Drug Plan's Side Effect Is Severe/NYT

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April 8, 2006

Drug Plan's Side Effect Is Severe

By ALEX BERENSON

YEADON, Pa. — As a result of the new Medicare drug program, thousands

of people who take pills to fight cancer have suddenly found

themselves with new bills to pay for their essential medicines.

Frances Blue is one of them.

Ms. Blue, a retired teacher, learned five years ago that she had lung

cancer. In December, her doctor decided that her old medicine was not

working and that her best bet would be the cancer drug Tarceva, a

medication from Genentech that costs about $3,000 a month.

A few weeks later, on Jan. 1, the new Medicare Part D program, which

is supposed to help provide prescription drug coverage for people like

Ms. Blue, went into effect.

Ms. Blue says she cannot afford the $3,600 in annual co-payments that

are required before her Part D insurance fully kicks in. And her

income from her teacher's pension and Social Security disability

payments, about $4,000 a month, is too high to qualify for charitable

programs that help patients with drug co-payments.

Now, as her cancer spreads slowly through her lungs, Ms. Blue is

getting no medicine at all. " I've had a month of crying, " she said in

an interview in mid-March.

The details of Ms. Blue's case are complex. But from interviews with

doctors, patients, drug makers and charitable foundations, it is

evident that Part D has posed new complications for at least 10,000

Medicare patients who had been getting free cancer medicines directly

from manufacturers, or, in some cases, through special programs run by

insurance companies.

The drugs include Gleevec, for stomach cancer; Thalomid, for multiple

myeloma; and Tarceva. They are all taken orally in pill form, rather

than given by injection like most cancer medicines. Medicare has

always covered injectable drugs given in hospitals or doctors'

officers, but it generally did not cover oral medicines until Part D

began on Jan. 1.

Because the oral cancer drugs cost up to $4,000 a month, more than

most people without coverage can afford, many Medicare patients

received them free through charity programs from the drugs'

manufacturers. Or, like Ms. Blue, they received them through extended

Medicare policies provided by private insurers that charged minimal

co-payments.

But now that the oral cancer drugs are covered by Part D, they are

bound by rules requiring Medicare enrollees to pay $3,600 in

out-of-pocket costs each year.

As the year continues, that proviso could put financial pressure on

millions of Medicare patients. But it is already hitting hard at

patients who take cancer pills, among the most expensive of the

medicines covered by the new program. Patients taking these drugs

often must meet their entire annual co-payment requirement when they

fill their first two prescriptions — a daunting prospect for retirees

with limited savings and incomes.

And in many cases, added pressure is coming from drug makers that have

begun restricting their charitable free-drug programs and encouraging

— or in some cases, forcing — patients to enroll in Part D coverage.

Last year, about 4,500 patients in the United States received Gleevec

free from its maker, Novartis. Not all of those people are eligible

for Medicare. But Debra Freire, the company's director of patient

assistance programs, said Novartis wanted all patients eligible for

Part D to switch to Medicare. Novartis has not set a deadline for the

switch.

Medicare Part D, Ms. Friere said, is " a wonderful opportunity for

patients to gain access to a program that might provide them with

prescription coverage that they might not have had. "

Hahn, a spokesman for AARP, the lobbying group for older

Americans, said that once patients work through the upfront

co-payments, sometimes called the doughnut hole, Part D provides

excellent coverage for cancer drugs. But the high initial cost can be

frightening, he said.

" AARP would like to see the elimination of the doughnut hole

altogether, " he said.

V. Norwalk, a deputy administrator for Medicare, acknowledged

that some cancer patients were struggling with the transition to Part

D. But over all, she said, the program has worked well for millions of

people, offering new benefits for patients who might not have

qualified for drug-maker assistance programs.

In addition, low- and middle-income people can get co-pay relief, Ms.

Norwalk said. For patients making less than about $15,000 a year, the

co-pay requirements are lower, and for those making less than $40,000

some charities offer co-payment assistance.

" There are terrific options for every beneficiary, " she said.

No firm statistics exist for how many cancer patients are being moved

from free drug programs to Part D. But the number appears to be

between 10,000 and 20,000, according to the drug makers and the

charities that run co-payment programs.

