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11/16/2000

Enrollment Program Starts for Etanercept

Cheryl A. Thompson

Citing an expected problem in producing enough etanercept to meet the growing demand for this biological agent, Wyeth-Ayerst Laboratories and Immunex Corp. today announced that patients must register for an "Enbrel Enrollment Card" to continue receiving the drug after Jan. 1.

According to the companies, which comarket etanercept, a drug used to treat rheumatoid arthritis, pharmacists cannot order a supply of the drug after Dec. 31 without having the patient's enrollment card number.

The product has always been "drop-shipped" from wholesalers to pharmacies, rather than supplied through normal distribution routes, said R. Duane Tackitt, Wyeth-Ayerst's director of global professional affairs, who described the program to ASHP staff members last Friday during a visit to the Society's headquarters.

Tackitt said a "Dear Pharmacist" letter would be mailed, as well as "Dear Doctor" and "Dear Patient" letters. For the patient-directed letters, he said, the companies are relying on lists obtained from outside sources. The companies are encouraging pharmacists, physicians, and nurses to alert all etanercept users about the urgent need to obtain an enrollment card.

Patients must call 888-436-2735 (888-4ENBREL) to request enrollment material. Information is available in English or Spanish. After completing and returning the material by mail, patients will receive their enrollment card number. The process may take up to two weeks, the companies stated.

To fill a prescription for etanercept starting Jan. 1, 2001, pharmacists must call 888-436-2735 (the same number that patients call to obtain enrollment material) and provide the following information:

  • Patient's enrollment card number,       
  • Pharmacy's "NCPCP" number,       
  • Quantity of packages (four 25-mg vials per carton) to be delivered, and       
  • Number of days of therapy to be covered by the new supply.

A patient-specific confirmation number will be given once the above information has been verified. Pharmacists obtain etanercept from wholesalers by providing the order confirmation number. A new confirmation number must be obtained for each refill.

In the two years since etanercept first became available in the United States, the Food and Drug Administration has twice approved additional indications for use. Etanercept is now approved for the (1) treatment of moderately to severely active juvenile rheumatoid arthritis in patients who have not responded adequately to at least one disease-modifying antirheumatic drug and (2) reduction of signs and symptoms of moderately to severely active rheumatoid arthritis and  delay of structural damage from the disease.

Immunex obtains etanercept from Boehringer Ingelheim Pharma KG, a contract manufacturer in Germany. In June, Immunex and American Home Products, the parent company of Wyeth-Ayerst, agreed to increase payments to the overseas manufacturer in order to boost production, according to Immunex's quarterly financial report released Nov. 7.

American Home Products owns more than half of Immunex's stock.