Drug Cost Debate

Before getting into today’s topic, a brief follow up from my last post. The radiologist’s report on my head & neck CT scan with contrast from June 23rd showed no evidence of disease. That makes it 20 months with no evidence of disease. Yahoo.

The Wall Street Journal had a terrific article on June 23 2009 titled, “Cost-Effectiveness of Cancer Drugs Is Questioned.” Here’s the link…

http://online.wsj.com/article/SB10001424052970203872404574258302761872972.html?mod=djkeyword

For those of you who have trouble with the link, I have included the entire article at the bottom of this posting for ease of reference. The article hit very close to home as I’ve used two of the drugs highlighted in the article. Erbitux (Cetuximab) is the drug to which I had a severe allergic reaction and Avastin is the drug which I credit (along with Tarceva) as the drug which has kept my cancer at bay (or maybe even eliminated it). It is also a very expensive drug and is the one with which I had a dispute with my insurance company.

There were a few points in this article that I’ve been thinking about over the past two years. As such, it may be a good idea to read the article before reading my thoughts.

1. These “expensive” drugs do actually work for some people. Although the average benefit (per the article) is an increase in longevity by 1.2 months, in my case it has been 2+ years. Cancer breakthroughs have been more akin to marginal improvements (like increasing the average miles per gallon in cars), than revolutionary breakthroughs. I don’t think I would be here today if it were not for these drugs.

2. The cost of bringing a new drug to market (see blog entry dated April 8 2009) averages almost one billion dollars ($1,000,000,000). The drug companies are not benevolent entities. They are in business, they have stock holders, and they are there to make a fair and reasonable profit. Among paying their employees, the revenue generated by these drugs funds research into better drugs. In some cases it allows larger drug companies with established drug distribution and marketing networks to acquire smaller innovative companies and spend the money required to move a drug through the arduous drug trial process.

3. Extending time in the last year of life is disproportionately expensive when compared to the years before the “last” year. The article says that this situation “is one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system.” Unfortunately, no one has a crystal ball. In my case, I may be one of the fortunate few where it looked like I was in the last year of life, but I wasn’t. I don’t have an answer here, but it’s an interesting question. Warren Buffet calls it the birthplace lottery. If I had been born in many other countries, these drugs would not have been available to me. Other articles I’ve read on the subject estmate last year of life health care cost at 25 to 30% of total Medicare costs. This percentage includes hospice care. Residents in some states cost twice as much than others. Given the magnitude of this cost and the differences, this should lead to further evaluation and recommendations for change at a strategy level.

Oh well, these are the things that clutter my mind and I thought I’d share them here.

Take care and good health to you all.
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Cost-Effectiveness of Cancer Drugs Is Questioned

By AVERY JOHNSON

Wall Street Journal – June 23 2009

The widespread use of expensive cancer drugs to prolong patients’ lives by just weeks or months was called into question by an article published Monday in the Journal of the National Cancer Institute.

Crunching data from published studies, the authors found that treating a lung-cancer patient with Erbitux, a drug that costs $80,000 for an 18-week regimen, prolongs survival by only 1.2 months.

Based on that estimate, extending the lives of the 550,000 Americans who die of cancer annually by one year would then cost $440 billion, they extrapolated.

How to control escalating spending on end-of-life care is one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system.

Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S.

The use of costly cancer drugs to prolong patients’ lives was called into question by researchers

Other Big Sellers

In addition to Erbitux, which is co-marketed by Eli Lilly & Co. and Bristol-Myers Squibb Co., the authors questioned the cost-benefit calculus for other big sellers such as Roche Holding AG’s Avastin and Nexavar, which is co-marketed by Bayer AG and Onyx Pharmaceuticals, citing similarly limited survival data. The latter two drugs cost more than $34,000 for a standard course of treatment.

The authors, Tito Fojo, an oncologist with the National Cancer Institute, and Christine Grady, a bioethicist at the National Institutes of Health, called for changes in both the testing and practice of medicine, noting that more than 90% of cancer medicines approved in the past four years in the U.S. cost more than $20,000 for a 12-week course.

