[Congressional Record Volume 147, Number 68 (Thursday, May 17, 2001)]
[Senate]
[Pages S5125-S5126]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. SNOWE (for herself, Mr. Rockefeller, Mr. Smith of Oregon, 
        and Mrs. Feinstein):
  S. 913. A bill to amend title XVIII, of the Social Security Act to 
provide for coverage under the medicare program of all oral anticancer 
drugs; to the Committee on Finance.
  Ms. SNOWE. Mr. President, I rise today to introduce a small bill, but 
one with important consequences. My measure, the Access to Cancer 
Therapies Act, would provide coverage of all oral anticancer drugs 
under the Medicare program. I am pleased to be joined by Senators 
Rockefeller, Gordon Smith, and Feinstein in introducing this measure.
  As my colleagues know, there is no Medicare outpatient prescription 
drug benefit today. If there was, we would not need this legislation. 
There should be and there must be a Medicare prescription drug benefit 
this year. Seniors are reeling from the burden of their prescription 
drug expenses, and they can't defer their illnesses or their costs.
  This legislation also reminds us of how crucial prescription drugs 
are, not only now but even more so in the future. Eight years ago, 
Congress created a unique Medicare drug benefit for oral anti-cancer 
drugs, but only if the drug is equivalent to drugs provided 
``incident'' to a physician visit; for example, drugs that must be 
injected. At present, upwards of 95 percent of cancer drug therapy is 
covered by Medicare either in a physician office or in a reimbursed 
oral form. But in the near future as much as 25 percent of cancer drug 
therapy will be in the form of oral drugs that are not currently 
covered.
  In fact, this is already happening. Today, there are about 40 oral 
anti-cancer drugs, but less than 10 are reimbursed by Medicare. For 
example, one of the most common drugs used in the treatment of breast 
cancer, tamoxifen, is among the drugs not currently reimbursed by 
Medicare.
  As cancer therapy moves more toward reliance on oral drugs, Medicare 
coverage policy must be updated to cover the new therapies, or else 
even the intent of this very limited policy will be meaningless and 
Medicare beneficiaries will increasingly lose access to the best cancer 
therapies. And without this legislative change, beneficiaries will 
increasingly bear the burden of buying these drugs from their own 
pockets, which most seniors can ill afford.
  Let me provide one very exciting example of an oral anti-cancer drug 
that illustrates both the urgency of this policy change and of enacting 
a Medicare prescription drug bill. Last week, the Food and Drug 
Administration approved a compound known as STI-571. Also known by its 
brand name Gleevec, this medication was approved in a record setting 
two and one-half months. Gleevec is used to treat one kind of leukemia 
and may also be effective against a rare but lethal stomach cancer.
  Gleevec is the first, let me repeat, first, cancer drug to 
specifically address a molecular target which is not only in the 
cancer, but actually the cause of the cancer, according to the National 
Cancer Institute. More precisely, Gleevec knocks out a specific enzyme 
needed for the cancer to thrive. By contrast, most current cancer 
therapies act like a shotgun, killing both cancer and normal cells. 
Moreover, Gleevec is among the first fruits of three decades of 
research into the basic biology of cancer.
  But Gleevec is not a cure, it simply arrests the cancer and returns 
most lab tests to normal. Patients may need to take the drug for life. 
And treatment is not cheap--a month's supply of Gleevec costs upwards 
of $2,400.
  While biomedical research is providing new, more targeted, and less 
toxic methods of treatment through new oral anti-cancer drugs that 
patients can safely take in the comfort of their own homes, Medicare 
policy is currently unable to provide reliable access to these 
medications for beneficiaries with cancer.
  At the very least, we must ensure all oral anti-cancer drugs are 
available to our seniors. The Access to Cancer Therapies Act will build 
on current Medicare policy by ensuring coverage of all anti-cancer 
drugs, whether oral or injectable, are available to Medicare 
beneficiaries. The Act will provide beneficiaries with access to 
innovative new therapies that are less toxic and more convenient, more 
clinically effective and more cost-effective than many currently 
covered treatment options. I urge my colleague to support this bill.
  Mr. SMITH of Oregon. Mr. President, I have spoken many times about 
the importance of adding a prescription drug benefit to Medicare. There 
are other ways in which the Medicare program could be strengthened, for 
example, by upgrading for innovative medical technologies not covered 
under the old structure of Medicare. One example of advanced 
technologies that should be in use are oral anti-cancer drugs. I rise 
today in support of the Access to Cancer Therapies Act.
