A Cancer Drug Shows Promise, (?) at a Price That Many Can't Pay

[Guest guest]

A

Wed, 15 Feb 2006 10:16:52 -0500

A Cancer Drug Shows Promise, (?) at a Price That Many Can't Pay

 

 

 

 

The New York Times

 

 

February 15, 2006

A Cancer Drug Shows Promise, at a Price That Many Can't Pay

By ALEX BERENSON

 

Doctors are excited about the prospect of Avastin, a drug already

widely used for colon cancer, as a crucial new treatment for breast

and lung cancer, too. But doctors are cringing at the price the maker,

Genentech, plans to charge for it: about $100,000 a year.

 

That price, about double the current level as a colon cancer

treatment, would raise Avastin to an annual cost typically found only

for medicines used to treat rare diseases that affect small numbers of

patients. But Avastin, already a billion-dollar drug, has a potential

patient pool of hundreds of thousands of people — which is why

analysts predict its United States sales could grow nearly sevenfold

to $7 billion by 2009.

 

Doctors, though, warn that some cancer patients are already being

priced out of the Avastin market. Even some patients with insurance

are thinking hard before agreeing to treatment, doctors say, because

out-of-pocket co-payments for the drug could easily run $10,000 to

$20,000 a year.

 

Until now, drug makers have typically defended high prices by noting

the cost of developing new medicines. But executives at Genentech and

its majority owner, Roche, are now using a separate argument — citing

the inherent value of life-sustaining therapies.

 

If society wants the benefits, they say, it must be ready to spend

more for treatments like Avastin and another of the company's cancer

drugs, Herceptin, which sells for $40,000 a year.

 

" As we look at Avastin and Herceptin pricing, right now the health

economics hold up, and therefore I don't see any reason to be touching

them, " said William M. Burns, the chief executive of Roche's

pharmaceutical division and a member of Genentech's board. " The

pressure on society to use strong and good products is there. "

 

Studies show that Avastin can prolong the lives of patients with

late-stage breast and lung cancer by several months when the drug is

combined with existing therapies. Genentech expects to seek federal

approval later this year to sell it specifically for those diseases.

But even now, doctors, who are free to prescribe the drug as they see

fit, are using Avastin for some breast and lung cancer cases — and

finding its cost beyond the means of some patients.

 

" Avastin is a superb drug, but its cost is already discouraging

patients and doctors from using it, " said Dr. David Johnson, who heads

the cancer unit at Vanderbilt University and is a former president of

the American Society of Clinical Oncology. " I wish it were one-tenth

the cost, and if it were I would be giving it to almost everybody. "

 

With colon cancer, a year of Avastin treatment costs about $50,000.

But the drug will be used at higher doses for lung and breast cancer,

and Genentech does not plan to reduce the unit price, even though the

additional cost of producing a higher dose is minimal. Roche

executives described the pricing plans were described in a recent

interview.

 

Because Genentech is a leading developer of cancer therapies, some

doctors also fear that the company's pricing plans for Avastin —

around $8,800 a month — may encourage other companies to charge more

for their own oncology drugs. That could potentially drive up the

overall cost of cancer treatment to unsustainable levels, they say.

 

Right now, one of the few cancer drugs with a higher monthly price

than the level planned for Avastin is Erbitux. The drug, used for

colon cancer, sells for $9,600 monthly, but is not as widely

prescribed as Avastin and is typically used only as a last-resort

treatment for a few months.

 

Dr. Susan Desmond-Hellmann, the president of product development of

Genentech, which is based in South San Francisco, Calif., said that

Genentech had set Avastin's price based on " the value of innovation,

and the value of new therapies. " Genentech, which had more than $6

billion in sales last year, has many programs to help patients afford

its medicines, and last year contributed $21 million to charities that

help patients with their insurance co-payments, she said.

 

Genentech intends to file an application later this year with the Food

and Drug Administration to expand the drug's label to include

treatment for breast and lung cancer. While nothing stops doctors now

from prescribing Avastin for those diseases, F.D.A. approval would let

the company promote and advertise it for such treatments and make

insurers more likely to pay for the treatments.

 

For now, insurers are deciding case by case whether to cover Avastin

for breast and lung cancer, and in many instances they are rejecting

coverage or at least delaying decisions.

