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Advocacy > Background > Our Letter | Endorse Our Letter | Attachments 08/31/2007 Please show your support for this effort by adding your name to this petition. |
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The Honorable Herb B. Kuhn Re:
CMS-1392-P - Proposed reimbursement
rates for Radioimmunotherapy: Bexxar (I131 tositumomab) and Zevalin (Y90 ibritumomab) Dear
Administrator Kuhn: Patients
Against Lymphoma is a non-profit organization, independent of health
industry funding. In this
letter we are representing the concerns of many lymphoma survivors and
their loved ones regarding proposed CMS payment policies for
radioimmunotherapy (RIT) agents (Bexxar and Zevalin),
administration, and supply.[i]
As shown in the enclosed chart [ii],
the proposed reimbursement for Bexxar (I131Tositumomab) is regrettably
less than half its cost, which causes hospitals to lose money, which
if approved would force hospitals to subsidize its use, which is
highly unlikely. These are our main concerns about
proposed reimbursement rates
for RIT for patients with life-threatening lymphomas:
We agree with Dr. Mark Kaminski, [2]
a principal inventor of radioimmunotherapy, that the low payment
policies for RIT will have a “devastating” effect on
lymphoma patients living with the disease today, on future patients,
and on cancer research in general – creating a domino effect[v]
described in the appendix. The need: Each person’s lifetime risk of developing a lymphoma is approximately 1 in 50. Presently, in the United States about 500,000 individuals live with the disease. [3] Most, but not all lymphomas are of the b-cell type, which carries the target receptor for currently approved RIT. The
proven importance of RIT: Radioimmunotherapy
is a targeted antibody-based treatment that more selectively binds to
cancer cells and delivers radioactive isotopes, which kill the tumor
cells. It
combines radiotherapy with immunotherapy, which may explain both the
potency and the long duration of benefit that is often achieved and
measured in years. iii[vi]
Indeed, RIT therapeutics are the most potent and effective
therapeutic agents ever invented for lymphoma, and arguably for
any cancer: Dr. Bruce Cheson – an internationally recognized expert on lymphomas and long-standing former member of the FDA Oncological Drug Advisory committee – recently stated: "RIT is the most effective, least used
treatment in oncology. "Companies are both losing money. Done
once, it's over. 70-80% CR (complete response rates); up to half
the patients depending on the context. It's easily tolerated, but you
can't sell it. .... Reasons you can't do it?" Complicated, but
mainly: Requires the oncologist to send the patient somewhere else to
get treatment." [4] Also, in order to highlight the impact of
RIT: “In clinical trials
of Bexxar, objective response rates ranged from 54%-71% in heavily
pretreated patients. In the pivotal trial, the number of patients
with a longer duration of response after treatment with Bexxar was
significantly greater than the number of patients with a longer
duration of response after their last qualifying chemotherapy
regimen. In 76 newly diagnosed patients, the objective response rate
was 97%, and 63% of patients achieved complete responses.” It’s worth noting that RIT is many times an alternative to more expensive and higher-risk stem cell transplantation[5] (SCT), which can be effective but has a significantly higher mortality risk and a greater negative impact on quality of life. Importantly, SCT is often contraindicated in older patients – which is the population most dependent on Medicare. So we urge the leadership within CMS to reconsider the “mean unit methodology” for determining payments to hospitals for RIT in order to safeguard and utilize a proven effective treatment for patients in need, as outlined in the appendix [vii] In
summary: Low payment rates to hospitals for RIT sets a dangerous and
disturbing precedent that: o
Would
increase pain, suffering, and loss of life. Real people, such as my spouse as well as the
undersigned, and many thousands more may lose the opportunity to
benefit from RIT in order to live longer and better, to provide for
themselves and their families and to contribute to society. The alternative to RIT will many times be death, or
rescue via less effective or higher-risk therapy and more expensive
in-patient treatments, such as Stem Cell Transplantation. o
Would limit a physician's ability to prescribe a highly
effective therapy today A well-established body of literature clearly
shows that RIT is highly effective yet underutilized 3 ;
and that RIT can induce durable complete responses in a sizable
percentage of patients refractory to chemotherapies.iii o
Could lead to the termination of radioimmunotherapy in the near
future. These drugs are already at a financial disadvantage
because oncologists must refer patients to nuclear medicine physicians
or radiation oncologists and thus oncologists are more likely to
prescribe drugs which they can administer. CMS statistics on usage already shows that these agents
are rarely prescribed in relation to other protocols that are not as
effective. [viii] The marketplace difficulties faced by both Bexxar and
Zevalin have both been well documented in national press, including a
recent feature in the NY Times and JCNI.3 Coupled with the referral problem, many experts and
advocates believe that the proposed reimbursement will spell the end
of these drugs. o
Would be a disincentive for the pharmaceutical industry to develop
new cancer drugs. As
you know, developing and testing new cancer drugs is high risk,
time-consuming, and expensive process.
Recent estimates show the cost may be as high as $900 million
to develop and assess a new cancer drug.
