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Why all the fuss over fuzeon
Aug 11, 2003

I am the first consumer member of the Minnesota DHS formulary committee and recently was appointed to the Advisory committee, which was established to vote on any issues where a concensus cannot be reached. Our first meeting was held in conjunction with the full formulary committee.

I invited myself to my first formulary committee meeting when I found out that it was an open public meeting and wanted to attend to see just how decisions are made. The attendence has grown to about 25 at the last meeting and the discussion focused on the number of "slots" that may be alloted to patients in MN.

Fuzeon is extremely expensive (10,000/week) requires preparation prior to being injected (I understand that it may be made up in advance but refrigeration is required) and many of the clinical trial group needed assistance in administration and adherence to the rigid protocol.

What concerns me as an informed citizen is how will the decisions be made regarding who will get the medication, will their clinic/caregiver have enough time to assist every patient receiving fuzeon, and if fuzeon is a drug of last choice, when other drugs are not working, who will have to make life or death decisions.

Do we need to organize massive fund raising efforts, let the lottery of who gets the drug take its toll or other kindred things.

Please help all of us by giving us the strait scoop on Fuzeon so we can plan our courses of action.

Thank you,

Jerry in the Twin Cities (MN)

Response from Dr. Boyle

Good points, but I think decisions regarding Fuzeon (enfuvirtide, T-20) are best left to experienced clinicians and their patients. The experienced clinician can help to select patients that are appropriate for Fuzeon and then prepare them for its use. The patients, of course, will have the right to decide whether it is an option they choose to accept. As demonstrated by the TORO-1 and TORO-2 trials, Fuzeon can be a valuable addition to an optimized background antiretroviral therapy in experienced patients. Still, due to some of the issues you raised, especially the preparation time, the need for injection and the almost universal local site reactions, it may be difficult to get patients to accept it, even those patients with limited options. I think both clinicians and patients should weigh the issues together and make a decision on a case-by-case basis. Of course, society has to figure out how to pay for the medication (its <$20,000/year, not the $10,000/week you mentioned) as well as how to support clinicians and patients, since if it doesn't do that then, in many cases, the cost of the medication may be going down the drain. So, what should the committee do? First, make Fuzeon available to patients that need it. Second, leave the decisions regarding need to experienced clinicians and their patients. Third, provide the support necessary to get the patients on and keep them on the therapy. Regarding the final point, we should keep in mind that if society had provided adequate adherence support in the first place some of those patients who now need Fuzeon, which as you point out is very expensive, might never have failed their earlier therapy.



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