Yesterday evening, the Centers for Medicare and Medicaid Services (CMS) announced that it was opening a “national coverage analysis to determine whether or not autologous cellular immunotherapy [for prostate cancer with sipuleucel-T/Provenge] is reasonable and necessary.” The official statement from CMS can be found on its web site.
The determination whether to advise all Medicare contractors to cover a specific form of therapy (“national coverage”) is actually a very normal process. Important new forms of treatment commonly undergo such a national coverage analysis, and a period for public comment is a usual and customary part of that decision process.
However, some on Wall Street responded to this announcement from CMS as though it was a suggestion that Medicare might not cover the costs of treatment with sipuleucel-T. The fact that it could take up to a year to complete the analysis also appears to have made some people nervous about whether Medicare would cover the costs of sipuleucel-T.
Until such a national coverage determination is in place, the nine regional Medicare contractors are at liberty to make individual decisions as to whether to cover costs associated with Provenge therapy. To date there seems to have been no question about such coverage from any regional Medicare contractor.
The manufacturer of sipuleucel-T made the following statement in response to the CMS announcement: “Dendreon welcomes the opportunity to continue our discussions with CMS about how Provenge will be provided to Medicare beneficiaries, particularly given the survival benefit and safety profile of Provenge. We plan on continuing to work closely with CMS during this process to ensure patients with advanced prostate cancer have broad access to Provenge.”
Current policies actually require CMS to cover costs associated with on-label treatment with all approved cancer therapeutics for all appropriate Medicare patients. It is hard to see that Medicare would not cover costs associated with sipuleucel-T. However, those who wish to do so can take the opportunity to give public input to CMS through the appropriate comments page on the CMS web site. Prostate Cancer International, Inc. (the parent organization of The “New” Prostate Cancer InfoLink) has already submitted comment to CMS requesting national coverage approval. All such comment must be submitted on or before July 30, 2010.
The issue of Medicaid coverage for Provenge may, however, be very different. Medicaid is a state-based program when it comes to coverage. Most states already have a budget crisis on their hands, and Medicaid budgets are liable to be severely restricted in 2011 and the remainder of 2010. There will inevitably be questions about whether individual states can afford to cover the costs of sipuleucel-T for Medicaid patients.
Filed under: Management | Tagged: coverage, Medicaid, Medicare, Provenge, sipuleucel-T |
THE "NEW" PROSTATE CANCER INFOLINK 
For those interested in getting another “take” on the CMS decision to open a national coverage analysis process for sipuleucel-T, we recommend this commentary by Avik Roy on Forbes.com.
There does not seem to be a debate, under the current regulations Medicare will ultimately be required to cover the cost of Provenge. Yet, another road block, or at least a speed bump, has been thrown up for men who are in fact the ones in the most need.
Despite an overwhelmingly positive FDA Advisory Committee recommendation to approve Provenge, the FDA delayed its approval for years. How many men were denied access and its potential benefit as we waited. Now, for many men, another delay and maybe even an ultimate denial as their disease continues to progresses as what seems to be, under current regulations, this meaningless process meanders on.
There have been many private insurers who have already recognized their responsibility and paid for Provenge. Some regions (MACS) have also acknowledged their responsibility and approved the treatment for men living in their region, but other regions have instead delayed their determination. They continue to make men jump through hoops and wait.
My cynical self can’t help but believe that their game plan is to delay approval long enough to allow the disease to continue to progress so that the men will fall outside the FDA’s approved label so approval can be denied.
Come on guys, the law is clear, if the FDA has approved the drug it must be paid for by Medicare, despite the price. This delaying tact is unethical and despicable.
Now, despite the law, it is reasonable to assume that there will be many men “left in the cold.” They have spent their entire working life paying into the Medicare fund and now will be delayed out of the treatment.
What about the poor under the age of 65 years, are they any less deserving of sharing the benefits of Provenge? Our current health care system might end up determining that they are not deserving of equal treatment.
Joel: Which regional MACS have refused to pay for sipuleucel-T?