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PHARMA: Vioxx study hits Merck stock price

Cox-2 inhibitors (Merck’s Vioxx and Pfizer’s Celebrex being the leading products) were introduced a few years back as being as effcective as older painkillers but without the stomach problems that affect about 30% of aspirin, ibuprofen or NSAID users. The most common ailment these drugs are targeted at is arthritis, but any long term low-grade pain is a candidate. Of course, they have been widely prescribed and used by people who either hadn’t been proved to have stomach problems on non-Cox-2 painkillers or are taking aspirin anyway. Additionally Celebrex has been alleged to actually not be as helpful for those with GI problems as it has been marketed to be. None of that news, almost all based on studies by PBM Express Scripts, seemed to affect the sales of Cox-2 inhibitors much, and it reamins a $6bn market.

But today a study from Kaiser Permante has a study out based on its own members data that suggests that Vioxx creates a three-fold risk of heart attacks compared to other NSAIDs and Celebrex. Merck’s stock price is down nearly 2% as a consequence, as presumably if this study gets come currency with physicians they might start switching patients to Celebrex or one of the newer Cox-2’s coming on the market later this year. If Merck is lucky those Cox-2s will include Arcoxia, Meck’s replacement for Vioxx which is undergoing FDA approval here, but is already on sale in Canada and Europe.

POLICY: Uninsurance–It’s 45 million now

It’s taken a long while but the Census bureau yesterday confirmed that in 2003 45 million Americans lacked health insurance. Of course that’s actually a wrong number, it’s a snapshot which actually means that 45 million lacked health insurance at any one time. Some 25 million are uninsured more or less permanently and some 70-75m go through some period of uninsurance in each year. Last year a study showed that 84m are uninsured for a period of 3 months or more in a 4 year period.

This is a real problem and the US Chamber of Commerce has the gall to say that there are real market based solutions to cure this:

The U.S. Chamber of Commerce said the solution to the health insurance problem already is in the pipeline: “Today’s news that the number of uninsured Americans totaled 45 million in 2003 is a tragedy in that real solutions already exist,” said Kate Sullivan Hare, the Chamber’s executive director of health policy, in a press release.“More can — and should be — done to make health coverage affordable for employers and workers,” Sullivan Hare said. The Chamber said the best way to make health coverage more available and affordable is to allow pooled-purchasing for small businesses – what President Bush recommends — along with “equitable tax treatment” for individuals who purchase their own health coverage; and tax credits targeted to people with modest incomes. The Chamber said it opposes efforts to add new mandates and expand employers’ liability for the health coverage they voluntarily provide to their workforce.

I’m not sure this needs to be dignified with a response, but let me just say that there is no such thing as voluntary universal insurance.

HEALTH PLANS: The Wellpoint-Anthem merger saga goes on

Politics continues to impact healthcare as California insurance commissioner John Garimendi continues to block Wellpoint’s merger with Anthem. The latest round is that Garmimendi has asked the court to throw out Wellpoint’s challenge to his decision. While there’s been plenty of industry tut-tutting about this, recall that the whole approach of Wellpoint/Anthem–which dangled the carrot of huge pay-offs to executives in front of a Democrat with both power over the merger and strong political ambitions–was not very smart.

I don’t know if it’s too late for them to sell off California Blue Cross’s Life and Health subsidiary, but I’d assume that they must be working on it.

PHARMA/POLICY: Oncologists, chemo and the new reality, by Gregory Pawelski

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New contributor Gregory D. Pawelski writes for THCB about the changes in oncology and chemotherapy reimbursement. TCHB has posted several articles about those changes, notably from regular contributor Matt Quinn. Gregory writes from a slightly different viewpoint with considerable passion. As he wrote in this heartfelt article on the Johns Hopkins site, he nursed his wife through the agony of chemotherapy, and has since researched into chemotherapy and cancer treatment in depth. Passionate he may be, but Gregory has some important things to say that are well worth considering:

Some irate oncologists are angry and hope to turn patients into lobbyists, warning patients that they may face a return to hospitalization. And yes, some of them are threatening to refuse treating Medicare patients altogether. These kinds of threats are abhorrent! Even Medicare officials have denounced some of these oncologists as alarmist and untrue.

