January 30, 2015—The biotech company Celgene, acting at the request of the Health Resources and Services Administration, has posted a notice on the 340B program website explaining why it has stopped adding providers to its limited distribution networks for three of its products, including its top-selling blood cancer drug Revlimid. [ms-protect-content id=”2799″]
In the undated notice, the company explains that the Food and Drug Administration directed it to implement Risk Evaluation and Mitigation Strategies (REMS) for Revlimid, Pomalyst, and Thalomid, all of which can cause severe birth defects and fetal death. Under the terms of each REMS, Celgene strictly limits distribution and dispensing through networks of specialty pharmacies, hospitals, and clinics. “The REMS for each of these products mandates than only a trained network of providers subject to contractual arrangement with Celgene may dispense the product and, in turn, requires Celgene to engage in rigorous training, certification, auditing, and monitoring activities,” the company says.
There are fewer than 250 providers in the networks and Celgene says that 340B covered entities “are proportionately represented.” It says its selection criteria for accepting providers “is and always has been based on factors unrelated to a pharmacy’s 340B status.” The company said it closed the networks to all new entrants, 340B and otherwise, in 2013 because accepting more “could unnecessarily weaken the operation and effectiveness of our REMS and could make the certification, training, auditing, and monitoring requirements of the REMS infeasible.”
Celgene said it was posting the notice “in order to ensure that our distribution procedures are transparent to all 340B program stakeholders.”
Celgene’s notice came to light at about the same time it reported its earnings for 2014. Revlimid accounted for $4.98 billion of its $7.56 billion in total net product sales globally. [/ms-protect-content]