Medicare Official Defends Decision On Anemia Meds
4 CommentsBy Ed Silverman // February 8th, 2008 // 5:39 pm
In fact, Barry Straube, the agency’s chief medical officer, says the case for restricting payments for the anemia drugs has become stronger since the the controversial decision was made. His remarks come as the US Centers for Medicare and Medicaid Services is reviewing its decision following a storm of criticism from cancer docs and Amgen and Johnson & Johnson to restrict payments.
Mounting evidence, including two studies casting more doubt on the drugs’ safety, backs the original policy, Straube tells Reuters. “I think that our national coverage decision has been shown, with even more evidence coming out since we made it, to have been the right thing to do,” he says.
The drugs are one of the biggest prescription costs for Medicare, Reuters notes, adding that Amgen’s Aranesp generated about $3.6 billion in 2007 sales, and J&J’s Procrit had $1.7 billion in 2007 sales. But CMS issued its payment restrictions last year after four large studies raised safety concerns and the FDA added Black Box warnings, based on studies that suggested a higher risk of death and other adverse events.
The FDA holds a hearing next month to consider two recent studies that suggested the drugs pose more serious risks for some cancer patients. Straube says a likely discussion item will be rejecting use of the drugs at all for chemotherapy-induced anemia. “I think that FDA is clearly thinking through all of its options,” he tells Reuters, citing meetings with staffers. “One severe option, depending on what the evidence is, is that they clearly could consider removing ESAs for some of the indications they are being given now.”
A J&J spokeswoman tells Reuters “there are other studies CMS should take into account,” and that the drugs are safe when used according to the label. Amgen was not available for comment.
The payment issue revolves around the level of a patient’s hemoglobin the treatment should start. The agency is struggling with whether there can be exceptions to the current policy in certain patients. The American Society of Clinical Oncology, which represents cancer doctors, and the drugs’ makers, are continuing to submit new evidence to bolster their argument that the restrictions will boost the risk of blood transfusions, he says.
Straube adds that he hasn’t seen convincing evidence to support reversing the decision. A recent poll released by cancer and blood docs suggesting they believe the policy is leading to more blood transfusions will have little sway, he notes. The survey of about 500 oncologists and blood docs asked about views on Medicare policy and its impact on care.
And he says there’s no evidence in properly controlled trials that blood transfusions could rise based on the policy, and that he was “disappointed” and surprised by the fervent reaction of the cancer doctor community. “Our staff looked at over 800 evidenced-based articles published in the literature,” he says. “I doubt seriously whether most clinicians read all 800.”
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Pharmalot ยป Medicare Official Defends Decision On Anemia Meds…
In fact, Barry Straube, the agency’s chief medical officer, says the case for restricting payments for the anemia drugs has become stronger since the the controversial decision was made. His remarks come as the US Centers for Medicare and Medicaid Ser…
Steve Knows
It’s obvious that Medicare/CMS have not reviewed ALL
the voluminous work that has been reported on
EPO/ARANESP. Many, many studies and clinical trials
reveal that these drugs do an excellent job when
prescribed by physicians who go by the label
instructions. Proper use of these therapies is a blessing to many who have low red cell counts.
Leave it alone Medicare/CMS!
Barbara V. Gunn
Those making this decision have no idea what havoc they are causing in the lives of those who have chronic severe iron deficiency anemia. Since January 2008 I have had two transfusions. During the second one I experienced a reaction and had to be rushed to the Emergency Room from the Out Patient Department. My anemia is not caused by Chemotherapy or renal failure but is just as life threatening. In addition, transfusions for patients like me only place a larger burden on the nation’s blood supply.
Ellen Schleifer
As Barbara V. Gunn wrote above about herself, my mom is also on her way to being rushed to the hospital for a transfusion any day, but she won’t make it through that. She’s beautiful, well-kept, and an independent, almost 87! year old, who has lived alone and HAD enjoyed a very fine quality of life since my dad died over 25 years ago, except for over past two months since that CMS requirement came down, and possibly @ a bout with Non-H lymphoma which she beat, with her head up & with pride the entire time, 7 years back, with radiation ONLY, not bad at all. Her good doctor saved her from the chemo which would have been hard to take at any age, let alone at 80. So this is not chemo-related anemia either.
She’s had a dx for myelofibrosis, a rare blood disease which causes severe anemia, for just over 3 years & has NEEDED Aranesp shots approximately every three weeks since her Hem level landed her in the hospital. Her wonderful doctor who saved her from receiving chemo for the cancer, has maintained her Hem between 11 & 12. If he ever found her above that number, which I believe may have happened twice at most, it was ever so slightly.
In the past two months, she’s been holding the walls to walk in her apt. and I’ve been praying before each of her appointments with the dr., that she will be found to have a Hem level at a fraction below 10 so that he could administer this expensive shot and Medicare will pay for it (albeit off-label…at the moment, even thinking about FDA taking EPAs off the market next month is too mind boggling). Between 10 and 11 SHE’S IN VERY BAD SHAPE. This is WRONG. Her quality of life has gone done dreadfully since the CMS decision. We’re thinking of forcing her to move in with us, even as this is an option she is flat out refusing. Never mind home care! The process of natural aging over the past year or so is undeniable, but just LESSthan a year ago, she was still walking (albeit not very quickly), a 1/2-mile back & forth with her shopping cart to buy groceries at the nicer supermarket. Until recently, in November 07, she was able to walk to get groceries or mail letters two blocks away. Since she didn’t get the Aranesp until her Hem was under 10 a few weeks back, she’s barely able to walk around her apt., never mind getting to the elevator & down to the mailbox!
She’s a great mom. She worries more about MY falling apart over this (I have two teenaged sons), but it’s painful, particularly knowing SHE knows she won’t be around much longer & thinks that’s what it needs to be if her QOL continues. She hardly had an idea that she was in her 80s until now. If she did, she could have fooled all of us.
She can’t live this way. This is horrifying. Those studies are so OBVIOUSLY small and do not take into any account the individual situation of a patient or QOL issues involved. This is all political and extremely sad.
Also, shame on you NEW YORK TIMES “Business!!!” section for exploiting this subject in such a manner. These days your writers exploit fear (same journalist behind negative press re: EPA studies…without asking the important stat ?s) almost as much as my downtown bklyn- neighbor journalists get to sell a borough (in the Sunday CITY and REAL ESTATE section read worldwide; read: inflating real estate prices…I guess at least that gig is about up) which they, unlike my mom and I, were not born in. Am I mad? You betcha. Displaced anger? Not really here, but sometimes…..