Money for comparative effectiveness research for drugs was salvaged in the federal stimulus, despite the intense lobbying of the drug industry. This is a good thing. PhRMA has criticized the bill, arguing (risibly) that somehow more information in the marketplace will lead to denial of treatment. They would prefer us to have less information — to keep doctors and patients guessing about what drug works better for a particular ailment.
… Now, we often get criticized on this site for being “anti-business”. And sometimes we get criticized on this site for being anti-union. One might well ask, What's the point of consistency? I hope that we try to evaluate the actions of either unions or business, based on how closely they have aligned their own interests with those of the public at large. All interest groups will claim “What's good for us is good for the country” or state, or community. So in any given situation, we can ask, Is that a plausible claim? Or an excuse to charge a rent, or extort some unearned benefit from the public, via unequal power of politics or markets?
Everyone — especially those of us in Massachusetts — has an interest in a thriving drug industry, for reasons medical and economic. The question is the mode of doing business: Does the corporations' good overlap with the public's? Or are they appropriating value from us?
If drug companies are required to compete directly on cost and effectiveness, their business strategy will indeed have to change. Currently, the typical strategy seems to be: a.) develop a drug, b.) test it for general efficacy and safety, and c.) market it. In the absence of neutral, reliable comparative data between drugs, marketing weighs much more heavily in how drug companies compete than efficacy, safety, and price.
With the federal government playing the role of an honest and neutral broker, the balance will shift; the function of efficacy/safety/price will become much more prominent. Maybe we would see a shift in resources away from marketing, and toward R&D. Drug companies will still compete, they will still sell drugs, the winners will still make money — lots of it. But the results of such competition will be much more likely to bear real medical benefits for the public.
It's not that drug companies can't do business this new way; but since the old business model has been so lucrative, they're resistant to change. Their behavior is rational, in a way; but they circumscribe their own interests away from those of the public at large. Perhaps they will realize someday that the alternative will make them money, too.
Get ready for a lot of propaganda about how comparative studies will lead us down the road to Aunt Betty being denied the latest cancer treatment. They might as well throw in a video of some Medicare bureaucrat taking her out back and shooting her like in Old Yeller.
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p>But the truth is that cancer drugs is not where comparative efficiency will have a lot of bite. There, the drugs have highly fragmented indications and populations. Plus, the powers that be know that rationing decisions like this would be highly contentious (there’s actually a huge fight in New Zealand right now over this).
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p>No, the low-hanging fruit here will be the “me-too” drugs that Big Pharma churns out. These are drugs with many established competitors in the field, and they often show NO improvement over pre-existing (often much, much cheaper) options. Their market share truly lives and dies by marketing — direct-to-consumer and to physicians. What am I talking about? Here’s a few areas overwhelmed by me-too drugs: season allergy medication, statins, arthritis medication, atypical psychotics, heartburn treatment, and, yes, ED treatment. Why do the drug companies keep creating new options here? Because unlike many treatments such as cancer medication, patients take these drugs on an ongoing basis. As in forever. That makes them very profitable. And, for you and me as taxpayers, very expensive. In many cases, drug companies also need to keep pumping out new drugs because their older drugs are going / have gone generic. Of course, the generic manufacturer doesn’t market its products. But you can bet your last dollar that Joe the Pharma Rep will be in every doctor’s office to tell them how the new, new thing is so much better for their patients. Comparative efficiency treatment will seriously damage the ability of drug companies to keep pumping out new me-too drugs because they would have to show that their new (and more expensive) drugs are an improvement over competitors.
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p>Anyway, this was all a long way of saying that when people try to scare you about rationing cancer treatment, what they are really worried about is that you’ll be prescribed a generic rather than the “Purple Pill” for your heartburn.
… doesn’t have to change that much. Right now they control the information in the studies that they fund.
