Chief of Staph - Pharmaceutical Executive

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Chief of Staph
Many said it couldn't be done, but one small company is about to get a step ahead of one giant killer bug.


Pharmaceutical Executive


Pay Now, or Pay Later The potential for StaphVax to reduce or even eliminate resistant infections in hospitals makes a strong case for it to be adopted and paid for by any healthcare organization. Just ask Husserl, who as a clinical investigator ran a blinded study with 18 patients on his service. Would the product make economic sense at his clinic? "Absolutely," he says. "An admission to the hospital for an infected graft probably is going to cost Medicare, which pays for the admission, $15,000 to $20,000. That's $20,000 you could avoid with a $300 or $400 injection."

StaphVax will fall under the new Medicare Part D rules, explains Phil Patrick, president of PharmaStrat, a managed markets and reimbursement market research and strategy consulting firm. Reimbursement models will be changing in the months ahead, but he expects reimbursement of StaphVax to follow the same pattern as the erythropoietin (EPO) market, where reimbursement policies and procedures vary by the setting in which the drug is delivered.

"EPO products such as Epogen and Procrit are commonly used for ESRD and dialysis patients," Patrick says. "Under the previous reimbursement model, using Average Wholesale Price [AWP], physicians were able to generate significant profits on the 'spread' between acquisition cost and AWP. Our firm's analysis of these markets suggest that under Medicare Part D, with implementation of Average Selling Price [ASP] reimbursement, physicians will be less likely to administer the drug themselves than previously. The dialysis and renal disease market will certainly be a rapidly evolving market in the months ahead."

Husserl believes that infectious disease experts will be the likely drivers of institutional adoption of what amounts to a complete change in the way hospitals and medical professionals deal with resistant infections—a revolution, really, from treatment to prevention. He says for ID specialists, it's a no-brainer from both a clinical and economic perspective.

"How many vaccines can you give [for the cost of] one admission?" he asks. "You can vaccinate half a state. I would think that Medicare would jump on this if they just do the numbers, looking at the tremendous savings they can realize."

Whatever reimbursement structure prevails, Nabi will still have to convince hospitals to use the product if it takes more than one injection—booster shots—to confer long-term protection. Anatole Besarab, MD, director of clinical research for the division of nephrology and hypertension at Henry Ford Hospital in Detroit and spokesperson for the National Kidney Foundation, says that an effective vaccine would be useful but wonders how it will be used in the clinical setting.

"I do not look at a staph vaccine, at least in hemodialysis patients, as something you would necessarily use the way you would a hepatitis B antibody," he says. "With hepatitis B, the risk is always present. With staph, once you get past the initial phase of the first year or so, particularly if we can get AV fistulas in, then there is probably going to be less dependence. My feeling is that the utility would, in part, depend on whether we could start it three or four months before someone needs dialysis to have the immunity onboard in case we need to use a catheter."

McLain addresses this challenge in a description of the results of StaphVax's first Phase III trials in immune-compromised dialysis patients. These patients maintained protective levels of antibodies for 40 weeks, he says, "but clearly they're at long-term risk, because as their dialysis access line stays open, the bacteria have ready access to their bloodstream. They need booster doses to restore antibody levels."


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