Schering-Plough firmly believes that implementing the Access Assurance program was the medically prudent and responsible course to take. The overwhelming response to PEG-INTRON and REBETOL combination therapy since its launch has recently led the company to conclude that demand for PEG-INTRON would exceed its near-term ability to ensure supply of product in the United States at current new-patient enrollment rates. Consequently, in the next 10 days the Access Assurance program is expected to transition to a wait list system for newly enrolling patients in order to ensure uninterrupted access for those patients already on PEG-INTRON therapy.
As this wait list is implemented, all new patients seeking PEG-INTRON but not yet on therapy who enroll in Access Assurance will be placed on a wait list. Patients will be released from the wait list on a first-come, first-served basis, as additional PEG-INTRON becomes available. Product availability will be re-assessed daily, based on production and the rate that current patients complete therapy. At the outset, patients who enroll in Access Assurance and are placed on the wait list would be expected to be able to begin treatment in about 10 to 12 weeks (April 2002). Under the program, all patients initiating therapy will have access to a full, uninterrupted course of PEG-INTRON.
In addition, an independent medical board is being established to review individual urgent medical requests for PEG-INTRON therapy. A dedicated supply of PEG-INTRON has been allocated.