Medicare: Easy way to cut

iVillage Member
Registered: 10-25-2006
Medicare: Easy way to cut
Sat, 07-02-2011 - 9:14am
This is absurd....spending $93,000 to extend the life of a very sick person only 4 mos.


From Medscape Medical News CMS to Pay for Provenge for Metastatic Prostate Cancer

Nick Mulcahy

June 30, 2011 — In a final decision memo, the Centers for Medicare and Medicaid Services (CMS) announced today that it will provide coverage for the use of Provenge (Dendreon), the prostate cancer vaccine known generically as sipuleucel-T, in patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

"We are optimistic that innovative strategies may improve the experience of care for our beneficiaries who have cancer," said Donald M. Berwick, MD, administrator of CMS, in a press statement about the coverage decision of the unique treatment, which is derived from a patient's own white blood cells. "CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes."

The announcement means that the coverage decision is in keeping with the US Food and Drug Administration's (FDA's) indication for the vaccine.

"CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label," said Patrick Conway, MD, chief medical officer and director of Office of Clinical Standards & Quality at CMS.

Off-label usage will not be covered nationally but instead will be left for local Medicare administrative contractors to decide upon, according to CMS.

Off-label usage is likely to be highly scrutinized. "We do not believe there is any persuasive evidence for the off label use of sipuleucel-T at this time," reads the National Coverage Decision memo from CMS.

The new coverage decision comes after an unusually protracted review by CMS of Provenge, which costs $93,000 for a typical course of 3 treatments.

The vaccine was subject to a CMS National Coverage Analysis, which included a review by a federal panel known as the Medicare Evidence Development and Coverage Advisory Committee.

In November 2010, the committee gave what amounted to a middling vote of confidence for the on-label use of Provenge and a rejection for off-label use.

The combination of the high cost of Provenge and an atmosphere of high-intensity federal budget scrutiny contributed to widespread news coverage of the therapy and the CMS review.

However, there have also been questions about Provenge data because of potential confounding effects of subsequent treatments of some patients in clinical trials. In a technology assessment quoted in the CMS decision memo, the assessment authors noted that the benefit from Provenge occurred in clinical trials that included chemotherapy. "This treatment effect occurs in the context of use of post-progression chemotherapy," the document reads.

Although referred to as a vaccine, sipuleucel-T is actually an autologous active cellular immunotherapy, which means that it is made from the patient's white blood cells and stimulates a patient's immune system to respond against the cancer. The treatment needs to be manufactured individually for each patient.

Sipuleucel-T was the first product approved by the FDA in a new therapeutic class known as active cellular immunotherapies.

In a pivotal phase



iVillage Member
Registered: 05-13-2009
Thu, 07-07-2011 - 2:47pm

A nuanced conclusion based on a philosophical discussion that if resources are extremely limited, organs or rare vaccines, some will live and others will die. If that leads you to conclude that Emanuel believes public health policy should favor adolescents over seniors your understanding of his written and spoken body of work is much different than mine.

The Sophie's Choice example is one I'd make in my own family. If an organ, only 1 available, could save my father or my son, I'd make the choice to save my son, but I'd also move heaven and earth to ensure that my father received effective care with non-scarce resources.

iVillage Member
Registered: 11-27-2009
Fri, 07-08-2011 - 8:27am
It was an option he clearly spelled out in his thoughts, not just his thoughts, on the 5 or 6 options presented for approaching scarce resources.

"The Sophie's Choice example is one I'd make in my own family. If an organ, only 1 available, could save my father or my son, I'd make the choice to save my son, but I'd also move heaven and earth to ensure that my father received effective care with non-scarce resources."
And that would be your families personal decision, and I would assume that you have also given your father a voice in this decision.
iVillage Member
Registered: 05-13-2009
Fri, 07-08-2011 - 11:01am
No I would not ask my father for his opinion because it's a hypothetical discussion on the ethics of rationing scarce health care resources. It doesn't mean I have a plan or intent to kill my father.
iVillage Member
Registered: 11-27-2009
Fri, 07-08-2011 - 12:05pm
I was also speaking hypothetically.
Of course you have no plan or intent to kill your father, who would ever even think such a thing. That thought never crossed my mind. My thoughts were along the lines of the end of life care process. This isn't just a debate topic for me.