Since Jan. 1, for example, more than 5,000 people have applied for

help with co-payments from the HealthWell Foundation, a land

charity that provides co-pay assistance, according to Krista Zodet,

the foundation's director. Most of these people are in Part D, she said.

Some patients without co-pay relief feel compelled to decline Part D

coverage so they can continue to participate in drug-maker charity

programs.

For example, Maye Navarre, a 79-year-old retiree in Hertford, N.C.,

said she had been receiving free Tarceva from Genentech, its maker,

until she signed up for a Part D program through Blue Cross in

February. When she visited her pharmacy in early March to fill her

Tarceva prescription, she learned the drug would cost her $1,425, not

the $25 her insurance agent had told her to expect.

Ms. Navarre says her only income is $932 a month in Social Security,

and her savings total $4,000 in a money market account.

" I said, 'O.K., pull the plug on me right there,' " Ms. Navarre said.

Ms. Navarre's income is low enough that she should qualify for a

federal subsidy that would essentially eliminate her co-pay

requirement. It is not clear why she was told her co-pay was so high.

The insurance agent who arranged her Blue Cross coverage,

, did not return calls for comment.

In any case, Ms. Navarre said she had canceled her Part D enrollment

so that she could again get Tarceva free from Genentech. In mid-March,

in response to her pleas, Genentech shipped her another month of

Tarceva free, so she is not out of medicine, she said.

But Genentech warned her that the shipment would be her final free

prescription until Blue Cross and Medicare processed her cancellation,

she said.

" So there I am, in limbo, " Ms. Navarre said. " They did send me a free

month's supply, but they said that would be all. I got it on the 14th,

so I have until the 13th of next month. "

Genentech provides free medicines to people who do not have insurance

and earn less than $75,000 annually, according to Walter K. , the

company's vice president for government affairs. In 2005, the company

provided $200 million in free medicines to 18,000 patients and donated

$21 million to co-pay assistance programs, he said.

Unlike many drug makers, Genentech has not required Medicare patients

in its free-drugs program to enroll in Part D. But once patients join

Part D, Genentech bars them from participating in the company-run

program, because it does not want to run afoul of Medicare's complex

rules that cover patients who are enrolled in Part D but are also

getting free drugs from manufacturers.

Genentech is aware that some cancer patients in Part D are having

problems affording their co-payments or filling prescriptions, Mr.

said. " We understand that our drug has a significant co-pay, and

we're trying to do something about it, " he said. " It's incumbent upon

all of us that are trying to serve these patients to be vigilant and

try to seek out ways to be certain that nobody falls through the cracks. "

Still, patients like Ms. Blue seem to be slipping.

Ms. Blue, who lives in a tidy brick house in Yeadon, a suburb a few

miles southwest of Philadelphia, was told she had cancer in her left

lung five years ago. Doctors removed the tumor, but the disease

returned to her right lung in 2002. Despite chemotherapy, the cancer

continued to spread slowly through her lungs, leaving a grim prognosis.

In May 2004, she began taking Iressa, a drug from AstraZeneca. Since

then, her cancer has remained relatively in check. She received the

drug without co-payments through a supplemental Medicare policy

offered by Independence Blue Cross. Although she is under 65 — age 59

— she is eligible for Medicare because her cancer has left her unable

to work.

In December 2005, her oncologist, Dr. Shore, decided to switch

her from Iressa to Tarceva. Two clinical trials had cast doubt on

Iressa's effectiveness.

" All the indications were showing that the Iressa wasn't working, that

she wasn't getting any benefit from it, " Dr. Shore said. But in

January, Ms. Blue learned her first Tarceva prescription would cost

$2,800 — not because she had switched drugs, but because of Part D's

rules requiring co-payments.

While Ms. Blue's income is too high to qualify for co-payment

assistance, she has almost no assets aside from her house. She also

has substantial credit card debt and fears adding to it by spending

$2,800 on Tarceva, she said.

" Who expects to have to come up with a couple of thousand dollars? "

she said.

Dr. Shore said he had expected Ms. Blue to be able to find a way to

get Tarceva through Medicare. If he were certain Tarceva would benefit

her, he would advise her to pay the $2,800, he said. But uncertain

that the drug will help, he does not want to make her spend money for

a drug that may not work.

Dr. Shore said he and his staff found Ms. Blue's case very frustrating.

" We're used to roadblocks, " he said. " We're not used to this. "