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The Right Prescription
Avastin’s Double-Header
It’s one anyone interested in the health of his health care will be watching.
One drug, two federal agencies, and the future of patient access to the best possible medical treatment: That’s the drama playing out in Washington right now.
Avastin is an innovative biologic used primarily to treat various forms of late-stage cancer. It’s currently at the center of a landmark comparative study conducted by the National Institutes of Health (NIH), as well as a high-profile battle with the FDA — both of whose outcomes have the potential to affect the healthcare of every single American.
First up, on May 1st, the NIH will release the initial results of a study conducted by its National Eye Institutes comparing the safety and efficacy of Avastin and Lucentis for the treatment of an eye condition known as advanced wet macular degeneration (AMD).
Nearly two million Americans and a quarter of the over-80 population suffer from wet AMD, in which blood vessels behind the retina grow under the macula and leak fluid. If left untreated, wet AMD causes a central blind spot known as a scotoma, and eventually permanent blindness. Though it isn’t as well-known as cataracts or glaucoma, AMD affects more older Americans than both combined.
Avastin, which was not developed for the purpose of treating AMD — and is not FDA-approved to do so — has shown to be a worthy alternative to Lucentis, an AMD-specific biologic.
But beyond broadening a doctor’s options for treating AMD, Avastin is attractive for another reason, especially to government bean counters, and that is its much lower cost. At just $50 per dose, compared with Lucentis’ $2,500 price tag, it’s no wonder that nearly 60 percent of all AMD patients are prescribed Avastin.
The motivation for the study, which was commissioned in 2008, is crystal clear: to prove Avastin is equally effective as Lucentis. The “benefit” of such irrefutable proof? With this study in hand, insurers will be able to implement a “fail-first” policy, restricting patients’ access to Lucentis until their doctors prescribe Avastin first — and it doesn’t work.
If this happens, the first and last word on a patient would rest with a provision in an insurance policy, not a doctor’s best judgment. This is a precedent sure to be loved only by those whose top priority in health care is saving money, not patient care.
To preempt outcomes like this, Sen. Jon Kyl (R-AZ) has introduced and garnered bipartisan support for the “Preserving Access to Targeted, Individualized, and Effective New Treatments and Services Act” — also called the PATIENTS Act of 2011. Its intent is to protect patients from government use of data obtained from comparative effectiveness research to deny or delay health coverage under federal programs like Medicare and Medicaid.
The second Avastin storyline involves the FDA — and a similar battle over cost with similar, wide-reaching implications.
Last December, the FDA stripped Avastin of its temporary approval for treatment of metastatic or late-stage breast cancer. To reach this conclusion, the FDA had to disregard the results of clinical trials and patient testimonials demonstrating Avastin to be effective for more than 50 percent[1] of patients — whose survival is extended on average, by a few months, but in some cases for years.
This decision, in practical terms, almost certainly means that for the thousands of women currently relying on Avastin to prolong their lives, insurers will stop covering its cost. While Avastin is a cheap treatment for wet AMD, it’s needed in a much higher volume and concentration for breast cancer. The annual cost of an Avastin regimen can reach upwards of $90,000. Without insurance coverage, the only breast cancer patients who will have access will be those who can afford it out of pocket. This result would be a textbook illustration of healthcare rationing.
Although the FDA claims its approval process looks solely at safety and efficacy, it’s clear in this case that cost is a driving factor.
Predictably, the FDA’s decision caused an outcry among patients, family members, and doctors. In February, they got some good news: a two-day hearing scheduled for the end of June, when Avastin’s manufacturer Genentech will have the opportunity to call witnesses to support its appeal.
In the coming weeks and months, it’s in the interest of every American concerned about their own health care to pay attention to this story. Whether you’re a senator or an everyday citizen, the health of your health care is on the line.
About the Author
Robert M. Goldberg is vice president of the Center for Medicine in the Public Interest and founder of Hands Off My H ealth, a grass roots health care empowerment network. His is new book, Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit, was published last month by Kaplan.
Letter to the Editor View all comments (34) | Leave a comment
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Dee See| 4.29.11 @ 6:26AM
---Nice article.
Of course anyone sincerely interested in
health care, or indeed, health generally
will be asking WHY American Spectator,
in capstone lockstep with the world media
cover-up, is FAILING to feature ANY
significant reportage or comments on
the most awesome world radiation disaster
in human history in Fukishima?
NOT LOOKING GOOD BOYS
WAY________________!
John Navratil| 4.29.11 @ 10:24AM
Dee See,
Could it be that there has been plenty of coverage of Fukishima? When it gets down to reporting on finding dogs at sea, hasn't it been covered in sufficient depth?
