A couple of months ago we posted on the great Avastin versus Lucentis competition, two drugs for treating age-related macular degeneration (AMD). AMD is the major cause of blindness in the elderly. The interesting thing is that there is about a 100-fold difference in cost between the two drugs and both are made by the same company, Genentech.
Avastin is an anti-angiogenesis drug used to treat colon cancer. It works by inhibiting the new blood vessels the tumor needs to grow. New vessel growth (neovascularization) is also the pathologic process behind AMD. Several years ago an ophthalmologist had the idea of injecting a small dose of Avastin directly into the eye to treat AMD. The results have been described as nothing short of remarkable for many patients. Because the dose needed is so small, the original Avastin package for an individual dose to treat cancer can be split into a large number of eye treatments, lowering the cost so much that the use of this advanced biotechnology product is low enough even for use in developing countries.
Clearly this isn't to Genentech's advantage, so they developed a brand new described as a fragment of Avastin. It is called Lucentis. Cost? $1950/dose (treatment needed every couple of months). Both drugs seem to work for AMD. Does one work better and is the difference worth the cost? What is needed is a randomized clinical trial comparing the two. This makes sense and is what has been recommended by the National Eye Institute, where a proposal to do such a study was favorably reviewed. Except that they are still trying to figure out how they will fund the study, according to Bloomberg News.
Huh? Look, I know studies like this are expensive. I'm an epidemiologist. But the bill for using Lucentis to treat AMD (the biggest cause of blindness in the elderly) goes to the U.S. Centers for Medicare and Medicaid Services (CMS) under the Medicare program. If you can use a drug that cost $20 instead of $2000 for the estimated 150,000 AMD cases a year, isn't this a bit penny-wise and pound foolish? Maybe Genentech should pay for the trial, since they think it's necessary:
Last night Genentech said its main concern over the use of Avastin to treat eye conditions was patient safety. "While there are some small, single-centre, uncontrolled studies of Avastin being performed, safety data on patients who are treated with Avastin off-label is not being collected in a standard or organised fashion," said a spokeswoman for the company. (The Guardian
That was from a story in June, the same month the US FDA approved Lucentis for AMD. Now the study to do what GEnentech recommended has been designed and reviewed. And Genentech is waffling:
Genentech isn't developing Avastin for treating eye conditions, said spokeswoman Dawn Kalmar in a phone interview today. "We are now focused on getting Lucentis to patients and ensuring that cost is not a barrier to access,'' she said.
The company hasn't received any formal proposals from NEI regarding a head-to-head study, Kalmar said. The company would evaluate its support for such a study based on whether it has the potential to address a significant unmet need or answers scientific questions, she said. (Bloomberg)
To use Avastin for AMD the larger cancer dose has to be split into many smaller doses, raising the specter of possible contamination. This could be solved (and maybe isn't even a problem) by packaging Avastin for eye use. But Genentech is apparently not interested. So much for Big Pharma's professed dedication to the health of the public.
To sum up, a big pharmaceutical company has the chance to provide a low cost a drug that may save tens of thousands of people in the US from blindness and many more elsewhere. They aren't lifting a finger to do so, and for all we know, actively obstructing funding this obviously cost-effective government study.
That's the way it works in the Bush administration, generally. Why not here?
I know this is going to sound snarky, but it seems the pharma company is charging 100 times more for the 'new' product because of the change in packaging. Those tiny bottles are just really hard to fill... sheesh.
This all comes back to the reason why pharmaceuticals are more expensive than the marginal cost of production, recoupment of R&D cost via monopoly-level profits provided by patents. Because the production cost is low vs compared to the R&D cost, the companies try to spread out the R&D over people treated rather than amount of active ingredient.
If Genentech were to package Avastin for AMD, they'd charge a similar price to what they're charging Lucentis, since they know what price people will pay for an AMD treatment. In fact, the relatively minor differences suggest that selling Lucentis is essentialy equilvalent to that, except they have a little more time on the patent than if they just repackaged Avastin.
Consequently, in order to actually reduce the costs of treating AMD, somebody needs to buy the cancer-strength AMD and dillute it, forcing Genentech to set a single price point for Avastin. It shouldn't be too hard to find interested parties to bankroll the study - both private insurance and Medicare stand to benefit a lot from it. The FDA should be facilitating this, rather than waiting on Genentech.
Also, its important to realize that this is solely an artifact of how patents work. The profits Genentech is making via monopoly pricing aren't an unintended consequence but rather an intentional subsidy for performing R&D. Companies are always going to game the patent system as effectively as they can - the question is how to make the patent system less likely to result in situations where companies are rewarded disproportionately to their contributions to R&D.
I took my aging father to a retinologist for his AMD on the very day the news broke about Lucentis. He told us that Avastin had been used so much and for so long that it had become the defacto standard of care for "wet" AMD.
"While there are some small, single-centre, uncontrolled studies of Avastin being performed, safety data on patients who are treated with Avastin off-label is not being collected in a standard or organised fashion,"
As my daddy would say, "Horsepucky."
I am being treated with Avastin for choroidal neovascularization of my left eye. The improvement in my vision has been miraculous. I went from being unable to read any lines of text on an eye chart to being 20/20 again (with a big blind spot, mind you) in a matter of a few weeks. I pay for each dose of the drug myself, obviously.
It is a blessing for me, at age 40, to have access to Avastin. Lucentis isn't FDA-approved for use in younger people, and, thus, my insurance wouldn't have covered it. Without my good fortune to be in a city (with a group of retinal specialists who work very closely with one of the premiere eye clinics in the nation)I likely would not have access to treatments with Avastin. Unable to cough up $2000 a shot out of pocket, I would, most likely, simply be blind now without this cheaper drug.
As it is, I'm going broke (there have been lots of peripheral costs to the treatment, including an initial attempt to stop the condition with costly laser surgery.) Someone making less than I am can't likely afford several shots of Avastin, frankly. In reading online fora about the drug, I've learned that the price per dose, plus ancillary charges from your doc's office, vary wildly across the country. A person without insurance couldn't handle any of these costs.
Genentech's reluctance to support this cheaper alternative to Lucentis is sad, indeed. Avastin could save so many people from blindness. I'm living proof that it works, and it works brilliantly. I just got my new driver's license - something I thought three months ago would never happen again.