Is EPO worth the price?
by billp830, Sat Apr 28, 2007 at 09:37:39 PM EDT
Matt Stroller's post on 4/28 points to recent reports regarding the drug Epogen manufactured by Amgen. Matt's take is pretty well summed up by the post's title "Killing Patients and Bilking Taxpayers" ... I take Epogen - I'm not dead and I do not think I'm ripping off the tax payers.
Matt quotes a study that showed that patients at for profit dialysis providers (80% of all US dialysis treatments are provided by for profit companies) "are given the highest doses" of Epogen, as compared to not for profits. This could indicate the for profits are "gaming" the system or it could indicate that patients at not for profit clinics are getting more/better dialysis. However, Matt links the quote to HR 1193 which does not address Epogen use or reimbursement. One thing at a time ... but the rampant conflating is instructive.
HR 1193 is cheaper then its forebearer HR 1298 in the 109th Congress, yet it seems to have less traction. These Bills and earlier versions address the lack of inflation adjustment in the dialysis reimbursement rate. This flaw in reimbursement law should be fixed by Congress but I think support of an inflation update frame work is being withheld until the Epogen issue is sorted out. I can understand, like I said one issue at a time. Here's my take on the Epogen issue in dialyzor anemia management.
Naturally occurring erythropoietin (Epo) is a hormone secreted by healthy kidneys, which in turn triggers bone marrow to produce red blood cells. Epogen is synthetic epo and is used to increase the body's red blood cell count in people who are anemic (need more red blood cells). For instance people on chemo or dialysis.
People on chemo have used erythrocyte (red blood cell) stimulating agents (ESAs - Epogen and others) to counteract the effects of chemo on bone marrow. By taking ESAs people on chemo get their still functioning bone marrow to produce more red blood cells. I think the issue with cancer patients isn't an abnormal level of natural epo production rather it's less bone marrow available to respond.
People on dialysis have a different problem. Their bone marrow is fine, their red blood cell count is low because either A)the native kidneys have stopped/decreased epo production or B)their red blood cells are not living as long or in all likelihood a combination of A & B.
The point is the studies of ESA use in cancer patients are not really relevant to the ESA needs of people on dialysis. Each study showing a mortality risk is similarly flawed - people on dialysis are a unique population, with vetted dosing guidelines. If the dosing guidelines for people who are predialysis are flawed that does not imply the dosing guidelines for people on dialysis is flawed. The "Black Box" warning is not directly applicable to people on dialysis.
The dosage disparity based on the ownership of the provider is more problematic and it does look like we've reached a tipping point on the issue of bundling. The data is suggestive of gaming and I think there is data that shows treatment lengths are longer on average at not for profit units. I contend treatment length is connected to ESA use through blood cell life span. Longer dialysis, longer blood cell life span. Longer blood cell life span, less ESAs needed.
If you bundle reimbursement for the dialysis treatment with reimbursement for anemia management then one would predict ESA use will go down. I hope that this bundle legislation incorporates the elements of HR 1193. Create a framework to update the bundled rate for inflation. As proposed in HR 1193 use all or part of the inflation adjustment to create a pool to reward high quality care and motivate continuous quality improvement.
And incorporate the other good ideas outlined in HR 1193. Pass legislation bundling treatment and anemia management but include tech certification, create a federal dialysis advisory board, provide predialysis and modality education. And go back and include HR 5321 from the 109th Congress. A Bill that included all that would give me a break from lobbying on dialysis and I could focus on the 2008 elections.
Until there is a "Bundle Bill" I encourage sponsorship of HR 1193. I hope the authors of the Bundle Bill will include the progressive elements in HR 1193. Congressional sponsorship will encourage progress.