NHIA takes Bayer to task over its new Bayer Direct system

By MATTHEW HAY

HHBR Washington Correspondent

ALEXANDRIA – The National Home Infusion Association (NHIA; Alexandria, VA) is spearheading an effort to have the Bayer Corp. immediately suspend Bayer Direct, the company’s new distribution system for Prolastin, a single-source IV drug used for the treatment of Alpha1 antitrypsin deficiency.

According to NHIA Executive Director Lorrie Kline Kaplan, NHIA has been inundated with phone calls, faxes, and e-mails opposing the program since Bayer Direct was announced Oct. 26. With almost no notice, she said, Bayer suspended all existing distribution channels for Prolastin. "Basically, it was available to any physician who had a patient and could buy it, and, with three days notice, they said physicians could only get it directly from them and their agent Express Scripts," Kaplan explained.

But Bayer Direct representative attorney Doug Bell says he thinks providers’ concerns might be more over the fact they can no longer purchase Prolastin for resale to their infusion clients than over whether they will be able to get it. Bell told sister publication Home Infusion Therapy Management (IVT) that the Bayer Direct/Express Scripts distribution system was designed to ensure equal distribution 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," Bell told IVT.

Kaplan said the lack of notice from Bayer Direct meant that providers and patients were forced to rely on inventory still available under existing distribution channels. "There is no guarantee that any inventory existed," said Kaplan. "And these are patients some of whom have 10% lung function."

She also argued that Bayer’s program will set a dangerous precedent if it is allowed to stand. "We fear this system would completely remove price and quality competition from the market and lead to dramatic increases in price," she asserted.

"There are serious product allocation issues," she added. "Our view is they could have developed an improved product allocation system that still allowed patients freedom of choice to select their own provider." But instead, said Kaplan, Bayer opted to establish their own (system) where patients must register with Bayer directly".

In a letter to Bayer dated Nov. 8, Kaplan wrote, "NHIA is well aware of the product shortages that have plagued Prolastin and other plasma-derived products during the past year. These medication shortages have been hard on patients, clinicians, and manufacturers." But Kaplan argued that Bayer’s program raises significant policy and ethical issues, especially when the medication involved is available only from one manufacturer.

"As the primary nursing and pharmacy care providers for Prolastin, IV immune globulin, and other infusion therapies, NHIA members have valuable expertise that could help Bayer to develop a truly fair and equitable solution for our patients," Kaplan added.

NHIA urged Bayer to take the following steps: 1) suspend immediately Bayer Direct for at least 60 days and re-initiate product allocation to current providers; 2) develop a representative working group of patients, infusion providers, home health nursing providers, physicians, or other key care team members to re-examine strategies for improved product distribution and pricing stabilization for Prolastin; 3) develop a patient registry to improve product allocation while still allowing patients to select their own healthcare provider, and; 4) establish a leadership position in the pharmaceutical community with an ethical commitment to quality patient care, patient freedom of choice, and a fair and equitable marketplace.