Saturday, July 01, 2006

Avastin/Lucentis Update 4: FDA Approves Lucentis for Treating Wet AMD

On June 30th, Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD). The FDA approved Lucentis after a six-month Priority Review. Genentech announced that it would begin shipping the product immediately.

Genentech further announced that it would price the drug at $1,950 a vial, estimating the average treatment would entail five to seven doses a year, which would bring the average annual cost of the treatment to between $9,750 and $13,650 a year.

Lucentis, at 0.5 mg, is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections. Compared to continued monthly dosing, dosing every three months will lead to an approximate five-letter (one-line) loss of visual acuity benefit, on average, over the following nine months.

The FDA approval of Lucentis was based on data from two large Phase III clinical trials -- MARINA and ANCHOR. (For details of both of these trials, see my previous reports on Avastin and Lucentis referenced below. The Marina trial results are shown in the ARVO 2006 report, while the Anchor trial results are shown in the original article, Avastin: A New Hope for Treating AMD report.)

In a conference call with analysts, following the announcement of the approval, company officials said that they expect about 85% of insured patients in the United States would be eligible for reimbursement for Lucentis. Many other patients, including the indigent, will be given access to the drug on a charitable basis.

However, this only begs the question: Why should Medicare pay $1950 per vial for Lucentis when Genentech’s other cancer battling drug Avastin appears to be as effective in treating wet AMD in an off-label use, and only costs about $50 or less per dose?

As reported in the ARVO piece, in some cases, private insurers are paying out-of-pocket costs, generally $300 to $500 for the drug and injection, while in other cases, ophthalmologists are “eating” the cost in order to provide the best available therapy for their patients.

Again, as previously reported, with FDA-approval, despite its inevitably much higher cost, Lucentis (drug and injection) will be reimbursed by Medicare for the treatment of neovascular AMD. Because of the reimbursement, as well as the medical-legal benefits of using an on-label drug when possible, Lucentis will likely be used for patients that are fully insured (either private insurance or Medicare plus supplemental insurance to cover the 20% co-pay). Avastin will likely still be used for uninsured or partially-insured AMD patients in the US that cannot afford Lucentis, as well as for the many off-label indications that are being treated with intravitreal Avastin.

As we also previously noted, internationally, where healthcare spending is more tightly constrained, Avastin will be much more difficult to displace. Longer term, it is likely that organizations such as CMS and NIH will initiate randomized, controlled studies to validate the safety and efficacy of intravitreal Avastin, given the enormous potential savings to the Medicare system.

Author’s Note on Avastin

Since the original posting on January 31st, I have now added eight updates on this important drug for treating age-related macular degeneration. In addition to the posting you are reading, here is a listing (with links) to the others:

Avastin: A New Hope for Treating AMD (January 2006)

Avastin Update: Medicare not Likely to Cover its Use (March 2006)

Avastin Update II: AAO supports Medicare Coverage for Off-label Avistan Use (April 2006)

ARVO 2006: A Further Update on Both Avastin and Lucentis for Treating AMD (May 2006)

Avastin Update 5: NIH Considers Comparing Lucentis and Avastin (August 2006)

Avastin/Lucentis Update 6: Latest Results Published in NEJM and Another Call for a Trial Between Them (October 2006)

Avastin/Lucentis Update 7: BREAKING NEWS – NEI/NIH Will Fund Comparative Study (October 2006)