Medicare denies a brain tumor drug after a patient moves

by John Fauber

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 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.

The tumor returned within four months.

What happened to Oertel stunned her doctor, Mark Malkin, MD. 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, MD, 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.”

Paula Oertel’s Story
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 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.

Malkin Battles the Bureaucrats
Over the last several months, Malkin has made calls and sent e-mails 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 e-mail to Petri’s office, Malkin said Oertel’s case illustrates some of the problems with healthcare 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.

Examining the Issues
ASCO’s Lichter said Malkin’s story is not unique, 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 balancing cost versus 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 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 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 the cost of cancer treatment has 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.

Off-Label Use Is an Issue
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 e-mail.

“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 healthcare 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.

Oertel’s Life Today
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 that 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 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 copay.

Temozolomide seemed to work for a while. Oertel was started on it in March 2008 and by January 2009 she was in remission with no sign of the tumor, Malkin said.

Oertel 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 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.’”

Why Interferon?

Malkin noted Oertel’s 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 Howard Colman, MD, PhD, 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 the 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.”

John Fauber is a Milwaukee Journal Sentinel reporter.

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

Comments are moderated before they are published. Please read the comment policy.

  • Melody Costanza

    FInally a responsible journalist that gives the facts rather than personal opinions. Thanks for a well written article on a difficult subject.

    I hope that everyone who reads this recognizes that the recent health care legislation that President Obama signed into law does nothing that would have helped Paula Oertel’s situation, and in fact, it is leading America down the path where the other two patients noted who do have private insurance paying for interferon will probably lose that coverage as insurers will be able to use the newly created government panels to deny coverage for off-label use of drugs which only help a small percentage of patients.

  • Doc99

    Enter the Death Panels …

  • Joanne Howard

    I am appalled that the riches country in the world can sit stoically by and witness the unnecessary death of an individual. There should not be such red tape within this country. Our decision makers must be reminded that they were “elected by the people, for the people” not for their own personal gratification and financial reward. In the end, it is all about the lobbyist. We must unite and ask to be counted. No…. not by the government census by our making a different in the poles.

  • Dr. Mary Johnson

    Believe me, Joanne, when it comes to medicine, the “richest country in the world” can stoically sit by and witness a whole lot.

    Obama’s precious new legistlation – over 2000 pages of more complex bureaucracy – is USELESS on so many fronts – because this was NOT really about improving healthcare.

    It was about buying votes – and keeping power.

    So let’s give the government – with all of its deaf, dumb & blind elected officials (who don’t return phone calls or answer correspondence) – MORE to do.

  • Melody Costanza

    Let’s be brutally honest here. No government run health care program will ever be able to pay for this treatment based on current knowledge – such a huge bureaucracy could never afford to pay for all of these expensive treatments that don’t have a statistically positive chance of working. The poor, disabled and non-employed who today are doomed to only having access to “basic” public funded healthcare (Medicaid) coverage will never receive such expensive treatments. It was likely a Medicaid screw-up that allowed Ms. Oertel to get the treatment as long as she did.

    If you want a real-life example of where we are headed, think NHS in the UK and the NICE rationing board. No one can get such expensive treatments unless they are proven to statistically significantly work, so the treatments available in the UK are years behind what can be bought in the US. And yes, I said bought – paid by cold, hard cash, or more likely, “Cadillac” health insurance.

    And there’s the rub…

    If we doom everyone to only having access to the “lowest common denominator” healthcare coverage to be “fair” to everyone, no one will ever get to try those expensive treatments, so they will never reach the point of being proven – so they will never get to be used by anyone.

    The US is the last place on earth where medical innovation is still occurring. Yes, there are breakthroughs outside the US, but if you trace them back I’m sure that ultimately it comes back to having a market – the 75+% of Americans who have insurers who will pay – and not because they expect to recoup the costs of R&D under any other health system.

    The US pays for virtually all of the innovation in medicine today – and by doing so it will make the expensive, trial medications available at a lower cost into the future. Too late to help Ms. Oertel, I’m afraid, but the Ms. Oertel of the next generation may get access to this drug under her government plan as long as innovation isn’t stifled.

    I will pray for Ms. Oerterl, as it looks like a miracle is the best that can help her. But let’s not doom countless generations to her fate, for if we cripple the best healthcare system in the world, all we will be doing is reducing healthcare for all.

  • stephanhatch

    It is called rationing…and it is coming. We will start looking at quality of life, and putting a price on it. Many people often speak of how much more affordable healthcare is in other countries. Do you think you can get Avastin in the UK???

    You can thank Mr Obama for that. It would have been nice to see reform. Reform in the way medicine is delivered, and reformi in the way the system is used. I’ve read the entire bill, and it is clear to me how many votes were bought. It’s a disgrace, and points to all that is wrong with politics and washington.

