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Tuesday, September 11, 2007

MEDICARE taketh away and giveth back -sorta

Recently, various Government agencies have been very active in regulating the use of erythropoiesis stimulating agents (ESAs) . The major ESA players are recombinant human erthropoietin (Epogen,Procrit) darbepoetin (Aranesp). In several groups of patients (mainly renal patients and patients with head and neck cancers receiving radiation therapy) clinical studies indicated increased mortality and thrombotic events in patients in whom the targeted hemoglobin was greater than 12. This lead the FDA to issue safety warnings and guidelines regarding the target level of hemoglobin and then CMS to propose limitations on Medicare and Medicaid coverage for the use of ESAs. This is a follow up to an earlier posting regarding this issue bearing some limited "good news".

Unfortunately, not only were renal patients the focus of proposed Medicare coverage restrictions but also were other clinical groups who have received ESAs with clinical benefit. Of particular concern to hematologists were patients with myelodysplastic syndromes (MDS). There is a ten year history of safe use of ESAs in MDS and evidence that there is improved survival and decreased progression of MDS to leukemia as well as decreased transfusion requirements .

Several professional groups ( including the American Society of Hematology, SWOG and ASCO) protested to CMS regarding possible restrictions regarding use of ESAs in MDS patients and apparently CMS listened and made no national coverage determination (NCD in CMS jargon) limiting its use in MDS patients.This gives the green light to its use if there are no limitations imposed by regional Medicare carriers.

So, it is at least a partial victory for the physicians and their patients but battles may still have to be fought with the local Medicare contractors.

Some of us can still remember from the early days of Medicare when the powers that be needed the cooperation of both physicians and hospitals to make the thing work and they promised to not interfere with patient treatment and the physician and hospital fees were not directly determined by the government. The days of " reasonable and customary" charges are long gone and doctors now have to refer to the latest CMS decision memo to see what medications they can use.

1 comment:

Greg Pawelski said...

Growth Factor of Anemia Drugs

EPO is a "natural" substance made by the kidney. It stimulates the bone marrow to make red blood cells. Healthy adults are usually at about 15 grams a deciliter. For cancer patients, upping the production of "natural" EPO via our hair follicles could be very beneficial.

Increasing the hemoglobin level above 12 is very risky with "pharmaceutical" EPO. Pharmaceutical EPO makes sludgy blood. When normal people take it, their blood gets too thick and they die of heart attacks and strokes.

The anemia drugs, which boosts patients' counts of hemoglobin (a protein that carries oxygen in the blood), raise the danger of heart attacks, strokes and death at "high" doses. The FDA has said there is "serious" cardiovascular risks for patients who take "higher than recommended" doses of these drugs.

These anemia drugs are approved to treat patients whose weakness and fatigue is caused by chronic kidney disease or by the side effects of cancer chemotherapy. They stimulate production of oxygen-carrying red blood cells, which can boost patients' energy and strength, if red blood cells are brought back to "normal" levels.

The issue is over the drugs' safety on how big a dose to use to boost concentrations of hemoglobin. The FDA-approved level is doses sufficient to increase hemoglobin to a maximum of 12 grams a deciliter.

The adage of some physicians is that if some improvement in hemoglobin was good, higher levels of hemoglobin would even be better. However, clinical trials have shown the drugs can reduce the need for blood transfusions and improve the quality of life "when used within the original dosing range."

New studies have raised questions whether these drugs might be harming patients. Those study results suggest the drugs may make the cancer worse. One such study published in the New England Journal of Medicine found that patients treated aggressively with Procrit had a higher risk of heart problems or death than those treated less aggressively.

And now there is emerging evidence that pharmaceutical EPO can feed the growth of tumors in cancer patients (it IS a "growth factor" afterall).

A “growth factor” is about twenty small proteins that attach to specific receptors on the surface of stem cells in bone marrow and promote differentiation and maturation of these cells into morphotic constituents of blood.

And blood is a circulating tissue composed of fluid plasma and cells (red blood cells, white blood cells, platelets). Problems with blood composition or circulation can lead to downstream tissue (which is made up of cells) dysfunction.

As Dr. Weissmann stated, "the study also is important because it suggests that there is still much to learn about well known processes in the body." The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for.

Take medical oncologists out of the retail pharmacy business and force them to be cancer "doctors" again!