T-20 has finally been launched and Roche is struggling to get it into orbit.

According to Kathy Presto of Roche (Fuzeon's mission control director), as of March 26, only two days after the drug's price had been published, 633 prescriptions had been received and demand was reflecting a diverse mix of payers, with roughly 30% private insurance and 70% public payers. Due to limited production capacity, Roche estimates that only 1,500 patients can be added during the first month after launch. Also, because of the high price of Fuzeon and the limited circumstances in which it is most likely to be useful, Roche has established a gatekeeping system to handle physician requests for the drug.

Each prescription that is received by Chronimed, Roche's exclusive pharmacy source for Fuzeon, is date- and time-stamped on a first-come, first-served basis and each patient is guaranteed that a supply of drug will be held for them while their reimbursement situation is worked out. Chronimed will perform a preliminary screening for ability to pay, then pass along the prescriptions to Roche's reimbursement specialist group for verification. Roche can then refer difficult cases that require advanced processing to another contract company that "really knows how to work the system." The goal is to see that everyone who submits a prescription is served, although it remains to be seen if that can be achieved and how long the wait will be for those unable to pay for the $20,000+ drug.

Patients with no ability to pay will be evaluated by several, somewhat flexible, criteria, says Roche, and those with no recourse to third party payers will ultimately be covered by the company's patient assistance program. Eligibility will hinge on a number of variables besides income and insurance coverage and could include the size of the patient's household and whether the applicant is a head of household, the state of residence and number of dependents. Non-U.S. citizens will not be eligible. For now, at least, no medical criteria will be used to allocate Fuzeon, although that could change if the demand puts a severe strain on the supply.

The state AIDS Drug Assistance Programs (ADAPs) are keenly interested in having Roche establish a clear definition of medical need for Fuzeon so they can rationally allocate the drug within their systems. Since there is no CD4 or viral load indication for Fuzeon, the best recipe for success may be that a person has other active drugs available to them. If the list of active drugs is two or less, then Fuzeon may be appropriate. Determining an optimal background regimen when few choices are obvious calls for educated judgement based on resistance testing and the patient's treatment history. Physicians with light HIV case loads are less likely to have the expertise to make those judgements. Hopefully, Roche will be able to assist clinicians in making these complicated decisions without inappropriately pushing Fuzeon for people who don't need it.

Volunteers in the U.S. clinical trials have been guaranteed uninterrupted access to Fuzeon. They will be transitioned from the study supply to the commercial supply and Roche will continue to pay until third-party payment can be secured. Presto said, "We will not interrupt Fuzeon for trial participants even if they never get any other reimbursement." By year end, the 1,500 U.S. trial participants could consume up to 17% of the commercially available drug supply.

One outstanding question is what will happen when a person earns too much for their state's ADAP, yet still can't afford T-20. Or if their private insurance won't deal with Chronimed. The answers will become clearer as Roche gets a month or two into the process.

The Price Is WAC

Roche has announced that the wholesale acquisition cost (WAC) of Fuzeon will be about $20,000. A more commonly quoted price is the average wholesale price (AWP), which typically runs about 25 percent higher than the WAC. The price paid by ADAPs and Medicaid is likely to be less than WAC. People who can afford to simply write a check will pay the highest price for Fuzeon. On launch day, a Chronimed employee quoted a cash-and-carry price of $2,200 a month, or $26,400 a year for the drug.

State ADAP Directors Meet Pharma Reps

During the latter part of March, a coalition of state ADAP directors met with major pharmaceutical makers in Washington, D.C. to try to win lower drug prices and ease their programs' budget crises. Participants are being tight-lipped about the discussions, but news reports singled out Roche as the sole maker willing to meet state programs in the middle with a deal over the price of Fuzeon. Of course when you're starting at $20,000 a year, meeting in the middle might end up being in the $15,000 range -- $3,000 higher than many ADAP programs initially budgeted for the drug. Talks with the other PharmCos will continue.