  Most people would be surprised to know that all cancer therapies are 
covered under Medicare. This situation is due to an accident of fate. 
When Medicare was created in 1965, orally administered cancer drugs 
were completely unknown. While 90 to 95 percent of anti-cancer drug 
therapy is covered under Medicare Part B, this coverage is largely 
limited to injectable drugs that are administered incident to covered 
physician services. Orally administered anti-cancer drugs are only 
covered if they have an injectable equivalent. Currently there are only 
seven of these pharmaceuticals available. Researchers fully expect that 
in the near future, cancer care will be much more heavily based on oral 
drugs; while oral drugs currently make up around 5 percent of the 
oncology market, it is projected that they will become 25 percent or 
more within a decade. Continuing to exclude coverage of oral cancer 
medications will impose significant unnecessary cost burdens on 
Medicare beneficiaries, and could influence treatment decisions more on 
the basis of cost than quality.
  The cure for cancer has long been the golden ring of medical 
research, eluding the grasp of even the most intrepid scientists. But 
today, in Oregon, we are one step close to a cure. At Oregon Health & 
Science University, or OHSU, in Portland, Dr. Brian Druker has 
discovered a treatment for a specific form of leukema--a treatment that 
offers hope to cancer patients everywhere. Dr. Druker's treatment, 
known as Gleevec, offers hope to cancer patients everywhere because it 
shows us how to fight cancer: at the molecular level. As Dr. Peter 
Kohler, President of OHSU, said: ``People have won the Nobel Prize for 
lesser work.''
  For Dr. Druker, this was a dream that began over twenty years ago, as 
a medical student. He sat through a lecture on chemotherapy and thought 
the practice barbaric. He dreamt of the day that chemotherapy could be 
replaced with a more humane treatment that killed cancerous cells, but 
didn't ravage the body. In his research, he developed an interest in 
the proteins responsible for signaling cell growth. He believed these 
proteins were perfect targets for new therapies. In particular, he felt 
that BCR-ABL, an abnormal protein responsible for overproduction of 
white blood cells in a certain type of leukemia, was the best bet for 
targeted therapy.
  In 1993, he came to Oregon to head up his own leukemia research lab 
at OHSU. It was at that point that his research really started to 
blossom. He began to experiment with potential treatments for chronic 
myelogenous leukemia, or CML. One chemical compound, STI 571, 
immediately showed the most promise. Clinical testing began in June 
1998 and the results were nothing less than astonishing. In every case, 
white blood cell counts returned to normal within six weeks. ``I 
thought it was too good to be true,'' Druker says.

  In fact, further clinical trials have shown that STI 571, now known 
as Gleevec, is, if anything, more effective than Dr. Druker originally 
thought.

[[Page S5126]]

Trials have been extended to 30 countries and nearly 3000 patients. 
Over 90 percent of those in the disease's acute, or blast, phase have 
seen their white blood cell counts return to normal, and one-third in 
the same phase have no remaining traces of leukemia. In other words, 
not only did Gleevec treat the leukemia symptoms, it began to eliminate 
the molecular basis of the disease altogether. Not surprisingly, the 
Food and Drug Administration last week approved Gleevec for the 
treatment of CML, the fastest ever approval by the FDA for an anti-
cancer treatment.
  Further clinical trials have shown that Gleevec is effective for a 
rare form of cancer known as gastrointestinal stromal tumor, or GIST. 
Similar to the way Gleevec inhibits the BCR-ABL protein that is found 
in nearly all CML sufferers, Gleevec also appears to inhibit the so-
called KIT protein that is prevalent in most gastrointestinal tumor 
patients. Trials are also planned or already underway to test Gleevec 
on brain tumors and soft tissue sarcoma. As Dr. Druker says, Gleevec is 
unlikely to be a cure for every form of cancer. Nevertheless, it does 
provide a road map. The important step is to find the molecular defect 
that underlies each form of cancer and target it for therapy. And with 
the completion of the Human Genome Project, the information to help 
find those molecular defects is now available.
