Avastin v. Lucentis Trial Hits Snag: Co-Pays Essentially Unblind NIH Study

In addition to roiling physicians and patients, the cost disparity between Lucentis (ranibizumab) and Avastin (bevacizumab) may also be undermining the study design of a head-to-head comparison of the two Genentech drugs, the lead investigator says.

Trial leader Daniel Martin, a professor of ophthalmology at Emory University, discussed problems with the study at a Sept. 20 CMS town hall meeting. The trial is designed to randomize 1,200 patients with age-related macular degeneration into one of four groups. Martin said most patients with macular degeneration are eligible for Medicare and could tell by their copay which drug they are receiving.

The 20 percent copay for those receiving Lucentis is $400, compared to $10 for those receiving Aventis. "It would be pretty easy to figure out which drug you have been assigned to," Martin said.

Trial organizers had proposed a demonstration project to determine if an alternative payment mechanism would enhance the participation of Medicare beneficiaries in the study. Under the proposal, the National Eye Institute would have paid the balance of copays so patients had no out of pocket expenses and thus would not know which drug they were receiving. Martin said the CMS administrator cleared the project in May but three months later the HHS Office of General Counsel "deemed the project as unapprovable."

The trial design was subsequently changed so the drugs will not be masked. While trial investigators are working with CMS to have the drugs masked, Martin said they are moving forward and intend to enroll the first patient by the end of the year.

Genentech has been taking heat for its efforts to limit the off-label use of its cancer drug Avastin by macular degeneration patients in lieu of the approved, but vastly more expensive, Lucentis (see ¹ (Also see "Genentech Meets With Eye Groups Protesting Avastin Sales Restrictions" - Pink Sheet, 29 Oct, 2007.)). Problems with a study that could definitively establish one drug over the other could present another public relations headache for the company.

The macular degeneration study is not the only NIH-sponsored trial that could complicate Genentech's sales strategy for Lucentis. The National Eye Institute has fully enrolled a Phase II study of Avastin for treatment of diabetic macular edema, which could provide results a year or two ahead of Genentech's own trials of Lucentis for DME (² (Also see "Lucentis Faces Additional Pressure From NIH’s Avastin Trials" - Pink Sheet, 16 Apr, 2007.), p. 8). If the NIH trial shows Avastin is equivalent to Lucentis for DME, Genentech may have a hard time getting patients to choose Lucentis.

- Brenda Sandburg ([email protected]) and Gregory Twachtman ([email protected])