8/17/2010

Government moves to ration cancer care for women

So private insurance covers this? Why should the government make a decision that this treatment isn't cost effective? Can't patients, doctors, and insurance companies make this decision on their own? If people want to buy insurance policies that pay for this, why can't they do that? Personally, I don't see why the government should be able to approve the treatments that cancer patients receive in any case, but this notion of them evaluating drugs based on cost effectiveness just seems wrong.

A decision to rescind endorsement of the drug would reignite the highly charged debate over US health care reform and how much the state should spend on new and expensive treatments.
Avastin, the world’s best selling cancer drug, is primarily used to treat colon cancer and was approved by the US Food and Drug Administration in 2008 for use on women with breast cancer that has spread.
It costs $8,000 (£5,000) a month and is given to about 17,500 women in the US a year. The drug was initially approved after a study found that, by preventing blood flow to tumours, it extended the amount of time until the disease worsened by more than five months. However, two new studies have shown that the drug may not even extend life by an extra month.
The FDA advisory panel has now voted 12-1 to drop the endorsement for breast cancer treatment. The panel unusually cited "effectiveness" grounds for the decision. But it has been claimed that "cost effectiveness" was the real reason ahead of reforms in which the government will extend health insurance to the poorest.
If the approval of the drug is revoked then US insurers would be likely to stop paying for Avastin.
The Avastin recommendation led to revived allegations that President Barack Obama’s overhaul of the US health care system would mean many would be denied treatments currently available.


UPDATE: From the WSJ:

Remember, too, that these are only averages over a narrow population, while individual patients respond in dramatically different ways. That includes prolonging survival, which Avastin does in some situations. The median overall survival benefit for one subgroup of 496 patients between the ages of 40 and 64 was an additional 5.7 months of life. Some individuals gain years. At any rate, even the 31% reduction in the risk of disease progression or death is better than the status quo.

Such quantifiable progress, moreover, was the "endpoint" that Avastin had been required to hit. In February 2009, the FDA confirmed that the drug would be approved if it showed "demonstrated improvement in progression-free survival and evidence that survival is not impaired," according to the agency's minutes.

The FDA later unilaterally redefined its regulatory expectations, devising a pretext to undermine Avastin. The terms of ODAC debate are set by instructions from FDA staff reviewers, and in round two they suddenly emphasized topics that had been resolved in round one, such as the lack of overall survival benefits and safety issues such as toxic side effects. . . .

The Avastin mugging is really an attempt to undermine regulatory modernization like accelerated approval that offends the FDA's institutional culture of control and delay. It is also meant to discourage innovations like Avastin that the political and medical left has decided are too costly, with damaging implications for the next generation of cancer drugs.

Investigations at the frontiers of genomic science have only begun, and the learning curve for how subsets of patients respond to biologics, and how to target them, is steep. Yet the world's oncologists agree that the future of their science lies in patient-specific, biologic treatments. Cancer survival rates have improved gradually over the last several decades, thanks in part to improvements at the margin like Avastin. . . .

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