Bayer Corp. changes Prolastin sales from infusion providers to contractors

Exclusive deal with Express Scripts questioned by NHIA

Bayer Direct, a product distribution channel created by Bayer Corp., has signed an exclusive distribution contract with pharmacy benefit manager Express Scripts to distribute Bayer Corp.’s widely used infusion drug Prolastin. Bayer is the sole manufacturer of Prolastin, which is used for patients with alpha1-antitrypsin deficiency, a lung dysfunction for which there is no cure. Prolastin distribution through infusion therapy providers stopped Nov. 1, 1999.

Lorrie Kline Kaplan, executive director of the Alexandria, VA-based National Home Infusion Association (NHIA), says the Bayer Direct program raises serious concerns for the infusion community because infusion services must now contract with Express Scripts in order to continue providing infusion services.

Conflicts highlighted

Kaplan says NHIA contacted Bayer Direct and expressed concern about this manufacturer-controlled program and its implications for patient care. "There was conflicting information and misinformation about the program," she says. "For example, the alpha1 support group Web site [sponsored by Bayer] stated that nursing and infusion services will be arranged through Express Scripts as part of the Bayer Direct program.’ However, it also suggested that patients talk with Bayer Direct or your current nurse to see what possibilities exist for keeping your current nursing services.’"

However, Bayer Direct representative attorney Doug Bell says infusion providers’ concerns may derive more from the fact they can no longer purchase Prolastin for resale to their infusion clients. "I think the issue is that they were purchasing and providing the product, as well as providing the infusion services,’’ he says. "Now they are looking at just providing the infusion services."

Bell says the Bayer Direct/Express Scripts distribution system was designed to ensure equal distribution of Prolastin to all alpha1 patients. "Essentially, the (Prolastin) patients came to Bayer, the media, and folks on Capitol Hill complaining about product hoarding [by infusion service providers who purchased Prolastin for resale to patients] and exorbitant prices being charged where the product was in short supply."

According to Bell, the current supply of Prolastin does not meet demand for the drug. "Our manufacturing facilities are running 24/7, 365 days a year because of the increasing number of patients being diagnosed with alpha1," he says. "What we’ve got here is a system that tries to level the playing field by giving identification numbers to all patients. . . . Each patient receives a 28-day supply of Prolastin, delivered to the location of choice. This distribution sequence continues until every patient who is enrolled in the Bayer Direct program has received the product. Shipment continues until all available product is shipped. If there is a temporary interruption of delivery due to lack of supply, the next patient in the sequential line receives his product shipment when the supply is replenished."

Follow the patient

Bell sees another benefit for infusion patients with the Bayer Direct system because in the past, due to Prolastin’s short supply, a patient who moved to another state without first creating a relationship with a distributor could have difficulty obtaining the product. "With the Bayer Direct program, wherever the patient goes, there also goes the Prolastin," he says. "Bayer Direct has contracted with AlphaNet, a for-profit organization that provides consultation services to alpha1 patients on how to obtain the product and receive insurance reimbursement."

AlphaNet began as a not-for-profit group and is still described that way on the Bayer Direct Web site.

Kaplan says Bayer Direct patient representatives told her they are "making every effort to allow patients to retain their current nursing service." She adds NHIA understands that this would mean becoming a contracted provider through the Express Scripts network. NHIA representatives were unable to speak directly to the Express Scripts contracting department to gain additional information about the contracting process, Kaplan says.

According to Kaplan, Bayer says it has positioned the Bayer Direct program as designed to meet the needs of patients, specifically to deal with product shortages of the past year and pricing variations. However, Kaplan says Bayer inaccurately implies that infusion providers are the source of those problems, and that moving the product out of the infusion provider community is the only solution to them.

"Providers have worked diligently to serve their alpha1 patients under extremely difficult product shortage conditions," says Kaplan. "There is no evidence that Bayer attempted to discuss these problems with the provider community to develop a solution that could truly be a win-win for all concerned."

Kaplan says NHIA believes that Bayer Direct may be good for Bayer, but that it’s not good for patients. She adds that while the Bayer-sponsored Alpha Foundation Web site raves about the new program, actual discussions among alpha1 patients produce a different story. She says some patients fear they will be unable to receive their next scheduled dose, suffer anxiety over the loss of choice of provider, and are concerned over the possible implications of Bayer Direct’s control of the distribution process. Though Bell says Bayer Direct has no ability to increase the cost of Prolastin, Bell acknowledges that Bayer Direct is a channel for Bayer Corp., which could increase the drug’s cost.

