LETTER FROM SCHERING PLOUGH: wait-list for PegIntron.
A newsarticle in a newspaper said a medical review board will be set up to
review medical necessities who cannot wait to be treated.
January 14, 2002
SCHERING-PLOUGH STATEMENT ON PEG-INTRON ACCESS ASSURANCE PROGRAM
Schering-Plough in October 2001 announced the U.S. availability of
PEG-INTRON (peginterferon alfa-2b) Powder for Injection for use in
combination with REBETOL" (ribavirin, USP) Capsules for treating chronic
hepatitis C in patients with compensated liver disease who have not been
previously treated with interferon alpha and are at least 18 years of age.
Prior to the launch of the combination therapy, Schering-Plough anticipated
that demand for
PEG-INTRON could be heavy, but the extent of that demand could not be
estimated with certainty. As a result, the company implemented the
PEG-INTRON Access Assurance program in order to ensure that individual
patients who begin treatment will have uninterrupted access to a full course
of PEG-INTRON therapy. Continuity of hepatitis C therapy is critical to
achieving optimal patient outcomes. Access Assurance enables Schering-Plough
to systematically manage the distribution of PEG-INTRON so that no patients
who have begun therapy risk having their hepatitis C treatment interrupted
due to product availability. The company emphasizes that there is an
adequate supply of PEG-INTRON to meet the needs of all patients currently on
therapy. To date, more than 60,000 patients have enrolled in the Access
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
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 to meet these emergency needs.
The PEG-INTRON Access Assurance program is administered by an independent
third party that has been contracted to maintain all patient-level
information in a strictly confidential manner solely for the purpose of
monitoring PEG-INTRON use. Schering-Plough has no access to identifiable
Some 4 million Americans are infected with the hepatitis C virus, according
to the Centers for Disease Control and Prevention (CDC). U.S. physicians
have reported large numbers of patients who have delayed starting therapy
over the past year in anticipation of being able to use PEG-INTRON in
combination with REBETOL. It is unknown how many U.S. patients may undergo
treatment or over what time period they may begin therapy. In addition,
PEG-INTRON is approved for dosing according to patient body weight. Thus, it
is expected that prescribed doses of PEG-INTRON will vary, potentially
affecting total product consumption.
Manufacturing at Full Capacity
Schering-Plough is manufacturing PEG-INTRON at full capacity at its
biotechnology production facility in Ireland. The company has recently begun
construction of a new biotechnology manufacturing facility in Singapore that
will provide future additional capacity for PEG-INTRON as well as other
company biotechnology products.
PEG-INTRON was granted marketing approval in the European Union (EU) in May
2000 and REBETOL received EU approval in 1999. These products subsequently
received marketing approval in several additional international markets.
Since the U.S. launch of PEG-INTRON and REBETOL combination therapy in
October 2001, Schering-Plough has closely monitored distribution of
PEG-INTRON on a weekly basis. The company believes that there is an adequate
PEG-INTRON to meet current demand for the product in international markets.