Lucentis

Costly Lucentis gets NICE nod

Tracy Staton — Thu, 28 Aug 2008 10:37:49 -0400

As researchers in the U.S. compare Genentech's macular degeneration drug, Lucentis, with Avastin, another Genentech drug used off-label to treat the eye disease, notoriously tight-fisted regulators in the UK are clearing the much more expensive Lucentis for funding by the National Health Service.

As you know, Genentech has run into controversy over Lucentis, which costs $2,000 per treatment, versus $60 per dose for Avastin when used for the eye malady. The company had moved to restrict distribution of Avastin to compounding pharmacies that repackage the drug for ophthalmic use, but the outcry from doctors and patients led Genentech to soften its stance.

Genentech has come in for criticism from the National Eye Institute, which wanted the company to be part of the head-to-head study. Unsurprisingly, the company wasn't eager to sink money into a trial that pitted two of its drugs against each other--but some have read that refusal as evidence of the company's lack of faith that Lucentis will prevail.

Most importantly, though the study results won't be available for a couple of years, folks are already talking about the prospect that, if the drugs prove comparable at treating macular degeneration, Medicare would refuse to pay any more for Lucentis than it does for Avastin.

In the U.K., however, the National Institute for Clinical Excellence has decided to make Lucentis available to NHS patients. The series of 14 injections will run about $18,000 per eye; under its deal with NICE, Novartis, which markets the drug in Europe, will cover any additional injections needed. Even at the $18,000 cost, NICE figures it will save money compared with the cost of patients' vision impairment.

Why didn't NICE recommend Avastin instead? There's no trial data showing the drug's effectiveness against macular degeneration. And there won't be--until the National Eye Institute trial wraps. We'll see how NICE reacts then.

- see the Boston Globe story
- read the news from the Wall Street Journal

FDA: Don't blame us for Avastin change

Tracy Staton — Thu, 19 Jun 2008 09:33:36 -0400

Remember last year when Genentech said it wouldn't sell its cancer med Avastin to compounding pharmacies, which repackage it for off-label use in patients with macular degeneration--and then blamed the FDA for the change? Well, Genentech ended up backing down a bit. But it never stopped stressing the fact that the restriction was FDA's fault. The company flatly denied that it was trying to protect Lucentis, its drug approved for use in macular degeneration, which just happens to cost roughly $2,000 per treatment course versus some $50 for repackaged Avastin.

Now, though, a Senate investigation appears to show that Genentech's blame game was unfounded. The company had claimed that agency inspectors were concerned that some batches of Avastin didn't meet standards for ophthalmic use, but the agency says they didn't meet standards, period. Inspectors “identified deficient practices and the lack of of effective processes to know what was in those four lots," the agency wrote Senate investigators. "Consequently, the Agency recommended that those lots should be considered unfit for use for any indication.” Genentech disputes this, saying that the lots were OK for cancer use.

When Genentech started citing FDA for its distribution change, some officials were miffed. "Genentech has found a way to blame FDA for their decision to limit their distribution of Avastin," an official wrote.

Curiouser and curiouser, FDA declined to expressly limit the use of Avastin. When Lucentis was approved, Genentech asked the FDA to change Avastin's label to say that the drug was not for ophthalmic use, according to an internal FDA email obtained by the Senate. The agency concluded there was "no safety-related basis adequately justifying that labeling change."

- read the (lengthy) Wall Street Journal Health Blog post

Avastin-Lucentis trial may reshape pharma

Wed, 14 May 2008 06:59:56 -0400

We thought the head-to-head trial of Avastin and Lucentis for age-related macular degeneration was a big deal for Genentech, which makes both drugs. Now, IMS Health is saying that the trial could be "a Pandora's box" for the entire pharma industry.

Conducted by the National Eye Institute, part of the National Institutes of Health, the trial is designed to see whether the much cheaper Avastin, often used off-label to treat AMD, measures up to the AMD-specific--and very expensive--Lucentis. If Avastin passes muster, then prescribers may desert Lucentis completely. And if docs don't do so voluntarily, then insurers and other payers may nudge, cajole, incentivize, or downright push them to.

And there's the rub, IMS says. By taking the drugmaker out of the testing, this trial could fundamentally reshape relations between payers and pharma. Payers could sponsor comparative drug studies of their own or lobby the government to do so, IMS theorizes, especially as databases make those comparisons easier. There's plenty of time to worry about it, though: The Avastin-Lucentis trial won't wrap till 2010.

