Date: 27 June
2011
Source: Then
New York Times
Link: http://www.nytimes.com/2011/06/28/health/28prostate.html?_r=1
A group of new
drugs is promising to prolong the lives and relieve the symptoms of men with
advanced prostate
cancer, but could also add billions of dollars to the nation`s medical
bills.
In the
last 15 months, three new drugs that extended the lives of prostate cancer
patients in clinical trials have been approved by the Food and Drug
Administration and several other promising medicines are in clinical trials.
Before last year, only one drug had been shown to improve survival — docetaxel,
which was approved in 2004.
“What a
great time it is in prostate cancer,” Dr. Daniel J. George of the Duke Cancer Institute
proclaimed earlier this month at the annual meeting of the American Society of
Clinical Oncology.
And it`s
a great time for the drug makers, with several drugs competing to fill a niche
for longer-term survival. Analysts estimate that some of the new drugs,
particularly Dendreon`s Provenge and
Johnson & Johnson`s
Zytiga, could reach annual sales of $1 billion or even much more.
The
recently approved drugs and most of those in development are for cases in which
the disease has spread beyond the prostate gland and is no longer held in check
by hormone therapy.
Men
with that late-stage cancer had a median survival of about a year and a half
using docetaxel. The new drugs each added two to five months to median survival
when tested in clinical trials. Doctors say that men taking more than one of
the drugs in succession would be expected to live more than two years.
But the
price of these drugs has already stirred concerns about the costs of care among
patients, providers and insurers. For example, Provenge costs $93,000 for a
course of treatment, while Zytiga costs about $5,000 a month. Another of the
new drugs, Sanofi`s Jevtana, costs about $8,000 every three weeks.
With
other pricey drugs on the way, said Joel Sendek, an analyst at Lazard, “We
could be talking easily $500,000 per patient or more over the course of
therapy, which I don`t think the system can afford, especially since 80 percent
of the patients are on Medicare.”
Medicare
has already fired what some analysts interpret as a warning shot over prices,
conducting a yearlong inquiry into whether to pay for Provenge. In its final
decision, due Thursday, Medicare is expected to pay for the drug when used
according to the label.
Medicare
officials denied that price was the reason for the review. But some patient
advocates and politicians portrayed the review as a step toward rationing.
Private
insurers are also paying only if drugs are used according to the label,
according to doctors and patient advocates.
“The
reality is, there`s pushback,” said Dr. Oliver Sartor of Tulane University.
Still,
for now, one company`s price is prompting the next one to follow suit.
“The
pricing environment is encouraging and getting better for us,” Andrew Kay, the
chief executive of Algeta, told securities analysts earlier this month, after
announcing that his company`s experimental drug had extended median survival
nearly three months in a clinical trial.
Mr. Kay
said he had initially thought that his company, which is based in Norway, would
charge about $25,000 for a typical course of treatment with the drug,
Alpharadin. But with the rival drug Jevtana costing about $50,000, Algeta and
its partner, Bayer, are considering a higher price.
About
218,000 men in the United States get prostate cancer each year and about 32,000
die, according to the American Cancer Society.
In many
cases, the cancer is caught before it has spread beyond the prostate gland and
can be cured with surgery or radiation
therapy.
If the
cancer has spread, men usually are given drugs, particularly Abbott
Laboratories` Lupron, that suppress the body`s production of the hormone testosterone,
which can fuel tumor growth.
The new
drugs, for now at least, are for use when this hormone-deprivation therapy has
stopped working.
“This
is a small subset of people with prostate cancer,” said Dr. Charles Myers, a
prostate cancer specialist in private practice in Charlottesville, Va., who is
a survivor of the disease himself. However, he noted, “It`s the group of people
who are dying.”
Provenge
was approved in April 2010 for patients whose cancer was late-stage but not yet
causing many symptoms.
Once
symptoms, mainly bone
pain, have appeared, men are likely to receive docetaxel, a generic drug
also sold by Sanofi as Taxotere .
Two
other new drugs are approved for use only after docetaxel has been tried. One,
Sanofi`s Jevtana, is a chemotherapy
drug in the same class as docetaxel; it was approved in June 2010. The other is
Johnson & Johnson`s Zytiga, approved this April.
Many
patients and doctors are most enthusiastic about Zytiga and Provenge because
they are alternatives to chemotherapy, which many men want to avoid because of
side effects. Provenge works by training the body`s immune system to fight the
tumor.
Zytiga
is a new form of hormone therapy. While Lupron mainly blocks production of
testosterone by the testes, there is still some hormone produced by the adrenal
gland or even by the tumor itself. Zytiga, by inhibiting an enzyme called
CYP17, clamps down on testosterone production.
Doctors
and patients say the new drugs can offer some men a decent quality of life,
although they are not free of side effects. For instance, Zytiga, also known as
abiraterone, can cause hypertension
and liver damage and must be taken with the steroid prednisone.
Many
men are likely to try several of the drugs. Mark Maldonado, a retired postal
worker in Omaha, said that Jevtana had helped keep his cancer in check without
debilitating side effects. But knowing that the drug would eventually stop
working, he and his doctor “talked about abiraterone being the next step in our
progress through the drugs.”
More
competition is coming. Takeda Pharmaceutical and Medivation, a San Francisco
company, are separately developing other drugs that block testosterone`s
production or its effects.
Some of
the most exciting advances, doctors say, are in the area of fighting the spread
of prostate cancer to the bone. Such bone metastases are very common in men
with advanced prostate cancer and account for most of the death and disability
from the disease.
Cabozantinib,
an experimental drug being developed by Exelixis, seems to be able to virtually
eradicate bone metastases in some patients, at least as measured by bone scans,
something no other drug has done.
Amgen
won F.D.A. approval in November for Xgeva, a drug that reduces the risk of
fractures and other problems caused by cancer in the bones. The drug can also
delay the spread of cancer to the bones, according to the results of a more
recent trial.
Dr.
Christopher J. Logothetis, of the M. D. Anderson Cancer Center, predicted
further progress.
“It`s
beyond the individual drugs,” he said. “One sees a manual now on how to go
forward.”
Keywords:
Drugs / Cancer / Costs / High
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