Does anyone have any ideas on how to help with these issues? Now with TMC 114 EAP and future approval and the Merck integrase study starting now, patients need access to another active agent.

States like NY and Fl have no such restrictions. Texas just lifted its waiting list restriction also.

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Current Requirements to get Fuzeon through ADAP in CA:

Patient is rolling over from enfuvirtide (Fuzeon) clinical trials/expanded access protocol.

Or

Patient has CD4+ count </=200 AND recent resistance test shows sensitivity to 2 or more ARV agents.

Or

For patients with CD4+ count </=100 AND recent resistance test shows sensitivity to 1 or less ARV agents.

Supporting documentation requires: The ARV history form MUST denote the patient’s CD4+ count prior to starting enfuvirtide (Fuzeon) as well as more current  CD4+/viral load values(</= 3 months old).

Current problems that patients and doctors face:

Any patient who is currently on Fuzeon and needs to switch insurance to CA ADAP must meet the original starting criteria. If a patient had private insurance with a starting CD4 of over 200, got Fuzeon and was on drug and doing well and then needed to go on ADAP, he would be denied access and have to stop taking Fuzeon. This also applies for patients who move to CA from another state’s ADAP plan that allowed for Fuzeon access. These criteria are also being applied to patients seeking help with co-pays under Medicare Part D. There is no continuity of care.

In addition to complete ARV history, doctors must also provide a current resistance test showing sensitivity to active agents. Some clinics will limit the number of tests that are paid for. The duplication of having to write out the complete history and provide a resistance test is too time consuming for doctors. Patients who need a regimen change and are trying to get drug through an EAP or study have a hard time getting the review committee to recognize these agents as active since they do not appear on a resistance assay yet.

Patients who have a higher CD4 count but a rapidly increasing viral load are forced to let their CD4 counts drop below 200 before they can get access to Fuzeon if they have two active agents to use with Fuzeon and those with only one active agent need to let their CD4 drop under 100 before they can get Fuzeon. People with HIV are doing better on meds, have higher CD4 counts, and are not waiting until they at risk for an OI before they change their regimens to include new active agents.

Changes that need to happen:

Allow any patient who is eligible for ADAP and is currently taking Fuzeon to continue on drug, regardless of their starting baseline CD4. Apply the same standards to Fuzeon as the other medications in one’s current regimen.

Reduce the number of active agents required to one and leave the CD4 count decision to the treating physician. Patients do not need to be at risk for OIs and should not be forced to lose T cells to become eligible for a drug that they need to take.

Recognize drugs that are in EAP status and clinical trials as active drugs for a patient’s Fuzeon regimen.

Allow doctors and patients to provide either a complete ARV history or recent resistance assay.

Provide doctors the opportunity for a fair clinical appeal process based on medical necessity.

Who to contact:

California Department of Health Services
Office of AIDS
MS 7700
P.O. Box 997426
Sacramento, CA 95899-7426

(916) 449-5900
(916) 449-5909 (Fax)

ooa-web@...

It has been nearly two years since the CA ADAP committee has reviewed the criteria for Fuzeon. Another meeting can not come and go without changes being made to allow those who need and want to take Fuzeon to have access to this drug. The CA ADAP committee will be meeting on March 16, 2006 in Oakland, CA and needs to hear from the people.