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In support of its new drug Copaxone, Teva Marion Partners of Kansas City, MO, has launched an ambitious disease management program for people with multiple sclerosis (MS). Called Shared Solutions, the program was designed in cooperation with the New York City-based National Multiple Sclerosis Society (NMSS). The program is offered free to anyone with MS, although enrollees who use Copaxone (glatiramer acetate for injection) receive a greater range of services.
Teva Marion decided to get involved with disease management as a way to "create value for the patient," says John Hassler, director of marketing for the company. "We understood that a lot of different issues can be very central to the patient and can influence the perception and the use of our product. So, in looking at the needs within the marketplace, we felt that the best approach was to take a holistic view of the patient."
Hassler cites, in particular, the results of a 1996 study conducted by Roper Starch Worldwide and sponsored by Teva Marion. According to the report, more than a quarter of people with MS claim that they don’t receive the emotional support and understanding they need. More than half said that the disease had damaged their feelings of self-reliance and ability to enjoy life. Two-thirds reported that MS had placed a "serious drain" on their financial resources.
After reviewing the results of the survey and consulting NMSS, Teva Marion concluded that "there are things unique to this disease state and also to the therapies currently available that make a disease management approach particularly appropriate," says Hassler.
Issues of emotional support aside, the main focus of Shared Solutions remains the company’s drug. "It’s really to try to make people aware of the product, manage their expectations, and help provide access to those who want to pursue using the product," Hassler concedes. "We want to help people get started on the product appropriately, making sure they have all the materials that they need. And we want to support compliance and persistence."
The drug’s potential market includes the more than 300,000 people in the United States who have MS, according to NMSS estimates. Another 200 cases are diagnosed every week.
Despite the product focus of the program, Nancy Holland, EdD, vice president of clinical programs at NMSS, bristles at the notion that the program is focused too strongly on marketing issues. "I wouldn’t say that the support program has anything to do with the marketing of the drug," says Holland. "The program truly is for people with MS to call up and speak with the nurse counselors, who are not involved in marketing at all. They really are available for support."
Nurse counselors, however, are unavailable to enrollees not using Copaxone. Those enrollees receive general information about the disorder and the types of therapies available, in the form of quarterly newsletters and brochures provided by NMSS, says Lillian Pardo, MD, medical director at Teva Marion. Holland adds that these enrollees do receive information about the other two major drugs used in the treatment of MS: Betaseron, made by Berlex Industries of Wayne, NJ, and Avonex, made by Biogen Inc. of Cambridge, MA. The NMSS has also assisted in developing disease management programs with Berlex (Multiple Sclerosis Pathways) and Biogen (the Avonex Alliance).
"When a person with MS or a health professional calls for information, we will offer our information, the pharmaceutical company’s information, and we also ask if the person would like information about all three therapies," says Holland. "We really try to provide a balanced array of information."
Enrollees using Copaxone have access to nurse counselors employed by Teva Marion. Each of the counselors is a registered nurse who has undergone a seven-week course developed in part by NMSS to provide "an in-depth understanding of MS and some of the local resources that are available through NMSS," says Hassler.
"The nurse counselors are available by phone for any kind of information about the drug and how to take it," says Pardo, who assisted in training the nurses. "They’re also trained in following up on how patients are doing in terms of their response to the medication, and for any other kinds of concerns the patients have expressed." (For a graphical representation of the program, see flowchart, p. 81.)
During the developmental phase of the program, representatives from NMSS also insisted that the nurses be trained in crisis intervention, says Holland. "Even though [the nurses] are primarily answering questions related to the drug, we felt that anyone answering an 800 line should have some understanding of crisis management," she says. "People will use the 800 line when they’re in distress, so there needed to be an understanding of suicide assessment and of abuse and neglect assessment."
Another significant service also provided by the nurse counselors is the dissemination of information about reimbursement. Such information can be vital for people with MS, given that Copaxone’s average wholesale price is $922.98 for a 32-count package. That translates to $28.84 per day, a cost Teva Marion claims is comparable to that of the two competing drugs.
"The assistance that they are extending right now in terms of the whole reimbursement issue is really important because many times, new drugs are not yet in formularies," says Pardo.
The nurse counselors mainly provide general information on reimbursement such as explaining different sources of funding and insurance terminology. Patients who report problems with insurance, such as denial of coverage, are referred to a reimbursement specialist. This specialist can act as a "personal advocate" for the patient, "even helping to fill out insurance paperwork if needed," according to Teva Marion’s Guide for People with Multiple Sclerosis. Patients who have exhausted all sources of reimbursement are referred to a patient assistance program run through the Washington, DC-based National Organization for Rare Disorders. There, says Hassler, "they go through a fairly extensive financial assessment and may be able to receive products through that mechanism."
Pardo says that pharmaceutical companies like Teva Marion have taken the lead in disease management for conditions such as MS because "managed care companies in this era of cost containment tend to be very selective in terms of the services they offer." She adds that "the perspective of the industry now is that we’re not just selling a drug. Compliance in the use of the drug is really dependent on the other factors that will allow a patient to follow the right protocol for the medication."
"It’s a recognition that what people are purchasing when they buy your product is a health care benefit," says Hassler. "And with various products, a lot more goes into providing that benefit than just the pill or the liquid or the injection itself. I think it’s still sporadic, though, and still isolated to specific segments where it seems to make sense."
Meanwhile, the NMSS has just formed a department of clinical programs headed by Holland to encourage more managed care companies to provide the types of therapies and support now supplied by pharmaceutical companies like Teva Marion and Biogen. "I don’t know that drug companies are the best organizations to be providing disease management," she says. "I see them really as another point along the continuum, expanding the help that’s available to people with MS."
[For information on Shared Solutions, contact the following sources: Teva Marion Partners, Shared Solutions hotline, Telephone: (800) 887-8100. National Multiple Sclerosis Society, New York City. Telephone: (212) 986-3240.]