Dear friends,
Centers for Medicare and Medicaid Services (CMS) is proposing deep cuts in reimbursement of RIT (bexxar now) See details buried in this large document: http://www.cms.hhs.gov/QuarterlyProviderUpdates/downloads/cms1392p.pdf
Many thanks, again, to Betsy de Parre for the alert and the information that follows regarding how to voice your concern about the CMS proposal.
Please make your voice heard ... again ... as we did successfully when CMS proposed cutting off-label use of cancer drugs.
Here are the steps:
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If desired, prepare your comments in advance in a word processing program.
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Go to: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=CMS
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On the left, click on CMS-1392-P and then click "Go" on the right.
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Fill out your name and category on the new page, when prompted.
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Click continue and select the "issue area" on a new page.
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Scroll down (midway) in Issue Area and click:
Payment for Therapeutic Radiopharmaceuticals"
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Type or copy your comments in the space provided on the new page.
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We posted the following:
Dear Sir or Madam:
I am writing to share my deep concern for the proposed deep cuts in reimbursement for radioimmunotherapy (RIT).
Through our non-profit organization, Patients Against Lymphoma, I represent patients and caregivers touched by lymphomas. I also serve as a patient consultant to FDA (ODAC). My spouse, Joanne, was diagnosed in 1996 with an incurable type of indolent lymphoma: follicular center cell.
Her response to CHOP in 1997 was short-lived lasting less than 8 months. Following each relapse the lymphoma progressed relentlessly, requiring numerous courses of chemotherapy to keep the lymphoma from getting too advanced. Subsequent treatments never achieved a remission, and the lymphoma was evident quickly following therapy each time, often before her hair grew back fully.
In February of 2005 following a single course of Bexxar RIT the disease is no longer detectable today – more than 2 years later. Her weight has returned to normal, as are her blood counts – and her life.
I feel certain that without the availability of RIT, Joanne would have required a stem cell transplant, which, as you know, involves high dose chemotherapy, radiation, extensive hospitalization, and significant mortality risks.
Importantly, a review the literature will show that Joanne’s experience with RIT is not unique. Many patients with advanced disease and many prior therapies RIT can and often do achieve durable complete remissions. See http://lymphomation.org/treatment-rit.htm#about
I feel that the policy change will devastate lymphoma patients and their families, present and future.
* It’s likely to change prescribing practices, which already favor using chemotherapy and Rituxan over RIT.
* It will make RIT too expensive for many patients to afford.
* It will move the sponsors of Zevalin and Bexxar to discontinue them, as it is widely known that each are not yet profitable.
Finally, cutting reimbursements for RIT will be a disincentive for companies to develop new therapies, which are still urgently needed. We need to adopt policies that will make companies more willing to take these financial risks, not less willing, if we are to make significant progress in treating the victims of cancer.
Karl Schwartz
President, Patients Against Lymphoma
