Anyone paying objective attention to what the new healthcare legislation has spawned has noticed creative juices beginning to ooze out here and there. To wit: Royal Philips Electronics and its from-hospital-to-home heart patient monitoring technology collection. Two desired endpoints here: Saving lives and saving money.
Next year – if the healthcare legislation stays intact – hospitals that have an inordinate amount of readmissions for heart failure, MI or pneumonia will start losing Medicare reimbursement. Year one: 1%, year two, 2%, year 3, 3%. After that, the list of readmitted conditions grows that can produce a penalty. Medicare has been paying big-time for unplanned hospital readmissions, according to a study in the New England Journal of Medicine: $17.4 billion in 2004.
Philips unveiled its tech collection at the recent American College of Cardiology conference; the ACC is one of its partners in this endeavor. No doubt critics of physician-industry collaboration will be screaming while reading this – but how else are cardiologists supposed to learn about these products?
The products include bedside monitors with early warning systems; a cable-free progressive care monitoring system; home tele-health system; and a remote cardiac service with diagnostic arrhythmia monitoring and additional patient self-testing.
It’s all about connecting the dots: giving cardiologists insight into how their patients fare when they get home.
But it's also about patient education and better communication among patients and providers along the healthcare continuum – make no mistake, it will always be about these two. We doubt this country would be facing this healthcare debacle if we had a handle on the first issue and had never sacrificed the second.
Showing posts with label Comparative Effectiveness. Show all posts
Showing posts with label Comparative Effectiveness. Show all posts
Monday, May 2, 2011
Thursday, April 7, 2011
$4 Generics and Medication Non-Adherence
Let’s face it – the business of healthcare is enough to make anybody nuts.
Take the recent study, conducted in 2007, showing only a handful of people, relatively speaking, who took advantage of their healthcare insurance provision to buy $4 generic drugs. If all the people who could buy $4 generics did so at that time, society would have saved nearly $6 billion. A lot of money, no question. The study included 31,000 people; fewer than 6% bought $4 drugs.
It’s tough to imagine that 93% of these people hated society, so maybe there’s something else going on here. They didn’t know? Perhaps. They don’t like generics? Unlikely. According to the Kaiser Family Foundation, 72% of all scripts written in 2008 were generics, and sales of generics grew 8% from 2005 to 2006. The percentages wouldn’t have changed that much from 2007.
In that same study, “Over half of physicians say they frequently talk with patients about the out of-pocket costs of medicines they prescribe, 62% say they switch patients to less expensive drugs, and 58% say they give patients office samples.”
It's anybody guess why those patients chose to spend more money. But, none of the above is the good-grief part. The following is.
Back in November, the New England Journal of Medicine ran a piece about the possible damage that these $4 generic sales can do to long-term improvements in healthcare.
Normally, when a patient purchases a prescription with insurance, that purchase generates a claims record. The pharmacy sends the claim to the pharmacy benefit manager. These claims can be used for healthcare management, including medication safety, verifying clinical trial results, and ensuring medication adherence.
But, with the $4 generics, patients often pay in cash. The authors say the pharmacies often do not submit the claim information “since they have no incentive to do so.” The result: patients are classified as non-adherent or non-users. And, because these drugs are often prescribed for chronic diseases, “the consequences of these missing claims are not insignificant.” This is also important to the topic of medication adherence because it already suffers from a lack of awareness. With almost 80% of the prescriptions today being dispensed as generic, medication non-adherence will become more of a silent disease.
The authors, Niteesh K. Choudhry, M.D., Ph.D., and William H. Shrank, M.D., M.S.H.S., aren’t labeling the pharmacies as bad guys – their actions are unintentional, they say. But, as they point out, new systems need to be devised to make sure the claims are filed.
Take the recent study, conducted in 2007, showing only a handful of people, relatively speaking, who took advantage of their healthcare insurance provision to buy $4 generic drugs. If all the people who could buy $4 generics did so at that time, society would have saved nearly $6 billion. A lot of money, no question. The study included 31,000 people; fewer than 6% bought $4 drugs.
It’s tough to imagine that 93% of these people hated society, so maybe there’s something else going on here. They didn’t know? Perhaps. They don’t like generics? Unlikely. According to the Kaiser Family Foundation, 72% of all scripts written in 2008 were generics, and sales of generics grew 8% from 2005 to 2006. The percentages wouldn’t have changed that much from 2007.
