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Companies Try Different Plans for Same Clotting Factor Product

Cheryl A. Thompson

Although Aventis Behring L.L.C. and Bayer Corp. market the same technologically improved clotting factor product, the two companies have taken different approaches to meeting the needs of the bleeding disorders community—with one of the companies recently retreating from its original plan.

As Bayer prepared to start selling Kogenate FS in the third quarter of 2000, the company announced that distribution of the antihemophilic factor product in the United States would occur only through subsidiary Bayer Direct because demand was expected to outpace supply. Bayer has described the subsidiary as a business-to-consumer portal that "acts as an online pharmacy, selling biological products directly to patients."

With Bayer Direct, patients enroll in the program and, as they need a new supply of clotting factor VIII, Express Scripts Specialty Distribution Services ships the product directly to the patient's location of choice. Usually, this means bypassing hemophilia treatment centers, home infusion companies, and hospitals—the regular suppliers of antihemophilic factor products and services.

The program promises to reserve an inventory of appropriately sized bottles of Kogenate FS for each enrollee, set a stable price for the product, streamline the process for handling product recalls, and assist patients with insurance issues. According to Express Scripts, its subsidiary delivers the drug and provides related administrative, reimbursement, and pharmacy services.

Aventis Behring, which has a long-term contract to sell a portion of Bayer’s hemophilia products, faced a similar problem in meeting the anticipated demand for Helixate FS. The product, essentially Kogenate FS with an Aventis Behring label, was initially available only through an allocation system, but this restriction was lifted within a month.

Both companies recently modified their plans. Bayer now lets patients receive Kogenate FS from their health care provider, and Aventis Behring offers a program aimed at improving the quality of care for patients with bleeding disorders.

Purity at a cost. Kogenate FS and Helixate FS, like their predecessors Kogenate and Helixate, offer patients with hemophilia A the safety of factor VIII protein produced by recombinant DNA technology, not blood donations.

But the "FS" products incorporate an additional safety feature—formulation with sucrose rather than albumin, thus further decreasing patients’ risk for contracting viral infections, such as hepatitis C, from coagulation therapy. Presumably, a product formulated with little human or animal protein would incur fewer recalls by the manufacturer than products containing greater amounts of albumin obtained from potentially virus-harboring donors.

The power of advocacy. While neither company’s initial approach fully met the needs of patients with hemophilia A, the National Hemophilia Foundation objected only to Bayer’s plan.

At a September meeting with company officials, the foundation expressed "vehement opposition" to the Bayer Direct program. The group went as far as to refuse all funding from Bayer and request that the company not send representatives to the foundation’s national meeting in November.

According to a foundation memo documenting a second meeting, Bayer budged a little in its stance, allowing for direct sales of Kogenate FS to hospitals. The company had previously agreed to allow federally funded hemophilia treatment centers to buy Kogenate FS at a special discount without enrolling patients in Bayer Direct.

During the week of the foundation’s national meeting, Aventis Behring announced the launch of a bleeding-disorders program not linked directly to the purchase of Helixate FS. Aventis Behring Choice, also known as AB Choice, will offer open distribution of the company’s products, customized support services, patient education programs, and research grants from an independent, nonprofit foundation. The company said it is interviewing health care providers interested in joining the program (see box).

Bleeding-Disorders Community to Gain Services

Launched in November 2000, Aventis Behring Choice aims to give members of the bleeding-disorders community customized access to resources and educational services, without regard to the coagulation product used.

Although the program is still in the design phase, the company has been speaking with hemophilia treatment centers and home infusion companies about creating services useful to patients with bleeding disorders, said Aventis Behring Vice President Alain Delongchamp. One such service, he said, would focus on encouraging patients to use prophylactic doses of coagulation products rather than wait for bleeding to occur, which requires higher doses to correct. The change could improve patients’ quality of life.

Delongchamp sees an opportunity for pharmacists to become more involved in the care of patients with bleeding disorders. For example, clinical pharmacists can evaluate the use of coagulation products, a service provided sporadically across the country, he said.

Research grants to improve the treatment of bleeding disorders will be available from the newly established Aventis Behring Foundation for Research and Advancement of Patient Health. The independent, nonprofit foundation started with $1 million donated by the company. 

The same day that Aventis Behring announced its program, Bayer sent the National Hemophilia Foundation a letter detailing further changes, or "refinements," to Bayer Direct.

According to the Nov. 9 letter, Bayer will allow all hemophilia treatment centers, hospitals, and home infusion companies to buy Kogenate FS without enrolling patients in Bayer Direct. Also, Bayer and Express Scripts will revise the enrollment procedures for Bayer Direct to ensure that patient information remains confidential at Express Scripts.

Despite Bayer’s declaration, two weeks later the Web site for Bayer Direct still described itself as the exclusive distributor of Kogenate FS.

Changes on the horizon. Supplies of technologically improved antihemophilic factor may improve in the near future.

With expansion of Bayer’s biotechnology facility in Berkeley, Calif., the company should double its output of recombinant protein-based drugs, including Kogenate FS, a senior vice president told the San Francisco Business Times in August.

Also, Baxter Healthcare Corp. has under way a Phase III trial of a recombinant antihemophilic factor product made without addition of human or animal proteins. Baxter already manufactures Recombinate, a recombinant antihemophilic factor product.