Sunday, August 15, 2010

Medical Rationing Begins

I HATE to see stories such as this:

Medicare Says No to Stem Cells for MDS
By Charles Bankhead, Staff Writer, MedPage Today
Published: August 06, 2010

WASHINGTON -- Medicare patients with myelodysplastic syndrome (MDS) will receive coverage for allogeneic hematopoietic stem cell transplantation only when participating in qualified clinical trials, the Centers for Medicare and Medicaid Services (CMS) has ruled.

CMS decided against coverage because available evidence "does not demonstrate that the use of allogeneic hematopoietic stem cell transplantation improves health outcomes in Medicare beneficiaries with MDS."

However, the agency also ruled that allogeneic stem cell transplantation is "reasonable and necessary" for MDS through the Coverage with Evidence Development provisions of Medicare regulations. As a result, Medicare beneficiaries can qualify for coverage of therapy provided through clinical trials that meet certain criteria.

CMS will consider only prospective clinical trials that examine allogeneic hematopoietic stem cell transplantation's effect on the outcomes of relapse-free mortality, progression-free survival, relapse, and overall survival. Trials must address one or more aspects of three questions:

* How does transplantation affect outcomes in Medicare patients with MDS as compared with no transplantation?
* How do the International Prognostic Scoring System score, patient age, cytopenias, and comorbidities affect the outcomes?
* What characteristics of treatment facilities predict clinically meaningful improvement in the outcomes?

The complete text of the CMS decision is available at

NICE in the UK is notorious for denying life-saving drugs to their citizens (one of the latest is Vidaza for myelodysplastic syndrome, which is a side-effect for CLL patients of FCR). This is one of the few drugs that is available for MDS, but because medical care is under the purview of the government, and not private insurance companies, there is real pressure to save money.

This is not a good development. Look for further degradation of the American health care system to 'save government money'.

Things pretty much the same

No real changes to report. I have been a bit bothered by some pain in my duodenum. I found this out when I took a couple of aspirin because of some severe back pain I was having. I hurt my back when I filled my car up with gas. Perhaps a somatic response to the pain of paying $50 for a fill-up.

Anyway, besides the back pain, the pain in my duodenum, and miscellaneous pains elsewhere, more due perhaps to advancing age than the CLL, I have been feeling fairly well. I know that the average remission after flavopiridol (Alvocidib) is only nine months for 11q- folks like myself, so I'm half-way there. (My last treatment was in March.)

Unlike many chemotherapy regimes, most responders respond as well the second time to flavopiridol as they did the first time. I must be frank and tell you that I simply don't look forward to giving another eight months over to feeling fairly rotten two days of the week, four weeks in a row, with a blessed two week holiday after each cycle.

But if it keeps me alive, I would do it again.

And I understand that the treatment pattern has changed in the trial. Now, apparently, they are giving the drug for three weeks in a row, with two weeks off. Well, that's better than nothing!

My personal feeling (which may be totally without foundation) is that they might give flavopiridol once a month as a maintenance dose for those who do respond. The drug, it turns out, does depress the neutrophils, and perhaps the platelets, and the hemoglobin levels. So contrary to what I was given to understand, there is some hematologic effects.

In any case, I will see Dr. Kipps within the month, to see how I am doing. Since I stupidly did FCR, I am at a higher risk for MDS and Richter's transformation.

BTW, I did get a once-over by the dermatologist, and seem to be free from the other scourge of CLL patients, melanoma. I also have a fair number of dysplastic moles from my days as a frequent swimmer, hiker, and all-around pool guy. I love the out-of-doors, but there can be a price to be paid.