Talking points for discussions with the media or your
Regarding the CMS (Centers for Medicaid and Medicare) Ruling on
I am contacting you regarding a CMS ruling that will
a devastating effect on the survival of patients with lymphomas
The ruling is contained with CMS-1392-FC
The ruling, if let to stand, will have grave
consequences to patients.
The CONSEQUENCES include:
Patients in need will be denied access to a life saving therapy.
Future patients will be denied access to RIT and similar targeted drugs.
As ASH (The American
Society of Hematology) writes:
it will have “a chilling effect on the development of future drugs
and radiopharmaceuticals for treating other forms of cancer and other diseases.”
We are asking that a "legislative fix" be written into the Appropriations
that would maintain the 2007 reimbursement rates for Bexxar and Zevalin.
This will give CMS the necessary time to correct its methods prior to setting rates for 2009.
We urge you to support this revision so that these important treatments will continue
to be available to patients.
IMPORTANTLY: CMS warns that “it may terminate the provider agreement of any
hospital that furnishes this or any other service to its patients but fails to also furnish
it to Medicare patients who need it.”
Thus, if RIT treatments are unavailable to Medicare patients, they will also be unavailable
to anyone else.
We are not asking for charity -
nor is it self-indulgent - to insist that CMS pays for
treatments proven effective for lymphomas. We are not asking society to satisfy wasteful
appetites and desires.
To make good decisions we must consider all the information, not just a few parts of it.
CMS has failed miserably on this account with it’s decision to cut reimbursements to hospitals
in half for radioimmunotherapies (bexxar and zevalin).
In the spirit of transparency, the sponsor (GlaxoSmithKline)
has proposed using the
Average Sale Price (ASP) because
the data used by CMS was not reflective of the true costs.
CMS has not accepted this proposal, while it accepts the ASP for
ASCO (American Society of Clinical Oncology) writes:
“As proposed [and now ruled on], the rates for therapeutic radiopharmaceuticals will be significantly
lower than 2007, and for some hospitals are likely to be lower than their acquisition costs.
We are particularly concerned that availability of (Bexxar) and (Zevalin) not be adversely
affected by this proposal.”
~ Signed by Joseph S. Bailes, MD, Chair, Government Relations Council
ASH (The American Society of Hematology) forceful comment:
“ASH is extremely concerned about the proposed payment rate for Bexxar … which is a
(RIT) agent. Similar issues apply to Zevalin … which is also an RIT.” …
“It is clear that the CMS’ estimate of costs grossly undervalues actual costs of [Bexxar].
Whether this is because [reasons provided] other reasons, unless corrected, this could prove devastating
to this important therapy. It may severely limit patient access to this invaluable treatment option since
hospitals will not be able to absorb a loss exceeding $16,000 per patient.
If this occurs [it did], it will eliminate one of the few treatment options and perhaps the only
treatment option for some patient with non-Hodgkins lymphoma who have failed
~ Signed by Andrew I. Schafer, President
EFFICACY and NECESSITY:
In summary, we believe that CMS very low
reimbursement rates for RIT:
(1) will increase pain, suffering, and
unnecessary loss of life for patients with lymphomas;
(2) will limit a physician's ability to
prescribe a highly effective therapy today;
(3) will lead to the termination of
radioimmunotherapy in the near future; and
(4) will be a disincentive to develop urgently needed
innovative drugs for all cancers.
Please help us to ensure that CMS amends the
CY2008 reimbursement rates for Zevalin and Bexxar most
potent and effective therapeutic agents
so that hospitals can be adequately paid for providing
radioimmunotherapy, which in turn will
allow patients to continue to benefit from these highly
effective new cancer therapies,
which have been described by experts as the
ever invented for lymphoma, and arguably for any cancer.
Who to Contact? See Contacts
Q: What is the cost to hospitals versus reimbursement by CMS?
This is a very difficult question to find a clear answer
Our reasons for protest are based on our own independent analysis
of the CMS proposal, and more importantly, the public comments of
ASCO, ASH, and the sponsor.
We think it's fair to ask why it is that ASH and ASCO, two highly
credible professional clinical organizations have gone on the record
to forcefully protest payment rates for RIT, and not other
Typical hard-to-decipher text from the CMS
tositumomab is not approved as either a drug or a
radiopharmaceutical, but it is a supply that is required as part of
the BEXXAR treatment regimen. ...
