$93K for cancer drug raises new ethics question

Lifetime caps on insurance benefits are hitting many patients, and laws are being pushed in dozens of states to get wider coverage of cancer drugs. In Quincy, Mass., 30-year-old grad student Thea Showstack testified for one such law after pharmacists said her first cancer prescription exceeded her student insurance limit. "They said 'OK, that will be $1,900,' " she said. "I was absolutely panicked." The federal health care law forbids such caps on plans issued or renewed Sept. 23 or later.

Tens of thousands of people are seeking help from drug companies and charities that provide free medicines or cover copays for low-income patients. Genentech's aid to patients has risen in each of the last three years, and the company says nearly 85 percent of Americans earn less than $100,000, making them potentially eligible for help if no other programs like Medicaid will pay.

Doctors and insurers increasingly are doing the cruel math that many cancer patients want to avoid, and questioning how much small improvements in survival are worth. A recent editorial in a medical journal asked whether the extra 11 weeks that Genentech's Herceptin buys for stomach cancer patients justified the $21,500 cost.

Doctors also have questioned the value of Genentech's Tarceva for pancreatic cancer. The $4,000-a-month drug won approval by boosting median survival by a mere 12 days. Here's how to think about this cost: People who added Tarceva to standard chemotherapy lived nearly 61/2 months, versus six months for those on chemo alone. So the Tarceva folks spent more than $24,000 to get those extra 12 days.

When is a drug considered cost-effective?

The most widely quoted figure is $50,000 for a year of life, "though it has been that for decades — never really adjusted — and not written in stone," said Dr. Harlan Krumholz, a Yale University expert on health care costs.

Many cancer drugs are way over that mark. Estimates of the cost of a year of life gained for lung cancer patients on Erbitux range from $300,000 to as much as $800,000, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer.

Higher costs seem to be more accepted for cancer treatment than for other illnesses, but there's no rule on how much is too much, he said.

Insurers usually are the ones to decide, and they typically pay if Medicare pays. Medicare usually pays if the federal Food and Drug Administration has approved the use.

"Insurance sort of isolates you from the cost of health care," and if people lose coverage, they often discover they can't afford their medicines, said Dr. Alan Venook, a cancer specialist at the University of California, San Francisco. He wrote in the New England Journal in August about three of his patients who stopped taking or cut back on Gleevec because of economic hardship.

Two of the three now are getting the drug from its maker, Novartis AG, which like most pharmaceutical companies has a program for low-income patients. About 5,000 patients got help for Gleevec last year, said Novartis spokesman Geoffrey Cook.

"We have seen a steady increase in requests over the past few years" as the economy worsened, he said.

Showstack, whose leukemia was diagnosed last year, gets Gleevec from Novartis. The dose she's on now would cost $50,000 a year.

"I'm not actually sure that I know anyone who could afford it," she said.

Gleevec's cost is easier to justify, many say, because it keeps people alive indefinitely — a virtual cure. About 2,300 Americans died each year of Showstack's form of leukemia before Gleevec came on the market; only 470 did last year.

"I don't think we quibble with a drug that buys people magical quality of life for years," said Venook.

It's unclear whether Provenge will ever do that — it needs to be tested in men with earlier stages of prostate cancer, doctors say. So far, it has only been tried and approved for men with incurable disease who have stopped responding to hormone therapy. On average, it gave them four months more, though for some, it extended survival by a year or more.

Until it shows wider promise, enthusiasm will be tepid, said Dr. Elizabeth Plimack, a prostate specialist at the Fox Chase Cancer Center in Philadelphia.