Bayer Corp. responds: Update on Prolastin

In response to concerns voiced by representa- tives of National Home Infusion Association (NHIA) about the new method of distribution for the infusion drug Prolastin, Home Infusion Therapy Management contacted Bayer Corp. to request clarification of its position about NHIA’s questions and concerns about Bayer Direct, the company’s new marketing arm, and received the following statement:

Bayer Corp. has been providing patients with medications they need for over 50 years. Bayer is pleased to announce the continuation of that tradition with the introduction of a new program designed to give patients direct, fair, easy, and reliable access to two important life-saving pharmaceutical products, Prolastin and Gamimune, that patients rely on in treating such serious illnesses as emphysema, liver and lung diseases, and pediatric HIV infection. This new program is called Bayer Direct.

Prior to the introduction of the Bayer Direct program, Prolastin and Gamimune were distributed to the public exclusively through various providers in the distribution channel. We implemented the Bayer Direct program in direct response to complaints we received from Prolastin and Gamimune patients and patient advocacy groups about serious inequities in the way some providers in the distribution channel were distributing and pricing these products. Prolastin and Gamimune are often in short supply because the amount of each product Bayer can produce is limited by the availability of human plasma (which itself is often in short supply).

These shortages have made it difficult for patients to obtain reliable access to Prolastin and Gamimune on fair terms from certain providers in the distribution channel. Those problems were compounded when patients traveled or moved and needed to find a new source for their prescriptions. In fact, some entities in the distribution channel tried to take advantage of the shortages by imposing huge price increases. Bayer Direct was designed to eliminate these problems by giving patients direct access to Prolastin and Gamimune when, where and how patients need them.

Why is the Bayer Direct program necessary?

Bayer traditionally has distributed Prolastin and Gamimune through intermediary channels of distribution such as distributors (which sell pharmaceuticals to retail pharmacies) and home health care agencies (which provide pharmaceuticals to patients). Patients were unable to avoid the middleman by making purchases directly from Bayer.

There were a number of problems associated with this method of distribution. Some providers in the distribution channel capitalized on the high demand for, and short supply of, Prolastin and Gamimune to raise their prices unfairly. Many patients whose health depended upon their access to these drugs were forced to pay exorbitant prices. Indeed, Bayer has received reports of certain entities in the distribution channel forcing patients to pay as much as $14,000 a month for Prolastin — thousands of dollars more than the price charged by others in the distribution channel. Patients who were unable to afford these steep prices were forced to go without these life-saving drugs.

Patients also complained that, in addition to the problems caused by exorbitant and inconsistent pricing, the shortages of Prolastin and Gamimune created significant confusion and uncertainty among patients about their ability to obtain further supplies. Individual providers in the distribution channel used their own allocation systems to allocate Prolastin and Gamimune. Many patients felt that they had no way of knowing when, how, where, or even whether they would be able to get needed dosages.

Moreover, some entities in the distribution channel refused to allow patients to transfer their allocations of Prolastin or Gamimune to new providers when patients relocated or wanted to switch health care companies for some other reason. Patients complained to Bayer about their fears that, if they chose to switch doctors or pharmacies or to move across the country for that matter, they would lose their access to Prolastin and Gamimune. Indeed, even some patients who stayed with the same supplier were unable to count on receiving a steady supply of these products since many suppliers had no system in place for distributing the drugs in an orderly fashion. Patients and patient advocacy groups asked that Bayer do something about these inequities. Bayer responded with Bayer Direct.

How does Bayer Direct work?

In November 1999, Bayer introduced the Bayer Direct program to address the problems patients were facing in obtaining Prolastin and Gamimune. Bayer Direct allows patients to obtain the Prolastin and Gamimune they need when and where they need it by shipping these products directly to patients (or to whomever patients designate).

Bayer Direct is open to all patients. Any patient whose health depends upon Prolastin or Gamimune can receive these products through Bayer Direct regardless of the pharmacy they use or the state where they live. Patients can sign up through the mail, via the Internet, over the phone or through their physician. Bayer’s representatives are on hand at all times to help patients and physicians complete enrollment forms, obtain the patients’ insurance information, and schedule any nursing visits that may be needed for administration of the products.

How does Bayer Direct help patients?

First, Bayer Direct protects patients from the practices of certain providers in the distribution channel who, in the past, have used product shortages as an excuse to institute dramatic price increases. Now, patients are guaranteed the benefit of being able to buy directly from Bayer.

Second, Bayer Direct eliminates patients’ uncertainty and confusion about when, where and how they can continue obtaining new supplies of Prolastin and Gamimune. Bayer Direct operates on a clear and fair set of ground rules for the allocation of Prolastin and Gamimune. For instance, with regard to distributions of Prolastin, during enrollment each patient is given, in sequential order, a patient identification number. When Bayer assembles a sufficient amount of Prolastin to ship a patient a 28-day supply of the product, it ships a 28-day supply to that patient, beginning with Patient No. 1 and continuing until the supply of product is exhausted. When new supplies become available, the next patient in line will receive his or her shipment. These ground rules give patients certainty about when and how they can expect to receive their needed dosages in times of shortage.

Third, Bayer Direct guarantees that patients will not have to give up their ability to obtain Prolastin or Gamimune if they choose to change doctors or move to a new neighborhood. Patients who sign up for Bayer Direct will be able to get the Prolastin and Gamimune they need shipped directly to them at whatever location they choose. Moreover, in conjunction with Express Scripts, the nation’s largest independent pharmacy benefit manager, Bayer Direct will also arrange for those patients who need infusions of Prolastin or Gamimune to receive treatment at a location of their choice. For more information about Bayer Direct, please call toll-free, (800) 305-7881, or visit our Web site at