In that same study, “Over half of physicians say they frequently talk with patients about the out of-pocket costs of medicines they prescribe, 62% say they switch patients to less expensive drugs, and 58% say they give patients office samples.”
It's anybody guess why those patients chose to spend more money. But, none of the above is the good-grief part. The following is.
Back in November, the New England Journal of Medicine ran a piece about the possible damage that these $4 generic sales can do to long-term improvements in healthcare.
Normally, when a patient purchases a prescription with insurance, that purchase generates a claims record. The pharmacy sends the claim to the pharmacy benefit manager. These claims can be used for healthcare management, including medication safety, verifying clinical trial results, and ensuring medication adherence.
But, with the $4 generics, patients often pay in cash. The authors say the pharmacies often do not submit the claim information “since they have no incentive to do so.” The result: patients are classified as non-adherent or non-users. And, because these drugs are often prescribed for chronic diseases, “the consequences of these missing claims are not insignificant.” This is also important to the topic of medication adherence because it already suffers from a lack of awareness. With almost 80% of the prescriptions today being dispensed as generic, medication non-adherence will become more of a silent disease.
The authors, Niteesh K. Choudhry, M.D., Ph.D., and William H. Shrank, M.D., M.S.H.S., aren’t labeling the pharmacies as bad guys – their actions are unintentional, they say. But, as they point out, new systems need to be devised to make sure the claims are filed.
Tuesday, March 29, 2011
ACOs and Fierce Communication
So here’s a question to ponder while you’re reading our carefully honed prose: How do you attract patients to sign up for an accountable care organization?
Last week, Cigna announced that its two ACO pilots were doing, at least preliminarily, what they should be doing: improving patients’ health and saving money. The giant insurer is so happy with the results that it is planning a national expansion of its ACO program this year.
Here’s why they’re happy: At its multi-specialty medical group practice division in Phoenix, the average annual savings per patient was $336; ambulatory surgery was down 11%; preventive care visits, overall, were up 3%, and up 12% for adults. And, its partner in New Hampshire is “closing gaps in care 10% better than the market.”
A few years ago, Cigna jumped on the ACO bandwagon. The goal: “Achieve the ‘triple aim’ of improved quality, lower medical costs and improved patient satisfaction by creating a care model anchored in the principles of the patient-centered medical home that also builds in accountability by rewarding physicians for results.”
In its press release Cigna says its collaborative ACO model is big on communication. Its doctors and nurses speak frequently with its customers’ doctors and nurses, “to help with coordination of patient care.” Cigna’s program also includes disease management programs and lifestyle management programs, including stress management.
Cigna doesn’t say how its customers reacted to the idea of participating in an ACO. That notion is even more interesting for Medicare patients. How will Medicare—by law, mandated to start pilot programs by next January—attract its seniors, normally an independent, privacy-loving lot? According to the new healthcare law, the pilot ACOs will take care of all the healthcare needs of at least 5,000 Medicare patients for three years, minimum.
FierceHealthcare says the success of these ACOS will require “fierce communication strategies,” like physicians doing things they don’t normally get paid for—contacting patients by e-mail, instant messaging and so on.
But as usual, it comes down to communication. We somehow doubt that it will matter what the medium is: word of mouth, Twitter, radio, smoke signal. If the ACO healthcare providers are communicating among themselves, sharing information about a patient’s well-being, and that patient’s health is improving, along with his quality of life, then that patient will spread the word.
And that can be pretty fierce, don’t you think?
Last week, Cigna announced that its two ACO pilots were doing, at least preliminarily, what they should be doing: improving patients’ health and saving money. The giant insurer is so happy with the results that it is planning a national expansion of its ACO program this year.
Here’s why they’re happy: At its multi-specialty medical group practice division in Phoenix, the average annual savings per patient was $336; ambulatory surgery was down 11%; preventive care visits, overall, were up 3%, and up 12% for adults. And, its partner in New Hampshire is “closing gaps in care 10% better than the market.”
A few years ago, Cigna jumped on the ACO bandwagon. The goal: “Achieve the ‘triple aim’ of improved quality, lower medical costs and improved patient satisfaction by creating a care model anchored in the principles of the patient-centered medical home that also builds in accountability by rewarding physicians for results.”
In its press release Cigna says its collaborative ACO model is big on communication. Its doctors and nurses speak frequently with its customers’ doctors and nurses, “to help with coordination of patient care.” Cigna’s program also includes disease management programs and lifestyle management programs, including stress management.