Perhaps you could start the Fukishima24 channel and syndicate it over cable.
vtwin| 4.29.11 @ 2:51PM
Actually, coverage has been too focused “ on finding dogs at sea” stories and not on the real impact this disaster is/well have on the lives of the Japanese people.
Good point, Dee See!
Ivan Ivanovich| 4.29.11 @ 7:21AM
It seems very strange to read opinions such as this at AS. The flawed assumption here is that someone, in this case the government, should pay any cost to keep granny alive for a few more months. The solution is so obvious. First; be clear that Health Care is NOT Heath Care Insurance. Second; all health care insurance, government or private should pay a percentage of the cost. A patient should be given a choice between a $50 drug that costs them $5 and a $2,500 drug that costs them $250. Let them, with the advice of their doctor and family make the decision.
Notary Sojac| 4.29.11 @ 9:48AM
When it comes to Medicare and Medicaid beneficiaries, "Hands Off My Health" inevitably leads to "Hands On Someone Else's Wallet".
Hillel| 4.29.11 @ 10:03AM
Well if leeches and Calomel don't work we'll have to chose between sealskin and walrus hide to put beneath granney on the ice foe.
PolishKnight| 4.29.11 @ 10:25AM
This is all a bit of a red herring. As I noticed going overseas, the street cost of ordinary drugs, such as good ol' penicillion, is a fraction of the cost in the states. This is a totally "generic" drug yet Americans pay several times more for ALL drugs than overseas.
Isn't the best benefit of a "free" market for the consumer supposed to be competitive costs?
In theory, this drug should go generic in about a decade or so and the issue of accessability moot. The free market would mean that the wealthy would pay that $90K out of pocket while the poor would die BUT in the future, the drug would be available to all. This is why business class seats on airplanes pay for the economy steerage in the rear (I know, very bad example!)
The right is falling for a trick from the left (and from their own sentiments) for the notion that everyone should have access to all life saving technologies regardless of cost. A socialist healthcare promises, in the beginning, to make that possible. Of course, they're lying through their teeth (that's what socialism is all about, lying and getting away with it.)
Jack London| 4.29.11 @ 12:23PM
I realise most of you are anti-science and pro-voodoo but surely you:
1) would prefer to pay much less for a drug that does the same job (as in the eye study)
2) would prefer not to pay for a very expensive drug that shows no survival benefit (as in the breast cancer studies for Avastin - the writer above is confusing progression free survival with overall survival).
While it is possible that Avastin will play a part in survival in a few people with advanced breast cancer, we don't know who or why. So do we give it to everyone regardless (and pay for it through Medicare or increased insurance premiums, and also see a lot of very bad side-effects)? This needs a grown up discussion and not the childish ranting of the ill-informed.
Incidentally, does anyone here think our government shouldn't have carried out the eye study to find out if our Medicare dollars are being best spent?
Nunya| 4.29.11 @ 2:23PM
Jack, I agree that there should be some study to determine the efficacy and economic efficiency of various medications so that one can make an intelligent decision about which to use and pay for. No problem there. However, the problem comes when bureaucrats make decisions on the part of doctors. A doctor should make medical decisions, not some pencil-necked geek behind a desk.
I know from experience that the FDA overreaches and basically comes up with ways to justify their own existence (not unlike most government bureaucracies, I would guess). My ex works in the medical device industry, and if she wanted to change the PACKAGING of an item--that is, nothing with the device itself, only the color or shape of the box it was in, she had to get FDA approval--adding weeks to the process of getting the item to market. People wonder why our drugs are so expensive? That's part of the reason. It's completely absurd.
vtwin| 4.29.11 @ 2:44PM
I agree doctors should make the medical decisions not bureaucrats, Government bureaucrats or healthcare insurance provider bureaucrats, provide these medical decisions are based solely on the health needs of the patient, but unfortunately healthcare in America is BIG business and more and more of these decisions are made with profits in mind.
George S| 4.29.11 @ 3:13PM
Profit is what brings things to you. Every drug on the shelf is there because of profit, not charity. We all should be thankful that big businesses exist to make these things available. Because government will not. The siren song that tyrants sing is to give you all the wonderful things the free market gives you -- and give them to you for little or no cost. But you know that is impossible, for things offered for free dry up very quickly because more people demand than the supply is available. Profit is the great equalizer, rationing scarcities fairly.
