March 21, 2010 -- For nearly a decade, Paula Oertel's brain tumor was kept at bay by a drug that was not approved to treat her condition.
Then Oertel did something she never imagined would jeopardize her good health.
She moved -- less than 30 miles -- from one county in Wisconsin to another.
That move triggered a review of her health insurance from Medicare, which eventually led to a loss of coverage, including the drug.
And the tumor returned within four months.
What happened to Oertel stunned her doctor, Dr. Mark Malkin. Nothing he learned in medical school prepared him for what now is too often a sad and frustrating part of his job as an oncologist: fighting Medicare and private insurance companies over life-or-death decisions.
Doctors aren't supposed to get emotionally involved in the cases of their patients, but tears well up in Malkin's eyes when he talks about Oertel, the 40-year-old Oshkosh woman he has been treating for several years.
"I wish Paula would have a second chance," he said, choking up.
Oertel and Malkin are facing an ailment no drug can cure: a complex health insurance system that can overwhelm a seriously ill patient unequipped to deal with its complicated rules.
In Washington today members of the House of Representatives are slated to meet for a showdown vote to decide the fate of the nation's latest attempt at healthcare reform.
But while politicians and pundits trade sound bites cases like Oertel's illustrate how important decisions made between doctors and patients can be overruled, leaving patients with no options and the likelihood of dying in a matter of months.
All over the country, oncologists are having to advocate more for their patients as a growing number of expensive drugs have come on the market in the last few years, said Allen Lichter, M.D. chief executive officer of the American Society of Clinical Oncology.
"It is part of the landscape now," Lichter said. "There is a great amount of effort (advocating for patients) today in oncology."
Oertel, a shy, single woman, said she has tried to remain upbeat throughout the ordeal, but the decision to deny coverage for the drug that was keeping her alive made her mad.
"My attitude was pretty optimistic, even now," she said.
Oertel's saga began 12 years ago, when she was 29.
She began having headaches, stiffness in the neck and then had a seizure. A CAT scan done at a hospital in Oshkosh revealed that she had a tumor on the left side of her brain. The tumor was a glioblastoma multiforme, the same kind that killed Massachusetts Sen. Edward Kennedy last year.
Glioblastoma is the most common primary malignant brain tumor in adults, affecting about 9,000 Americans a year. On average, survival is about 15 months.
Oertel went to Froedtert Hospital in Wauwatosa for surgery followed by radiation.
Within two months, the tumor had returned.
She had a second surgery and more radiation.
At the time there were no approved drugs for treating Oertel's cancer, but as a last resort doctors decided to try interferon beta, a drug approved to treat multiple sclerosis that also had shown promise in treating cancer, Malkin said.
At best, it was a long shot, but Oertel began injecting herself with interferon three times a week.
Within a few months something amazing happened: Oertel's tumor disappeared completely.
"It worked beautifully," said Malkin, chief of neuro-oncology at Froedtert Hospital. "Her tumor just went away. She went into remission and stayed in remission for nine years."
Over those nine years Medicare picked up the cost of the drug, which now runs about $8,000 a month without questioning it, Malkin said.
Brain scans were done every few months and each time remission was confirmed. Each time there was no sign of the tumor. Medicare continued to pay for the drug.
Malkin, a professor of neurology at the Medical College of Wisconsin, said he has no doubt that the tumor's disappearance was caused by the interferon.
"You don't see spontaneous remissions with this disease," he said.
Now, Malkin estimates that Oertel has less than five months to live if she doesn't get treatment with interferon.
She has been receiving other treatments that are covered by Medicare, but the tumor remains.
The prospect of getting Medicare approval for interferon is looking as grim as Oertel's prognosis.
Not that Malkin hasn't tried.
Over the last several months, Malkin has made calls and sent emails to a cast of officials, hoping that someone would be able to intercede and get the drug approved.
He has contacted both U.S. Sens. Herb Kohl and Russ Feingold from Wisconsin, Oertel's congressman, Thomas Petri, her state senator and assemblyman, the state Commissioner of Insurance, the private company that administers Medicare in Oertel's area and the Medicare office in Chicago - all without success.
His office also contacted Biogen, the maker of interferon (Avonex) to see if it would supply the drug for free on the grounds of medical hardship. That too was denied because the drug was being used for someone who was not diagnosed with MS.
In a February email to Petri's office, Malkin said Oertel's case illustrates some the problems with health care now being debated in Washington.
"I have been practicing neuro-oncology for more than 20 years, yet decisions I wish to make on behalf of my patients are second-guessed or outright denied by representatives of insurance carriers who cannot even pronounce the name of the tumor I am treating," he wrote.
"My staff and I spend hundreds of wasted hours trying to obtain authorizations and appealing wrong decisions when we could be treating patients."
In a given year, Malkin said, his office appeals cases for dozens of patients. That out of about 200 new brain cancer patients he sees each year.
ASCO's Lichter said Malkin's story is not unique, but the but the issues are not always clear cut.
On the one hand, he said, are doctors who may have a "boundless urge to save their patients."
On the other, are the insurance companies that must use good sense and not rubber-stamp every request for an expensive, unproven drug.
Insurers have to balance the needs of one patient against those of millions of people who pay premiums, he said.
"We wouldn't be talking about this if these were $10 generics," Lichter said.
Cancer cases often are the most troublesome when it comes to cost vs. benefit.
In recent times, the cost of cancer medications has shot up 14% a year, according to a January study in the journal Health Affairs.
The expense of these new cancer therapies, which often produce an added survival benefit that is at best measured in weeks or months, has been the subject of national debate in and out of medicine.
Peter J. Neumann, ScD, of Tufts Medical Center in Boston and colleagues surveyed 1,379 oncologists to find out if cost of therapy was a consideration in their practices.
