Biologics open new, long-term approaches to doctors; patients face economic challenges

Sep 01, 2004, 4:00am

New York - In administering biologic treatments for psoriasis, doctors must balance the drugs' clinical promise with a number of practical realities.

New York - In administering biologic treatments for psoriasis, doctors must balance the drugs' clinical promise with a number of practical realities.

"Now that we have three biologics approved for psoriasis and five that are potentially usable in the marketplace, it has made a tremendous difference in the way dermatologists are looking at the treatment of moderate to severe psoriasis," says David M. Pariser, professor, department of dermatology, Eastern Virginia Medical School and secretary/treasurer of the American Academy of Dermatology. "We have options that possess efficacy certainly as good as what we've had in the past, with much better safety, and with the ability to use for long-term, chronic treatment."

Different modelThe first biologic to win approval for treating psoriasis was alefacept (Amevive, Biogen). The drug is injected by a physician.

The process of buying and billing for the drug represents both an opportunity and a potential hurdle.

In the former area, Dr. Pariser says, "As with most injectable drugs given in the physician's office, the acquisition cost is usually a little less than the fee for administering it. But it's also a challenge. Since almost all the biologics will require some insurance precertification, it's very important that the doctor's office know ahead of time that the patient's insurance is going to cover the cost of the drug, so that the treatment can be given without interruption and the physician will be assured that they'll be reimbursed for the cost of the drug."

Patients also can purchase alefacept themselves through specialty pharmacies and take it to the doctor's office.

"Whether a physician is buying and billing or prescribing and getting the medicine through a specialty pharmacy, there must be some evaluation of the patient ahead of time and a weekly determination of the CD4 lymphocyte count, which is the prerequisite for doing the injection," Dr. Pariser says.

RaptivaPatients also can purchase efalizumab (Raptiva, Genentech) from specialty pharmacies. However, they can inject this drug themselves. Efalizumab's maker offers a program that handles forms, including a statement of medical necessity and verifies insurance availability.

"When prescribing Raptiva," says Dr. Pariser, "patients have to be instructed on how to give themselves a subcutaneous injection. That's usually done in the office the first time the patient gets the drug. So the doctor's office has to be set up to instruct patients on how to administer the drug."

EnbrelEtanercept (Enbrel, Amgen/Wyeth) also allows patients to self-administer.

"That makes it really easy for the doctor," says Dr. Pariser. "But with this drug, the doctor writes the prescription, and the patient gets it directly from any pharmacy. So there's no specialty pharmacy involved. Just like with Raptiva, patients have to be instructed on the appropriate use of Enbrel and appropriate injection techniques."

Unapproved biologicsBiologics not yet approved for use with psoriasis that nonetheless have proven quite effective against this illness include infliximab (Remicade, Centocor) and adalimumab (Humira, Abbott Immunology). As do etanercept and efalizumab, the latter allows self-injection, though it has the shortest track record with psoriasis.

Conversely, Dr. Pariser states, "Remicade has been around for five or six years and is indicated for treatment of rheumatoid arthritis and Crohn's disease, but not for psoriasis or psoriatic arthritis at this time.

"However, it does have some reasonably strong published literature on its use in psoriasis. Of all the (biologics), it's the most difficult to administer in the doctor's office in that it has to be administered by intravenous infusion over two to three hours.