[Ip-health] Setting a price for putting off death: A few more months of life may not be worth the costs of new cancer therapies, some argue.

[James Love]

* This year, cancer drugs are expected to account for nearly 22% of
the nation's drug bill, up from 13% in 2002, according to Morgan
Stanley.

* Several countries, including Britain, refuse to pay for the drugs
for all patients. Here, Congress is considering legislation to
control the costs of biotech drugs.

* In the current issue of the Journal of the American Medical Assn.,
a general practitioner from Oklahoma City described his experience
with the lack of uniform access to new cancer drugs.  In a one-page
commentary, Dr. Perry Klaassen, 66, wrote how he was diagnosed with
colon cancer in 2001 and was surviving because of a series of cancer
drugs he has taken regularly since then. He pays $450 a month, which
he described in an interview this week as manageable. One of his
patients wasn't so lucky. Three years ago, Klaassen diagnosed a 63-
year-old woman with late-stage colon cancer. He recommended that she
try chemotherapy and other drugs, but she declined, saying she didn't
have insurance and didn't want to burden her family with unneeded
debt. She died a year later.  "We have to be able to do better than
this," Klaassen said.


http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?
ctrack=3D1&cset=3Dtrue

Setting a price for putting off death: A few more months of life may
not be worth the costs of new cancer therapies, some argue.
By Daniel Costello, Times Staff Writer
March 18, 2007

What is the value of a few months of life?

That question is at the center of one of the most controversial
debates in medicine today involving a new generation of hyper-
expensive cancer drugs.

On Tuesday, the Food and Drug Administration approved
GlaxoSmithKline's Tykerb, a once-a-day pill for late-stage breast
cancer patients that costs nearly $35,000 a year. It's the latest of
half a dozen new cancer therapies with names such as Avastin and
Tarceva that can run as much as $100,000 for an annual supply.

Although the medications work much longer in some patients, they help
extend the lives of most for only a few months.

The drugs' sky-high costs compared with their relatively small health
benefits have sparked arguments among policymakers and medical
professionals about what to do with the growing number of people who
are depleting their life savings on the drugs or, worse, who can't
get them at all.

More broadly, they ask, is this the best way for society to spend its
increasingly limited healthcare dollars?

Harriet and Mort Frank illustrate the ethical and financial dilemmas.

Since December, the retired Mission Viejo couple have been paying as
much as $2,000 a month in out-of-pocket costs for Harriet's lymphoma
medication, Rituxan, by Genentech Inc. and Biogen Idec Inc.

The Franks get by on $1,432 a month with their combined Social
Security checks and a small amount of savings. But with the drug's
expense eating into their modest nest egg, they're worried about what
might happen next.

"So far this medication is working wonders," Mort said. "But I keep
thinking, how are we going to keep affording it?"

Drug companies and many patients insist even incremental gains are
worthwhile. Small clinical advances are likely to turn into larger
ones over time, and patients who can afford the treatments say they
deserve them.

Traditionally, drug companies have said the prices of their drugs are
based on the costs to develop them. Now, they say, drugs are priced
according to what the market will bear.

"The cost of our product incorporates both the extensive costs
incurred during research and development as well as the price
determined by the market, " said Walter Moore, vice president of
government affairs for Genentech in South San Francisco.

But doctors, patient advocates and healthcare economists warn that
the drugs are simply too expensive at a time when medical costs are
rising rapidly =97 and more patients are picking up a growing share of
their medical bills.

The costs aren't borne only by those who are sick. Because insurers
pay for almost all federally approved drugs, the costs of covering
them would eventually spill into the nation's overall medical bill
and therefore would raise everyone's insurance premiums.

This year, cancer drugs are expected to account for nearly 22% of the
nation's drug bill, up from 13% in 2002, according to Morgan Stanley.

Several countries, including Britain, refuse to pay for the drugs for
all patients. Here, Congress is considering legislation to control
the costs of biotech drugs.

The debate also is raging among oncologists, who admit being torn
about wanting to give patients marginally effective drugs that could
cause serious financial harm.

"These drugs are good, but it's important to remember they aren't a
cure," said Peter Eisenberg, an oncologist at California Cancer
Center in Greenbrae, Calif. "Drug companies are in another world if
they think people can afford these things."

Dr. Edith Perez, co-director of the breast cancer center at the Mayo
Clinic, said some patients with insurance were paying thousands of
dollars for the therapies.

Because many patients now pay as much as 30% of their medical bills
rather than flat co-payments, some physicians have started offering
payment plans for patients who rack up bills as high as tens of
thousands of dollars, Perez said.

In the current issue of the Journal of the American Medical Assn., a
general practitioner from Oklahoma City described his experience with
the lack of uniform access to new cancer drugs.