 

" Insurers may say, 'It's not approved for that indication, so we're

not paying for it,' " said Dr. Paul A. Bunn Jr., the director of the

University of Colorado cancer center.

 

In those cases, patients must sign a waiver agreeing to reimburse the

hospital for the price of treatment if the insurer will not agree to

do so. And some patients are afraid to sign the waivers, Dr. Bunn

said. " A couple of patients have refused to sign or take treatment. "

 

So far, insurers are generally covering Avastin's use in colon cancer,

and they say they will probably cover its F.D.A.-approved use with

other cancers.

 

Other medicines as expensive as Avastin are typically prescribed only

for rare conditions affecting small numbers of patients, and their

makers justify the costs as necessary for getting a return on their

up-front investments in the drugs. A few medicines, like Ceredase, a

treatment for Gaucher disease (pronounced go-SHAY) from the

biotechnology company Genzyme, can cost as much as $500,000 a year for

some patients. Gaucher disease is a rare metabolic disorder whose

symptoms include anemia.

 

Avastin is currently used mainly in cases of late-stage colon cancer,

a disease that affects about 50,000 Americans annually. On average,

those patients take the drug for 11 months and it extends their lives

an average of 5 months, compared with other treatments.

 

Genentech and Roche are also testing Avastin for use in earlier stages

of colon cancer, lung and breast and cancer, which collectively are

diagnosed in almost 500,000 Americans a year. Genentech and doctors

hope that if the drug is used earlier in treatment it can extend lives

much longer — although that would require patients' finding the means

to pay for it longer, too.

 

Earlier this week Roche stopped recruiting patients for one clinical

trial that included Avastin, while researchers try to explain the

deaths of several patients. But doctors generally view Avastin as one

of the safest cancer treatments. About 200 clinical trials including

Avastin are taking place worldwide.

 

With Avastin's expanded use, analysts expect the drug's sales to soar

to $7 billion in the United States alone by 2009, compared with $1.1

billion last year. Over the same period, Genentech's overall profits

are forecast to triple, to $4 billion in 2009, as sales — $6.6 billion

last year — climb to $18 billion.

 

" They are certainly blazing new ground with the price of the drug, "

said Geoffrey C. Porges, an industry analyst at Sanford C. Bernstein &

Company. " They're saying, we think this is fair value, at least on a

relative basis. "

 

Genentech has always been aggressive in pricing its therapies, Mr.

Porges said. But insurers and government agencies have eventually

accepted Genentech's terms, because its treatments, which include

Herceptin, its current breast cancer treatment, have been shown to

prolong life.

 

When they were originally discovered, drugs like Avastin, which aim at

the blood vessels that tumors use to grow, were expected to replace

traditional chemotherapy, which directly fight tumor cells. Instead,

the drugs have been found to work best when used in conjunction with

chemotherapy. That has caused the overall cost of cancer treatment to

soar, said Dr. Len Lichtenfeld, deputy chief medical officer of the

American Cancer Society.

 

" The financial resources are not limitless, " he said. " There are

tremendous pressures on the cost of cancer therapies today. "

 

The high prices are especially discouraging for patients who have been

told that the new drugs may have only marginal benefits for them.

 

Ellis Minrath, who has pancreatic cancer, said he had chosen not to

take Tarceva, a drug from Genentech that is approved for lung cancer

and has shown promise in pancreatic cancer. He did so after learning

that it would cost him about $1,000 a month in co-payments, even

though he is covered by Medicare.

 

" If anybody came out and said, 'By God, this is the stuff. You want to

get well, find a way to buy it,' that would be one thing, " said Mr.

Minrath, who is 87. " But that isn't the case. The forecast of how much

it's going to do is not that wonderful. "

 

But Dr. Desmond-Hellmann, the Genentech product development chief,

said she would recommend that Mr. Minrath be treated with Tarceva. " I

don't think any patient should go without a Genentech drug for an

inability to pay, " she said. " If this is about money, that would

disturb me. "

 

The higher cost of using Avastin in breast and lung cancer, compared

with colon cancer, is a result of cancer drugs' being priced on the

basis of weight. In colon cancer, Genentech tested Avastin at a dose

of 5 milligrams of the drug per kilogram — or 2.2 pounds — of the

patient's body weight. But in lung and breast cancer, the company

tested the drug at a dose of 10 milligrams per kilogram of body weight.

