Will The NIH Avastin Trial Open A Pandora’s Box?
6 CommentsBy Ed Silverman // May 14th, 2008 // 7:31 am
A pioneering clinical trial recently launched by the National Institutes of Health may fundamentally reshape relations between payers and drugmakers, IMS Health is warning, The Financial Times reports.
The National Eye Institute’s head-to-head trial will compare the effectiveness of two drugs made by Roche’s Genentech, and could lead to a much cheaper way to treat age-related macular degeneration, which causes blindness. Medicare, for instance, may save $1 billion or more annually (look here).
But IMS says the $16 million study, called CATT, opens “a Pandora’s box” by taking testing out of industry hands, changing the rules of development and potentially undermining a blockbuster long before it comes off patent. CATT is listed as one of the top seven ”harbingers of change” highlighted in its yearly analysis of significant events likely to affect the evolution of the industry.
The trial, which is being conducted without involvement from Genentech, may result in prescribers widely switching from Lucentis, developed for AMD, to Avastin, which was developed for cancer but can be split into small doses for injection into the eye at a fraction of the cost.
Lucentis was tested for safety and efficacy in treating AMD and approved by the FDA two years ago, but is closely related to Avastin, which was approved for cancer in 2004 and since then widely prescribed off label because it is much cheaper. A single dose of Lucentis for AMD costs $2,000, while a larger concentration in a bottle of Avastin can be split and cost only $40 to $75 for each injection.
IMS argues that if CATT shows Avastin is safe and effective for AMD as Lucentis, it may pave the way for an increasing number of payers to take comparative drug studies out of the hands of drugmakers, especially as databases of patients make it much easier to conduct such tests, the Times writes. And this would also create a disincentive for drugmakers.
Last year, you may recall, Genentech angered opthamologists with plans to restrict sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into smaller doses and repackaged for docs. Opthalmologists complained that would hurt patients, because Lucentis is so much more expensive. Genentech eventually backed down.
Nathan
That’s interesting — I never thought about the broader implications of this trial on the pharma industry. Imagine if insurance agencies start running clinical trials designed to prove that cheaper (generic, etc) drugs are just as effective as newer (expensive) branded medications. This could have a major impact on pharma revenue.
Atlex
While industry is often accused of bias, government-sponsored and payer-sponsored trials also have significant potential of bias. In the latter instance, there is signficiant financial motivation to prove that the lowest cost option is equally effective. While the Avastin/Lucentis case may be an easy one, previous efforts such as in antihypertensives and antipsychotics have not proven to signficantly impact prescriber behavior because the studies weren’t well-designed.
Outside the Box
So long as they a re being run for the right reasons (i.e. medical benefit rather than just cost reduction) these are good studies to run out of NIH. Head-to-head is pretty straightforward when you only have two heads. As soon as more than two get involved, or when there is multi-staged therapy, lengthy outcomes or co-prescribing the problems and costs of study design will probably get in the way. In any event these types of trials will only be conducted post-approval (until someone decides to change the rules - but that is an entirely different conversation).
Ambulance Chaser
If I were a malpractice attorney, I would be salivating at the opportunity to sue healthcare providers using the products off-label. Currently the manufacturers maintain liability for appropriate use, who will own this liability under this system?
M Helm, MD
Why is this assessment coming from IMS Health? I can’t see if this is the usual “Year in Review” presentation that Rich Ferring did for years or if this is some other report. Does anyone know?
Nathan - Insurers would not usually need to sponsor comparative trials to determine that older medications (like simvastatin or ACE inhibitors) have long-term outcome benefits which are greater than newer medications (like Zetia - and formerly Crestor to whom congratulations should go for the recent positive outcomes results, or Tektura - new MOA, but no proof of any benefit). There are many non-novations (my term)offered by PhRMA these days think of transdermal diclofenac, transdermal selegiline, a combination analgesic with a slightly lower dose of acetaminophen, etc. ad nauseum. These product in most cases offer no conceivable benefit over other, older products available, however, they can cost as much as 100 times more than the older alternative.
Your assumption in your many posts usually seems to be “newer is better.” This is an assumption not supported by evidence (also know as a bias). I don’t always assume that older or cheaper is bettter (I’ve never prescribed Levsin for example), but it is very hard to beat diphenhydramine or hydroxyzine for a bad allergy attack. In many cases there are already sufficient comparative data to pick “winners and losers” among treatments in a category. I can tell you that, your assumption that the least expensive medications would always win with insurers is untrue.
How do I know? This is what I do for (most of) my living for a couple of health plans. We have had a dramatic impact on cost growth for the plans, while creating incentives for use of the medications with the best associated outcomes. One self-insured plan experienced only a 3% increase in PMPM pharmacy costs over the past two years. This is far lower than the mean rate of increase for most plans. For another plan, we are reducing their total pharmacy costs by around 10%, compared to what they might have spent otherwise.
Atlex - the problem with government sponsored trials failing to affect behavior is (I think) not one of trial design. (I’d say the CATIE trial was pretty well designed for what it set out to establish, don’t know which antihypertensive trial to which you refer.) Instead there appears to be a lack of promotion/marketing of the results, relative to the promotion and marketing of the choice which are supported by financial (not public health or efficiency of resource alloction) interests.
In my experience, when we have aligned the research findings and plan policies, we have seen amazing changes in prescribing behavior. This has also lead to significant (multi million dollar) cost savings without impacting on quality of care.
A significant problem in all of this, and the reason for the study is the lunacy associated with pricing products in the pharmaceutical industry. Honestly, the price of a product bears no relation to development or production costs. It has a great deal more to do with what does the price need to be to hit next quarter’s revenue targets. When you have two uses for essentially one drug, and there are dramatic differences in the dose size and therefore costs, this creates the pharmaceutical equivalent of an arbitrage opportunity.
Are we expected to ignore that man behind the curtain?
Ambulance Chaser - there are issues with off-label uses of medications, but the providers don’t have the deep pockets to make it worth your while. However, if you want some real dough, look into PhRMA promoted/encouraged/supported off-label uses of medications. A good example would be use of atypical antipsychotic agents in children (the younger the child the better for you). There is very good evidence that at least one of the companies dropped samples and called on pediatricians and child psychiatrists years before any study in children was conducted, let alone an approved indication.
Very likely these agents cause more harm in children’s developing brains than would be the risk to a person’s vision by using small amount of Avastin instead of Lucentis. Even better, (as I understand) the statute of limitations for malpractice involving a child doesn’t start ticking until the child reaches majority - please correct me if I’m wrong on that. Even if you weren’t already a lawyer already, there would be plenty of time to go to law school, pass the bar, develop the expertise, and sue everyone. Call me if you need expert testimony.
compound pharmacy
not likely. bio-identicals are proving to be no better than the regular HRT, as you may have read in the news lately. if our insurance companies were to start covering these exorbitantly high costs, our insurance costs would go even higher. I suggest you become better informed and stop listening to Suzanne. we aren’t going to be young forever
http://www.greatearthpharmacy.com