Medicare reverses a brain tumor drug decision

by John Fauber

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.

“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.”

John Fauber is a Milwaukee Journal Sentinel reporter.

Originally published in MedPage Today. Visit MedPageToday.com for more oncology news.

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  • SmartDoc

    For now, the Medicare Death panels are pretending to be quasi-reasonable, if however passive aggressively delaying treatment.

    This won’t last long as the $500 billion in ObamaCare Medicare cuts sink in.

    Note that Congress has exempted itself from all this, and will continue to get Teddy Kennedy style instant state of the art neuro-oncological care.

  • http://nostrums.blogspot.com Doc D

    Ms Oertel’s experience with this very serious tumor points to some very serious issues. To my knowledge we don’t have good scientific evidence that this treatment has been accepted as meeting standards of effectiveness. The history suggests strongly that it works for her. Is this an anomaly? In looking at comparative effectiveness will single cases be enough to establish acceptable standard of care and authorize payment? My guess is this is not how cost containment can be achieved in the reform law. It clearly will cause great pain and suffering if every patient who falls outside the “one-size-fits-all” comparative effectiveness standard has to go through Ms Oertel’s experience. Also, there’s a lesson here about how patients are unique, each responds in an infinite variety of ways to illness and injury…and frequently we don’t know why.

  • http://www.silvercensus.com/ Steffan Lozinak

    This whole article really gets me thinking about the “value of a human life”. Really there is no good way to put a price on someones existence, but we do so everyday. The very subject and idea will carry a taboo with it as people are quick to state that a life can’t have any value placed on it!! Yet are slow to pay to help feed the people dieing of starvation in the world.

    The second step of the denial system people put up to protect their ego from thinking that they are indeed putting a price on a life is to create imaginary borders of separation. A common response that may be raised to the response I noted above would be, “But this is a story about an American!” As though that somehow makes her life more valuable than the lives of those around the world. That response can be taken even further as the people in congress seem justified in the higher treatments and protection they receive as they are higher up on the ladder of value of life….

    So yes, we do put specific value to lives every day. Do I agree with it? No I don’t, but at the same time, I am not going to be so blind as to pretend like we don’t do it. As harsh as it may sound, I can completely understand why Medicare wouldn’t want to cover the $8000 a month to keep her alive. AGAIN, NOT THAT I AGREE WITH THIS…. However, this is the way our world is currently working, and this is how money flows.

    I guess it’s not that I don’t value her life so much as I don’t value her life more than the life of anyone else, and there are lot of people in this world who need help. I honestly feel the system itself needs to go as our values are all wrong… Things like food, shelter, and healthcare should not be things that cost anything at all. It should be the primary goal of society to ensure these things be provided at the highest quality to everyone free of charge. The immediate response that idea will get from just about anyone who reads it is, that would be nice, but it’s not possible… Well I’ll agree that it isn’t possible in the system we currently have, or at least it would come at a “high cost”… This is the main reason I feel a new system should be implemented, and our goals re-evaluated.

  • Doc99

    The problem with Evidence is that it is a lagging indicator. A trial of 1000 patients begins with but a single anecdote.

    • B Corey

      AMEN! With the push for evidence based medicine people forget that the first step is careful observation of anecdotal cases. We can’t become so closed minded or evidenced based ‘snobs’ that we lose our curiosity or the ability to think outside the box.

  • http://Malpracticelawfirm.net Jimeyers

    A physician is permitted to compound medications but is not deemed competent to to ascertain the benefit of a particular treatment. The biologic variabily of each patient guarantees that some therapies will fail and succeed in diferent patients. A patients improvement on a particular regimen in treatment of a fatal illness should be attributed to the regimen unless there is clear evidence to the contrary. In principle, this is very different than advocating a treatment in spite of it’s failure in many instances. The was an individual patient who was improving and the decision to discontinue was not medical but economic.

  • greg zurbay

    How is it that simple ideas seem to have fallen out of use?

    Doesn’t anyone remember – “If it ain’t broke don’t fix it”?

    To change a program that has a record of working means you just bought a 50-50 chance at minimum of no longer having a working program.

    SOP might be a fine procedure most of the time, but don’t throw away what appears to work.

  • Anonymous

    My 89 yr old mother has a benign brain tumor approx 6 centimetr and not a canidate for surgery. She is 2000 keppra for seizures. Would this drug help her?