Some of them are telling their patients that because of the new reimbursement system, patients might have to “switch to older medications”. That may not be a bad idea! Presently used chemotherapy drugs have a high rate of failure, according to January 10, 2002 issue of the New England Journal of Medicine. Oncologists at a single institution may obtain a 40% – 50% response rate in a tightly controlled study, but when these same chemotherapy drugs are administered in a real world setting, the response rates decline to only 17% – 27%.

Real world setting after real world setting has been showing that presently used chemotherapy drugs have failed to show clinical advantage over standard (older, less toxic drugs) regimens. According to a multicentre Southwest Oncology Group study, there is no significant difference in survival, response rates or quality of life between standard (cheaper) regimen and dose-intense (more expensive) treatment arms.

The results of years of clinical trials on patient populations are considered enough indication on how an individual will respond. The percentage of patients that must respond to a drug before it is approved varies from as low as 20% to as high as 80%, depending on the type of cancer. Thereafter it is used routinely for all patients with the same form of cancer, though unfortunately a drug that helps one person does not necessarily mean that it will help all people with the same diagnosis.

One of the commonest methods to test a new drug is not against an already effective treatment but against a placebo. However, what matters most to patients is not whether a company’s drug is better than nothing, but whether it is better than established treatments. European regulators already require drug makers to compare new drugs with older ones (comparative drug testing), while the FDA simply asks that drug makers compare new drugs with placebos. When you look at the results, there is almost never a difference between active treatments.

Oncologists long avoided cuts forced on other specialists because the government allowed them to bill Medicare for cancer drugs in amounts that often far exceeded their actual costs. The system was widely criticized and the General Accounting Office found that doctors were able to get discounts as high as 86% on some drugs.

Even the American Society of Clinical Oncologists say, “we did not like the old system, even the perception that it set up inappropriate incentives we did not support.” Some studies suggest that American oncologists overuse cancer drugs, particularly in the last months of patients’ lives after the patients have failed to respond to treatment. Advocates for cancer patients say that Medicare’s reimbursement system encouraged overtreatment.

The January 1, 2001 issue of the Journal of Clinical Oncology revealed that in 1999 the average annual income of oncologists in private practice was $253,000. By comparison, oncologists in academic medicine earned “only” $142,000. Where does the bulk of a private oncologist’s income come from? The Journal of the National Cancer Institute (JNCI) commented that “private-practice oncologists typically derive two-thirds of their income from selling chemotherapy” (JNCI 2001;93:491).

An editorial from Dr. Larry Weisenthal, one of the very first medical oncologists to call attention to this issue at a Medicare Reimbursement Executive Committee meeting held in Baltimore, Maryland on December 8, 1999 states, “the new law was simply concerned about the indisputable fact that the ‘structure’ of the old reimbursement system was indefensible. It rewarded oncologists for administering chemotherapy. It did not reward oncologists for spending a half hour explaining to the patient why she/he is more likely to be harmed by chemotherapy than to be helped by it.”

The new system still has major flaws, in that it continues to provide incentives to administer chemotherapy, in the same way that surgeons have a financial incentive to recommend surgery. Additionally, it is a certainty that there will be large differences between the profit margins of administering different drugs, providing continuing incentives to base drug selection on profit margin. However, the new system is clearly an improvement from the standpoint of cancer patients, taxpayers, and advocates of basing drug selection on individual tumor biology, rather than on a least common denominator approach which invites conflict-of-interest medical decision-making.”

Office-based oncology practices derive most of their revenues from treating patients with chemotherapy. The practices are compensated both for delivering the drugs and for the drugs themselves. The Journal of the National Cancer Institute (JNCI) states that private-practice oncologists typically derive two-thirds of their income from selling chemotherapy.

