While this is a good response from Medicare, the risks of kidney and liver failure with interferon are very high.
Brain tumor growth linked to lowered expression of hundreds of immune function genes
ScienceDaily (2010-04-28) -- A new study links progression of a lethal type of brain tumor with reduced expression of more than 600 immune system genes, suggesting how complex the immune response is to the cancer and the resulting difficulty in targeting specific immune system proteins for treatment. ... > read full article
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Medicare Reversal Ignites Hope for Glioblastoma PatientSee also Avastin
By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
April 09, 2010
Paula Oertel's brain tumor disappeared for nine years while she was on a drug not approved for her condition. The tumor returned when a move to a new home triggered a Medicare review -- and subsequent denial of coverage for the experimental treatment.
Now Medicare officials have decided she will be allowed to go back on the drug.
"I am hoping that it will help," Oertel said Friday. "I am hoping it will shrink the tumor and that my body can take over and fight it."
Oertel, 40, who now lives in Wautoma, Wis., with her mother, said she will begin giving herself interferon-beta injections on Saturday.
The decision to resume paying for the drug -- which is approved for treating multiple sclerosis, but not brain cancer -- comes after her story was told March 21 in the Journal Sentinel and MedPage Today.
Medicare officials were not available for comment Friday, but a letter Thursday to Oertel's doctor, Mark Malkin, MD, chief of neuro-oncology at Froedtert Hospital in Milwaukee says that after an independent review, Medicare will begin paying for the drug, which costs about $8,000 a month (see attached pdf).
"We read the entire case file very carefully," said the letter from Maximus Federal Services in New York, a company hired by Medicare to review Oertel's case. "Avonex (interferon) has been determined to be reasonable and necessary for this patient who has shown prolonged response to the drug in the past and who has no other appropriate treatment options at this time."
The big question: Will the drug have the same effect now that it did in the past?
Oertel's tumor is growing. Just in the last six weeks it has moved from her left frontal lobe to the right frontal lobe, said Malkin.
And the tumor's biology may have changed as well, allowing it to develop resistance to interferon.
"The tumor has never been bigger," said Malkin, who is also a professor of neurology at the Medical College of Wisconsin. "That's what the delay has resulted in."
Oertel was first diagnosed with glioblastoma multiforme 12 years ago when she was 29. The tumor is the same kind that killed U.S. Sen. Edward Kennedy of Massachusetts last year.
Oertel twice had undergone surgery and radiation, and both times the tumor returned within months.
At the time there were no approved drugs to treat the condition. As a last resort, doctors tried interferon, which has shown some promise but is not approved to treat brain cancer.
Within months the tumor disappeared, and for nine years there was no sign of it on repeated brain scans.
Medicare paid for the drug for those nine years.
Due to a mix up, Oertel temporarily lost her Medicare coverage when she moved from one county to another.
It was restored after a few months.
In the meantime, two drugs had been approved to treat glioblastoma. Doctors tried those first, but the tumor did not respond. When they tried to put her back on interferon, the local Medicare carrier refused to cover the drug. It provided no explanation.
Calls and e-mails by Malkin and his staff to various public officials and government offices failed to resolve the situation.
However, after Oertel's story appeared in the Journal Sentinel and MedPage Today, Malkin got a call from the office of U.S. Rep. Thomas Petri (R-Fond du Lac), Oertel's congressman.
The Congressman's representative went to Oertel's home and got her to sign a form that led to the appeal to Maximus Federal Services, Malkin said.
"They (Maximus) asked if it was true that interferon is the only alternative for her," Malkin said.
Malkin cited the fact that it had worked so well for nine years.
"Paula is the only patient in my experience where it has worked that well," he said.
Last month, Malkin estimated that, without treatment, Oertel had only about five months to live.
He said it likely will take another month or two to know if the interferon is having an effect on the tumor.
There are three possibilities, Malkin said: It may be too late because the tumor has evolved so that interferon no longer has an effect; it could have partial benefit by shrinking the tumor and allowing Oertel to remain stable for a while; or it could allow her to go into remission indefinitely.
"I don't have a clue," Malkin said.
Even if Oertel eventually goes into remission, she is likely to get worse before she gets better, he said.
Oertel has been experiencing headaches and verbal and memory problems along with weakness on her right side. She walks with a cane.
"The tumor has a certain momentum of growth," Malkin said. "It may take the interferon a while to catch up with that."
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