Medicare announced Wednesday it would pay for Dendreon Provenge prostate cancer drug. Whose $ 93,000 price tag had triggered a debate on the cost and effectiveness of drugs against cancer.
The Centers for Medicare and Medicaid Services said in a note posted on its Web site that Provenge was "reasonable and necessary" treatment for Medicare patients who had stage prostate cancer for which the drug was approved by the Food and Drug Administration in April.
However, he said the evidence was "virtually nil" that Provenge was effective for men who had other stages of the disease, and therefore, he did not use so-called off-label must be repaid.
The coverage plan proposed was widely expected since he was in line with the findings of a Medicare advisory committee last November. The proposed decision will be open for public comment, with a final decision expected in June.
Medicare rule for drugs that receive FDA approval. Thus, the decision of the Agency able to undertake a formal "national coverage determination" has generated some controversy.
Some securities analysts, investors in Dendreon and patient advocates said Medicare move represented the beginning of drug interdiction at high prices, or even the beginning of the "rationing of health care" that critics of the new legislation federal health care accompany the affirm.
Medicare officials refused, saying they simply wanted a uniform payment policy, rather than leaving the decision to the regional Medicare contractors. Officials also said that Provenge raised new questions, because he resembled a method of treating a drug over mass produced.
Some health experts have argued that society cannot continue to pay for cancer drugs prolong the lives of only a few months if that much. In clinical trials of Provenge main, men with advanced prostate cancer who received the drug lived an average of about 26 months, about four months longer than those who received placebo.
In November, an advisory committee on Medicare have expressed a relatively high level of confidence in the evidence showing that Provenge extended life, at least for the type of patients enrolled in clinical trials.
But the committee, which does not consider the cost of the drug, said the evidence was not convincing that Provenge would help men who had earlier-stage prostate cancer or more advanced than men in the trials.
In the memo on Wednesday, officials from the health insurance said they would not be put in place a national ban on reimbursement for off-label uses of Provenge, leaving room for local entrepreneurs develop policies of insurance. But the memo officials said Medicare hopes that all these off-label uses would only be in clinical trials.
"We can, if it proves to be an overly optimistic view, this NCD review to ensure that Medicare coverage is limited to uses that are supported by substantial evidence," said the memo.
Provenge is approved for men whose cancer has spread beyond the prostate and who no longer respond to androgen blockade, while having little or no symptoms.
Medicare said it had received 657 public comments in its deliberations on Provenge, which 620, or 94.4 percent was in favor of paying for the drug.
Provenge is sometimes called a vaccine against cancer, because it mobilizes the body's immune system to fight cancer. The immune system cells are removed from the blood of a patient and incubated with a protein by Dendreon GM, which in a sense, trains theimmune cells to recognize and attack tumors of the prostate. Theimmune cells are then reinjected into the patient.
Dr. J. Leonard Lichtenfeld, deputy medical director of the American Cancer Society, said Wednesday's decision was a "they had to come" given the laws of health insurance. He was surprised that the decision left the door open for off-label by delegating those decisions to local carriers for Medicare.
The Centers for Medicare and Medicaid Services said in a note posted on its Web site that Provenge was "reasonable and necessary" treatment for Medicare patients who had stage prostate cancer for which the drug was approved by the Food and Drug Administration in April.
However, he said the evidence was "virtually nil" that Provenge was effective for men who had other stages of the disease, and therefore, he did not use so-called off-label must be repaid.
The coverage plan proposed was widely expected since he was in line with the findings of a Medicare advisory committee last November. The proposed decision will be open for public comment, with a final decision expected in June.
Medicare rule for drugs that receive FDA approval. Thus, the decision of the Agency able to undertake a formal "national coverage determination" has generated some controversy.
Some securities analysts, investors in Dendreon and patient advocates said Medicare move represented the beginning of drug interdiction at high prices, or even the beginning of the "rationing of health care" that critics of the new legislation federal health care accompany the affirm.
Medicare officials refused, saying they simply wanted a uniform payment policy, rather than leaving the decision to the regional Medicare contractors. Officials also said that Provenge raised new questions, because he resembled a method of treating a drug over mass produced.
Some health experts have argued that society cannot continue to pay for cancer drugs prolong the lives of only a few months if that much. In clinical trials of Provenge main, men with advanced prostate cancer who received the drug lived an average of about 26 months, about four months longer than those who received placebo.
In November, an advisory committee on Medicare have expressed a relatively high level of confidence in the evidence showing that Provenge extended life, at least for the type of patients enrolled in clinical trials.
But the committee, which does not consider the cost of the drug, said the evidence was not convincing that Provenge would help men who had earlier-stage prostate cancer or more advanced than men in the trials.
In the memo on Wednesday, officials from the health insurance said they would not be put in place a national ban on reimbursement for off-label uses of Provenge, leaving room for local entrepreneurs develop policies of insurance. But the memo officials said Medicare hopes that all these off-label uses would only be in clinical trials.
"We can, if it proves to be an overly optimistic view, this NCD review to ensure that Medicare coverage is limited to uses that are supported by substantial evidence," said the memo.
Provenge is approved for men whose cancer has spread beyond the prostate and who no longer respond to androgen blockade, while having little or no symptoms.
Medicare said it had received 657 public comments in its deliberations on Provenge, which 620, or 94.4 percent was in favor of paying for the drug.
Provenge is sometimes called a vaccine against cancer, because it mobilizes the body's immune system to fight cancer. The immune system cells are removed from the blood of a patient and incubated with a protein by Dendreon GM, which in a sense, trains theimmune cells to recognize and attack tumors of the prostate. Theimmune cells are then reinjected into the patient.
Dr. J. Leonard Lichtenfeld, deputy medical director of the American Cancer Society, said Wednesday's decision was a "they had to come" given the laws of health insurance. He was surprised that the decision left the door open for off-label by delegating those decisions to local carriers for Medicare.
