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3401 Princeton Pike, Lawrenceville, NJ 08648
340B Notice Regarding Limited Distribution Plan for Nulojix (belatacept)
February 21, 2017
This notice provides information for 340B covered entities regarding the distribution of Nulojix (belatacept)
NDC#00003037113. Nulojix is an orphan drug therapy. Specifically, Nulojix is a selective T-cell costimulation
blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. Nulojix is
administered through an intravenous infusion, and it is used with corticosteroids and certain other medicines.
Bristol-Myers Squibb (“BMS”) projects that the supply of Nulojix in 2017 will not be sufficient to enable new
patients to start treatment with Nulojix. In order to ensure that the existing patients being treated with Nulojix
continue to have access to this medicine, BMS has developed a limited distribution plan to achieve this goal. All
pharmacies - 340B and otherwise – are subject to this plan equally. BMS is providing a service to ensure
continued access to Nulojix for all existing patients through the Nulojix Distribution Program. Effective March
15, 2017:
•
BMS will not be able to supply Nulojix for new patients because there is currently a shortage and
BMS wants to preserve the ability for existing patients to receive Nulojix. In order to preserve the
ability of existing patients to receive Nulojix, you must register your existing patients in the Nulojix
Distribution Program and receive a unique patient identification number.
• A unique patient identification number will be required when placing orders for Nulojix. A
unique patient identification number can be obtained by completing a registration form. Please call 1-
855-511-6180 to request a registration form. Once registered, you will receive notification of
enrollment.
• McKesson Plasma and Biologics will be the exclusive distributor of Nulojix in support of the
Nulojix Distribution Program. Please contact McKesson Plasma and Biologics directly at 1-877-625-
2566 to confirm your existing account and/or establish a purchasing relationship.
Once the Nulojix Distribution Program registration form is complete and faxed to the program, you will be
notified whether the patient was successfully registered into the program. All existing patients on Nulojix will
be permitted to register in this program at any time. Effective March 15, 2017, requests for new patients
(patients receiving Nulojix for the first time, not part of a clinical trial) will not be accommodated and
new patients will not be registered into the Nulojix Distribution Program. Acceptance is premised purely
on supply; no other criteria will be used in reviewing the form other than completion.
BMS anticipates that the supply shortage will be abated by the end of December 2017, which will enable supply
to new patients again starting in 2018.
BMS takes its obligations under the 340B program seriously and will make every effort to ensure that Nulojix is
available to 340B covered entities in a manner that is no more restrictive than it is for non-340B entities. If you
have any questions regarding this program, please call the Nulojix Distribution Program at 1-855-511-6180
from 8AM to 8PM ET, Monday through Friday (except holidays).