Health Business Blog

In Europe, reimbursement decisions for drugs often include explicit consideration of cost effectiveness and a comparison of the efficacy of the new drug with products that are already available. In the US, such considerations are excluded, at least for Medicare, which is the biggest payer. In the latest Health Affairs, Joshua Cohen, Ashley Malins and Zainab Shahpurwala conclude that the European approach leads to lower costs, better access to therapy for patients, and better outcomes –at least in some cases.

I asked Cohen –a senior research fellow at the Tufts Center for the Study of Drug Development– to comment on some of the findings.

Why did you base your research on patient access rather than market availability?

I’ve been studying patient access for over 10 years. I try to distinguish between key dimensions of patient access. Broadly, patient access is a function of: i. market availability (off-label uses are an exception to the rule); ii. coverage by payers; iii. patient out-of-pocket costs. Market availability captures one element of access. It is a necessary, but insufficient condition of access given that the vast majority of cancer drugs are paid for by third party payers.

From the patient standpoint, what are the advantages and disadvantages of the US v. European approaches?

The biggest advantage in the U.S. versus Europe with respect to cancer drugs is faster market availability of a greater number of drugs. Two rather stunning facts stood out: 1. None of the common subset of 29 drugs were approved in Europe before the U.S. And in most instances the lag was at least 4 months. 2. At the same time, for drugs licensed by the EMA and approved for reimbursement by the national health authorities there were hardly any out-of-pocket costs for patients in Europe. Contrast this with co-insurance percentages of as high as 40% for some drugs in the US. There are medications with annual price tags of over $20,000 –and 40 percent of  $20,000 is a lot of money to shell out, especially for those on fixed incomes.

The comparative outcomes information you cite in the article is very old and excludes drugs approved since 2002. Why is this the case? Is there any way to look at more recent information?

The articles themselves are not old. They are recent publications (2009, 2010, 2011). However, if one looks carefully at the time period during which survival data were being measured it becomes clear that the newer vintage drugs were not included in the studies. Hence, one cannot conclude that better survival statistics for a number of cancers in the U.S. are due to better access to newer cancer drugs. Until we have data showing survival that can indeed be attributed to better access to newer drugs, we are left to speculate. My hunch is that better access in the U.S. to newer cancer drugs (i.e., faster and greater numbers of approvals, as well as fewer coverage restrictions) has been beneficial to some patients, as has improved screening and earlier diagnostic work-up.

In the timeframe you considered, 41 oncology drugs were introduced in the US but only 31 in Europe. Are there clinically significant products that make it to market in the US but not elsewhere? Can you provide an example?

Provenge (sipuleucel-T) comes to mind as a drug with a lot of fanfare in the U.S. It was approved in 2010 by the FDA, yet still not approved in Europe. At the same time, it should be said that there are certain differences in regulatory mechanisms that have benefited market uptake of a number of drugs in Europe, including Iressa (gefinitib). Iressa has led practically a moribund existence in the U.S., while in Europe, as a result of EMA approved of a companion diagnostic in 2009 – an EGFR mutation test kit – sales have increased steadily.

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By David E. Williams of the Health Business Group 

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It’s probably impolite and childish of me, but my first reaction when I read about Chinese hackers breaking into US health care organizations was that this may be the poison pill that finally sends the Chinese off the rails. It will serve them right if they blindly copy the byzantine business processes of certain hospitals and health insurers and end up bankrupting the Chinese economy in the process.

Reading a little further into the piece I see they are mainly looking for secret information about novel drugs and devices, but business processes are also on the list.

By David E. Williams of the Health Business Group.

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The recent study of the benefits of the Mediterranean diet and olive oil got huge buzz. I heard about it everywhere –even from my mother. Whenever something so definitive is released it makes sense to be skeptical. And no one’s been quicker to critique the findings than proponents of low fat diets, whose reputations and livelihoods are threatened if this study achieves lasting influence.

The following guest post was written by Pritikin Research Director and UCLA professor, James Barnard, PhD.

