Rheumatoid arthritis patients wishing to start Wyeth/Immunex' Enbrel after Dec. 31 will be placed on a waiting list under the Enbrel Enrollment program.

As of Jan. 1, Enbrel will only be available to patients who have registered with the program and received an Enbrel Enrollment card. "After Jan. 1, 2001, new patients will be registered in this program and placed on a wait list," program materials state.

"Immunex and Wyeth-Ayerst have created the Enbrel Enrollment program to help ensure that Enbrel users are able to continue to receive an uninterrupted supply of medicine" during a projected temporary shortage, program materials explain.

Immunex' new West Greenwich, R.I., Enbrel production facility is scheduled to be completed in 2002 and is expected to double existing production capacity, the company noted.

"Our highest priority is to help ensure that current patients continue to receive Enbrel," Immunex said. "This program will allow us to identify and accurately count the number of Enbrel users so we can reserve a place for them."

Enbrel patients who have not joined by the deadline "are still eligible to enroll, provided they can present a proof of purchase for Enbrel dated between May 1 and Dec. 1, 2000, and that product is available," Immunex said.

Patients considering initiating therapy with Enbrel are advised by Enrollment program materials to discuss with their physicians whether they should register now. Prospective patients and their doctors "should be aware that supplies of Enbrel will likely be limited in the future," Immunex noted.

Patients can register for the program by calling the patient support line (1-888-4ENBREL). Enrollment materials will be mailed to the patient, and, after receipt of these materials, patients will be sent a "personalized Enbrel Enrollment card."

"It is important to note that" the Enbrel Enrollment program "is not a marketing program, and all patient information will be used for the sole purpose of administering the Enbrel Enrollment program," Immunex maintained.

"This information will remain confidential and patients will not receive additional mailings unless they choose to join" Immunex' patient support program, Enbrel Enliven, "an option offered in the Enrollment program registration materials."

Patients already enrolled in Enliven will not automatically be enrolled in the Enrollment program, the materials note. "These programs are mutually exclusive and patient information cannot be transferred to the Enrollment program database."

Enrollment program members will have to present their card or call in their membership number each time they fill an Enbrel prescription. Beginning Jan. 1, new or existing Enbrel patients who do not have an Enrollment card will be required to complete the enrollment process before their prescription is filled. The registration process is expected to take about two weeks, Immunex said.

To order Enbrel, pharmacists will first have to call the Enbrel patient support line. After providing the Enbrel Enrollment card number, pharmacy NCPCP number, order quantity by carton and number of days supply needed, pharmacists will receive a confirmation number.

"The order confirmation number is good for one-time use only and does not guarantee reimbursement," Immunex said.

After receiving a confirmation number, "pharmacists can then proceed to order Enbrel through their wholesaler," the program information continues. "Please note that a different order confirmation number will be required for each prescription filled or refilled."

To place an Enbrel order, the wholesaler will have to provide the confirmation number to Immunex customer service. The Enbrel order will be drop-shipped to the pharmacy.

The same process will be used for patients filling Enbrel prescriptions through mail-order pharmacies. Pharmacists will not be paid for the additional steps in the dispensing process, Wyeth said.

In a notice about the Enbrel Enrollment program, the National Association of Chain Drug Stores suggested to its members that "pharmacy operators may wish to instruct pharmacists, as a customer service opportunity, to contact their Enbrel patients now" and alert them of the need to register.

Immunex and its marketing partner Wyeth-Ayerst are not providing specific information about the number of patients they will be able to supply.

Immunex estimates that its current capacity is sufficient to provide approximately $750 mil. worth of Enbrel each year, although the company is working with its contract manufacturer Boehringer Ingelheim to increase supplies. Enbrel sales in the third quarter suggest that it is already at the production cap (¹ Also see "Enbrel Sales Near Production Cap; New Plant To Produce Clinical Lots In 2001" - Pink Sheet, 30 October, 2000.).

Wyeth said that the companies anticipate being able to supply all patients who are already on Enbrel and are registered in the Enrollment program. The available Enbrel supply will be distributed "based on such factors as currency of use and receipt of Enrollment program registration materials," the program materials state.

Physicians will not be able to obtain priority status for patients believed by their physicians to be in greatest need. "In the interest of fairness, we regret that special consideration cannot be given to individual patients," Immunex said.

The company also noted that Enbrel patients who know an Enrollment program member who has discontinued treatment cannot take his or her spot in the program. "Like their prescription for Enbrel, a person's Enrollment number is not transferable."

Enrollees who stop taking Enbrel on a temporary basis will be allowed to keep their place in the program for up to 12 months, Immunex said, as long as they are stopping due to physician-directed interruption, pregnancy, military leave, vacation, insurance lapse or use of a non-standard dosing regimen.

Immunex pointed out that sales representatives "cannot influence the enrollment process." Reps will provide Enrollment program information to physicians, however, including "tear sheets to help you explain the program to patients, and a Rolodex card with contact information."

Centocor, which markets the RA therapy Remicade, said it is preparing its sales reps to answer questions from rheumatologists about its product supply. The company manufacturers Remicade in a 55,000 square-foot facility in Leiden, the Netherlands, and is in the process of validating a new 116,000 square-foot manufacturing facility in Malvern, Penn. The company hopes the plant will be ready for production in 2001.

Immunex Enbrel Patient Starts After Jan. 1 Will Be Via Waiting List

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