Is CMS using the process of National Coverage Determination to sneak comparative effectiveness into the back door? That might be an overstatement. Probably fairer to say that CMS is putting it right on the table. It will control the methodologies and when it will be used and under what conditions unless a more transparent and consumer focused approach is quickly developed. And CMS, much like NICE is aiming straight for the most innovative technologies that allow more personalized and preventive treatment of diseases such as cancer. Here's an example of a technology CMS worries might not be comparatively effective:
"A limited body of evidence informs gene expression profiling tests to inform cancer therapy decisions. It is unclear if the widespread addition of such testing to the evaluation of patients with would result in a meaningful change in disease management and improved health outcomes."
Yes, and it was unclear if the widespread addition of taxol to breast cancer patients would result in a meaningful change either. But it did. But only after we had a widespread addition through clinical use.
The larger issue is how CMS sticks approaches to evaluation that are outdated and fail to incorporate the same science used to develop the technologies they want to measure. This includes biological m markers of disease, disease progression, differences in treatment response and effects. This was and is the rate limiting factor that led the FDA to launch the Critical Path.
The Personalized Medicine Coalition has offered to meet with CMS to encourage a more patient-centered approach in evaluation, which is a great first step. But we need a Critical Path for Personalized Medicine to insure that the old tools and methods of evaluation are not used to exclude and delay access to innovations but instead help guide appropriate use from the outset and learn from how clinicians optimize care.
Here's a laundry list of some of the new technologies (and a few old ones) that CMS wants to apply outdated comparative effectiveness evaluation as NICE does in the UK
http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19
Contact PMC for a copy of the letter it sent to CMS. It lays out a set of common sense set of patient-centered principles for evaluating new medical technologies.
http://www.personalizedmedicinecoalition.org/
"A limited body of evidence informs gene expression profiling tests to inform cancer therapy decisions. It is unclear if the widespread addition of such testing to the evaluation of patients with would result in a meaningful change in disease management and improved health outcomes."
Yes, and it was unclear if the widespread addition of taxol to breast cancer patients would result in a meaningful change either. But it did. But only after we had a widespread addition through clinical use.
The larger issue is how CMS sticks approaches to evaluation that are outdated and fail to incorporate the same science used to develop the technologies they want to measure. This includes biological m markers of disease, disease progression, differences in treatment response and effects. This was and is the rate limiting factor that led the FDA to launch the Critical Path.
The Personalized Medicine Coalition has offered to meet with CMS to encourage a more patient-centered approach in evaluation, which is a great first step. But we need a Critical Path for Personalized Medicine to insure that the old tools and methods of evaluation are not used to exclude and delay access to innovations but instead help guide appropriate use from the outset and learn from how clinicians optimize care.
Here's a laundry list of some of the new technologies (and a few old ones) that CMS wants to apply outdated comparative effectiveness evaluation as NICE does in the UK
http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19
Contact PMC for a copy of the letter it sent to CMS. It lays out a set of common sense set of patient-centered principles for evaluating new medical technologies.
http://www.personalizedmedicinecoalition.org/
