FUZEON (T-20)

ATAC's Fuzeon FAQ (April 2003) now available for download!

ATAC Drug Development Committee sends questions to Roche Labs. See Roche page.

Groups offer up news releases, statements, policy/position papers, and at least one street action...

• Roche Announces FDA Approval, Selection of Distributor, Pricing, and "Progressive Distribution Program"
  
• ATAC Reaction
  
• TAG Issues Fuzeon Position Paper
  
• Other Reactions to Fuzeon Approval and Pricing
  
• ATAC Supports Price Negotiation Efforts of State ADAP Directors
  
• ACT-UP New York Creates "Fuzeon Graveyard" at Roche HQ

FUZEON FREQUENTLY ASKED QUESTIONS FOR THE HIV COMMUNITY
(FAQ prepared by the ATAC Drug Development Committee)

This FAQ is intended to answer basic questions that have arisen about Fuzeon. Word Document PDF Document

Q. What is Fuzeon?
A. Fuzeon is an anti-HIV drug from a new class that fights HIV in a different way than other AIDS drugs you may have taken before. When HIV enters the body, it seeks out important immune cells to invade. One target is the CD4 T cell, where HIV attaches, fuses with the outer coating of the cell, and inserts itself into the cell. All of these steps work like a series of locks and keys that get HIV into the cell so it can take it over and make copies of itself, kind of like a copy machine. If one lock or key is out of place or damaged, HIV cannot attach and enter the cell. Fuzeon stops one of those keys from working and prevents HIV from fusing with the human cell.

Q. Who is Fuzeon for?
A. Fuzeon has been approved by the FDA for use in combination with other anti-HIV drugs in treatment-experienced patients unable to fully suppress HIV on their current regimens. For most people, this means that Fuzeon is an option of last resort-if you're resistant to a lot of HIV medications, Fuzeon might be useful in constructing a new regimen, especially if you have one or two other drugs you can take that you're not resistant to. Your doctor will probably use resistance tests to select which drugs may have the best chance of still fighting the virus. Studies show that Fuzeon will work best for people who take it with two other drugs that they have never taken before. In general, people who aren't resistant to a lot of drugs will prefer HIV medications that are easier to take because Fuzeon must be taken as an injection (see next question).

Q. How do you use Fuzeon?
A. Fuzeon is not a pill but a powder that has to be mixed with sterile water (taking up to 30 minutes to dissolve). The solution is then injected with a needle into the upper layer of skin (usually in the abdomen, upper legs, or upper arms) twice a day. This process takes a while to learn and to get used to, but over time, people adjust to it in a similar way as people with diabetes learn to self-inject insulin. Your doctor, pharmacist, and other health care providers can teach and assist you with how to do the injections properly.

Q. Aren't needles tricky? Does the injection hurt?
A. Everyone reacts to needle injections differently. The needle that is used is very small but it may hurt a little going in, like a pin-prick. When the fluid is pushed into the skin, it also can cause some pain. In most people Fuzeon causes a stinging reaction that can cause bumps, itching, redness, and pain. The reactions usually go away, but sometimes can last a few weeks. You have to alternate where you inject yourself to avoid the bumps. Some people who have been using Fuzeon for a long time get hardened layers of skin that limit the sites where they can inject.

Q. What if I have a fear of needles?
A. Fuzeon is not for everyone, so it is your choice to decide whether you want to take it and whether you can tolerate it. Some people get used to the injections. Others simply choose another therapy, if available, or choose to wait for a new therapy to come along that is easier to take.

Q. How do I get Fuzeon?
A. Have a talk with your doctor to decide if Fuzeon is right for you. If so, the process required is different than what happens with the typical prescription and initially most local pharmacies will not carry the drug. First, your doctor should call 1-866-694-6670 or go to the website www.fuzeon.com to get a "Prescription Enrollment Form." The doctor fills out and then faxes the form to the "Fuzeon Progressive Distribution Program" at 1-877-428-9520. They will check if you have insurance or coverage by a state AIDS Drug Assistance Program (ADAP) to pay for the drug. You can find out more information about ADAPs, including a listing state-by-state, at www.atdn.org/access/adap. Because Fuzeon is the most expensive AIDS drug ever ($25,000 per year), some payment plans and prescription drug programs may not pay for it. Once your method of payment is verified, your prescription will be filled. The drug either will be sent to you or will be available for you to pick up at your doctor's office or a Statscript pharmacy in your area.