The survey, which was returned by 787 clinicians, found that 84% of oncologists said now say patients' out-of-pocket expenses influenced their treatment recommendations, but only 43% said they regularly discuss costs with their patients.
Just last week a commentary in the Journal of the American Medical Association noted that cost of cancer treatment has cancer care cost have jumped from $27 billion in 1990 to more than $90 billion in 2008.
Still, Lichter said, given Oertel's nine-year history of success with interferon, he thought the interferon should have been approved.
Spokespeople for Medicare and Cigna, which handles some Medicare claims in Wisconsin, said they could not comment on Oertel's case because of privacy rules.
In general, it is not unusual for companies that administer Medicare to reject a claim for a drug that is being used off-label (for a purpose it was not approved) or because it is not part of a plan's formulary, said Elizabeth Surgener, a spokeswoman for the Center for Medicare and Medicaid Services in Chicago.
Even when there is some support in published medical research for using a drug off-label, it still may be denied unless the drug is one of three compendia: American Hospital Formulary Service Drug Information, United States Pharmacopoeia Drug Information, or the DRUGDEX Information System, Cigna spokeswoman Lindsay Shearer, said in an email.
"Cigna and other Medicare Part D plan administrators are not permitted to cover excluded drugs," Shearer said.
Surgener said patients still have options, such as an appeal, when these types of claims are refused, although the process can be long. She said such drugs also might be covered if they are given in a hospital or by a doctor, as opposed to being taken by the patient at home.
However, unless the patient completes paperwork, their doctor can't file an appeal on their behalf, Shearer added.
Malkin said Oertel's case highlights several of the problems with health care in America, including a lack of portability of health insurance and a lack of respect for the treatment decisions made by doctors.
He said there is an utter random nature to the approval process in which people at private insurance companies as well as Medicare and Medicaid can make ill-informed life-or-death decisions.
With weakness on her right side from the growing tumor, Oertel moved from her apartment into an assisted living center earlier this month.
How she got to that point is complicated.
The pivotal event appears to have been a move from Fond du Lac County to Winnebago County in November 2007.
The change in residence triggered a review of her Social Security disability status, Oertel said. Oertel said Social Security personnel said they sent her a letter, but she said she never received it.
In any event, she went to a Walgreen's in Oshkosh to pick up her interferon and was told that her coverage had been canceled.
Oertel and her sister, Terrie, a registered nurse, said it took five months to reinstate her insurance coverage.
In the meantime, an FDA-approved drug, temozolomide (Temodar), that was not available when Oertel was diagnosed in 1998, now was available, Malkin said
Because the drug was proven and interferon was not, Malkin said he felt ethically compelled to use the approved drug.
He said he always felt he had interferon to fall back on in case temozolomide Temodar failed.
"I never dreamed that access to interferon would ever be an issue in Paula's case, or in anybody else's for that matter," he said.
He said he has two other glioblastoma patients on interferon. Both are stable and, without appeal, their private insurance companies are paying for the drug, minus a $20 monthly co-pay.
Temozolomide (Temador) seemed to work for awhile. She was started on it in March 2008 and by January 2009 she was in remission with no sign of the tumor, he said.
She went off temozolomide, as is recommended after a 12-month standard course. However, in June 2009 the tumor returned and the drug was started again.
This time there was no response, so she went back to Froedtert for a third brain surgery. She also was started on bevacizumab (Avastin), another newer drug that was approved to treat her condition.
Both drugs are expensive - temozolomide, about $2,500 a month, and bevacizumab, about $20,000 a month, Malkin said. But because they were approved, Medicare covered the cost.
Malkin said bevacizumab produced a partial response. But by February of this year the tumor was back.
"Now we have run out of FDA-approved agents," said Malkin.
Malkin is a consultant for Genentech, which makes bevacizumab, and until recently had been a speaker for Genentech and Schering-Oncology, marketers of which makes temozolomide. He said his financial relationship with those companies played no role in his treatment decisions with Oertel.
When he tried to put Oertel back on interferon, it was rejected, he said.
Malkin said he believes it is the only drug that has a chance.
But Medicare won't pay for it.
"We don't get explanations," he said. "We just get 'yes' or 'no.'"
He noted her impressive response and nine-year remission with interferon.
In addition, there is some research suggesting that interferon might be effective in some brain tumor patients. Unlike chemotherapy, he said, the drug seems to work primarily by boosting the immune system's own ability to fight the tumor.
A 2006 study involving 109 glioblastoma patients found that interferon plus conventional radiation showed a trend toward improved survival.
Indeed, there may be a small minority of patients who benefit from the drug, said Dr. Howard Colman of the University of Texas M.D. Anderson Cancer Center in Houston and lead author of the 2006 study, which was published in the International Journal of Radiation Oncology Biology Physics.
"You just don't know how to pick out those patients ahead of time," said Colman.
Colman said there needs to be more lenient rules for patients such as Oertel.
"It is very unfortunate, especially for a patient who is benefiting from a drug," he said. "The system has to figure out what is reasonable."
With tears running down her face, Oertel said she thinks her tumor would shrink if she could get back on interferon.
Malkin said he thinks there is a chance it will work.
"It might not," he said. "But that fact that it worked before is the most powerful lesson that it might work again. This isn't a crap shoot. She at least has a track record with the drug.
"But I'm worried that this thing is starting to grow back while we are being forced to spin our wheels."
Malkin and Oertel are one doctor and one patient, but MedPage Today believes that experiences like theirs are playing out among clinicians and patients across the country and across many medical specialities. If you are one of those clinicians, please share your story in an "Add Your Knowledge" comment