New Administration Procedures for Amevive and Enbrel
First posted Sept. 19, 2003
New administration procedures were announced recently for Amevive, manufactured by Biogen, and Enbrel, manufactured by Amgen and Wyeth.
As of Oct. 3, 2003, Biogen will discontinue its manufacturing and distribution of Amevive given intravenously (IV) (through the vein). This method required patients to receive the dose in a physician's office through an infusion lasting about one minute. The amount of medication administered was half that of the intramuscular (IM) (through the muscle) dose.
The demand from physicians for the IM dose was much greater. According to Biogen's records, after 8 months on the market, 85 percent of dermatologists preferred to use only the IM form. The IM form may be easier to administer in dermatology offices, which traditionally have not given medications by IV. The low demand for IV forms of Amevive resulted in Biogen not being able to justify its manufacturing cost. The cost of each course of the IM form is approximately $10,000; for IV it is approximately $7,000.
According to Biogen, Amevive patients now taking the medication by IV will be able to order enough of the IV form to finish their treatment course. One course of Amevive lasts for 12 weeks at one dose per week. Patients are eligible for a second course after a minimum waiting period of 12 weeks. Initiation of a second course depends on how well the patient responded and the how much the symptoms improved.
Amevive is a systemic therapy that works by blocking and eliminating certain T cells that play a role in psoriasis. It was approved in early 2003 for the treatment of moderate to severe plaque psoriasis.
New needle for Enbrel injections
By the end of September or early October, a new Enbrel injection system will be available for patients to make mixing and withdrawing the medication more convenient. Enbrel patients will be informed of the change through several mailings.
Patients will receive a smaller needle and a new vial adaptor in the kit. The needle replaces the previous needle, which some patients found difficult to use when giving themselves Enbrel injections under the skin. The vial adaptor is a new feature that punctures the vial containing the drug. The previous kit had no adaptor, and the needle was at risk of being bent or broken as it punctured the vial.
Enbrel is given by injections under the skin; patients self inject the medication twice per week. The medicine works by blocking a chemical in the immune system that overstimulates inflammation. This chemical is called "tumor necrosis factor-alpha" (TNF-alpha), an immune-system chemical messenger.
It is approved for psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis, a disease that causes inflammation in the spine. The company also filed in June for approval for psoriasis treatment.
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