The median cost of G3001
from CY 2004 claims is $1,210 based on 69 single claims.
Based on our CY 2005
claims data that show a final median cost of $1,367 for APC
0442, which contains only the service described by G3001, we had 148
single claims for the service. The median cost of G3001 from CY 2004
claims is $1,210 based on 69 single claims." (
Our comment: The CMS ruling fails to provide readable and
clear answers to basic questions:
How much will paid to hospitals this
year, versus past years, versus average sales price?
What are the data used by CMS to
calculate the Median Cost, and what are the sources?
Why has CMS classified part of the
bexxar therapy as a diagnostic?
Clearly, cold, warm, and hot doses of RIT all have
therapeutic effects, and have
nothing to do with diagnostics. Only a biopsy and
resulting evaluation of tissue can diagnose a lymphoma.
Based on patient-reported bills, GSK, ASCO, ASH, and investigator
comments), the data on which the calculations were based appears to
be insufficient, and grossly inaccurate.
GSK summary of proposed payments by CMS for CY2008:
See comments on the CMS proposal, which has become a ruling:
GSK's letter is on pages 1 through 15. | ASH's comments are on pages 18 through 21
with RIT comments in pages 20 and 21. | ASCO's letter is on pages 32-36,
with RIT comments in page 35.
G3001 Supply and Admin of Bexxar (is billed
twice): $1,925.11 x 2 ($2,250 x 2 in CY2005)
A9544 Bexxar, diagnostic: no separate
A9545 Bexxar treatment: $8,283
Compared with rate of $26,163.00 in CY 2005
NOTE: It has come to our attention that GSK
has offered to provide the Average Sales Price, but CMS has
not accepted this offer, which is a way that the payment rates are
determined for other drugs. Thus, confusion about how bexxar
is classified (as in part a diagnostic procedure) appears to be
central to the bottom-line problem:
* underpayments to hospitals will lead to diminished access to RIT
for patients in need.
Other Reference Points on cost of Bexxar/Zevalin:
ASH writes: "Whether this is because [reasons provided] other reasons, unless corrected, this could prove devastating
to this important therapy. It may severely limit patient access to this invaluable treatment option since hospitals will not be able to absorb a loss exceeding
$16,000 per patient.
Our bill for Bexxar was in the year
2005 was: $32,158
Another patient reported: "For
my Zevalin treatment Medicare was billed $79,075, as best I can
tell from their summary of my account. Medicare in turn paid the
Report on Cost of Zevalin
Radioimmunotherapy Versus Cost of Standard Regimens for
Treatment of Relapsed or Refractory Indolent NHL in
|6 x R-CVP
|90Y-ibritumomab tiuxetan (Zevalin)
|6 x R-CHOP
|8 x R
|8 x R-CVP
|8 x R-CHOP
Q: Are the sponsors charging too much for
Bexxar and Zevalin?
It's worth noting
that for RIT there are two approved agents (Bexxar and Zevalin) and
therefore, atypically, price competition is already in effect
for these new agents - and
for Bexxar when it was first approved
Furthermore, the price of Zevalin (as best we can
tell) did not edge downward when Bexxar also won marketing
We think these facts are very good
indications that manufacturing and development costs are the primary
reasons these biological agents cost so much to provide ... and that
it is not a result of greed.
Finally, CMS policy of cutting reimbursements so
far is exclusive to radioimmunotherapy - a treatment for lymphoma.
Other similarly expensive targeted biological therapies have not
been treated the same.
discriminates against this "organ," but not others,
based on misinformation. The supply is cut despite warnings of
ASCO, ASH, the sponsor, and many nonprofit groups that CMS has
made an error: has grossly underestimated the costs. http://lymphomation.org/wordpress/?p=14
Q: Can society afford to pay for expensive
therapies for cancers?
We think you have to
compare the one-time cost of an effective agent against the costs of
repeated use less effective therapies - financial and to the
Notably, the alternative to RIT will many times be death, or rescue via more toxic, less effective or higher-risk therapy and more expensive in-patient treatments, such as stem cell transplantation, which is contraindicated in older patients – the population most dependent on Medicare.
