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Alert Number 53

Cancer Drugs, Wheelchairs on Medicare's Cutback List

Date: October 25, 2004

Just in case you did not consider important the recent Alert on the need to have patient advocates on the Medicare Advisory Committee, you might want to read the attached news report. On the Medicare cutback list are two drugs that are of tremendous importance to non-Hodgkin's lymphoma patients. NHL is also a B-cell cancer. Bexxar and Zevalin are monoclonal antibodies just like Rituxan. In fact the only major difference between these drugs and Rituxan is that they also carry a radioactive payload, to increase the cancer cell kill. They are not often used in CLL, since most of our patients have significant bone marrow involvement, and the collateral damage due to the radioactivity causes unacceptable level of bone marrow toxicity. They have been used in CLL patients undergoing full allo-bone marrow transplants, where the idea is to nuke the patient's bone marrow, replace it with the donor's.

But this could be just the leading edge of things to come. There are ominous rumblings that Medicare will stop paying for off-label use of drugs. If the FDA has not specifically approved the use of that particular drug in that particular situation, you may be out of luck. Well, guess what folks. Rituxan is still not approved for use in CLL, as frontline single agent therapy. There are several good studies that show that in fact Rituxan works a lot better in chemo naive patients, as opposed to folks who have already had chemotherapy. Maintenance therapy with Rituxan has become a popular option for many CLL patients. But the FDA has yet to get caught up with the reality of our choices. If Medicare stops paying for Rituxan use as frontline therapy, it will not be long before the rest of the insurance companies follow suit. How many of us can afford to pay for Rituxan maintenance therapy out of our pockets? Here is a case where your preference and your doctor's prescription may get trumped by Medicare payment guidelines.

FDA rulings are a fig leaf that is often used by insurance companies to deny benefits. In fact they also provide cover for public policy guidelines in other countries as well. Many patients in Canada and Europe, Australia and other developed and wealthy countries have restricted access to Rituxan therapy, more so than in the U.S.A. Since many CLL patients tend to be Medicare eligible, this is a huge issue for us.

I welcome your comments and suggestions.

Be well,

Chaya
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Press Report

Cancer Drugs, Wheelchairs on Medicare's Cutback List

ConsumerAffairs.com
February 2, 2004

http://consumeraffairs.com/news04/medicare_wheelchairs.html

Medicare has been cracking down on claims for motorized wheelchairs in recent months and may soon refuse to pay for experimental cancer drugs.

In the case of the motorized wheelchairs, officials of the Centers for Medicare and Medicaid Services (CMS) say the crackdown is a response to a growing incidence of abuse and does not represent a new policy.

Providers of the wheelchairs and spokesmen for affected groups disagree. Long-term care providers say that denying the powered wheelchairs means that staff members or family caregivers will have to perform many functions that ill or disabled persons are able to do by themselves if they have the motorized chairs.

"They are going to force people to impoverish themselves in institutional settings. People who have not committed fraud are penalized, and the punishment doesn't fit the crime," said Andrew Imparato, president of the American Association of People with Disabilities.

The crackdown was ordered by Thomas A. Scully, who stepped down as CMS administrator to take a lobbying position last month. At the time Scully said the increased scrutiny was in response to increasing fraud.

Demand for the motorized wheelchairs has nearly tripled in recent years, much of it sparked by shady companies who used high-pressure salespeople to sell the chairs and who took advantage of a relative loose Medicare approval process.

More than 60 cases have been filed against alleged such perpetrators.

Besides prosecuting fraudulent wheelchair salespeople, CMS instituted a new ten-point program that includes much tighter screenings of claims and narrows the outline of who is eligible for a power wheelchair.

The cutback in payments for expensive cancer drugs would initially affect only four drugs, used to fight non-Hodgkin's lymphoma and colorectal cancer. But a decision on those four could set a precedent that would apply to many other costly drugs.

The drugs in question include Bexxar and Zevalin, from GlaxoSmithKline and Biogen Idec respectively. They are sometimes used as first-line treatment for non-Hodgkin's lymphoma at a cost of more than $22,000 for a course of treatment. They are approved for use only as third-line treatment, after other drugs have failed.

The other two drugs are Camptosar and Eloxatin, made by Pfizer and Sanofi-Synthelabo, used to treat colorectal cancer. Medicare administrators face the uneasy task of living within their budget as they prepare to initiate a costly new prescription drug benefit. Excessive spending in one area means spending in other areas must be cut back.

In the case of "off-label" cancer drugs, Medicare would try to cut back on reimbursements for drugs that doctors prescribe to treat one type of cancer that may not be approved by the F.D.A. or recognize by medical texts as being effective. Such off-label use is commonly accepted and is a part of nearly every cancer specialist's arsenal.

If Medicare stopped paying for off-label treatments, the government would save billions of dollars but elderly cancer patients would either have to pay the cost out of their own pockets or their doctors would have to prescribe other drugs that might not work as well.

There might also be intense pressure on the drug companies to reduce the cost of the drugs, or to broaden their compassionate programs, under which expensive drugs are made available at little or no cost to those who cannot afford them.

Currently, Medicare pays only for drugs administrated in a physician's office or hospital. But when the prescription drug plan goes into effect in 2006, Medicare will pay for all drugs. Thus a ban on drugs used for unapproved purposes would have enormous impact.
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