In a one-page commentary, Dr. Perry Klaassen, 66, wrote how he was
diagnosed with colon cancer in 2001 and was surviving because of a
series of cancer drugs he has taken regularly since then. He pays
$450 a month, which he described in an interview this week as
manageable.

One of his patients wasn't so lucky. Three years ago, Klaassen
diagnosed a 63-year-old woman with late-stage colon cancer. He
recommended that she try chemotherapy and other drugs, but she
declined, saying she didn't have insurance and didn't want to burden
her family with unneeded debt. She died a year later.

"We have to be able to do better than this," Klaassen said.

Irene Knoll, 81, of Santa Ana is suffering the financial consequences
of taking expensive medications. She was diagnosed with pancreatic
cancer in December and is now on regular chemotherapy while taking
several other drugs, including Johnson & Johnson's Procrit, which
boosts red blood cells, to treat her cancer-related anemia.

Her Medicare HMO plan requires her to pay 20% of many medical bills.
As of this week, she has an outstanding balance with her oncologists
for $4,700. With her $1,200 monthly Social Security check, she has
paid only $400.

Knoll is trying to apply for Medi-Cal, the state's program for the
poor that would cover most of her bills, but she may not qualify.

"I try to look at the brighter side of things, but, sure, there are
days when I can't help thinking this is just crappy," she said.

As recently as a decade ago, cancer therapies rarely cost more than a
$1,000 a year. But they weren't very effective and had harmful side
effects.

The newer, so-called targeted drugs work like Trojan horses, slipping
inside cancer cells and attacking them without killing lots of
healthy cells. Although some patients on the new cancer drugs such as
Gleevec, a leukemia drug made by Novartis Inc., live significantly
longer, most lives are extended for just a few months.

Nonetheless, the prices are steep. When Herceptin, the first targeted
therapy that treats breast cancer, arrived in 1998, it cost about
$20,000 for a typical cycle.

All of the drugs' price tags jumped considerably by 2004, when
ImClone Inc. and Bristol-Myers Squibb Co. introduced Erbitux, a late-
stage colorectal-cancer therapy that costs about $10,000 a month.
Drug companies point out that some late-stage cancer patients don't
survive on therapy for long and use less than a year of treatment.

Tykerb, GlaxoSmithKline's breast cancer drug, costs slightly less
than most targeted drugs, but it extends the lives of most patients
only about two months.

A trial of 399 women given Tykerb along with chemotherapy showed that
it stopped the progression of tumors in patients for nearly seven
months versus about five months for those on chemotherapy alone.
Soon, such drugs may grow in popularity. Although most are now used
solely in late-stage cancer patients, some are being approved to
treat early-stage cancer, potentially expanding their use significantly.

Last year, the Food and Drug Administration approved Herceptin for
women who were in remission and Genentech's Avastin for earlier-stage
colorectal cancer. Many drug companies also are trying to expand the
use of targeted drugs.

That could quickly turn several of the drugs into some of the top-
selling medications in the world, raising healthcare costs overall.

Analysts expect Avastin's sales to reach $7 billion in the U.S. by
2009, compared with $1.1 billion in 2005.

The targeted cancer drugs and better detection are helping reshape
cancer treatment, leading some to believe a corner has been turned in
the fight against the disease.

Last year, cancer deaths fell for a second straight year. Three out
of 5 cancer patients now live at least five years after their
diagnosis, and there are now 10 million cancer survivors in the U.S.,
according to the National Cancer Society.

But those gains have to be taken in context of what else the money
spent on cancer treatment could have been used for, said Peter
Neumann, director of the Center for the Evaluation of Value and Risk
at Tufts-New England Medical Center.

"In terms of the cost of a life saved, it's possible other areas of
medicine, like better disease prevention or better cardiovascular
care, may be more effective."

Although it's a vague metric, one historical tool used to judge the
value of a medical intervention is known as the Quality Adjusted Life
Year, which is essentially a rule of thumb that a year of prolonged
life is worth around $50,000 in today's dollars.

By that standard, some of the new cancer drugs may not be worth their
costs when measured against their benefit to society, Neumann said.

Increasingly, advocate groups such as Breast Cancer Action in San
Francisco are pushing Congress to pass laws limiting the price drug
makers can charge for such drugs. .

The recent pressure, however, appears to be having an effect on the
companies themselves. Last year, when Amgen Inc. won approval for a
new colon cancer drug, Vectibix, which costs $8,000 a month, the
Thousand Oaks-based company said patients would receive it free after
co-payments exceeded 5% of their adjusted gross income.

Soon after, Genentech unveiled its own plan. The biotech company said
it would impose a cap of $55,000 per patient per year no matter their
income or insurance status.

daniel.costello@latimes.com