National Patient Advocate Coalition Commends Pricing of New HIV/AIDS Drug (PR ATAC, 25 06 06)

National Patient Advocate Coalition Commends Pricing of New HIV/AIDS Drug New York, New York, June 25, 2006 - 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, member of the ATAC Drug Development Committee (DDC). “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.

Fair Pricing Coalition

June 23, 2006 Contact : Martin Delaney 415-519-8631

Fair Pricing Coalition Applauds Pricing of New AIDS Drug

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.”

The Fair Pricing Coalition is not a formal organization but rather an ad hoc association of groups and individuals concerned with and affected by the prices of drugs used in the treatment of HIV disease. The Coalition organizes meetings between company executives and community leaders to discuss pricing each time a new drug nears approval. The Coalition’s goal is to keep companies fully apprised of the problems created by excessive prices and to urge limits on the prices charged. The statements made by Coalition spokespeople are backed up by petitions signed by hundreds of organizations and individuals.

Forwarded message :

As many of you know by now, Tibotec’s new drug Prezista was approved on Friday afternoon, June 23, 2006. Though the FDA press release doesn’t mention anything about pricing, we are very pleased with the outcome of the pricing discussions we had with the company, which were attended by many of you. For those who weren’t there, Tibotec was under pressure from their masters at Johnson & Johnson to price the drug ABOVE Fuzeon, on the grounds that it is a superior drug. That it is. And if not above Fuzeon, they thought at least well above Aptivus, since that drug isn’t remotely comparable to Prezista. Neither such price was acceptable.

Here’s the final outcome, which should explain why we’re pleased :

All prices are WAC :

Prezista : $25.00 per day

Reyataz : $24.76 per day

Aptivus : $29.80 per day

Fuzeon : $61+ per day

In short, it is a virtual match to the price of Reyataz.

This represents a major reversal in the price of new drugs, as each past drug has pushed pricing to new and higher thresholds. This time, it’s taken 3 steps backwards, matching the lowest price of the last three approvals. We hope this can become a model for future pricing.

Prezista is likely to actually lower the cost of health care for its intended patient audience. The drug is aimed at people with advanced disease and high levels of drug resistance. People in this situation are typically put on 4 to 6 drugs since none of them are working very well any more. With Prezista, even without a second new drug, upwards of 50% of patients are able to achieve undetectable viral load and substantial CD4+ cell increases. It is likely that many of people in such situations will be able to drop some of the drugs they’re taking but which aren’t really working.

Thanks to all who helped on this, which was probably our most complex and most successful pricing strategy. We also have a verbal agreement Gilead and Bristol Myers Squibb over the price of their upcoming "1 pill, once a day" 3 drug combination. They’ve agree to price it as the sum of the cost of the 3 component drugs, with no added premium for the benefits of the new Fixed Dose Combination. This too sets a positive new example for other companies.