Cigna doesn’t say how its customers reacted to the idea of participating in an ACO. That notion is even more interesting for Medicare patients. How will Medicare—by law, mandated to start pilot programs by next January—attract its seniors, normally an independent, privacy-loving lot? According to the new healthcare law, the pilot ACOs will take care of all the healthcare needs of at least 5,000 Medicare patients for three years, minimum.
FierceHealthcare says the success of these ACOS will require “fierce communication strategies,” like physicians doing things they don’t normally get paid for—contacting patients by e-mail, instant messaging and so on.
But as usual, it comes down to communication. We somehow doubt that it will matter what the medium is: word of mouth, Twitter, radio, smoke signal. If the ACO healthcare providers are communicating among themselves, sharing information about a patient’s well-being, and that patient’s health is improving, along with his quality of life, then that patient will spread the word.
And that can be pretty fierce, don’t you think?
Monday, March 7, 2011
Pharma: Know Thine Enemy
Mindless habitual behavior is the enemy of innovation.
Harvard Business Professor Rosabeth Moss Kanter
Might we suggest that pharma begin thinking about investing serious money into healthcare that does not only involve drugs? We keep tripping over stories and studies of how non-traditionalists are stepping into the healthcare space using social media.
We found this interesting.
One group of researchers has published two papers on smoking cessation; both papers involved the same number of subjects, 27. Another group took a look at the 47 apps, designed to help smokers quit smoking, all of which are currently sold for iPhones only.
The two groups of researchers found different results.
In the first paper the researchers first used fMRIs on the subjects, all heavy smokers, to learn which parts of the brain were fighting, or giving in, to the urges to smoke. Their description of this battle: “A war that consists of a series of momentary self-control skirmishes.”
The researchers theorized that by mapping the brain areas where these skirmishes are fought, they could predict which of the subjects would have more success at quitting–-because these brain areas were more active. The motivation they used on these subjects was text messages, eight messages a day for three weeks.
“We are really excited about this result because it means that the brain activation we see in the scanner is predictive of real-world outcomes across a much longer time span than we thought,” said one researcher. “The tasks that we use in the laboratory are simplified models of these real-world processes–-but they seem to be valid models.”
In the apps paper, the researchers checked out the 47 smoking cessation apps, just to see how effective they might be. They looked at how each app approached smoking cessation and its adherence to the U.S. Public Health Service's 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence.
The conclusions? The apps had “low levels of adherence to key guidelines in the index. Few, if any, apps recommended or linked the user to proven treatments such as pharmacotherapy, counseling, and/or a quitline.”
What an opportunity for pharma; it’s tailor-made.
Harvard Business Professor Rosabeth Moss Kanter
Might we suggest that pharma begin thinking about investing serious money into healthcare that does not only involve drugs? We keep tripping over stories and studies of how non-traditionalists are stepping into the healthcare space using social media.
We found this interesting.
One group of researchers has published two papers on smoking cessation; both papers involved the same number of subjects, 27. Another group took a look at the 47 apps, designed to help smokers quit smoking, all of which are currently sold for iPhones only.
The two groups of researchers found different results.
In the first paper the researchers first used fMRIs on the subjects, all heavy smokers, to learn which parts of the brain were fighting, or giving in, to the urges to smoke. Their description of this battle: “A war that consists of a series of momentary self-control skirmishes.”
The researchers theorized that by mapping the brain areas where these skirmishes are fought, they could predict which of the subjects would have more success at quitting–-because these brain areas were more active. The motivation they used on these subjects was text messages, eight messages a day for three weeks.
“We are really excited about this result because it means that the brain activation we see in the scanner is predictive of real-world outcomes across a much longer time span than we thought,” said one researcher. “The tasks that we use in the laboratory are simplified models of these real-world processes–-but they seem to be valid models.”
In the apps paper, the researchers checked out the 47 smoking cessation apps, just to see how effective they might be. They looked at how each app approached smoking cessation and its adherence to the U.S. Public Health Service's 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence.
The conclusions? The apps had “low levels of adherence to key guidelines in the index. Few, if any, apps recommended or linked the user to proven treatments such as pharmacotherapy, counseling, and/or a quitline.”
What an opportunity for pharma; it’s tailor-made.
Friday, March 4, 2011
Can the NIH Innovate Faster than Industry?