Kaplan says NHIA "supports freedom of choice and opposes this cynical attempt by a manufacturer to shortcut the nation’s drug distribution system and infusion provider community for its own profit. All consumers should have the right to obtain quality pharmaceutical services from a provider of their choice. This right is guaranteed by law for Medicare and Medicaid patients and in more than 30 states under pharmacy freedom-of-choice legislation. The Bayer Direct program clearly violates these principles."

Alpha1 Association in middle of the road

Sandy Brandley, executive director of the Alpha1 Association, a nonprofit 501C3, membership-based organization incorporated in 1991, says her group’s position lies between Bayer Direct and NHIA.

"For better than two years, the association has been actively investigating and pursuing a direct patient allocation system," says Brandley. "By that we mean to link the product with the end-user and somehow have a way that the end-user enjoys a greater level of portability because the product is being provided to them personally rather than first being sold to an intermediary."

Brandley says that a shortage of Prolastin began in January 1998. "There’s a sole manufacturer for this product for this patient community. Two other biological manufacturers have the potential of making a product like this for the alpha1 community. But at this point in time, neither one of them have a product to market."

Brandley says that the reason is that the alpha1 community has only a population of about 5,000 people identified with the disease — a market too small for other pharmaceuticals manufacturers to find sufficient financial incentive to compete with Bayer. "The potential for the number of people we feel have the severe form of the deficiency is somewhere between 80,000 to 100,000 people. We know that because of the frequency of the gene in the (general) population," Brandley says. There is a simple blood test available for alpha1, but it’s not done in many cases because of a "profound under-appreciation and under-recognition of the disease in the medical community."

According to Brandley, only about 3,000 of people diagnosed with alpha1 are considered appropriate for therapy with Prolastin. "Alpha1 is a disease in which the liver fails to produce a protein that protects the lungs," she says, in either an adequate amount or in a form the lungs can use. The disease also manifests itself as liver disease in infants and children. It may be that most of the people with the genetic marker live their entire lives with no symptoms of alpha1 and still have a severe deficiency of this particular protein. They either have very few symptoms, which leads their physicians to believe they have allergies, asthma or slight chronic bronchitis, or they have no symptoms whatsoever. Symptoms include shortness of breath after exercising, a cough that won’t go away, infections that fail to resolve in a timely manner, or year-round allergies.

Brandley says radiological evidence for alpha1 is emphysema in the lower portions of the lungs, and the people most easily diagnosed are those with profound symptoms in their 30’s or 40’s. "If they go into their 50’s," she says, "we believe they are often misdiagnosed with chronic obstructive pulmonary disease or asthma."

She says that living with the current Prolastin shortage has meant that new patients have been identified with no product available for them to take. "We’ve also watched the portability issue," she says. "We’ve had patients whose spouse’s insurance has changed, the home care company they were with is not the same company the new insurance company uses, and the previous company has been either unwilling or unable to notify Bayer they are losing that particular patient and request assignment of that product allocation to another company."

She also says there’s been a difference of as much as 50 cents per milligram in the prices that non-Medicare, non-VA patients are being charged for Prolastin. Prolastin dosage is 60 milligrams per kilogram of body weight per week, creating a treatment expense of about $1,000 per week for the average patient in the 18-to-20-cent-per-milligram price range. "This is a very, very expensive product," Brandley says, "so even small variations in the cost of the product can create a huge burden on the end-user."

Finding a rate

Jean Marc Quach, vice president and general manager of the Special Distribution Division for Express Scripts, says that if home infusion therapy companies want to continue to provide infusion services to their existing clients, they must become subcontractors to Express Scripts.

"In the Bayer Direct program," he says, "Bayer sells Prolastin directly to the patients. Express Scripts acts as a distribution arm for the product." Express Scripts does not charge infusion companies an application fee, but the companies and Express Scripts must agree upon a fee rate for nursing services that is acceptable to both.

"Let’s say the market rate for infusion is $80," Quach continues, "and a home infusion company that wants to continue providing nursing services wants to charge $150. That’s obviously over the market and we would work out a rate that is acceptable to both of us."