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We’ll start by talking about what’s good about the newly published study (1) that garnered headlines like “Mediterranean Diet Shown To Ward Off Heart Attack and Stroke.”

The study affirmed the benefits of a healthy diet even for people already taking medications for high cholesterol, blood pressure, or diabetes.

The takeaway:  Drugs have benefits.  Drugs plus diet have even more benefits.

And there’s no question that a Mediterranean-style diet (fruits, vegetables, legumes, fish, whole grain, nuts, olive oil, wine) is healthier than a typically American diet, full of fast food and other artery-cloggers like cheese, butter, red meat, processed meats, refined flour, sugar, and salt.

Now to the problems (and there are many) with this study.  We’ll focus on three major ones.

• The study followed 7,447 people with heart disease risks who were randomly assigned to either Mediterranean-style diets or a low-fat diet, but the low-fat diet was not low in fat.  Not even close. The people in the “low-fat” group started out with a diet that was 39% fat.  They decreased fat intake to 37%.

So, the authors weren’t really comparing a Mediterranean diet to a low-fat diet.  It’s much more accurate to say they were comparing a Mediterranean diet with a fatty American-style diet.  And sure enough, a lot of the foods the so-called “low-fat” group was eating were heart-damaging foods like red meat, commercially baked goods full of refined flour and fat, and sugary sodas.

• Some argued that the people in the “low-fat” group were unsuccessful in reducing their fat intake because a low-fat diet is too difficult to maintain, but it could also be argued that the scientists conducting this study never really gave the “low-fat” diet group a chance.

During the first half of the study, the people assigned to the Mediterranean diet received intensive education in eating well, including regular visits with registered dietitians.  The people in the “low-fat” group got one visit.  That’s it.  It was the equivalent of a doctor’s visit in which the doctor hands you a pamphlet with what to eat, and what not to eat, and essentially says, “Good luck.”

Moreover, the “low-fat” diet that the scientists designed excluded an important food proven to protect against heart disease, a food that is a part of many low-fat plans, including the Pritikin Program – omega 3-rich fatty fish.  The subjects in the study were discouraged from eating fatty fish like salmon.

And ironically, this “low-fat” diet devised by the scientists had no limits on some foods known to increase heart disease risk, like soft drinks.

• The scientists summarized that the Mediterranean diet “reduced the incidence of major cardiovascular events” compared to a low-fat diet, and media articles led with announcements like “30% of heart attacks, strokes, and deaths from heart disease were prevented.”

But in the study itself, the scientists reported no significant reductions in heart attacks or cardiovascular-related deaths among the Mediterranean dieters. They wrote, “Only the comparison of stroke risk reached statistical significance.”

So how did they jump from stroke reductions to all reductions in cardiovascular risk?  Well, it’s easy when you know how to play with numbers.  They pooled all the data on heart attacks, strokes, and deaths, and the numbers on strokes were high enough so that the average of the three looked good.

Bottom Line:  It appears that the scientists were doing everything they could to make the Mediterranean diet the winner.  Why?  We don’t know for sure, but consider this:

The olive oil, nut, and wine/alcohol industries were very involved in this study.   Two olive oil companies supplied all the olive oil.  Two nut companies supplied all the nuts.  The lead author, Dr. Ramon Estruch, has served on the board and received lecture fees from wine groups like the Research Foundation on Wine and Nutrition and the European Foundation for Alcohol Research.

The other authors of the study have deep ties with other olive oil, nut, and wine groups such as the California Walnut Commission, the International Nut and Dried Fruit Council, the Mediterranean Diet Foundation, and an wine/alcohol public relations group in Spain called Cerveceros de España.

Yes, it could be argued that these scientists had a vested interest in making the Mediterranean diet look as good as it possibly could.  By contrast, there was no financial interest in making the “low-fat” diet look good.

What would have been a far better study is one in which a Mediterranean diet was compared with a truly healthy low-fat plan like Pritikin.

Pritikin includes all the excellent elements of a Mediterranean diet (fruits, vegetables, whole grains, legumes, fish) as well as the ability to shed excess weight (something the subjects in the Mediterranean study did not achieve) because on Pritikin calorie-dense foods like oil and nuts are kept to a minimum.

