[Ip-health] Genentech Will Restrict Eye Use of Cancer Drug

[Joana Ramos]

http://www.nytimes.com/2007/10/11/business/11cnd-eye.html?_r=3D2&oref=3Dslo=
gin&oref=3Dslogin

Genentech Will Restrict Eye Use of Cancer Drug

By ANDREW POLLACK
Published: October 11, 2007
NY Times

Genentech is moving to restrict the use of its cancer drug Avastin by
ophthalmologists, a move that could substantially raise the costs of
treating a common eye disease.

The move is already angering some eye doctors, who say it may force them
to instead use Genentech=92s much more expensive drug Lucentis.

=93I think the retinal community is deeply saddened by the decision
Genentech has made to restrict the availability of Avastin in the United
States,=94 said Dr. Philip J. Rosenfeld, a professor of ophthalmology at
the University of Miami. He said the move would have a =93profound=94 effec=
t
on retinal practices.

Lucentis is approved to treat wet age-related macular degeneration, the
most common cause of blindness in the elderly. But it costs about $2,000
a dose, with a dose needed as often as once a month.

As a result, many retina specialists prefer off-label use of Avastin,
which has not been rigorously tested for macular degeneration but has
the same mechanism of action as Lucentis. When injected into the eye in
tiny amounts, Avastin costs only about $50 a dose.

In a letter sent today to retina specialists, Genentech said that its
wholesalers would no longer provide Avastin to compounding pharmacies,
which are businesses that, under sterile conditions, divide a vial of
Avastin into tiny portions for use in the eye.

Genentech said it was taking the step in part because Lucentis was now
widely available. Eye doctors had started using Avastin before Lucentis
won approval from the Food and Drug Administration in June 2006.

The company also said that the F.D.A. had expressed concern about
possible microbial contamination when a vial of Avastin is split into
multiple doses. Such contamination could lead to serious eye infections.

The agency sent a warning letter to one compound pharmacy about this
last December. Genentech said F.D.A. inspectors had also expressed
concern on routine inspection of one Genentech=92s own factories.

It said it had a program in place to help patients who had trouble
paying for Lucentis. The company said the distribution change would take
effect Nov. 30 to allow physicians and pharmacies time to adjust.

But Dr. Rosenfeld and some other ophthalmologists have argued that
Avastin has been used safely by many physicians for about two years and
appears to be as effective as Lucentis. He said he thought Genentech=92s
move was for business reasons, because the cheaper Avastin was cutting
into sales of Lucentis.

In its last quarterly earnings teleconference with analysts, a Genentech
executive said that Lucentis was being used to treat 55 percent of new
patients and 50 percent of all patients. Retina doctors say Avastin
accounted for most of the rest of the patients =97 or nearly half the marke=
t.

Genentech did not plan to compete with itself. It said it designed
Lucentis specifically for use in the eye, believing that Avastin, a
bigger molecule, would not work there. But while waiting for Lucentis to
be approved, doctors started using Avastin and found it worked.

Using Lucentis instead of Avastin to treat all patients with wet macular
degeneration could add hundreds of millions of dollars in annual costs
for Medicare. That National Eye Institute is now sponsoring a trial that
will directly compare the two drugs as a treatment for macular degeneration=
.

Genentech said today that hospital pharmacies and physicians would still
be able to purchase Avastin. So retina specialists in hospitals would
still have access to the drug. And it seems possible that private
practices could purchase Avastin and then send the drug to a compound
pharmacy for processing.

=93It=92s going to make life a little bit more difficult but I don=92t see =
it
as an insurmountable issue,=94 said Dr. George A. Williams, chairman of
ophthalmology at William Beaumont Hospital in Royal Oak, Mich.

He said he thought Genentech did face some legal risks by having allowed
sales of Avastin to compound pharmacies because it could be perceived
that the company was facilitating off-label use of the drug. Doctors are
allowed to use drugs off label but drug companies cannot promote such uses.

But Dr. Raj Maturi, a retina specialist at Midwest Eye Institute in
Indianapolis, said the extra steps of having to take the drug to a
pharmacy would add to the expense and risk. Still, he said he would try
to get Avastin because =93I don=92t want to see my patients go blind becaus=
e
they can=92t afford a $2,000 drug.=94

He said that the possible loss of Avastin would have the biggest impact
on patients getting the drug to treat certain eye diseases other than
macular degeneration, like diabetic retinopathy. About 45 percent of his
use of Avastin is for these other diseases.

=93Lucentis is not F.D.A.-approved for anything besides macular
degeneration, and insurance companies are reluctant to approve use of
Lucentis for other diseases, given its cost.,=94 Dr. Maturi said.


-----------------
Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramsolink.info/
www.cancersurvivorsproject.org
www.healthyskepticism.org