As you are probably aware, Schering Corporation instituted
the Access Assurance Program for PEG-INTRON (peginterferon alfa-2b)
Powder for Injection in October 2001. The intent of Access Assurance was to launch
PEG-INTRON for combination therapy with REBETOL (Ribavirin, USP)
Capsules in the most responsible and ethical manner; ensuring that no patient's therapy be interrupted
as a result of demand exceeding supply. Access Assurance enables Schering to help ensure that
enrolled patients have access to their full course of therapy.
Prior to the launch of the combination therapy, Schering Corporation anticipated
that demand for PEG-INTRON could be heavy, but could not be estimated with certainty.
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 supply product in the United States at current new-patient enrollment rates.
Currently all new patients seeking PEG-INTRON,
but not yet on therapy, who enroll in Access Assurance will be registered on a wait list.
The wait list only affects new patients seeking to begin treatment with PEG-INTRON.
Current patients on PEG-INTRON therapy that are enrolled in Access Assurance will
not need to do anything new or be concerned as they are already assured a full course of therapy.
You may be asking how does the PEG-INTRON Access Assurance wait list work?
First of all, there are no new steps for you or your staff in the next
phase of Access Assurance. Patients with a new PEG-INTRON
prescription wishing to begin therapy will still need to call Access Assurance (1-888-437-2608) and register.
Once a patient is registered, he or she will be put on a list and patients will then be eligible for
therapy on a first-come, first-served basis, as additional PEG-INTRON becomes available.
Patients will be instructed to go to or call their pharmacy once they have received an Access Assurance ID number.
At this time, we anticipate that initial patients on the wait list would be on it for approximately 10 to 12 weeks.
However, patients may start therapy earlier or later based on the number of patients,
their position on the registration wait list, and PEG-INTRON supply.
While we regret that some patients will have their PEG-INTRON therapy postponed,
I know you will appreciate that this delay allows us to ensure
that no patient's therapy will be compromised due to insufficient supply.
On a daily basis, Schering is working diligently to increase production and optimize
existing inventory to minimize wait times.
Lastly, if there are medical situations that require immediate treatment with PEG-INTRON,
Schering has set up an independent 3rd party medical review board to evaluate critical situations
on an individual basis. A dedicated supply of PEG-INTRON has been allocated to meet
these emergency needs. If you need to submit a case to this medical review board,
please contact 908-298-2202 for more information.
If you have any further questions or need additional information please contact your local
Schering Corporation representative or call (908) 298-2202.
Please see accompanying full Prescribing Information.