So strong are the data affirming the heart-healthy benefits of the Pritikin Program that Medicare is now covering it for people with a history of cardiovascular disease.

In summary, the Pritikin Program combines daily exercise with an eating plan that emphasizes:

• Hearty consumption of fruits, vegetables, whole grains, and legumes like beans
• Moderate intake of fat-free dairy products and lean animal protein like fish, skinless poultry, and bison
• Little or no intake of added sugars, saturated fats, trans fat, and sodium (no more than 1,500 mg of sodium a day).

Is this a low-fat diet?  Yes.  Average intake is about 10 to 15% fat.

But more importantly, it’s an extremely healthy diet, proven in more than 100 studies over the past three decades to dramatically reduce virtually every modifiable risk factor for cardiovascular disease, including LDL bad cholesterol, trigylcerides, blood glucose, insulin, hypertension, inflammatory markers like C-reactive protein, and excess weight/obesity.

A study comparing this type of healthy, low-fat diet with the Mediterranean diet would have been a study that deserved headlines.  Not the study that was published this week.

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A new study purports to demonstrate that primary care physician offices in Ontario discriminate against the poor by being less likely to offer them appointments. I saw an article about the study in the LA Times (Canada’s universal healthcare may not be so universal after all) and was a bit puzzled. Here’s what is said:

The researchers posed in each call as one of four types: a wealthy banker in good health, a wealthy banker with diabetes and back problems, a welfare recipient in good health, or a welfare recipient with diabetes and back problems.

Overall, the callers were 50% more likely to be offered an appointment when they posed as bankers than when they posed as welfare recipients.

‘Staff at physicians’ offices may hold negative attitudes toward this group, especially toward people receiving social assistance,’ the authors wrote. ‘Physicians have been shown to perceive patients with low socioeconomic status more negatively in terms of their personalities, abilities, behavioral tendencies and role demands.’”

Certainly the results sound bad and are consistent with the general notion that rich people get away with things while the poor get the shaft. But do Canadian primary care offices routinely try to assess the socioeconomic status of patients? It seemed odd to me.

So I read the original study (which is not linked to in the article) and my assessment is that the methodology is biased. Researchers were given scripts to use when calling the doctor’s office and were told to read them neutrally. Even if we assume they were able to be neutral (which I doubt) the language is biased in a way that throws the results and conclusions into question.

Let’s compare the wording of the two questions:

“Hi, I was just transferred to Toronto with [name of major bank], and I need a family doctor for my diabetes and back problems. Is Dr. ____ accepting new patients?”

vs.

“Hi, I’m calling ’cause my welfare worker told me that I need a family doctor for my diabetes and back problems. Is Dr. ___ accepting new patients?”

The researchers assume that the only important difference between these scripts is the information about whether the person is employed in a highly paid job or is on welfare.

I disagree. In particular, the first patient sounds like a self-motivated individual who is calling because s/he is conscientious and is making an effort to be responsible and take care of him/herself.

The second patient sounds like someone who is calling because they were told to, not because they wanted to. And why on earth does the script say “’cause” instead of because? Now imagine switching around the script so the banker is calling “’cause my wife told me I had to” and the second calls to say they needed a doctor and doesn’t make it sound like someone else told them to do so.

My guess is that the main driver of the results is that office staff are giving priority to a patient who is motivated to show up for appointments and be compliant with therapy rather than one who sounds like they’re calling just so they can tell their welfare worker that they did what they were told. If the caller hadn’t told the office of their profession or welfare status I doubt the office would have raised it. 

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The remarkable and inspirational story of the development of Israel’s Iron Dome missile defense system is told on the front page of today’s Wall Street Journal (Israel’s Iron Dome Defense Battled to Get Off Ground). It made me wonder: is there anything from that story that we can apply to our big health care problems?