So it’s come to this: The federal government plans to entice industry with basic bench, and maybe even clinical trial results, to spur drug development.
Concerned that so few promising drugs are in the pipeline, that let alone meet FDA standards, the NIH is setting up a new research shop. Anticipating that penny-pinching Republican House members may give him a hard time about his idea, NIH chief Frank Collins is willing to “cannibalize other parts of the health institutes to bring more resources to the new center,” says the Times.
“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he told the Times. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”
For those who need a recount: The FDA approved 21 drugs in 2010, 25 in 2009, and 24 in 2008. No drugmaker, says Fiercebiotech, had more than one drug approved last year. The approval rules are getting tougher: We all saw what happened with the obesity drugs. Collins said in the Times article that industry’s “productivity has been declining for 15 years.”
It doesn’t look like many drugs will be approved this year: The Street said in January that 26 were in the queue and one’s already been rejected: Contrave, the obesity drug.
Industry is all tied up in what it considers a bad situation. While profits are increasing for some members, companies choose to focus on patent expirations, tough regulators – on both sides of the Atlantic – the new U.S. health care reform, and no doubt myriad other issues.
Fiercebiotech penned the apt phrase: A wave of impatience has crashed over the drug development and discovery business.
How did we get here? Another phrase is apt: The perfect storm.
Pharma’s past behavior forced overregulation, which added more costs to R and D. And since no one in discovery appears willing to give up its quest for innovation – read blockbuster – the costs of discovery continue to rise. So mergers and acquisitions make sense, which in our experience has drained talented R and D personnel.
So, academic researchers and advocacy groups may be the ones who drive new innovation, but it's doubtful they'll have enough funds to see any product through all the regulatory challenges. It appears to us no one is reconciling the priorities with the limited dollars available.
In our opinion: Drug research is too inefficient.
Industry critics continue to scream that pharma spends way too much on marketing and has no reason to cry poor mouth. This may be true: But the fact remains that collaboration in pharma is still a business, and pharma must answer to a board of directors, shareholders and its own future. As for the NIH, do we have evidence that research dependent on the federal government for basic bench research is the way out of this mess?
We believe both parties can find new ways to conduct research and conduct clinical trials. We just began working with a company that's ready to break down some of those challenges. We suggest this type of communication, knowledge management and performance measurement tool can help all parties involved in research.
A comment from researcher Hugo Geerts posted on the Fiercebiotech article regarding the huge dependency on animal studies is another excellent point to consider.
A comment from researcher Hugo Geerts posted on the Fiercebiotech article regarding the huge dependency on animal studies is another excellent point to consider.
His suggestion: Pharma should use more computer-based mechanistic disease modeling.
Monday, February 28, 2011
Pharma: It Must Invest in Improving Health Outcomes
If you're a businessperson and you see an opportunity, don't you take it? Especially if the opportunity is in a business that doesn't seem particularly interested in protecting its territory.
The territory we’re talking about: the quest for improving health outcomes. In a new Ernst and Young report, the authors say that non-traditional companies are investing in projects designed to improve health outcomes. To be sure, some of these partners are traditional, like Apple and Abbott Labs.
The non-traditional investments far outweigh those of Big Pharma. The non-traditionalists have spent $20 billion since 2006; Big Pharma’s figure was not given, but it wasn’t close to that, according to a Bloomberg story.
The authors say that Big Pharma has no choice but to invest in improving health outcomes, and for two reasons: the current health care system is not sustainable -- but new technologies can make it so. These technologies, the writers say, can drive behavioral change.
Examples of these projects include the insurer UnitedHealth Group, the YMCA, and Walgreens, which are working together in a diabetes management program. Others, according to Bloomberg, include GE, Telus Corp, a wireless carrier, and IBM.
One company, called PharmaTrust, based in Toronto, is creating a device called MedHome that dispenses the appropriate amount of medicines to patients in their homes. At the same time, it communicates with providers and caregivers about patients’ compliance, according to the report.
And Qualcomm, the mobile technology company, is hoping to increase compliance and health outcomes with its “connections:” an Internet-connected pill bottle cap designed to increase compliance and also lets patients refill prescriptions by pushing a button on the underside of the cap; and a “connected” blood glucose meter that tracks how often patients are testing themselves and reminds them when they are running low on supplies. They can even reorder from the device.
“Pharma is significantly behind the medical device industry in thinking about connectivity and using its power for productivity and business model innovation,” wrote one Qualcomm exec.