If you let government provide health care in the delusion that it will be plentiful and free, only the latter will be true. Government will spend that health care money on where it benefits them politically. And it ain't necessarily on you.
vtwin| 4.29.11 @ 3:50PM
Ok, if the choice for provider is between Government and Free Market, with 47,000,000 million Americans without affordable healthcare has the free market not failed?
Mike| 4.29.11 @ 4:20PM
vtwin
There are not 47 million people without affordable healthcare. Even if you accept the 47 million figure, and I don't, it refers to people without health insurance. There is a huge difference between healthcare and health insurance. This difference has been intentionally blurred by those who support government controled healthcare.
Additionally the term affordable is tossed about. An ill defined term at best. Many people choose to not purchase health insurance because they have other wants or needs that they prioritize higher regardless of whether said health insurance is affordable of not.
If we did not pay for the sniffles with health insurance and instead used insurance to cover catastophic events then insurance will become affordable. If a third party was not paying for every office visit the consumer would be more apt to shop for the best value in medical services.
Mike Johnston
SFC USA (RET)
vtwin| 4.29.11 @ 7:32PM
Not 47 million Mike, than how many?
Yes, there is a difference between healthcare and healthcare insurance. Healthcare is something you hope you don’t need if healthcare insurance is something you don’t have.
Affordable is a relative term and it definition is clearly understood by all but the youngest and the wealthiest.
I’m only guessing here but I suspect that early diagnosis and regular checkups might actually lower medical costs for public and private insurers.
Jack London| 4.29.11 @ 4:22PM
So the 40% of all healthcare research that the government does is an illusion, right? And industry will always step in to research drugs for rare diseases, for which there isn't much of a market? And little pink pigs are flying past your window...
Jack London| 4.29.11 @ 3:05PM
You're falling for the idea that 'bureaucrats' treat patients, not doctors. They don't. But it is the 'bureaucrats' at the NIH (many of whom are no doubt MDs) who organised and funded the eye study with a view to helping us get better value for money. The more expensive drug - which by the way I see has been the subject of kickbacks to doctors - will not be banned as it is still an effective treatment. But surely it is appropriate for those managing Medicare to ask doctors to use the much cheaper drug unless there are clear clinical reasons not to do so.
By the way, Lucentis and Avastin are very similar drugs made by the same company - so we badly need evidence and guidance to combat the obvious conflict the company has.
As for the FDA, it can't win - people moan when it's slow and then moan again when it does things faster, like accelerated approval, ie for drugs like Avastin for metastatic breast cancer that then prove to be a wash.
I take it you're not among the voodoo people who would abolish our drug safety agency.
vtwin| 4.29.11 @ 4:05PM
Lucentis and Avastin are very similar drugs made by the same company, really?
That reminds me of the Old Pickle Seller Story.
When the pickle seller was asked why he was placing half of the pickles in a tray marked $1.00/lb and other half pickles from the same pickle barrow into a tray marked $2.00/lb the pickle seller responded “some people prefer a more expensive pickle.”
Jack London| 4.29.11 @ 4:25PM
Lucentis and Avastin are both made by Genentech. I see the New York Times last year exposed secret rebates made by the company to physicians:
'Under the program, which started on Oct. 1, medical practices can earn up to tens of thousands of dollars in rebates each quarter if they use a lot of Lucentis and if their usage increases from the previous quarter, according to a confidential document outlining the program that was obtained by The New York Times.'
Occam's Tool| 4.29.11 @ 5:23PM
Again, Jack, you have no clue as to what NICE or PHARMAC do. This argument here is what is known as the "thin edge of the wedge." Since I HAVE been a senior medical consultant in an NHS, and YOU HAVE NOT.
Occam's Tool| 4.29.11 @ 5:30PM
Actually, Jack, in NHSes, the bureaucrats DO treat patients. How many years do you have for me to give examples. Review PHARMAC and NICE.
Occam's Tool| 4.29.11 @ 5:20PM
Jack,
review the history of NICE and get back to me. If you don't know what NICE is you don't know enough to be participating in this conversation.
Jack London| 4.29.11 @ 7:29PM
Access to very costly end of life drugs is constrained in different ways in both the US and UK and no doubt in New Zealand. Have a look at:
http://www.medscape.com/viewarticle/715110
George S| 4.29.11 @ 2:57PM
Suppose Avastin didn't exist. Think of all the money we would save. Think of all the money saved on unnecessary MRI's and CAT/PET scans prior to the early 1970's (prior to them being invented). Is that voodooism or anti-science?
