. Instead, we’re celebrating what we hope will be the end of an era of escalating prices.” Martin Delaney added, “We have to share the credit with the leadership at Tibotec Therapeutics. Without their support and their understanding of the problems that drug prices have been causing, we would not have seen this reversal. I hope they are rewarded with quick approval on all the major formularies.”
National Patient Advocate Coalition Commends Pricing of New HIV/AIDS Drug
New York, New York, June 25, 2006 – The Drug Development Committee (DDC) of the AIDS Treatment Activist Coalition (ATAC) today applauded the general direction on pricing announced today for the new protease inhibitor Prezista from Tibotec Therapeutics. Prezista received accelerated FDA approval on June 23, 2006. Company spokespeople announced that the price would be well under the prices of two other recently approved HIV drugs and virtually the same as a third.
The new drug, a member of the class of anti-retroviral drugs known as protease inhibitors, is an important addition to this drug class since it works in people who have resistance to previous dugs of this type. ATAC Steering Committee Chair Rey Candelaria commended Tibotec for its decision to stop the continuing escalation of drug prices. “This is the first time we can remember an HIV drug company pricing a new drug lower than the last FDA approved anti-HIV medication. This pricing decision is especially necessary in light of the lack of political will and misplaced spending priorities in Washington.”
The price of prescription drugs has gone up radically over the last ten years. In 1996, when the first highly effective anti-HIV combination therapy became available, treatment for a single individual cost at least $12-15,000 a year per person for a typical 3-drug cocktail. Today, a single drug can cost this much or even twice this amount.
“Tibotec’s decision to do the right thing is a good first step that must be copied by other drug companies. Price escalation had to stop somewhere. We’ve drawn a line in the sand and there’s no turning back,” said Lynda Dee, long-time DDC member. “Tibotec has tried very hard to work in partnership with the patient community. We’re elated they have taken our suggestion and reversed the upward spiral of unconscionable new life-saving drug prices. While ATAC would still prefer even lower drug prices as the price point achieved here is still far from inexpensive, we believe this represents real progress.”
About ATAC: ATAC (www.atac-usa.org) is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS. The Drug Development Committee (DDC) of ATAC works with government, academia and the pharmaceutical industry to provide a community perspective in the development of new HIV drugs and access to HIV therapies.
MEDICAL PROVIDERS HIGHLY ENCOURAGED BY PRICING DIRECTION
TAKEN BY TIBOTEC THERAPEUTICS FOR NEW PROTEASE INHIBITOR
WASHINGTON, DC – Today, the American Academy of HIV Medicine (AAHIVM) commended Tibotec Therapeutics for pricing their newly-approved protease inhibitor, TMC-114 (darunavir), at a price near to that of one of its older, key competitors and far less than other antiretrovirals more recently approved by the Food and Drug Administration.
“AAHIVM commends Tibotec, Inc., a subsidiary of Johnson & Johnson, for its pricing restraint during this critical time,” said Tony Mills, MD, a physician in private practice and treasurer of AAHIVM’s Board of Directors. “According to Dr. Mills, HIV care providers have been fighting a “war of escalation” with spikes in health care costs -- particularly with prescription drugs. “HIV care providers and their patients, faced with increasing uncertainty and fixed programming budgets, have been stretched beyond capacity for years now,” said Dr. Mills. “Funding for the Ryan White CARE Act, which houses the AIDS Drug Assistance Program, was largely flat funded or cut over the last few years. Some recent entries into the antiretroviral market are priced higher than the public payers can afford.”
The Ryan White CARE Act is currently up for reauthorization before Congress; if current legislative language passes as is through Congress, authorization levels for funding the program over the next five years would be set with only limited increases, and only for certain sections.
Outside of the Ryan White CARE Act, other public payers are also struggling as the Deficit Reduction Act aims to limit Medicaid costs, and the states themselves face rising program costs. Even in the private insurance market, where increasing numbers of individuals are under-insured, patients are no longer shielded from the skyrocketing price of medicines.
“The pricing of darunavir, while not as low as we had hoped or asked for, is still a giant step in the right direction,” said AAHIVM Executive Director Dr. Howard Grossman. “We know companies have an obligation to their shareholders, but the pricing decisions need to be made with more criteria than just what the health care ‘market can bear.’”
According to Dr. Grossman, that health care market – including HIV/AIDS care -- does not exist in a vacuum, and advocates are realizing the level of responsibility that everyone shares in containing costs. “Darunavir looks like a highly effective drug that fulfills a need for people with HIV,” said Dr. Grossman. “It should be a significant new addition to the antiretroviral armamentarium. We’re sure there will be a great demand for it, but with no inherent controls on price, companies have to be self-policing – and it is refreshing to see someone buck the trend. We congratulate Tibotec on a pricing decision that we think demonstrates true leadership. Hopefully, others will follow.”
About The American Academy of HIV Medicine
The American Academy of HIV Medicine is an independent organization of HIV Specialists and others dedicated to promoting excellence in HIV/AIDS care. Through advocacy and education, the Academy is committed to supporting health care providers in HIV medicine and to ensuring better care for those living with AIDS and HIV disease. AAHIVM members provide direct care to more than 340,000 HIV patients. This is more than two thirds of the patients in active treatment for HIV disease. Nearly 50 percent of the Academy’s members receive Ryan White CARE Act funding, with 18 percent of the Academy’s members practicing in community clinics.