From our perspective the
price of a car (approximately 32K) is not too much to pay for
getting your life back. And with your life back you can earn and pay
taxes (give back to society, instead being a burden to society and
To make good decisions we must consider all the information, not just a few parts of it. CMS (Centers for Medicaid and Medicare) has failed miserably on this account with it’s decision to cut reimbursements to hospitals in half for radioimmunotherapies (bexxar and zevalin). …
… They have not tallied the significant benefits of RIT in their equations: Allowing patients with disease resistant to chemotherapy a good chance to be productive members of society; allowing parents to live longer and better so they can nurture and provide for their families. These are among the many invaluable and incalculable returns on investments — the reason our society rewards development of innovative health
as first line therapy (already highly promising - durable
as therapy to achieve responses in patients refractory to
chemotherapy (already demonstrated), but also in patients with
transformed indolent lymphoma (already suggested)
as consolidation to first primary chemotherapy - already showing
improvements in CR rates and durations of remission in controlled
as induction therapy to be followed by patient-specific vaccines,
or other immunotherapies?
as conditioning prior to autologous stem cell transplants (already
showing promise and improved safety of TBI
as therapy to be combined with adoptive immunotherapy (infusions
of NK cells or immune modulating agents to build on the
vaccine-like effect? A vaccine-like effect, which is
strongly suggested by the delayed optimal time to response to RIT
(well beyond the drugs half life) - as long as 2 years!
as an effective option for patients who relapse following stem
Probably not all
targeted biological agents will be as expensive to produce as RIT,
but some may be. If our society decides against reimbursing for
expensive therapies for cancer, expect a heated argument
could think of medical products as organs that are invented to
sustain life, dependent on blood supply - money supply - for
sustenance. As such, the CMS error is anti-angiogenic;
cutting supply of nutrients to RIT in half; requiring hospitals to
make up the difference. CMS discriminates against this
organ, but not others, based on misinformation. The supply is cut
despite warnings of ASCO, ASH, the sponsor, and many nonprofit
groups that CMS has made an error: has grossly underestimated the
Finally, in the "Access
to Life-Saving Medicine Act," introduced by
Waxman, Schumer, and Clinton should create a clear pathway for generic
biologic drugs, which will help keep costs down in future for this
important class of drugs. Hopefully, however, the correct
balance will be achieved so that incentives to develop and
market urgently needed new biological therapies is not undermined by
Q: Why are
biological therapies more expensive?
We are developing this section.
For now, see Monoclonal antibodies for a concise overview of
how they are made - http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/M/Monoclonals.html
Q: Why is it
important to everyone that companies make a profit on the therapies
they invent and bring to market?
It is estimated that it
costs approximately one billion dollars to develop and test a new
cancer therapies, and that the failure rate is exceedingly
Because of the benefits
we receive from effectively treating disease (touched on above) our
society has wisely chosen to provide an incentive system to ensure
Thus policy that
undermines the ability of companies to profit from developing new
cancer therapies must be challenged and overturned ...
cited above: You could think of medical products as organs that
are invented to sustain life, dependent on blood supply - money
supply - for sustenance. As such, the CMS error is
anti-angiogenic; cutting supply of nutrients to RIT in half;
requiring hospitals to make up the difference. CMS
discriminates against this organ, but not others, based on
misinformation. The supply is cut despite warnings of ASCO, ASH,
the sponsor, and many nonprofit groups that CMS has made an error:
has grossly underestimated the costs. http://lymphomation.org/wordpress/?p=14
... particularly now, that
we are beginning to see genuine returns on our investments: patients
living longer, more productively, and better with lymphomas and
condemnation of CMS proposal (now ruling):
American Society of Hematology September 11, 2007
RE: CMS 1392-P, Proposed Changes to the Hospital Prospective
Payment System and CY2008 Rates
“ASH is extremely concerned about the proposed payment rate for
Bexxar (I 131 -Tositumomab), which is a radioimmunotherapy (RIT)
agent. Similar issues apply to Zevalin (Ibritumomab Tiuxetan),
which is also a RIT. The principle use of a RIT is for the
treatment of non-Hodgkin's Lymphoma for patients who have not
responded well to a prior course of chemotherapy treatment.
