The headlines for pharmaceutical treatments have had a bleak tint to them in recent years. Vioxx and black-box warnings on erythropoietin-stimulating agents are a few examples. This has made doctors and patients alike somewhat wearier about accepting new drugs.
For example, two doctors outlined 25 principles for a more conservative approach to prescribing in the Feb. 25, 2009, issue of the Journal of the American Medical Association.
The guidelines included strengthening the patient-prescriber relationship, practicing caution and skepticism when prescribing drugs that are new to the market, considering therapeutic options other than drugs when appropriate, and reducing adverse drug events.
“When using new drugs, prescribing should be more limited and should target patients, indications, and situations for which benefit has been demonstrated,” the authors wrote.
Clearly, the burden of proof is on the drug makers and clinicians who develop the drugs. And the discerning eyes of physicians will be working overtime as the landscape of iron treatments for kidney disease patients continues to evolve.
The choice of what iron product to use will be especially relevant with the bundled payment set to start in 2011. According to an August 2009 BioTrends report, dialysis clinic medical directors foresee the increased use of IV iron to spare the use of ESAs (such as Amgen’s Epogen) as well as IV iron brand selection being heavily influenced by price.
The Current Landscape
There are currently two options for treating iron deficiency anemia in chronic kidney disease patients: oral iron supplements and intravenous iron, and the competition among drugmakers is heating up for this $560 million market.
In fact, the dialysis community represents the largest and most established place for intravenous iron replacement therapies to be used. And two companies, DaVita and Fresenius, care for 60 percent of all U.S. dialysis patients.
Right now, Ferrlecit and Venofer are the major players in the iron market. But the past two years represented a seismic shift that could affect what iron drugs are used in the future.
American Regent used to be the sole supplier of Venofer in the United States. However, last year, Fresenius signed an exclusive 10-year U.S. manufacturing and distribution sublicense for Venofer with Luitpold Pharmaceuticals, which makes and sells the iron drug through its subsidiary American Regent. Fresenius also signed a sublicense for a new iron drug called Injectafer. American Regent still distributes Venofer to non-dialysis chronic kidney disease patients.
So far, Venofer has helped Fresenius’ bottom line. According to the company’s 2009 third quarter report, “Dialysis product revenue increased by 14 percent to $209 million and was led by pharmaceutical sales, especially of the newly licensed intravenous iron products.”
With Fresenius tied to Venofer, this makes the competition among drugmakers tighter in order to reach the remaining clinics across America.
Watson Pharmaceuticals is leaving and, perhaps, reentering the iron drug market. It has been distributing Ferrlecit for years, but in 2008 the company received a letter from sanofi-aventis, which owns the rights to Ferrlecit, that said Watson’s license to distribute Ferrlecit would be ending. Through arbitration, Watson was able to distribute the iron drug through the end of 2009, and sanofi will be taking over this year.
However, Watson may not be lamenting the loss. In a filing with the U.S. Securities and Exchange Commission, Watson wrote that it had continued to experience declines in sales of Ferrlecit due to a customer transitioning to a competing product. The filing didn’t say what the competing product was, and Watson could be back in the future selling a generic version of Ferrlecit.
New Kid on the Block
Last year, the U.S. Food and Drug Administration approved AMAG Pharmaceuticals’ Feraheme for intravenous use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients. According to AMAG, a complete treatment can be given with two injections over a span of eight days.
In a recent regulatory filing, AMAG Pharmaceuticals explained the challenges for new iron treatments entering the dialysis market. “The iron replacement therapy market is highly sensitive to several factors including, but not limited to, the perceived safety profile of the available products, the ability to obtain appropriate insurance coverage, coding and reimbursement, price competitiveness, and product characteristics such as convenience of administration and dosing regimens,” the filing states.