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Breast Cancer Drug Femara Will be Restricted to FDA Approved Use and Reimbursement for Off Label Use To Treat Infertility May Be

Posted Apr 09 2010 5:24pm

The business intelligence divisions of Blue Cross and Blue Shield went to work on the off label use here to restrict compensation for using this breast cancer drug to treat infertility.  It is very widely used according to their analysis of over a million patients.  As you can read below they figured out they would save $174.00 a claim for this use.  image

The study used for the basis of this conclusion went back to Canada in 2005 with a group of 150 babies and found the potential 3 fold effect in the “risk” of birth defects.  I didn’t see any numbers here, so was it one baby that rose to 3 and what were the birth defects?  Also, is this just risk or were there actual birth defects too.  There are so many more drugs too on the market today than there were in 2005 and were the women taking other drugs too?   We want the “correct” algorithms for risk and not just those created with software to substantiate saving money and denying claims, in other words transparency. 

I don’t know on this one, it seems like a very small study and from what is here, there’s not enough to substantiate a huge danger and also did the FDA have any information on this issue too, and why was a US study not included? 

You be the judge here, business intelligence algorithms used to deny claims and treatment for infertility or is there a real substantiated risk?  Since the drug was so widely used I might guess there will be some not so happy doctors with this and we could be up for some challenges here to get a “real” answer on actual cases and risk assessment in case any of this was taken out of context in order to justify cutting compensation.  Again, did the FDA have anything on file with off label use to treat infertility?  BD 

CHICAGO - Three in 10 women being treated for infertility take the common breast cancer drug Femara, even though it could increase risks to the baby, U.S. researchers said on Friday.

They said the drug is often prescribed "off-label" to treat infertility, even though it is classified by the U.S. Food and Drug Administration as posing a pregnancy risk.

And a study of health claims suggests policies by health insurers to only pay for the drug's approved uses could improve both the care and safety of the women who take it.

Doctors that treat infertility say they use the drug in women with ovulation problems.

According to a Web site for the Advanced Fertility Center of Chicago, when the enzyme aromatase is blocked by the drug it causes estrogen levels in young women to fall, triggering the release of follicle stimulating hormone or FSH, which causes women to ovulate.

And they said the Canadian study was too small, and its trial design has been seen as flawed.

The Prime Therapeutics team and one of the company's Blue Cross and Blue Shield clients wanted to see if a program aimed at controlling reimbursement of the drug could improve patient safety and cut costs.

They reviewed about 1.5 million claims from two Blue Cross health plans between July 2008 and June 2009 to see how often letrozole is used for infertility.

They found it was common, with 29.3 percent of plan members using the drug to treat infertility. More than 95 percent of women over age 50 who took the drug did not have an FDA-approved diagnosis.

The average cost of treatment was about $174 per claim, the team told the meeting.

They said restricting reimbursement of the drug to FDA-approved indications might be a way to not only cut costs, but also reduce fetal risks if a woman taking the drug succeeds in getting pregnant.

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