There are two major problems with the proposed payment for I131-
Tositumomab. First, the initial treatment is considered as a
diagnostic procedure. Under the proposed rule, the cost of
radiopharmaceuticals for diagnostic as opposed to therapeutic
purposes will be "packaged" and not separately paid.
Second, the proposed payment level for I131- Tositumomab grossly
underestimates the cost .of this product.
The complete I 131 -Tositumomab
treatment regimen is provided over 7 to 14 days. After an initial
treatment, the patient is evaluated through whole body dosimetry
to determine if the biodistribution of the agent is acceptable. If
it is not, no further I 131 -Tositumomab treatment is provided.
In the proposed rule, CMS indicates
its intention to discontinue separate payment for diagnostic
radiopharmaceuticals and to package the cost of the agent in the
cost of the nuclear medicine procedure. CMS classified the initial
dose of I 131-Tositumomab as a "diagnostic" so that it
would be classified as packaged and given “N” status under
HOPPS. This decision is erroneous.
All the doses of I 131 Tositumomab are
intended to be therapeutic and part of a multi-day treatment
regimen and thus paid separately. This is the case even if the
decision is made not to furnish any further doses because the
biodistribution .of the initial dose .of the agent was not
It is also our understanding that the proposed payment rate for
the therapeutic use of I 131 -Tositumomab would cover less
than half of the $30,000 cost to hospitals.
It is clear that the CMS' estimate of costs grossly undervalues
actual costs of II 31- Tositumomab.
Whether this is because of a defect in the cost to charge method (CCR)
due to the unwillingness of hospitals to adequately mark up the
charges for very costly services (i.e., the phenomenon of charge
compression) or for other reasons, unless corrected, this could
prove devastating to this important therapy.
It may severely limit patient access to this invaluable treatment
since hospitals will not be able to absorb a loss
exceeding $16,000 per patient.
If this occurs it will eliminate one of the few treatment options
and perhaps the only treatment option for some patients with
non-Hodgkin's Lymphoma who have failed chemotherapy treatment.
And, finally, it could have a chilling effect on the development
of future drugs and radiopharmaceuticals for treating other forms
of cancer and other diseases.
For purposes of the proposed packaging
rule. ASH strongly urges CMS to reconsider the classification of
1131- Tositumomab as a diagnostic radiopharmaceutical and to treat
all doses of I 131 -Tositumomab as therapeutic.
With respect to the level of payment,
ASH is not presenting specific recommendations as to how CMS can
best fix this problem. The Society understands that this issue was
presented at the meeting of the APC Advisory Committee on
September 6, 2007 and that several options were proposed. This
included paying for the agent as a drug and not as a
radiopharmaceutical so that it would be paid at the rate of 106
percent of average sales price (ASP).
ASH further understands that the
manufacturer has indicated a willingness to submit quarterly ASP
prices. Also, the APC Advisory Committee and the manufacturer
urged CMS to consider establishing a "composite" APC
reflecting the full costs for the entire course of therapy
including all the procedural services, radiopharmaceuticals, drugs
and supplies. All of these methods would seem promising. However,
what is critical is that CMS find ways to substantially improve
the payment so that patients are not deprived access to this
valuable cancer treatment.
Thank you again for the opportunity to
offer these comments. If ASH can provide any further assistance
including furnishing the actual survey instrument and survey data,
please contact Carol Schwartz. ASH Senior Manager of Policy and
Practice. at 202-292-0258 or at email@example.com
Sincerely, Andrew I. Schafer President
Practical and clinical benefits of radioimmunotherapy lead to advantages in cost-effectiveness
in the treatment of patients with non-Hodgkin's lymphoma.
Nuclear Medicine Communications. 27(10):753-756, October 2006.
Otte, Andreas a; Thompson, Sally L. b
of 90Y-Ibritumomab Tiuxetan Radioimmunotherapy Versus
Cost of Standard Regimens
for the Treatment of Relapsed or Refractory Indolent Non-Hodgkins
in Switzerland. Session Type: Poster Session, Board #539-III
In conclusion, 90Y-ibritumomab tiuxetan is not
more expensive than other established treatments for relapsed or
refractory indolent NHL. Table 1. Per-patient costs by treatment