Confusion Persists Over IVIG Situation as Patients Continue Dying From Lack of Treatm

Confusion Persists Over IVIG Situation as Patients Continue Dying From Lack of Treatment

Reprinted from the October 2006 issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

Although action on the intravenous immunoglobulin (IVIG) front is occurring, it has not been enough to address the issue of patients’ lack of access to the treatment. The upshot? Even though more people than ever are familiar with the issue, and CMS has increased IVIG reimbursement in 2006, more patients continue to die because of inability to get IVIG. And as various groups conduct studies on the situation, disagreements persist over whether a shortage even exists.

IVIG is a biological product made from plasma that is collected and processed from human donors by only a small handful of companies. The treatment is used mainly for a large number of the 50,000 Americans with primary immune deficiency diseases, although much of its usage is for off-label indications. The drug costs anywhere from $20,000 to $80,000 annually per patient.

At a House Ways and Means Subcommittee on Health hearing on Average Sales Price (ASP) reimbursement on July 13, Marcia Boyle, chairman of the Immune Deficiency Foundation, testified on the current situation. She maintained then that “while the medical details are different, the medical outcome is the same as taking chemotherapy away from a cancer patient or insulin away from a diabetic. IVIG has been taken away from patients who will die without it.” She said that “Nebraska has only one hospital treating on an outpatient basis with IVIG; the state of Florida has a handful of hospitals left, and in the state of Texas, most Medicare patients in Dallas, Houston and Irving cannot receive IVIG in a hospital. We have reports of patients not receiving IVIG since last November.”

Michelle Vogel, who is a partner at Washington Strategic Consulting, adds that approximately “50% of public hospitals cannot buy IVIG at any price.”

Jordan Orange, chairman of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology (AAAAI), also testified at the July 13 hearing. He cited a survey of AAAAI members that “has ascertained that 95% of the more than 400 respondents feel current reimbursement standards present at least some risk to the health of patients with primary immunodeficiency diseases, and more than half estimate this risk as serious or extreme.”

Speculation within the specialty pharmacy industry abounds as to the reasons behind problems with patient access. Off-label use is high; in fact, CMS says that “off-label uses now significantly exceed on-label uses.” And some people have leveled charges of collusion or of physicians reselling their supply to the secondary wholesale market.

Some industry insiders point to the Jan. 1, 2005, change in reimbursement, when the Average Wholesale Price (AWP) was replaced by ASP, as mandated by the 2003 Medicare reform law, as the reason for the problem. “The formula needs changing,” contends Vogel. “ASP + 6% is just not working for IVIG.”

Asked about charges of supply and reimbursement issues, Chris Middendorf, spokesperson for FDA’s Center for Biologics Evaluation and Research, tells SPN, “Along with other HHS agencies, the FDA has received reports from stakeholders, patients, and health care providers regarding difficulty in obtaining immune globulin intravenous (IVIG) products. From discussions with manufacturers, distributors, providers and consumers, it is clear that availability and treatment patterns have shifted, but we did not find clear evidence that there is currently a shortage.”

Array of Theories on Reason for Problem

One industry insider who asked to remain unidentified because of the sensitivity of the situation tells SPN that the “military gets first dibs” on drug products and that it is “siphoning off” the plasma supply. While the source does not attribute the current IVIG situation to this, the person does say that this may be depleting already-low supplies. “This happened during the first Gulf War,” says the source, adding, “I’m not sure what the [military] allotment is, and those guys deserve the first pick.…But a lot of the supply is already contracted, and then you throw in an intangible, and I think that’s all it takes to tip the balance.”

Another industry insider who also spoke only on condition of anonymity refutes this contention. “I don’t believe the military is a problem at all with IVIG. However, I do believe that products being shipped to other countries” may be contributing to the current situation. The majority of U.S. plasma is shipped to Europe, where most of the manufacturing plants are located. “The question is, does all of the product come back here?” asks that source. With the dangers of Creutzfeldt-Jakob disease plaguing the plasma supplies in England and France, those countries need to look outside their borders. Rumors abound of U.S. plasma going for $90 per gram in Greece, says the source, and there are questions of how much U.S. plasma is sold in Asia. Canada also adds U.S. plasma to its own to meet the demand in that country.

During BioScrip, Inc.’s Aug. 8 second-quarter 2006 earnings conference call, Chairman and CEO Richard Friedman said, “as long as we’ve all been doing this, there tends to be an issue with IVIG. The fact.is that even though there’s a perception of an issue with IVIG, we always seem to be able to secure product to meet our customers’ demands, and that continues.…What occasionally happens is that we have to pay more for certain.products than for other products. But we have not seen a disruption at all in our ability to obtain the product.”

There are six IVIG products on the market now – Carimune NF, Flebogamma, Gammagard Liquid, Gammagard S/D, Gamunex and Octagam. But “every time a product comes into the market, another one leaves,” says Vogel. A subcutaneous immunoglobulin therapy, Vivaglobin, entered the market earlier this year, but it “has not really helped alleviate the problems,” says Vogel. Compounding the situation is the fact that while all of the products are a form of IVIG, they treat different immune deficiencies, and patients can respond in entirely different ways to each product.

Vogel says that there are also rumors of various IVIG manufacturers being up for sale. “It is not a stable market for the plasma industry,” she contends.

“People are having a hell of a time getting [IVIG],” an unidentified industry source asserts. “There is definitely some rationing going on, and there is definitely a pecking order.”

Adding to the situation, says the source, is that “manufacturers may like where they are right now.…I don’t know if anyone will ever get to the problem. Is this an artificial supply issue? A created supply issue? There is a black market for [IVIG]. Any time you see a product on the black market, there are either economic pressures, or someone is gaming it.”