 

Because the actual cost of producing Avastin is a fraction of what

Genentech charges for it, some analysts and doctors had expected the

company to lower Avastin's price per milligram for use in lung and

breast cancer.

 

Dr. Leonard Saltz, an oncologist at Memorial Sloan-Kettering Cancer

Center in New York, noted that Genentech had not tested the Avastin at

the dose level for colon cancer in large-scale trials of lung and

breast cancer. As a result, no one really knows whether the lower dose

might turn out to be equally effective in lung and breast cancer, he

said. Besides costing less, he said, a lower dose might have fewer

side effects.

 

" There are no meaningful data to allow us to address that question, "

he said.

 

Dr. Desmond-Hellmann said that Genentech was assuming that some cancer

doctors might, in fact, use Avastin at the lower dosage to treat

breast and lung cancer. That is a reason the company does not want to

lower Avastin's per-milligram price, she said, because doing so would

cut too deeply into revenues if doctors do not prescribe the higher

doses that were used in the breast and lung cancer trials.

 

" We don't actually know whether physicians will actually use Avastin

as was used in the clinical trials, " she said.

 

But Dr. Saltz and other doctors said that they would almost certainly

stick to the higher Avastin dose that was tested in the clinical

trials, for fear that a lower dose might not be as effective.

[Guest guest]

Genentech donated Tarceva for my dad's stage IV

pancreatic cancer treatment, so he received it free of

charge. When my dad was diagnosed on June 10, 2005,

he was still a full-time, practicing dentist at almost

83 years old! He had always been a believer in

alternative therapies, so we tried to get him into the

Gonzales program but we turned down due to Dad's

having terrible GERD which nothing seemed to control,

but we did try some other alternative approaches.

However, the GERD was a major obstacle.

 

In the end, I think qualityd's qulaity of life was so

bad and the disease was progressing so fast, that he

finally agreed to the Tarceva with Gemzar.

 

I have to admit that the Tarceva did seem to alleviate

his terrible pain (once he started on it, we only

needed Vicodin occasionally), but his original

prognosis was 4 to 6 months at the most and he died

October 10--four months.

 

Frankly, having lost two parents to cancer--Mom to

multiple myeloma and Dad to pancreatic--extending life

a few months, given the quality of life at that point

and charging such exorbitant prices for drugs that

only really prolong suffering and humiliation, is a

crime.

 

I am grateful that Tarceva eliminated for my dad the

terrible pain so often associated with pancreatic;

however, they are not marketing it as a pain killer.

 

Allopathic medicine decries alternative therapies for

offering the desperate hope where there is none and

for bleeding people dry financially when they are most

vulnerable. How is what Genentech doing any

different, I ask you!!!???

 

 

 

--- califpacific <califpacific wrote:

 

> A

> Wed, 15 Feb 2006 10:16:52 -0500

> A Cancer Drug Shows Promise, (?) at a

> Price That Many Can't Pay

>

>

>

>

> The New York Times

>

>

> February 15, 2006

> A Cancer Drug Shows Promise, at a Price That Many

> Can't Pay

> By ALEX BERENSON

>

> Doctors are excited about the prospect of Avastin, a

> drug already

> widely used for colon cancer, as a crucial new

> treatment for breast

> and lung cancer, too. But doctors are cringing at

> the price the maker,

> Genentech, plans to charge for it: about $100,000 a

> year.

>

> That price, about double the current level as a

> colon cancer

> treatment, would raise Avastin to an annual cost

> typically found only

> for medicines used to treat rare diseases that

> affect small numbers of

> patients. But Avastin, already a billion-dollar

> drug, has a potential

> patient pool of hundreds of thousands of people —

> which is why

> analysts predict its United States sales could grow

> nearly sevenfold

> to $7 billion by 2009.

>

> Doctors, though, warn that some cancer patients are

> already being

> priced out of the Avastin market. Even some patients

> with insurance

> are thinking hard before agreeing to treatment,

> doctors say, because

> out-of-pocket co-payments for the drug could easily

> run $10,000 to

> $20,000 a year.

>

> Until now, drug makers have typically defended high

> prices by noting

> the cost of developing new medicines. But executives

> at Genentech and

> its majority owner, Roche, are now using a separate

> argument — citing

> the inherent value of life-sustaining therapies.