  The discovery of Gleevec secures Dr. Druker's reputation as one of 
the foremost scientists of his generation, and may well put him in line 
for that Nobel Prize mentioned by Dr. Kohler. But it also symbolizes 
the growing strength of the Oregon Cancer Institute at OHSU. The 
institute is relatively new, but that hasn't hindered it from having a 
large impact on the field. That's a testament to the high intellectual 
caliber of the staff there. As Dr. Grover Bagby, director, points out: 
the Oregon Cancer Institute was founded on the principle of fighting 
cancer at the molecular level. And thanks to Dr. Druker, fighting 
cancer at the molecular level is now the guiding principle for cancer 
researchers everywhere.
  As I said at the beginning of my remarks, the cure for cancer has 
long been the golden ring of medical research. Yet today, thanks to the 
work of Dr. Druker and others at OHSU, cures for cancer are at hand. 
This is a proud day for medical research, and a proud day for Oregon.
  Passage of the Access to Cancer Therapies Act would give hope to 
Oregonians such as Jim Underwood, a Medicare beneficiary in Oregon in 
the last stages of leukemia. Because Medicare does not currently cover 
oral cancer treatments, many patients like Jim Greenwood may not 
benefit form the most innovative, appropriate cancer fighting 
technologies. I urge my colleagues on both sides of the aisle to move 
quickly to pass the Access to Cancer Therapies Act so that all Medicare 
beneficiaries can have access to the most technologically advanced 
medications available and appropriate for their conditions.
  Mrs. FEINSTEIN. Mr. President. I am pleased today to join as an 
original sponsor with Senators Snowe, Smith and Rockefeller, a bill to 
provide Medicare coverage of cancer drugs.
  More than 8 million Americans require some form of cancer care: 1.2 
million of these are newly diagnosed patients; some are already on 
treatment; some need follow-up care. Over half a million people will 
die from cancer this year.
  Medicare, generally, does not cover cancer drugs. This bill will 
provide that coverage.
  Providing Medicare coverage of cancer drugs is particularly important 
in light of a promising new class of drugs that are becoming available. 
One of those drugs is Gleevec, formerly known as STI 571.
  I am greatly heartened by the news that on May 10 the Food and Drug 
Administration approved Gleevec for the treatment of chronic 
myelogenous leukemia. Gleevec is revolutionary because it can precisely 
target the dysfunctional proteins that cause this cancer and it can 
disable cancer cells to the point that they are metabolically 
inactivated with 12 hours of administering the drug.
  Furthermore, Gleevec does not destroy the ``good'' cells, as other 
treatments do. It helped over 90 percent of patients in clinical trials 
and holds great promise for other cancers. Scientists say this drug is 
the wave of the future.
  Not only is this drug highly medically effective, it is cost-
effective. Gleevec is expected initially to cost around $25,000 
annually. While that is a high price, in my view, the other 
alternative, or standard treatment for this kind of leukemia, is a bone 
marrow transplant. Bone marrow transplants cost on average $250,000 per 
procedure. So this drug will be cheaper than the conventional 
treatment.
  Sixty percent of cancer cases occur among people over age 65, a 
number that will grow as the American population ages, so Medicare is a 
major payer of cancer care. Cancer therapies have evolved to the point 
where most cancer care is delivered on an outpatient basis, not in a 
hospital.
  In terms of Medicare, oral, outpatient, prescription cancer drugs are 
currently covered by Medicare only if the drugs have the same active 
ingredient as the equivalent injectable cancer drug. This means that 
very few cancer drugs are covered.
  No one really knows how much Medicare patients pay out-of-pocket for 
cancer drugs, but according to the Institute of Medicine, ``available 
evidence suggests that it is substantial.'' One study found that 
Medicare covered 83 percent of typical charges for lung cancer and 65 
percent of typical charges for breast cancer. Out-of-pocket expenses 
ranged from less than $100 to near $4,000. One-third of Medicare 
beneficiaries have private insurance that covers the prescription drugs 
that Medicare does not cover. Even if beneficiaries have private drug 
coverage, that coverage often has high deductibles and other limits so 
that beneficiaries still have high out of pocket expenses.
  The bill we are introducing today addresses just part of the problem. 
Clearly, we must work for a comprehensive Medicare drug benefit for all 
illnesses and we must work to improve private health insurance 
coverage.
  The cost of delivering cancer care is $50 billion a year, says the 
National Cancer Institute. These are costs that we can reduce and this 
bill is one step.
  I hope that by expanding Medicare coverage to cover cancer drugs we 
can garner support for broader coverage, we can encourage drug 
companies to make many more new drugs and we can give hope to millions 
who suffer from cancer.
  I urge my colleagues to support this bill.
                                 ______