Drug makers said the article exaggerated the overall costs of their treatments because few patients are on them for extended periods of time.

They added that many patients qualify for financial assistance and that the high list prices of the drugs reflect the high cost of scientific innovation.

Actual Price of Drugs

Brian Henry, a spokesman for Bristol-Myers, said that the real-world price that patients pay for Erbitux is closer to $10,000 a month; the $80,000 figure that the article uses reflects a benchmark price known as average wholesale price that isn’t typically paid by anyone.
“The total cost of Erbitux therapy varies depending on the course of treatment for an individual patient. The course of treatment is determined by the type of cancer, stage of disease, line of therapy, dosing schedule and duration of treatment based on clinical data,” said Mr. Henry, who added that Erbitux isn’t approved to treat lung cancer.

Nonetheless, the authors said that drugs with marginal benefits shouldn’t be tested unless they can be sold for under $20,000 for a standard course.

They also urged oncologists to cease the widespread practice of prescribing medicines outside of their officially approved indications and to avoid trying new drugs with limited upside on patients who have advanced cancer.

They offered Great Britain as an example, where the government has capped spending at £30,000, or about $50,000, per quality-adjusted life year, saying that bench-marking care to a fixed amount wouldn’t compromise care or innovation.

“Many Americans would not regard a 1.2-month survival advantage as ‘significant’ progress,” the authors wrote. “But would an individual patient disagree? Although we lack the answer to that question, we would suggest that the death of a mother of four at age 37 years would be no less painful were it to occur at age 37 years and 1 month, nor would the passing of a 67-year-old who planned to travel after retiring be any less difficult for the spouse were it to have occurred one month later.”

Consumer Resistance

While some policy experts consider the rationing of health-care resources inevitable in the quest to control medical spending, many Americans have long resisted putting the collective fiscal good over their individual health.

“We can’t add on Mercedes-like drugs one after another and have every single patient cost the system phenomenal amounts of money,” said Eric Winer, chief scientific adviser to Susan G. Komen for the Cure, a breast-cancer advocacy group. “But we have to be careful not to slow down the process of drug development. Ultimately it is medical therapy that will make a huge difference in people’s lives.”

The debate is complicated by the fact that, in some cases, the drugs work very well.
“A drug like Erbitux is not very impressive when you look at the statistics, but for some it’s just remarkable,” said Robert Erwin, who heads the cancer advocacy group Marti Nelson Cancer Foundation. “How much does it cost for the person to have the opportunity to benefit, whether they get the benefit or not?”

Richard Heimler, 49 years old, is among the patients who has benefited from high-cost treatments. He was diagnosed with lung cancer five years ago. In January, he added Avastin to a regimen of other expensive drugs. He credits it with shrinking his tumors within two months of starting with the treatment.

“My strategy has been to stay alive until the next drug comes out, and then stay alive long enough for the next drug after that,” said Mr. Heimler, who lives in New York and was head of development for a nonprofit before retiring two years ago. “If my family and I can afford a drug, we’ll try it. It’s hard to put a value on a life.”

But for Roger Megerth, 73, prolonged treatment with Nexavar wasn’t worth it.

He started taking Nexavar last June after being diagnosed with kidney cancer, but the side effects—indigestion, bleeding in the mouth and intestinal problems—were mounting.

Soaring Prescription Bills

So were the bills. The retired teacher said his school district switched prescription-drug plans and his co-pay for a bottle of 30 pills jumped from $20 to $988.18. He put one month’s supply on his credit card and decided to forgo further treatment after that.
“I would’ve borrowed money and run out my Visa,” but the side effects weren’t worth it, said Mr. Megerth of Billings, Mont.

He said his disease is under control for now, but he is in considerable pain and needs a walker to move around comfortably.

A spokeswoman for Onyx said that 75% of patients on Nexavar spend $50 or less out of pocket for the drug and that patient-assistance programs are available to cover the remainder of its costs.