Q. What if my state's ADAP or Medicaid will not add Fuzeon to its list of AIDS drugs?
A. It depends on your state. ATAC is working with Roche, the company that makes Fuzeon, to ensure that anyone who cannot construct a viable treatment regimen and needs Fuzeon will be able to get it regardless of coverage. Roche has promised to establish a Patient Assistance Program and to find a method of payment for you regardless if you have insurance or not.

Q. This all sounds very complicated! Doesn't it?
A. Yes, it is complicated. Fuzeon is a unique drug, and you will need lots of support to get access to it and to learn how to use it correctly. Because Fuzeon is an injectable drug with unpleasant injection site reactions and is not carried by all insurers, including ADAP and Medicaid, Fuzeon will not be the best choice for everyone. There are seventeen approved drugs for HIV and three more may be added this year. There are new protease inhibitors in expanded access (available from drug companies even though they are not yet approved by the FDA) that also work against drug-resistant virus. Also, there are other potential therapies in clinical trials. But for those who have absolutely no other choice, Fuzeon may be the drug of last resort.

ROCHE ANNOUNCES FDA APPROVAL, DISTRIBUTOR,
PRICING AND A "PROGRESSIVE DISTRIBUTION PROGRAM"

ATAC REACTION:
The ATAC Drug Development Committee issued the following statement, also available in these formats: Word Document PDF Document.

MARCH 10, 2003
HIGHEST PRICED AIDS DRUG EVER---
MEDICAL MAYHEM AND A DEADLY PRECEDENT

People living with AIDS and in need of a new drug to combat lethal resistant forms of the virus are outraged over an announcement of the highest price ever for an anti-HIV medicine. Roche Pharmaceuticals, headquartered in Nutley, New Jersey, has set a preliminary price in Switzerland equal to $20,500 per year for its new drug, Fuzeon.

Also known as T-20, Fuzeon is the first in a new class of drugs called �fusion inhibitors.� The drug works by stopping the virus from attaching to the human t-cell. Studies have shown that the medication is effective against resistant forms of the virus. To date, it has proven most effective in treating people with HIV who have few other treatment options.

Experts estimate that the U.S. price for Fuzeon will be $25,000 a year, at least four to five times higher than most FDA approved AIDS drugs. The high cost will make it unaffordable for most Medicaid and AIDS Drug Assistance Programs (ADAPs).

�It is a tragic state of affairs in drug development when an encouraging break-through drug cannot be accessed by the people who need it most,� said Daniel Raymond from the AIDS Treatment Activist Coalition.

Roche has submitted a new drug application in the U.S. and will seek FDA approval in late March. The company has said that the drug is extremely difficult to make and production and development costs have been exorbitant. AIDS activists are unimpressed.

�I am reminded of the days when drug companies priced protease inhibitors according to all the market would bear,� said Lynda Dee from AIDS Action Baltimore, �but this price is completely contemptible and the AIDS community will do everything in its power to stop Roche�s inhumane price-gouging.�

Some HIV treatment advocates say that Roche may be shooting itself in the foot with such a high price. Fuzeon could break the bank for HIV prescription programs such as ADAP and Medicaid, programs that are already financially strapped due to the lagging economy and the general high cost of all AIDS therapies.

�Existing drugs in these formularies are high priced as it is. Adding an elite, higher priced drug such as Fuzeon will bankrupt all existing programs, forcing them to pick and choose which drugs to include, or decide to close down. The programs have no choice but to not include Fuzeon. They are struggling as it is,� said Lei Chou of the AIDS Treatment Data Network.

The medication is not just expensive, it is also difficult to administer. Due to its complex chemical structure, Fuzeon must be injected twice daily. In studies, 98 percent of the people who used the drug experienced painful injection site reactions. Still, for some, this therapy is treatment of last resort.

�I have been on virtually every AIDS drug and have not had very good luck so far. T-20 has brought my virus levels under control, but I may not be able to get it if Oregon ADAP cannot afford it.� said Fred Schaich a person with AIDS from Portland, Oregon �I really need this drug to stay alive.�

OTHER REACTION TO FUZEON APPROVAL & PRICING