To summarize:

• The threat of short-range missiles fired at Israel has been apparent for several years.
• Though people have discussed solutions, it was assumed by lay people and experts that a solution was unlikely or impossible. Either it wouldn’t work technically, would be too expensive, or would take too long –or all of the above
• A senior official –in this case a Brig. General in charge of R&D at the Ministry of Defense– decided to make it happen anyway, despite opposition from almost all quarters
• An inexpensive, effective system was conceived, developed, deployed and utilized within just a few years
• Established defense contractors were brought into the project
• The system was integrated into the existing armed forces once completed

My favorite section of the story is where Gen. Gold describes his reaction to an audit that showed required approvals were  bypassed:

Gen. Gould said in an interview that the auditor’s report misrepresented some facts, declining to be more specfic. He disputes any allegation that he broke rules, saying he simply sidestepped red tape.

“I just canceled all the unnecessary bureaucracy,” Gen. Gold said. “I left only the most crucial bureaucracy needed for success.”

There are some similarities with health care. There is a clear cost, quality and patient experience problem in this country that poses an existential threat to our finances. That’s why many people have embraced the Triple Aim to address all three issues and why the Affordable Care Act sets up all sorts of mechanisms for experimentation. Yet it is a long, slow process and it’s unclear whether we are really making progress. A big bureaucracy and top-down rule-making provide protections and funding, but also tend to stifle innovations.

Maybe the US health care system is just too big and complex a problem even compared with the missile threat to Israel. But I hope the story of Iron Dome encourages our own Gen. Gold’s to come out of the woodwork and take action.

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Looking for a way to send ObamaCare foes into a tizzy? Try suggesting emulating the French system. In any way. And yet if we believe in the notion of learning from best practices in health care –as both Romney and Obama seemed to be pointing to in their idolization of the Cleveland Clinic– shouldn’t we be open minded?

A recent Health Affairs article (In Amenable Mortality –Deaths Avoidable Through Health Care– Progress in the US Lags That of Three European Countries) showed the US doing poorly compared to France, the UK and Germany in keeping people alive with conditions such as hypertension and cerebrovascular disease. We spend twice as much per capita yet those countries are progressing much faster. Those who continue to boast about America having the best health care system in the world might want to reconsider the evidence upon which their claim rests. Don’t get me wrong. I have confidence that the care I have access to in Boston is as good or better than anywhere in the world, and it’s nice for patients that costs aren’t a primary concern. But as a whole we spend more and get less than we should.

The Wall Street Journal (France Seeks New Ways to Manage Alzheimer’s Care) has an extensive report on how France is confronting the growth of Alzheimer’s. Alzheimer’s is a progressive, terminal illness.No cure is coming any time soon. So the French have done something smart, which is to address the issue holistically, with medical care as one important part of the solution. On the medical side, physicians are being made more aware of the needs of Alzheimer’s patients and there is an emphasis on avoiding unneeded, aggressive medical interventions. Other components include integrating Alzheimer’s care into broader social services and offering respite care, which gives families a break from caring for Alzheimer’s patients at home –something that can be exhausting and stressful.

These approaches are used in the US, too, but on a much more limited basis. Shouldn’t we have the courage to look for best practices wherever we find them, especially if it means lower costs and higher quality?

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The US is perhaps the only rich country without universal health insurance coverage, and that will still be true even if the Affordable Care Act is fully implemented. What’s interesting is that it’s not just rich countries that have the ambition to achieve coverage for all.

From the Harvard School of Public Health:

Despite periods of economic downturns and crisis, Mexico recently achieved a significant milestone – enrolling 52.6 million previously uninsured Mexicans in public medical insurance programs and thereby achieving universal health coverage in less than a decade.

Sure, the public coverage is more basic, and Mexican facilites generally less advanced than their US counterparts. Yet it’s notable that a middle income country made this health policy a priority even when it’s rich Northern neighbor has not.

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I’m no big Mitt Romney fan, but I’m warming to him a bit after his Israel stopover, despite the so-called gaffes. Since this is the Health Business Blog, I’ll focus on Romney’s praise of aspects of the Israeli health care system. A front page Boston Globe article basically ridicules Romney for complimenting the Israeli system, considering there is a serious socialistic element to it that is at odds with Romney’s free-market philosophy. The Globe gives multiple critics the chance to point out that Romney is praising a system that offers universal coverage and has plenty of central government involvement, which is the opposite of what he espouses for the US.