>

> If society wants the benefits, they say, it must be

> ready to spend

> more for treatments like Avastin and another of the

> company's cancer

> drugs, Herceptin, which sells for $40,000 a year.

>

> " As we look at Avastin and Herceptin pricing, right

> now the health

> economics hold up, and therefore I don't see any

> reason to be touching

> them, " said William M. Burns, the chief executive of

> Roche's

> pharmaceutical division and a member of Genentech's

> board. " The

> pressure on society to use strong and good products

> is there. "

>

> Studies show that Avastin can prolong the lives of

> patients with

> late-stage breast and lung cancer by several months

> when the drug is

> combined with existing therapies. Genentech expects

> to seek federal

> approval later this year to sell it specifically for

> those diseases.

> But even now, doctors, who are free to prescribe the

> drug as they see

> fit, are using Avastin for some breast and lung

> cancer cases — and

> finding its cost beyond the means of some patients.

>

> " Avastin is a superb drug, but its cost is already

> discouraging

> patients and doctors from using it, " said Dr. David

> Johnson, who heads

> the cancer unit at Vanderbilt University and is a

> former president of

> the American Society of Clinical Oncology. " I wish

> it were one-tenth

> the cost, and if it were I would be giving it to

> almost everybody. "

>

> With colon cancer, a year of Avastin treatment costs

> about $50,000.

> But the drug will be used at higher doses for lung

> and breast cancer,

> and Genentech does not plan to reduce the unit

> price, even though the

> additional cost of producing a higher dose is

> minimal. Roche

> executives described the pricing plans were

> described in a recent

> interview.

>

> Because Genentech is a leading developer of cancer

> therapies, some

> doctors also fear that the company's pricing plans

> for Avastin —

> around $8,800 a month — may encourage other

> companies to charge more

> for their own oncology drugs. That could potentially

> drive up the

> overall cost of cancer treatment to unsustainable

> levels, they say.

>

> Right now, one of the few cancer drugs with a higher

> monthly price

> than the level planned for Avastin is Erbitux. The

> drug, used for

> colon cancer, sells for $9,600 monthly, but is not

> as widely

> prescribed as Avastin and is typically used only as

> a last-resort

> treatment for a few months.

>

> Dr. Susan Desmond-Hellmann, the president of product

> development of

> Genentech, which is based in South San Francisco,

> Calif., said that

> Genentech had set Avastin's price based on " the

> value of innovation,

> and the value of new therapies. " Genentech, which

> had more than $6

> billion in sales last year, has many programs to

> help patients afford

> its medicines, and last year contributed $21 million

> to charities that

> help patients with their insurance co-payments, she

> said.

>

> Genentech intends to file an application later this

> year with the Food

> and Drug Administration to expand the drug's label

> to include

> treatment for breast and lung cancer. While nothing

> stops doctors now

> from prescribing Avastin for those diseases, F.D.A.

> approval would let

> the company promote and advertise it for such

> treatments and make

> insurers more likely to pay for the treatments.

>

> For now, insurers are deciding case by case whether

> to cover Avastin

> for breast and lung cancer, and in many instances

> they are rejecting

> coverage or at least delaying decisions.

>

> " Insurers may say, 'It's not approved for that

> indication, so we're

> not paying for it,' " said Dr. Paul A. Bunn Jr., the

> director of the

> University of Colorado cancer center.

>

> In those cases, patients must sign a waiver agreeing

> to reimburse the

> hospital for the price of treatment if the insurer

> will not agree to

> do so. And some patients are afraid to sign the

> waivers, Dr. Bunn

> said. " A couple of patients have refused to sign or

> take treatment. "

>

> So far, insurers are generally covering Avastin's

> use in colon cancer,

> and they say they will probably cover its

> F.D.A.-approved use with

> other cancers.

>

> Other medicines as expensive as Avastin are

> typically prescribed only

> for rare conditions affecting small numbers of

> patients, and their

> makers justify the costs as necessary for getting a

> return on their

> up-front investments in the drugs. A few medicines,

> like Ceredase, a

> treatment for Gaucher disease (pronounced go-SHAY)

> from the

> biotechnology company Genzyme, can cost as much as

> $500,000 a year for

> some patients. Gaucher disease is a rare metabolic

> disorder whose

> symptoms include anemia.

>

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