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    Some Insurers Still Reluctant to Pay for New Biologic Drugs

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    Dr. Abramovits
    Maui, Hawaii - Some insurers are reluctant to pay for the new biologic drugs for psoriasis, despite the approval of two of the drugs by the U.S. Food and Drug Administration, according to William Abramovits, M.D.

    "One of the biggest hurdle in prescribing these drugs quite often is the time our office personnel has to spend getting approval from the various insurers," said Dr. Abramovits, an assistant clinical professor of dermatology at the University of Texas Southwestern and professor of dermatology at Baylor University.

    Dr. Abramovits reviewed research on the biologics at the Noah Worcester Dermatological Society annual meeting.

    Biologics use protein from human or animal cells to disable the immune cells involved in psoriasis. The five biologics fall into three categories:

    1. Three tumor necrosis factor-alpha (TNF-alpha) inhibitors: etanercept (marketed by Amgen as Enbrel), infliximab (marketed by Centocor as Remicade), and adalimumab (marketed by Abbott as Humira).

    2. A co-stimulatory pathway inhibitor: alefacept (marketed by Biogen as Amevive).

    3. An anti-CD11a: efalizumab (marketed by Genentech as Raptiva).

    As of February, alefacept and efalizumab had been approved by the FDA for psoriasis; the others are being used for psoriasis off-label.

    The drugs are expensive. Henry W. Lim, M.D., chairman and C.S. Livingood chair, department of dermatology, Henry Ford Health System, Detroit, gave the following prices for one-year regimens at the 2004 American Academy of Dermatology annual meeting:

    • Etanercept, $15,679
    • Infliximab, $12,000
    • Adalimumab, $15,679
    • Efalizumab, $17,800


    Dr. Lim
    For 24 weeks of alefacept, Dr. Lim said the cost would be $16,800, if given intravenously, and $24,000, if given intramuscularly.

    The prices are so high that Mark Lebwohl, M.D., professor and chairman, Department of Dermatology, Mt. Sinai School of Medicine, who spoke at the same meeting, joked that their main side effect is poverty.


    Dr. Lebwohl
    Insurers raise questions Dr. Abramovits said that he sometimes must write letters to insurers telling them that patients have failed less-expensive therapies before the insurers will pay for the biologics.

    Insurers have also questioned Dr. Lim's use of the drugs. "Most companies are quite reasonable in approving this if the patients have gone through topical agents and one of the systemic therapy, including phototherapy," he said.

    This may be a false economy, Dr. Lim said. "Methotrexate is an inexpensive systemic medicine, but if you take into account lab tests that have to be done and liver biopsy that has to be done, the difference in cost is not as large as one thinks."

    Whether the insurance companies' objections are a problem for patient care may depend on how a physician thinks the biologics should be used.

    For Dr. Lim, biologics always come after topical therapies and phototherapy, and generally after methotrexate. "Once we have gone through topical agents and UVB, that's when the treatment ladder branches out," he said. "If there are no contraindications, I like to use methotrexate, mainly because it's been around for the longest time. We know what it does. However, many patients are not willing to consider the potential side effects on their liver or whole blood cells."

    On the other hand, Dr. Lim said, "if the patient has very inflamed psoriasis and you want to bring it down fast, you want to use Remicade (infliximab) first."

    Dr. Abramovits said the correct place for the biologics was still a matter of research, but said that, in general, he uses them after topical agents, phototherapy and systemic retinoids have failed. The biologics come "possibly before metho-trexate and certainly before cyclosporin."

    Another consideration is whether the patient suffers from psoriatic arthritis as well as plaque psoriasis; the biologics may be particularly effective against this combination of disorders, Dr. Abramovits said.

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