icon star paper   Articles  
Back grey_arrow_rt.gif
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 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 Assurance program.
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 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 patient information.
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.
International Markets 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 supply of PEG-INTRON to meet current demand for the product in international markets.
January 2002
  icon paper stack View Older Articles   Back to Top   www.natap.org