    Stephan Hatch, MD

  • Diana Lee

    How is the health care bill to blame for rationing? This situation developed outside any change in law brought about by that legislation and has nothing to do with any decision made by the Obama administration. We already have rationing of health care and this is a perfect example. Did you actually read the article, Dr. Hatch?

  • Dr. M

    Melody: Most drug trials involve drug given to the study by the company, NOT paid for by an insurer, and I can assure you it’s not that the Cignas of the world are any more generous approving drugs I request compared to Medicare.

    There is nothing keeping the producers of interferon performing the rigorous science it would take to prove IFN works or not. I suspect the data from their small study was underwhelming and so they didn’t continue. Sadly, we learn nothing from this patient’s disease course because she is not on a study, and as they say, the pleural form of anecdote is NOT data. Why isn’t this (drug company-money-taking) neuro-oncologist not studying this rigorously? (And I’ll concede that perhaps he is but that the authro didn’t think it would fit his muckracking tone.) I am all for being able to use IFN if it truly works, but your statement about denying “coverage for off-label use of drugs which only help a small percentage of patients” presupposes the drugs really do help. I believe in more creativity in rigorous clinical study and observational data design, as well as biomarkers to help determine, for instance, that small segment of the population that would benefit from a certain drug, but this case does not fit the bill.

    And I think it is disingenuous to invoke a “big bureaucracy” as the problem when the overhead in Medicare is in the single digits as opposed to the 30-40% range in insurance companies. As an oncologist, I actually have a much easier time getting drugs approved by Medicare, or believe it or not, MediCal, than by private insurers.

    I wish I could give any drug I wanted to my patients, but I acknowledge the opportunity cost of signing my name to a $30,000 infusion of Avastin every three weeks. And in a zero sum game (for who among you are prepared to see, say, 10% or 20% more of your income go to either taxation or higher insurance premiums to cover these expensive drugs in marginal indications, on top of the current pace of medical inflation?), when I write that prescription for an indication it is likely to be of extremely marginal benefit for, then that is money NOT spent on effective treatment for someone else.

    Stephen knows as well as I: rationing is already happening, even among the insured. I would argue we should at least make damn sure that the money we spent is not good money after bad. I hope we can learn something biologically from this patient, but in the meantime, extreme outlier situations like this are not the primary problem as we talk health reform.

    • Melody Costanza

      Dear Dr. M,

      All good points but it does not go to my basic premise, so I fear that I may have been a bit vague in expressing my bottom line concern with the way we are going about healthcare “reform”. Ms. Oretel’s example is too specific for my broader point.

      Simply put, under our current system there are no doubt winners and losers and indeed there are forms of rationing under both private insurance as well as public today. But I would submit that because there are many patients who now have “good” insurance plans that are now paying for expensive drugs and treatments (the “winners” if you will), the drug companies, medical device companies, etc., have the incentive to incur great costs and push the boundaries of research to find better treatments because if they come up with that new miracle treatment, there will be a market willing to reimburse for those expensive treatments. Although some will claim that this is unfair to the “losers”, there are long term benefits to everyone as down the road patents will expire, competing products in the same family, and generics will ultimate become available at a lower cost and therefore available to everyone.

      When we start to adopt a system where government boards are tasked with performing effectiveness studies, cost/benefits analysis, etc. of various treatment options – and this is part of the reform legislation – in order to control costs (we can call them rationing boards), the hurdle to justify a costly new treatment that is more effective or has fewer side effects than the currently available generic treatment, public plans will not be required to provide anything more and ultimately private insurance plans will have a safe harbor to always deny the more costly treatment.

      Even with all of its flaws (or maybe because of them in some eyes), I am of the opinion that the current US healthcare system, with many citizens who can get the latest, expensive treatments and therefore result in higher profits, is a key driving force behind innovation in medicine today. Do I have an irrational fear that transforming the US healthcare system to take out the profit margin will stifle innovation and stagnate medical progress? I hope so, but when I read the stories about NICE in the UK or read how the global wealthy flock to the US for their treatment because it just isn’t available where they live, I have a hard time seeing where I am wrong.

      Are their problems with the current system? Sure – billions of dollars in fraud and abuse, costly un-necessary tests for defensive medicine, doctors cutting off diabetic’s feet or ripping out tonsils of little children because they make more money that way – there are ways to fix these things without the more draconian approaches in the Healthcare Reform legislation. And I also concede that just fixing these things doesn’t address other major problems as well. But I just can’t accept that the “best” solution is to level the field by taking away the best of what we now have from the “winners” rather than finding a way to raise up the “losers” – because then nobody can win.

  • drsoup

    Dr. Lichter, as quoted in this article, says it best:
    “We wouldn’t be talking about this if these were $10 generics”

    How does Amgen justify $8000/month for Avonex? Or Genentech $20K/month for Avastin? The usual pharmaceutical company apologism for these costs falls apart under close scrutiny.

Most Popular