This is all about economics and scarcities -- what is more important: the cost of the drug or its availability. You cannot separate one from the other, unless government gets involved. That's when the whole pricing structure goes out the window. In a free market, the price of ANYTHING is what you must pay to get the good or the service when you want and as much as you want. In a regulated market, you have markups -- regulatory costs and legal burdens -- in addition to hampering the supply by regulatory actions. You cannot simplistically ask if we would prefer similar drugs at cheaper prices. The only way to get cheaper prices is for the cost of bringing them to market decreasing -- not by decree. If we could make our own drugs out of spit and dirt or cure ourselves, we wouldn't need to have this discussion. In fact, we wouldn't even need Medicare. But since we rely on the talent, hard work and lifelong dedication of others, we have to compensate them for setting straight the hand that God dealt us all. But that would make life difficult for socialism. No scapegoats.
Jack London| 4.29.11 @ 3:10PM
Can't see the relevance of anything you say. The article is about a clear choice between a much cheaper alternative and something that doesn't work. And as I said above, Lucentis and Avastin are made by the same company, which of course the article doesn't say, as well being scientifically illiterate on the cancer facts.
vtwin| 4.29.11 @ 3:26PM
Yes, “free markets,” no Government regulations, to the late nineteenth-century America and the Traveling Medicine Shows!
Occam's Tool| 4.29.11 @ 5:28PM
I'm obviously not antiscience. However, unlike you, I HAVE been a senior NHS consultant in New Zealand, whcih closely models its programs after the UKs. And I will tell you, price trumps everything in such a system. I don't want it, but I certainly hope you get it. Think about moving to Canada. They're always looking for immigrants.
Occam's Tool| 4.29.11 @ 5:29PM
Sorry, "which."
vtwin| 4.29.11 @ 2:19PM
I recently offered to pickup my granddaughter’s ear-drops prescription for my daughter who was pressed for time. When I arrived at the pharmacy to pickup the ear-drops I was informed that my daughter’s drug insurance card on file with the pharmacy had expired. Not wanting to bother my daughter I offer to paid cash for the prescription. At that point the pharmacist said “I don’t think you’ll want to,” ear-drops the doctor had prescribed were $495.00. To his credit, the pharmacist offer to and then contacted the doctor to prescribed an alternative the pharmacist “was sure” would be just as effective. The alternative ear-drops the doctor prescribed cost $19.00.
What was the doctor’s motivation for prescribing a $495.00 product when a $19.00 product was sufficient?
What is Senator Jon Kyl motivation?
What is Robert M. Goldberg motivation?
Occam's Tool| 4.29.11 @ 5:26PM
I doubt it was due to a steak dinner for the doc, vtwin. And we get no vacations paid for anymore, thanks to PHARMA. And, sometimes, you're dealing with things that have no easy alternative. For example, Provigil is impossible to get insurance companies to pay for. But it treats anergia in depressed methamphetamine addicted patients without significant abusive risk. The insurers would prefer you prescribe ritalin, which is obviously contraindicated.
vtwin| 4.29.11 @ 7:01PM
“Robert M. Goldberg is vice president of the Center for Medicine in the Public Interest “
AND
“The Center for Medicine in the Public Interest has been identified as a corporate front group engaged in orchestrating a public misinformation campaign about health reform.” -- sourcewatch
http://www.sourcewatch.org/ind.....c_Interest
AND
I seriously doubt that a cold blooded snake like Jon Kyl is pursuing this issue for any reason other than campaign contributions.
Danny| 5.1.11 @ 9:52PM
Amen to that story. A friend of mine wanted to get a tetanus shot. Went to the university hospital, which wanted to charge her $500. So she went to the student clinic, who charged her $50. Wonder why.
Another acquaintance went to the dermatologist. He and his assistant spent a total of no more than 5 minutes with him, and snipped a couple of skin tags. $500. Wonder why.
If you want to fix healthcare, address these issues, and the problem of access to healthcare will disappear on its own, I'll wager.
Gary J Shapiro | 4.29.11 @ 9:53PM
My wife is a retina surgeon and I have been incensed witnessing how Genentech has gamed they system and paid so many people to discourage Avastin use in favor of the more expensive Lucentis. See
Wrong Incentives in Medicare Waste Billions Gary Shapiro The ...
I am passionate about the free market, but when taxpayers are footing the bill – as they are with Medicare – we need to ensure that the government is ...
blogs.forbes.com/.../wrong-incentives-in-medicare-waste-billio...
Nite| 4.29.11 @ 10:18PM
Our wonderful President, FDA and Obamacare. See what we are going to be getting? Rationing and a much higher mortality rate.
Creative Recreation | 8.10.11 @ 9:37PM
is good