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gdpawel · 10-18-2007, 05:09 PM

The FDA backed CMS' National Coverage Decision (NCD), which limited use of the drugs because they have been shown to spur tumor growth.

The FDA has stated that the health risks associated with the use of pharmaceutical EPO (ESAs) for cancer patients include: Promotion of tumor growth in patients with advanced breast, head and neck, lymphoid, and non-small cell lung malignancies in studies adminstered EPO to target a hemoglobin of >12 g/dL, and have not been excluded with lower target hemoglobin levels.

The FDA believes that the approved labeling and CMS's National Coverage Decision are generally consistent in their recommendations regarding the use of pharmaceutical EPO in patients with cancer undergoing chemotherapy.

FDA's approved labeling recommends use of the lowest dose necessary to avoid the need for blood transfusions and transfusions are not normally given to patients whose hemoglobin is 10 g/dL or higher. The recommendation in the approved labeling that the hemoglobin not exceed 12 g/dL in cancer patients "is intended as an upper safety limit, not a target for therapy."

If ASCO has a complaint about CMS payment policy, it should provide evidence to the physicians at that agency who made the decision. There is no evidence that pharmaceutical EPO results in improved survival, "TUMOR CONTROL," health-related quality of life at any hemoglobin level in cancer patient undergoing chemotherapy.

Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment.

The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.

It's still your mother's chemotherapy concession. Although the new Medicare bill tried to curtail the drug concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Let's take physicians out of the retail pharmacy business and force them to be doctors again!!!

http://www.house.gov/stark/news/110th/letters/20071012-esa.pdf

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html

http://www.nytimes.com/2007/05/09/business/09anemia.html?_r=3&hp=&oref=slogin&pagewanted=prin t&oref=slogin&oref=slogin

http://www.healthyskepticism.org/news/2007/Jun.php

10-18-2007, 05:09 PM	#6
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	FDA Sides With CMS in EPO Battle The FDA backed CMS' National Coverage Decision (NCD), which limited use of the drugs because they have been shown to spur tumor growth. The FDA has stated that the health risks associated with the use of pharmaceutical EPO (ESAs) for cancer patients include: Promotion of tumor growth in patients with advanced breast, head and neck, lymphoid, and non-small cell lung malignancies in studies adminstered EPO to target a hemoglobin of >12 g/dL, and have not been excluded with lower target hemoglobin levels. The FDA believes that the approved labeling and CMS's National Coverage Decision are generally consistent in their recommendations regarding the use of pharmaceutical EPO in patients with cancer undergoing chemotherapy. FDA's approved labeling recommends use of the lowest dose necessary to avoid the need for blood transfusions and transfusions are not normally given to patients whose hemoglobin is 10 g/dL or higher. The recommendation in the approved labeling that the hemoglobin not exceed 12 g/dL in cancer patients "is intended as an upper safety limit, not a target for therapy." If ASCO has a complaint about CMS payment policy, it should provide evidence to the physicians at that agency who made the decision. There is no evidence that pharmaceutical EPO results in improved survival, "TUMOR CONTROL," health-related quality of life at any hemoglobin level in cancer patient undergoing chemotherapy. Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price. It's still your mother's chemotherapy concession. Although the new Medicare bill tried to curtail the drug concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Let's take physicians out of the retail pharmacy business and force them to be doctors again!!! http://www.house.gov/stark/news/110th/letters/20071012-esa.pdf http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html http://www.nytimes.com/2007/05/09/business/09anemia.html?_r=3&hp=&oref=slogin&pagewanted=prin t&oref=slogin&oref=slogin http://www.healthyskepticism.org/news/2007/Jun.php