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p>The controversy of the provision really doesn’t match the size of the fight over it because there is pharma money that can be had by leveraging access to information. Not a liberal or conservative issue unless you are so pro-business you don’t care about the resultant overall cost premium we pay by not knowing this stuff already, or are convinced that the public sector shouldn’t supply us with good information just because it’s the public sector.
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p>More Ezra:
First I think it’s important to clarify that the current proposal makes no mention of a cost consideration in the evaluations. Evaluations (at least initially), will be based in clinical data only. So assuming that most marketed statins or antipsychotics (or similar markets) have relatively similar therapeutic indices, it will be ‘outlier’ medications (those that are particularly ineffective or have especially harsh side effects)that are most at risk for losing federal reimbursement.
I include “at least initially” because while cost evaluations are not included, they are certainly on the horizon (the “slippery slope” feared by PhRMA). To that end, I would agree that branded “me-too’s” for which there are sufficient generic alternatives will be threatened (I’m interested to see what happens in the statin market when Lipitor goes generic). However, many MCO’s already allow pharmacies to switch a branded prescription for the generic alternative (both with and without notifying the patient). So while such medications are on the market, cost saving provisions are already in place.
With regards to more serious conditions, such as cancer, comparative efficacy & cost-effectiveness (CE) can have a significant bite. A recent example of this is the the debate over drugs to treat renal cell carcinoma in the United Kingdom (the UK has it’s own CE body, NICE). Initially, 4 medications were rejected outright for coverage on the basis of CE. To keep it brief, through a combination of policy change & cost sharing agreements, 1 on the 4 was finally approved. Its important to note, however, that these drugs were rejected for a condition that had NO targeted therapeutic option. (Other similar examples in cancer include drugs for lung cancer, breast cancer, myeloma…)
Thus, I fear an all-in-one evaluation process (again, see NICE’s use of QALY and ICER data) with manufacturers submitting clinical data and costs simultaneously. My hope would be – as the proposal seems to be building – a stepwise evaluation process that keeps clinical efficacy at the foundation, and allows for price negotiation afterwards (this is similar to the process in, dare I say, France).
I guess we’ll see.
…cost isn’t part of the study. I don’t see how that would necessarily change. Certainly cost considerations would have to be evaluated during some part of an approval process, but that would be true regardless of any effectiveness study. Presumably, people may be worried that these factors might be linked in some kind of approval process, but that’s not what is up for discussion now. If and when it does, I’d say that pertinent issues should be explored in full for that proposal. The purpose of this provision is to add to the body of knowledge,… that’s all. Whatever slippery slope people might be anxious about, better informed decisions are necessary for cost any cost containment strategy, even if you don’t analyze actual costs.
Admittedly I don’t know the fine print, but I’m not entirely convinced that much will be added to the body of knowledge without cost evaluations. I don’t think there is intention to sponsor new clinical trials in an attempt to update data. Without that, any clinical data must come from current published/reported clinical information (Phase I-IV trials, case studies, KOL presentations). This is information that any specialist (or GP for certain mediations) should be aware of and up-to-date on anyway. I’m concerned that certain physicians would need a government seal of approval to tell them if a medication “works”, or if a generic is an adequate substitute for the branded drug (or vice versa).
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p>I’m not against comparative efficacy evaluations. Particularly in countries that allow DTC advertising (a whole other discussion), impartial bodies are very important (as previous posters have pointed out). I like this proposal because I think it is going to make manufacturers think more about R&D (as a chemist I’m behind that). But I also think that adding approval and evaluation processes to the steps drug companies already have to take with the FDA etc., should be done efficiently, and am not entirely convinced have a body simply to review clinical data is particularly efficient.
“I don’t think there is intention to sponsor new clinical trials in an attempt to update data. “
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p>I think that’s exactly the point. As you point out, until that happens you’d have to rely on “current published/reported clinical information” and that’s the problem. What little ‘objective’ comparative study that has been done up till now points to the fact that ‘current literature’ can’t be trusted to give you an ‘objective’ overall view of comparison. Hence the need. Nobody is against efficiency. The whole impetus is a reaction to an inefficiency in the overall system suggesting that we need better information available to doctors to better inform their decisions.
