[zrmorgan]

So it is interesting....Aetna has delayed its reimbursement decision regarding anesthesia providers and propofol MAC. The decision has not been withdrawn or reversed due to Aetnas belief that...

"new medical devices as well as new sedatives are expected on the market by late summer, and are in review with the FDA now. They are designed to provide a patient experience that is very similar, or perhaps, better than MAC, but can be managed exclusively by the GI performing the screening procedure"

Does anyone here know what they are referring to? Medical devices? New sedatives? Is there a perfect sedative out there that the operator can give and not have to monitor their patient? What medical devices are they talking about?

Huh?

http://www.aetna.com/news/2008/0227.htm

[RN1989]

Sounds like they just don't want to pay because propofol is expensive.

[RedCell]

Originally Posted by zrmorgan

Does anyone here know what they are referring to? Medical devices? New sedatives? Is there a perfect sedative out there that the operator can give and not have to monitor their patient? What medical devices are they talking about?

Huh?

http://www.aetna.com/news/2008/0227.htm

New drug, aquavan (fospropofol), its a water soluble prodrug of propofol. Thats the answer for the GI and Insurance dudes. Respiratory and cardiac depression are not as worriesome. Standards of care i.e. monitors still apply. Doubt it will be used by anesthetists, but safer than someone pushing the white stuff with no airway expertise.

[deepz]

Aetna's just dragging their feet. Typical: deny payment, then delay payment.


Butg anyway, Google this

Aquavan® (fospropofol disodium)

That might be the reference.

[wtbcrna]

Originally Posted by zrmorgan

So it is interesting....Aetna has delayed its reimbursement decision regarding anesthesia providers and propofol MAC. The decision has not been withdrawn or reversed due to Aetnas belief that...

"new medical devices as well as new sedatives are expected on the market by late summer, and are in review with the FDA now. They are designed to provide a patient experience that is very similar, or perhaps, better than MAC, but can be managed exclusively by the GI performing the screening procedure"

Does anyone here know what they are referring to? Medical devices? New sedatives? Is there a perfect sedative out there that the operator can give and not have to monitor their patient? What medical devices are they talking about?

Huh?

http://www.aetna.com/news/2008/0227.htm

I think they are probably talking about aquavan which is a prodrug of propofol that is being specifically marketed towards moderate sedation. http://www.drugs.com/nda/aquavan_070927.html I would venture to say they new medical device is probably BIS or they might be talking about patient controlled "sedation". http://www.ncbi.nlm.nih.gov/pubmed/10781117

[Annony RN]

are they thinking ahead hoping for sedasys?

http://www.ethiconendo.com/dtcf/pages/press_room_27.htm

[zrmorgan]

US FDA staff-Proposed Eisai sedative seems to work

WASHINGTON, May 5 - An experimental sedative from Japan's Eisai Co Ltd appeared to be effective in a preliminary evaluation of data, U.S. drug reviewers said in an analysis released on Monday.
The Food and Drug Administration will ask an advisory panel, however, if the drug can be given safely by medical personnel without general anesthesia training, agency staff said. The panel of outside experts meets on Wednesday.
The FDA's review was ongoing but so far data seemed to back the maker's finding that the drug, Aquavan, was safe as used in clinical studies, according to the analysis dated April 11 and posted on the agency's Web site on Monday.
Eisai, Japan's fourth-largest drugmaker, is seeking FDA approval to sell Aquavan for sedation of adults undergoing various medical procedures.
The intravenous drug was tested in patients undergoing colonoscopy, as well as bronchoscopy, a procedure that gives a look at the airways, and various minor surgical procedures.
The generic sedative propofol is commonly used now for colonoscopies but requires the presence of an anesthesiologist.
Aquavan was designed to be less likely to put patients into sudden and unexpected general anesthesia and therefore permit use by more health-care workers, the FDA staff said. General anesthesia poses more risks than mild or moderate sedation.
"A preliminary review of efficacy suggests that (Aquavan) is efficacious as a sedation product," the FDA staff said.
Regarding safety, FDA staff said "the nature and frequency of adverse events, including respiratory adverse events, were limited under the conditions that the studies were conducted."
A key question to the FDA panel is "whether the applicant has presented adequate data to support the safety of the administration of (Aquavan) by persons without training in the administration of general anesthesia, the staff review said.
Mary Lynne Hedley, executive vice president of Eisai Corp of North America, said studies showed "any adverse event that occurs ... can be managed" by non-anesthesiologis ts.
Hedley declined to provide sales estimates for Aquavan. She said the company expects gastroenterologists who perform colonoscopies to be among those most likely to use the drug.
The FDA will consider the advisory panel's input before making a final decision on Aquavan, which is expected by July 26. The agency usually follows panel recommendations.
Eisai gained rights to the drug, known generically as fospropofol, through its recent acquisition of cancer specialist MGI Pharma.
__._,_.___

[INFIDEL]

The device they might be referring to could be the one in this article.http://www.cja-jca.org/cgi/reprint/46/3/235.pdf

TGI Target Controlled Infusions. It is computer controlled and takes severla factors into consideration to reach a pre determined plasma concentration of any drug using one of several pharmacodynamic models.

I have been waiting for these devices to get FDA apporoved here in the states having seen them at many overseas anesthesia meetings.