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2/8/2002

Patients Must Register, Then Wait for New Hepatitis Drug

Donna Young

To begin treatment with peginterferon alfa-2b, a long-acting form of a protein with antiviral activity, patients with chronic hepatitis C must wait until others have completed or stopped the therapy, according to a spokesman for the drug’s maker, Schering-Plough Corp.

The company initiated a waiting list for the product on January 18 to "ensure uninterrupted treatment" for patients who, once beginning therapy, "must be on the drug for a full 48-week course," said spokesman Robert J. Consalvo.

Peginterferon alfa-2b, marketed under the brand name PEG-Intron, was initially licensed in January 2001 as a once-weekly treatment for adults with chronic hepatitis C who had not previously taken an interferon alfa product and whose diseased liver still functioned well. In August, the license was expanded by the Food and Drug Administration (FDA) to include the use of ribavirin, an oral antiviral agent, in conjunction with peginterferon alfa-2b therapy. Interferon alfa products other than peginterferon alfa-2b must be injected subcutaneously three times a week.

When FDA approved the use of peginterferon alfa-2b in combination with ribavirin in August 2001, Consalvo said, there was a "glut" of patients waiting to begin the therapy.

"Many doctors had told their patients that the new drug was coming, and so many patients delayed their therapy until the combination was available," he said.

To prevent shortages of peginterferon alfa-2b, Consalvo said, the company established a registration program, known as PEG-Intron Access Assurance, in October 2001. Patients must call a toll-free number to obtain an identification number before they can have their prescription for the product filled.

Schering-Plough hired an "independent third party" to administer the program, including collect patient information and distribute the drug, Consalvo said. Although he declined to identify the program’s administrator, Consalvo said the company is a licensed wholesaler.

The access program was implemented as a "monitoring mechanism for the use of the drug," Consalvo said. "What this program allows us to do is manage the distribution of the product and assure to patients that they will have a full course of therapy allotted to them."

He said that Schering-Plough does not have access to any of the patient information collected for the access program by the third-party administrator.

"The third party is regulated by contract as to what they can do with the data," he said. They can’t use it for any other purpose or sell it for any marketing reasons. That data is kept confidential. We take patient confidentiality very seriously."

Consalvo said the program’s administrator acts as a "firewall" between Schering-Plough and patients who register for peginterferon alfa-2b therapy.

However, when contacted at the program’s toll-free number, a customer service agent, who said she was responsible for collecting patient information for the program, claimed she was a Schering-Plough employee and not an employee of a third-party company or a worker outsourced from any other firm. A second contacted person, who said he "handles" orders for the product, also identified himself as a Schering-Plough employee.

Patient advocate groups demanded in November 2001 that Schering-Plough drop its access program or not require patients to provide confidential information in order to receive an identification number. In an open letter to Schering-Plough, the groups complained that "it is inappropriate, unnecessary, and disrespectful for patients to be forced to give confidential information to Schering or to any outside representative of the company to receive prescribed treatment."

The company altered its program so that patients can give only their name to obtain the identification number, Consalvo said. But, he added, those patients would not receive reminder notifications about refilling their medication.

Consalvo said the third-party administrator gets in touch with only the patients who have provided contact information and gone 60 days without a refill. Patients who do not obtain a refill after 60 days and do not contact the administrator are dropped from the program and not guaranteed a full course of therapy.

Paul Richards, spokesman for FDA’s Center for Biologics Evaluation and Research, said the agency "is aware" of concerns about how Schering-Plough is distributing PEG-Intron.

"FDA is exploring our options and authorities," he said. "Our agency does not regulate distribution. It is our job to assure the product is safe and effective. But we are in continuing discussions with the company."

As a public health agency, Richards said, FDA is "concerned that patients have access to products that can improve the quality of life."

"We don’t want to burden industry in relation to unreasonable recommendations, but we will work with [Schering-Plough], as we would any firm, to assure that patients have access and that those products will be available to patients," he said.

Richards said he "could not confirm nor deny" reports, circulating in the media and some Internet discussion forums, that FDA had received complaints about missed doses of peginterferon alfa-2b or delays in the start of therapy because of the waiting list and registration program.

The American Liver Foundation and the American Association for the Study of Liver Diseases released a statement in January to "reassure patients with hepatitis C that this temporary shortage will not adversely affect their health."

"Because of the slowly progressive nature of chronic hepatitis C," the associations stated, "a delay in starting treatment of 3 to 6 months, or even longer, should not present a problem to most patients. Furthermore, conventional interferon alpha, which may be used in combination with ribavirin, is readily available should patients or physicians desire to start treatment now."

Schering-Plough expects its Access Assurance program to be "temporary," Consalvo said. Once the "treatment flow of patients becomes moderate, the program will go away."

Doses of peginterferon alfa-2b became available to patients on the first waiting list within two weeks, Consalvo said, adding that more than 60,000 patients in the United States have enrolled in the program since last fall.

FDA estimates that 4 million people in the United States are infected with the hepatitis C virus.

Patients outside of the United States are not required to participate in the access program to obtain the product, Consalvo said. Peginterferon alfa-2b became available in Europe several months earlier than in the United States, he said, but there were not large numbers of Europeans who had delayed therapy in anticipation of the new treatment’s availability.