I have to agree that comparitive effectivenes studies are needed but I feel this is only the precursor to cost effectiveness studies.
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p>The issue regarding me too drugs is real, when companies identify a potential candidate to move into clinical trials, say for high blood pressure, they set aside around 500 to 800 million to get the potential drug thru Phase 1, 2, and 3 trials. This process takes around 10 years. SOme here argue that companies should throw the compound away if another compound gets to market first. Companies move forward because they need to recoup their investment. Sometimes this proess of compound redcunacy pays off, Minoxidil was orginally a blood pressure drug that eventually was approved for hair loss. Having options in drug classes is a good thing. The real crime is when companies prevent patent loss by either making a extended release version of a drug or getting a pediatric indication for a drug about to lose patent, these tricks should be stopped. A me too drug isnt bad but more a by product of competition that in the end benefits patients. If drug developers stopped research into blodd pressure products when teh first compound was developed we would all be taking beta blockers for high blood pressure. Beta blockers have their place but for younger patients do you really want to offer them one agent that has many adverse effects that inhibit a good quality of life? Choice is good.
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p>Cost effectivenes comparisons is the real end game solution to current healthcare crisis. Why is it that the United States gives more chemotherapy to patients vs any other country? Patients do not live any longer here with cancer than say in the UK. There is already a move in effect to offer patients hospice soone vs later. In many instances cure is not available for end stage cancer patients. Hospice would be more cost effective than chemotherapy and the patient would have an increased Quality of life vs quantity of life. 2 extra months of life with debilitating chemo side effects is not anything any of us want. American consumers of healthcare need to change their feelings and thoughts about end of life care. What is the cost effectiveness of open heart surgery for a 92 year old? Here you can save huge amounts of money for the heatlhcare system vs focusing on drug companies. Drug spending amounts to about 10% of all dollars spent on healthcare, check out what open heart surgery costs for a 92 year old. Lets focus on real cost savings vs low hanging fruit.
Certainly, ‘choice is good’, but it also should be self-evident that cost data isn’t a ‘bad’ thing to have. Data is good to have in order to make decisions. Indeed, it’s hard to imagine a situation where cost containment was a priority, but where you didn’t actually want to look at cost data. Counterproductive, no?
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p>That being said, your point about choice is also salient. That is, just because a given ‘alternate’ drug that is less effective in the comparative study is much more expensive, doesn’t mean that it shouldn’t exist necessarily. Indeed, such an ‘outlier’ drug might work very well for minority of patients for whom the ‘more effective drug’ wasn’t.
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p>This is very similar to the problems of medicine in general. That is, differing treatments can have vastly different costs and rates of effectiveness. Also, the types of treatments required across the whole system suffer from the same problem. Insurance was supposed to be the great equalizer by spreading the financial risk of potential future treatments. It may be the case that some similar mechanism could be useful with regard to drug research and manufacturing to ‘spread’ the financial ‘risk’ of production and research.
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p>This is all very off-the-top-of-my-head. It’s just that the mechanism of spreading risk is very helpful to an overall system by minimizing the ‘shock’ of extreme outliers, of which there can be many in health-care in general and drugs specifically.
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p>I have no idea how something like that would work and it’s ‘intrusiveness’ could certainly be fraught with unintended risks.
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p>All that being said, however, it is necessarily the case that if containment and efficiency are goals, there has to be a place for cost and efficacy data. I don’t see how you responsibly design a system with those goals in mind without considering data from those factors.
from the medical industrial complex as they are already offshoring that.
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p>Just as media has blacklisted topics now there are blacklisted trains of thought. Effectiveness research? That would never go through. We are in a War on Drugs yet well into a new generation who have sat in front of the TeeVee telling them to “Ask your doctor for……”
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p>Obama’s medical policy is clear.
You “vill” get your mandatory shots.
You “vill” have your medical records used against you.
Und ve vill prescribe your treatment not you.