We
need to adopt policies that will make companies more willing to take
the considerable financial risks, not less willing, if we to make good
on our society’s commitment to wage war on cancers. It's
important to note and to fully consider that most new drugs don't win
marketing approval. Thus, it's essential that sponsors who
succeed in developing urgently needed drugs for cancer benefit
financially. The reporting system does not lend itself to stakeholder
participation and comments: o
The
people affected by cancer and their loved ones, are the
primary stakeholders, as are patients who will be diagnosed in
future (the public). As
patients and caregivers
of cancer patients, we respectfully request that CMS consider
evaluating and modifying the manner in which regulatory information is
conveyed. As a group, we
include individuals well versed in medical terminology and reading
regulatory publications. Nonetheless,
we hope it will be helpful to CMS to know that although we worked as a
group, we found it extremely difficult to decipher the meaning and
impact of the proposed regulations affecting reimbursement for Zevalin
and Bexxar. It’s our
hope that CMS will modify the manner in which such information is
conveyed in order for laypeople to comprehend the content and it’s
potential impact on our lives. In closing, we cannot afford to ignore these issues or to be silent. Underpaying hospitals for costs of providing radioimmunotherapy is already having a negative impact on the level of care for patients with lymphoma, who now have an improving hope of conquering or better managing the disease and living normal, productive lives. We, as well as the undersigned who share their concerns in the attachments to this letter, urge CMS to fully reimburse for the use of Bexxar and Zevalin. We also urge CMS,
the medical community, advocates, and our elected representatives, to
work cooperatively in order to fully fund CMS and identify responsible
ways to reduce health care costs in order to meet the urgent needs of
cancer patients, present and future.
Thank you for your attention to our concerns. Respectfully, Karl Schwartz
(caregiver) President, Patients Against Lymphoma Appendix i – ix (details and references)
[1] Market Forces Cited in
Lymphoma Drugs’ Disuse - New York Times | JCNI 7/14/2007 [2] Letter to CMS from Dr. Mark Kaminski dated 10/10/2006 [3]
SEER FastStats [4] Follicular Lymphomas, Dr. Bruce Cheson, LRF Education Forum - 2006 http://www.presentme.com/FLASH/20061027LRFCheson/ [5] Blood and marrow transplantation compensation: perspective in payer and provider relations. Biol Blood Marrow Transplant. 2004 Jul;10(7):427-32. Review. PMID: 15205664
[i]
Federal
Register / Vol. 72, No. 148 / Thursday, August 2, 2007 /
Proposed Rules Pg 43035 [ii]
Table: Estimated Cost versus Reimbursement - produced by
Patients Against Lymphoma
[iii]
Select RIT Abstracts – highlighting the ability of RIT to
induce durable remissions * Targeted Radio-Immunotherapy
with Bexxar Produces Durable Remissions in Patients * Efficacy and safety of Bexxar in
B-cell lymphoma, progressive after rituximab. * A clinical and scientific overview of
tositumomab (Zevalin) and iodine I 131 tositumomab (Bexxar). Semin
Oncol. 2003 Apr;30(2 Suppl 4):22-30. Review. PMID: 12728404 * Tositumomab (Zevalin)
and iodine-131 tositumomab (Bexxar) produces durable complete
remissions in a subset of heavily pretreated patients with
low-grade and transformed non-Hodgkin's lymphomas. J Clin Oncol. 2005 Oct
20;23(30):7565-73. Epub 2005 Sep 26. PMID: 16186600 * Zevalin
radioimmunotherapy produces high response rates and durable
remissions * Durable responses after ibritumomab
tiuxetan radioimmunotherapy (Zevalin) for
[iv] Lost
opportunities: For patients – the primary stakeholders – the low
payment rates to hospitals for RIT have almost certainly led to
lost opportunities to live longer and better with lymphomas.
This assertion is strongly suggested by the durable
remissions resulting from RIT, among patients with advanced
disease, refractory to standard chemotherapy in clinical trials.
iii Notably, the remissions from RIT can last many years - a
sizable number of very durable remissions suggesting that some
of these patients may even be cured. [v] The
domino effect: We submit that the concerns expressed by leading
investigators, patient advocates, and industry organizations
about the future of RIT are already taking place in part because
of market factors influenced by CMS payment policies.
The domino effect: [vi]
CMS Table on Minimum Unit Costs
[vii] Regarding
CMS calculations: Since
Zevalin’s approval in 2002 and Bexxar’s approval in 2003, CMS
has classified the components of the treatment separately. For
Calendar Year (CY) 2008, CMS proposes payment rates to hospitals
for RIT agents, administration and supply based on mean unit
cost as reported in the 2006 Outpatient Department Prospective Payment System (OPPS) claims data. Standing
out in our analysis is that the range from which the mean is
calculated starts at at $16.57(dx) and $4.34(rx) for Bexxar, and
$37.27 (dx) and $4.77(rx) for Zevalin, which are unrealistically
low estimates of cost for radio pharmaceuticals, which also
calls into question the validity of the calculated CMS payment
rate to hospitals. Whatever
the basis for the mean costs by CMS – in both the therapeutic
(rx) and diagnostic (dx) setting – the calculations, according
to multiple reliable sources, results in substantial reimbursement
reductions, resulting in payments to hospitals that “are too
low and inadequate”. *
*
ASTRO letter to CMS: MS-1206-FC: Medicare Program; Changes to the
Hospital Outpatient Prospective Payment System and Calendar Year
2003 Payment Rates https://www.astro.org/PublicPolicy/CommentLettersTestimonyAndReports/documents/cy03oppsfr1202.pdf
[viii]
CMS-1506-P Page
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