All we are suggesting is that innovation may quickly become the domain of others. What are the unintended consequences of this lack of pharma innovation?
The territory we’re talking about: the quest for improving health outcomes. In a new Ernst and Young report, the authors say that non-traditional companies are investing in projects designed to improve health outcomes. To be sure, some of these partners are traditional, like Apple and Abbott Labs.
The non-traditional investments far outweigh those of Big Pharma. The non-traditionalists have spent $20 billion since 2006; Big Pharma’s figure was not given, but it wasn’t close to that, according to a Bloomberg story.
The authors say that Big Pharma has no choice but to invest in improving health outcomes, and for two reasons: the current health care system is not sustainable -- but new technologies can make it so. These technologies, the writers say, can drive behavioral change.
Examples of these projects include the insurer UnitedHealth Group, the YMCA, and Walgreens, which are working together in a diabetes management program. Others, according to Bloomberg, include GE, Telus Corp, a wireless carrier, and IBM.
One company, called PharmaTrust, based in Toronto, is creating a device called MedHome that dispenses the appropriate amount of medicines to patients in their homes. At the same time, it communicates with providers and caregivers about patients’ compliance, according to the report.
And Qualcomm, the mobile technology company, is hoping to increase compliance and health outcomes with its “connections:” an Internet-connected pill bottle cap designed to increase compliance and also lets patients refill prescriptions by pushing a button on the underside of the cap; and a “connected” blood glucose meter that tracks how often patients are testing themselves and reminds them when they are running low on supplies. They can even reorder from the device.
“Pharma is significantly behind the medical device industry in thinking about connectivity and using its power for productivity and business model innovation,” wrote one Qualcomm exec.
All we are suggesting is that innovation may quickly become the domain of others. What are the unintended consequences of this lack of pharma innovation?
Thursday, February 24, 2011
Investing in Health Outcomes: Does Pharma Get It?
A new Ernst and Young report on what it calls Pharma 3.0 – the industry’s migration from its sole focus on selling medicines to the inclusion of improved health outcomes – reminds us of the tale of the Big Three. Yes, we mean Detroit.
We’ll get to that analogy in a minute.
“In Pharma 3.0,” the authors write, “companies will succeed or fail based not on how many units of a drug they sell, but on how well their market offerings improve health outcomes.” Considering that this report included roundtable discussions and more from numerous Big Pharma execs, it’s safe to say it has lots of industry buy-in.
The report says that some pharma members are investing in such programs. By the authors’ count, 220 programs were launched between 2006 and 2010, with the lion’s share, 44%, coming last year. The authors say nearly all the top pharma houses “are active in the Pharma 3.0 space” with a few, such as Pfizer, Novartis and Roche “leading the charge” with more programs. (Pharma 1.0 is how business was conducted; Pharma 2.0 is considered Pharma’s pursuit of blockbuster drugs and is now coming to an end.)
The report doesn’t talk about how big the programs are, or how much money industry has spent.
But it does mention how much money other companies – non-traditional organizations like Apple and IBM – are spending: $20 billion.
And counting. The writers aren't pleased with industry's skimpiness.
“Pharma is still focused on investing in drug innovation,” says a Johnson and Johnson exec. “We’re not making the kinds of investments in Pharma 3.0 that many non-traditional entrants are making.”
And now for that Big Three connection.
For those of us old enough to remember, do you recall when Toyota and other foreign automakers seriously started selling their cars on American soil? The Big Three ignored their fuel efficiency, their smaller size, their better performance – until it was nearly too late.
The article authors make a similar connection.
“It is important, however, for pharma companies to recognize that they may have a limited window of opportunity. Today’s non-traditional entrants, though unfamiliar with the health care business, could prove to be quick learners, and the advantages that the pharma companies have because of their domain knowledge could shrink in a few years.”
Tomorrow: what those non-traditional entrants are doing.
We’ll get to that analogy in a minute.
“In Pharma 3.0,” the authors write, “companies will succeed or fail based not on how many units of a drug they sell, but on how well their market offerings improve health outcomes.” Considering that this report included roundtable discussions and more from numerous Big Pharma execs, it’s safe to say it has lots of industry buy-in.
The report says that some pharma members are investing in such programs. By the authors’ count, 220 programs were launched between 2006 and 2010, with the lion’s share, 44%, coming last year. The authors say nearly all the top pharma houses “are active in the Pharma 3.0 space” with a few, such as Pfizer, Novartis and Roche “leading the charge” with more programs. (Pharma 1.0 is how business was conducted; Pharma 2.0 is considered Pharma’s pursuit of blockbuster drugs and is now coming to an end.)
