Funding the NIH Trial on MD

The Wall Street Journal gives front page attention this morning to the National Institutes of Health-sponsored trial of Genentech's two rival treatments for macular degeneration. One, Lucentis, costs $2,000 a shot; the other, Avastin, costs around $40. The trial was covered by GoozNews last fall here and here.

Near the top of the story, reporter Marilyn Chase calls this trial the "first" such NIH-funded comparative effectiveness trial, but later on qualifies that statement by saying that it is the first comparing two patented drugs. I doubt that's the case, since the government funds trials comparing cancer drugs all the time. But that quibble aside, it's important to recall that the NHLBI during the 1990s spent nearly $80 million comparing various blood pressure control medications as part of its ALLHAT trial, which eventually showed that generic diuretics were just as effective as first-line treatment as more expensive, still patented drugs.

Will the results this trial drive coverage decision by Medicare, which could save $1 billion a year if the two drugs proved equivalent (which they will, since they are basically the same thing)? Not necessarily. Unless Medicare is given the power to set formularies, there is nothing in the law that will allow it to deny coverage for an FDA-approved drug (Lucentis), and only pay for a drug that, while FDA-approved for other conditions (cancer), has not been approved for macular degeneration. And nothing requires Genentech to submit the results of this trial to the FDA.

That's why this paragraph, inserted in the middle of a discussion about NIH's struggle to finance this trial, jumped out at me. The Eye Institute at NIH has appropriated $16 million for the trial, but will probably need more since it will have to buy both drugs at retail prices.

Barry Straube, chief medical officer of the Center for Medicare and Medicaid Services, says he welcomes the trial as a guide for reimbursement policy, but lawyers for the agency have said it lacks legal authority to use the Medicare trust fund for such research expenses.

Someone should show Medicare's lawyers the 2000 Clinton presidential directive allowing Medicare to pay for the routine expenses of seniors who participate in clinical trials. Since Lucentis, the more expensive drug, is now FDA approved, why can't the agency pay for the more expensive arm of the trial and let NIH pay for the $50-a-pop arm? Sounds like a reasonable approach to me, since it's Medicare that will save the $1 billion a year should the two drugs prove comparable.