Express Scripts arranges for infusion services, but does not provide them to patients. "In the best interests of the patient, we get the rates that are competitive, as well as usual and customary. A home infusion therapy provider that wants to try and make up for the loss of revenue on the drug by charging more for its nursing services is probably not being fair to the patient. Express Scripts is a pharmacy benefits manager. We provide pharmacy benefits management to HMOs, employers, and insurance companies.

"If the HMO wants to use its own nursing contracts, that’s fine; we’ll work with the HMO and distribute the products directly from Bayer to the patients," he continues. "If the HMO does not want to use its own nursing contracts, Bayer Direct will arrange for nursing services to be provided to the patient. We like to do this at a rate that is competitive. We think it is in the best interests of the patient that Bayer went to this system, and we are working with Bayer to distribute the product."

Bayer’s concerns

Quach says that an infusion company that wants to continue serving its alpha1 clients needs to contact Express Scripts can call (800) 305-7881 and ask to become a subcontractor. "Assuming we can work out rates," he says, "it’s not a long process at all."

Part of the list of questions submitted to Bayer Direct on Nov. 8, 1999, in which NHIA asked, "How Bayer Direct will:

- address infection control issues such as: monitoring patients for infections potentially due to admixture outside the confines of a laminar air flow hood, disposal of empty vials of Prolastin (biological waste), disposal of used sharps?

- ensure that nurses visiting patients are competent to administer medications in a noncontrolled setting? How will Bayer Direct ensure that nurses are competent in accessing implanted ports, maintaining long-term indwelling catheters, and starting peripheral IVs?

- monitor for and report adverse reactions experienced by patients? Monitor a patient’s total medication profile for medication interactions or duplication of therapy, or monitor for and report outcomes of therapy?

- anticipate ancillary supply needs and preferences for individual patients?

- supply infusion pumps and poles to patients for a controlled rate of infusion? Will Bayer Direct have 24 hour-a-day, seven-day-a-week access to a pharmacist and a nurse for emergencies?

- ensure access for nursing visits that may increase from four hours to six hours with the addition of the time necessary to reconstitute product in the home?

- ensure that a patient’s environment is acceptable for home care (i.e., cleanliness of home, access to electricity for refrigerated storage of a 28-day supply of medication, and access to running water)?

- ensure that a patient is capable of learning to administer their medication or ensure continuity of care when a patient is travelling?

- monitor for compliance to therapy?

- communicate current patient clinical information to a hospital if a patient is admitted either acutely or planned (infection or transplant), or screen patients for nutritional risk, or help in accessing other needed therapies, such as oxygen therapies or intravenous antibiotics?"

In response to the Bayer Direct/Express Scripts exclusive distribution agreement, NHIA urges all infusion therapy providers to:

- Read the details of the Bayer Direct program on the Web at www.bayerdirect.com/pro.htm — or at www.alpha1.org/bayer.htm. NHIA will fax this information to providers who lack Internet access.

- Contact your Bayer service representative and voice your opinions about this program.

- Continue providing services to your Prolastin patients for as long as you have sufficient drug supplies available. Under your managed care contracts, you are still the contracted service provider — not Bayer or Express Scripts, the NHIA says.

- Notify your patients that due to a new program at Bayer, you will no longer be able to provide services. Urge them to call (800) 305-7881.

- Urge your patients to express their sentiments to Bayer if they are displeased with the new program.

- Notify your payers and referring physicians that you are no longer able to provide products and services to alpha1 patients as described under current contracts.

- Remember that JCAHO standards require accredited providers to "have a policy to refer, transfer, and discharge patients appropriately." In addition, "appropriate information [should be] exchanged when the patient is referred, transferred, or discharged."

- Providers should make every effort to continue to meet those standards despite the lack of information from Bayer on how to ensure a safe transition for the patient, and the apparent lack of interest from Bayer Direct in obtaining clinical history data from current providers, the NHIA says.

Need More Information?

Lorrie Kline Kaplan, Executive Director, National Home Infusion Association, 205 Dangerfield Road, Alexandria, VA 22314. Telephone: (703) 549-3740. FAX: (703) 683-1484. E-mail: lorrie.kaplan@ncpanet.org.

Doug Bell, Attorney, Bayer Direct, P.O. Box 13887, 4101 Research Commons, Research Triangle Park, NC 27709. Telephone: (800) 305-7881.

% Jean Marc Quach, Express Scripts, 13900 Riverport Drive, Maryland Heights, MO 63043. Web site: www.express-scripts.com.