- see the story in the Financial Times

ALSO NOTED: Senate postpones hearings on Lucentis;Antibiotics overused in dementia patients;

Tue, 26 Feb 2008 06:59:50 -0500

> Lawmakers investigating Genentech's pricing of macular degeneration drug Lucentis have backed off of holding hearings on the issue. Report

> A new study suggests that antibiotics are overused in people dying of dementia and should be reconsidered because of the growing problem of resistant superbugs. Report

> Sanofi Pasteur is sending 6 million doses of yellow fever vaccine to help quell an epidemic of the disease in Latin America. Release

> Pfizer has cut its workforce at a plant in Groton, CT, to a small shutdown crew; at its height locally, Pfizer employed thousands of people, and most recently had about 500 workers. Report

> Bayer has proposed a 2007 dividend of €1.35 per share, up from €1 per share a year ago. Report

> In a study that may change the way that cancer drugs are developed and prescribed, scientists have determined that genetic mutations are different in every cancer patient, suggesting that drugs will need to be "tailored" for small groups. Report

> Patients most likely to benefit from genetic testing are either avoiding it altogether or paying for it themselves to keep hereditary disease out of their health records--and most importantly, off the books of their insurers. Report

> The International Stem Cell Forum is meeting in San Francisco, bringing together 21 stem cell research institutes and representatives from 19 countries to review such issues as the moral and ethical guidelines needed for research and the registry of ESCs lines. Report

> High rainfall, biodiversity and rapidly growing populations are considered breeding grounds for new outbreaks of diseases like SARS and Ebola. Report

> Clarus Ventures has raised $660 million for its second life sciences fund. Report

And Finally... You know it's trendy to bash DTC ads when Saturday Night Live gets in on the act. Report

NIH launches Avastin-Lucentis trial

Mon, 25 Feb 2008 06:59:57 -0500

Gentlemen (and ladies), start your eye injections. In other Avastin news, the big trial pitting the cancer drug against Genentech sister med Lucentis is now underway. Sponsored by the National Institutes of Health, the independent trial is designed to show how the two meds stack up in treating age-related macular degeneration.

Lucentis has been FDA-approved for use against wet AMD. Though Avastin isn't, eye docs have commonly used it off-label, saying it's almost as effective as Lucentis, if not as effective. And Avastin costs much less: hundreds per treatment versus thousands.

The sticking point has been that, to use Avastin in the eye, it had to be repackaged by compounding pharmacists. Genentech moved last year to restrict supplies to those pharmacies, saying that the FDA was concerned about the repackaging. But Genentech had no plans to study Avastin for macular degeneration, preferring to push its already-approved and more expensive Lucentis.

So the NIH is doing it for them. After all, because macular degeneration tends to be a disease of the elderly, it's Medicare paying for much of the treatment. So the government has a vested interest in proving the cheaper treatment is a viable alternative.

- read the press release from the NIH
- see the story in the Wall Street Journal

Related Articles:
Genentech rethinks Avastin limits. Report
Eye docs confront Genentech exec. Report
Why should Medicare pay for Lucentis? Report
Genentech to curb Avastin sales. Report
Doctors balancing effects, costs of Lucentis and Avastin. Report

Canada to decide Lucentis' fate

Wed, 23 Jan 2008 06:59:56 -0500

The Lucentis versus Avastin match has moved to Canada. Officials there are arguing whether to pay the tens of thousands of dollars a year for Lucentis, the Genentech-made and Novartis-marketed drug that's approved to treat wet macular degeneration. Or should they instead reimburse for Avastin, another Genentech-made drug that's shown to be effective against WMD and is much cheaper to boot--but isn't approved by HealthCanada for that use.

Since Lucentis wasn't available in Canada until recently, eye specialists have been using Avastin against WMD. Many have reported success. But Genentech hasn't studied the drug in WMD, and a U.S. NIH study won't be complete until 2010. So provincial and federal health plans can't pay for the drug when it's used against WMD.

The federal panel responsible for deciding which drugs should be covered rejected Lucentis late last year. At Novartis' request, the group is reconsidering that application, and a decision may be announced as early as today. Novartis is pushing hard for the approval; alongside it is the Canadian National Institute for the Blind, which got a grant from the drugmaker and is using some of those funds to campaign for Lucentis.

You'll recall that a similar debate has been raging in the U.S. Genentech had tried to cut off Avastin supplies to the compounding pharmacies that repackage it for eye use, but ophthalmologists protested and the company agreed to keep some supply channels open to eye docs.

- read the The Globe and Mail report

Eye docs confront Genentech exec

Tue, 13 Nov 2007 06:59:58 -0500

Put a Genentech executive and a bunch of angry ophthalmologists in the same room, and what do you get? Fireworks. At a conference over the weekend, the company's president of product development, Susan Desmond-Hellman, defended its decision to stop selling Avastin to compounding pharmacies, which repackage the drug for use against macular degeneration.

Desmond-Hellman blamed the move on the FDA, saying, "[w]e had no choice." The FDA's worries about repackaging the cancer med could "put our entire manufacturing operation at risk." That's funny, the eye docs responded. The FDA told us different.

Genentech believes eye docs will still be able to get Avastin for their WMD patients. And Desmond-Hellman vigorously denied that the move was meant to steer patients toward the company's designated WMD drug Lucentis, which runs $2,000 a dose compared with $40 for Avastin.

- read the release from the American Academy of Ophthalmology
- see this the item and from the Wall Street Journal's Health Blog
- read the report from OSN SuperSite

Related Articles:
Genentech rethinks Avastin limits. Report
Why should Medicare pay for Lucentis? Report
Genentech cuts eye docs out of Avastin. Report
Doctors balancing effects, costs of Lucentis and Avastin. Report
Lucentis gets the green light from regulators. Report