The report doesn’t talk about how big the programs are, or how much money industry has spent.
But it does mention how much money other companies – non-traditional organizations like Apple and IBM – are spending: $20 billion.
And counting. The writers aren't pleased with industry's skimpiness.
“Pharma is still focused on investing in drug innovation,” says a Johnson and Johnson exec. “We’re not making the kinds of investments in Pharma 3.0 that many non-traditional entrants are making.”
And now for that Big Three connection.
For those of us old enough to remember, do you recall when Toyota and other foreign automakers seriously started selling their cars on American soil? The Big Three ignored their fuel efficiency, their smaller size, their better performance – until it was nearly too late.
The article authors make a similar connection.
“It is important, however, for pharma companies to recognize that they may have a limited window of opportunity. Today’s non-traditional entrants, though unfamiliar with the health care business, could prove to be quick learners, and the advantages that the pharma companies have because of their domain knowledge could shrink in a few years.”
Tomorrow: what those non-traditional entrants are doing.
Wednesday, January 26, 2011
Wednesday, December 8, 2010
CER: Learn How to Love It
Comparative effectiveness: It’s a concept that payers like, and like a lot. Case in point: Britain’s National Institute for Health and Clinical Excellence. NICE has rejected paying for drug after drug over the past year, claiming it couldn’t see paying high costs for brand drugs that don’t deliver much more than other medicines of lesser value. The latest rejection was Roche’s Avastin; another rejection was Novartis’ Afinitor.
For those industry members whose attention has been riveted on other business matters – and that’s understandable – it’s important to appreciate that comparative effectiveness isn’t going away. Tucked into the health care reform bill was $1.1 billion to study comparative effectiveness research.
According to the Annals of Internal Medicine, CER is “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care." While the point is to "assist [stakeholders] to make informed decisions that will improve health care at both the individual and population levels," all this information affords interested parties "the opportunity to address hitherto unexplored topics in clinical decision making.” In other words, how to save money.
Now, industry members could argue, and rightly so, that clinical trials produce data that come from homogenous groups. In The Health Care Blog, Norton Hadler, MD, wrote, “The science that the FDA reviews does not speak to the effectiveness of the drug, but to its efficacy… CER asks whether an intervention works better than other interventions in practice where the patients and the doctors are heterogeneous.” His argument: Redesign trials so they are more efficient. Good point, but considering industry's current reluctance to embrace this topic and FDA's current focus on safety, that argument will likely not be a top priority anytime soon.
Our advice? Take a look at PharmExec’s article The Fruits of Comparative Effectiveness.
It’s a thoughtful, well conceived piece on how industry members should approach comparative effectiveness. Quoting a Lilly exec, the article says, “The companies that survive and thrive in this new environment will be those that embrace comparative effectiveness research."
Fighting CER, friends, is not helping demonstrate the value of medicine.
For those industry members whose attention has been riveted on other business matters – and that’s understandable – it’s important to appreciate that comparative effectiveness isn’t going away. Tucked into the health care reform bill was $1.1 billion to study comparative effectiveness research.
According to the Annals of Internal Medicine, CER is “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care." While the point is to "assist [stakeholders] to make informed decisions that will improve health care at both the individual and population levels," all this information affords interested parties "the opportunity to address hitherto unexplored topics in clinical decision making.” In other words, how to save money.
Now, industry members could argue, and rightly so, that clinical trials produce data that come from homogenous groups. In The Health Care Blog, Norton Hadler, MD, wrote, “The science that the FDA reviews does not speak to the effectiveness of the drug, but to its efficacy… CER asks whether an intervention works better than other interventions in practice where the patients and the doctors are heterogeneous.” His argument: Redesign trials so they are more efficient. Good point, but considering industry's current reluctance to embrace this topic and FDA's current focus on safety, that argument will likely not be a top priority anytime soon.
Our advice? Take a look at PharmExec’s article The Fruits of Comparative Effectiveness.
It’s a thoughtful, well conceived piece on how industry members should approach comparative effectiveness. Quoting a Lilly exec, the article says, “The companies that survive and thrive in this new environment will be those that embrace comparative effectiveness research."
Fighting CER, friends, is not helping demonstrate the value of medicine.
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