CMS Counsel Almost Upset Eye Trial

The Wall Street Journal's Health Care blog over the weekend carried a letter from Sen. Herb Kohl (D-WI) to the Center for Medicare and Medicaid Services. The chair of the Senate Committee on Aging wants to know how much the agency spends on Lucentis and Avastin, both of which can be used for treating advanced macular degeneration (AMD) in seniors. The former cost $2,000 a shot. The latter cost $40 a shot. Kohl also wants to know what steps CMS is taking to lower its costs.

The agency, which is the primary insurer for the aged, has a big stake in showing the cheaper drug works just as well (it should, it's basically the same thing). What Kohl will be told is that CMS is helping to finance a comparative effectiveness trial testing whether the cheaper treatment works just as well. You can get lots of background on CMS' role in financing the trial of these two drugs in GoozNews posts here, here, here, here, here, and here.

Bottom line is that CMS last July agreed to pay for the more expensive drug as part of its new clinical trials payment policy, which says it will pay for "routine" care for seniors who participate in clinical trials. Genentech, which manufacturers both drugs, had refused to supply the drug to the trial's organizers, who are being funded in part by the National Eye Institute. Daniel Martin of Emory University in Atlanta is the principal investigator.

However, not everyone inside CMS was pleased. Martin made a presentation at an NIH conference a few months ago (it was on the web for a while, but I can't find it now) that revealed a glitch in the effort. The office of the general counsel at CMS intervened in a way that made it more difficult to get the trial up and running. The administration lawyers interpreted the new policy to mean Medicare was not allowed to provide ADVANCED payment for the drugs.

That meant the patients in the expensive Lucentis arm of the trial will not be blinded (an unfortunate double entendre) as to what treatment they are getting because they would be paying the usual co-pay for Lucentis, which could amount to hundreds of dollars per treatment. Seniors in the Avastin arm would only be paying $5 or $10 for their Avastin co-payment.

After reading this on the web, I emailed Martin to see if this was going to postpone the trial or make its results less relevant. Here's what he wrote back:

The Revised Medicare Clinical Trial Policy that became effective July 9 contains explicit language that allows Medicare to pay for Lucentis in this trial. That was the only thing that we absolutely needed. The demonstration project that I referred to (advanced payment) would have allowed for full masking of the drug. However, that is not essential and in fact really not necessary at all for the most important study questions. We were willing to work on that while we were waiting for the July 9 Policy change. But now that we are past that date, we are no longer willing to wait. We will have masked visual acuity assessment and masking of the treating physician at the local level. It will work well. It is a shame that our demonstration project was not approved by HHS. . . We hope to complete enrollment by the end of 2008. We hope to report first year results in the first half of 2010.

So the Bush administration succeeded in delaying the trial's start-up, but was unable to to deep-six it altogether.

Posted by gooznews at October 22, 2007 05:59 PM