Let’s give Romney the benefit of the doubt and assume he isn’t totally ignorant. Let’s assume he knows that Israel doesn’t have a completely free-market approach to health care. Let’s even imagine that Romney perceives universal health care and the high concentration of physicians as consistent with the “cultural” or (heaven forfend!) Jewish  character of the State of Israel.

I give Romney credit for calling out the advantages Israeli society enjoys as a result of spending only 8 percent of GDP on health care compared to 16 percent or more in the US, while attaining life expectancies that are three or four years higher. He’s brave to admit –if only implicitly– that different approaches work best in different places. It’s really not so inconsistent with the view he’s espousing about health care in the US –that what’s right for Massachusetts is not automatically right for the country as a whole. The emphasis on judging policies by their results rather than their ideological underpinnings is  a good one, and would represent a nice change for Washington, DC. And it has the advantage of seeming to be what Mitt actually believes.

Keep this kind of thinking and speaking up when you get home, Mr. Romney and you may find yourself closing in on the White House.

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FierceHealthIT highlights an example of telemedicine that I think is right on the money. A University of Pittsburgh team has trained hundreds of surgeons on procedures at the base of the skull. Most of the surgeons are from abroad, and when they get back home they often have questions. Some can be answered by email, but others need a more interactive approach.

So the Pittsburgh team has walked at least two surgical teams (including one in Slovenia) through procedures using telepresence –basically high bandwidth videoconferencing that is like being in the same room. I like how the Pittsburgh surgeon characterizes it:

“Our goal is not to try to teach someone to land an airplane who’s never flown an airplane before. …we’re trying to get them to the next level.”

This kind of approach can go a long way toward improving the quality of care and building bonds among an international network of surgeons. This approach is still in its infancy, which is why it’s newsworthy.

But technology doesn’t stand still, and we are not far from the time when there will be very little difference between being somewhere physically and being there virtually. For now, the surgeon in Pittsburgh is just explaining what to do and maybe using some illustrations. But there’s no real reason why they won’t soon be able to pick up a surgical instrument remotely and use it to operate.

I wonder how that will change the dynamics. Will the Slovenian surgeon feel as comfortable asking for help if it means the Pittsburgh surgeon ends up performing a key part of the operation? How will the economics of that work? And to what extent will patient needs be paramount versus surgeons’ egos and financial incentives?

Overall I’m optimistic. But I’ll be really excited when patients can be operated on routinely by surgeons in other parts of the world. And that includes the possibility of a Slovenian surgeon operating on someone in Pittsburgh if that makes the most sense.

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A Los Angeles Times article (Worries grow as healthcare firms send jobs overseas) laments the trend to perform functions such as data processing, pre-certification, and utilization review overseas in places like the Philippines and India. The US nursing lobby in particular is bent out of shape by the fact that some jobs done by nurses are affected.

The Times takes an alarmist view:

The outsourcing of nursing functions, in particular, may be the most novel — and possibly the most risky — of the jobs being shifted…

Patient advocates worry about crucial decisions involving a patient’s care being in the hands of foreign insurance adjusters. Analysts said there was another concern as well: patient privacy.

I’m glad that companies are starting to offshore these functions. The digitization of data makes location irrelevant, so why not go where things are less expensive? I don’t know who these “patient advocates” are, but why are they more concerned about “foreign” staff than domestic? The offshored resources are acting at the direction of their US bosses, so we shouldn’t be worried they will make the wrong decisions or violate patient privacy.

The nurse lobby is always putting out scary statistics about the huge shortage of nurses in the US. By their logic, wouldn’t it make more sense to have insurance company paper-pushing nurse shift back into clinical care? If a laid off nurse can’t find a job either the nursing shortage is bogus or there’s something wrong with that nurse.

Let’s not forget that US health care is dreadfully expensive. We should encourage health care organizations to cut costs. If offshoring helps them do it then they should go for it.

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