Reimbursement of any kind is often lacking with oral-dose drugs because the patient purchases them directly. The oncologist simply writes a prescription and the patient goes to a pharmacy and obtains the product. There are no administration fees for office-based oncology practices unless they also dispense the drugs, because there is no involvement in their purchase.

The practice will realize almost no revenue from those patients who are treated entirely with oral-dose agents. The core activity in medical oncology is the provision of infusional chemotherapy. The entire structure of office-based practices revolves around this activity and is what distinguishes medical oncology from most other specialties.

Oral-dose chemotherapeutic agents are easy to use and offer the promise of less frequent visits to the physician’s office and their infusion rooms. This promise is not trivial, especially as we have come to realize that many forms of cancer may be managed with these drugs, especially when they offer the equivalent outcome as intravenous drugs.

The fact that medical oncologists receive no reimbursement for providing oral-dose therapy to patients had been the principal barrier to the availability of oral-dose protocol. The advent of oral agents ultimately means that medical oncology will need to change its identity, prior to the chemotherapy drug concession.

They will be reimbursed for providing evaluation and management services, making referrals for diagnostic testing, radiation therapy, surgery and other procedures as necessary, and offer any other support needed to reduce patient morbidity and extend patient survival.

Because oral-dose drugs ultimately deliver on their promise of combining equally efficacious therapy with better adverse event profiles and easier administration, they will rightfully gain their appropriate share of the marketplace, again.

POLICY: A long and excellent series on health insurance, and a good review of the Kerry plan, with UPDATE

There is an excellent series on the current crisis in health insurance in the San Diego Union-Tribune written by Leslie Berestein. The really avid TCHB wonk reader may know all this, but it’s not often the three rings of the circus are put together in the popular press. The first article Insurance ills put squeeze on consumers explains the background to the current cost explosion. The second, employers benefits in critical shape, looks at the problem small and medium business are having providing insurance, while all employers are cutting back on health care and increasing employee contributions. Finally the third article, the individual insurance market sucks (Ok it’s not called that but it should be) has some harrowing stories about the collapse of the individual market for the 20% of those in it who really need it.

Go read the articles, and kudos to Leslie and her editors for running this series. I have two quick observations. One, this type of article started appearing in the early 1990s. We didn’t fix the problem then and now it’s back much worse. Second, there is no solution without compulsory insurance and compulsory risk pooling. Anything else is an illusion.

Finally, Jeff Lemiuex at Centrists.org has an interesting, long and thorough review of what in the Kerry plan (and also in the Frist plan) both conservatives and liberals can live with. I don’t share his optimism about the likelihood of a non-universal insurance system being able to contain long-term costs, but it’s a very thoughtful analysis of a possible legislative response to the developing crisis reported in the Union-Tribune.

UPDATE: The NY Times has a very similar article on the problems of small businesses buying health insurance.

TECHNOLOGY: Patient Physician email redux

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Here’s a quickie round-up of some activity in the patient-physician connectivity space (boy, that word makes me miss 1999!)

The BMJ has a pretty typical academic article summarizing the good and the bad of patient physician email. The two part article basically says that it’s pretty good for asynchronous connections that don’t require the hands-on caring touch. While the article is only worth reading for the harder core among us, the iHealthbeat summary is worth a quick perusal. Meanwhile Manhattan research, also reported in iHealthbeat confirms that only 8% of American docs currently email their patients.

So yes, the level of online interaction continues to be small. But there are some wins taking place. Relayhealth’s service counts my doctor as a sort of user. I can, via Calif Blue Shield, find his “online office” and fill in my health record form, but he doesn’t seem to have any of the features switched on nor has he emailed me back. But overall the concept does appear to be making forward progess, if only painfully slowly. The Rocky Mountain News reports it’s not going so badly in a clinic in Denver that now has over 700 patients using the service. Of course they are not really using it for online consults–the killer apps of online connectivity are appointment setting and prescription refill requests. iHealthbeat has a little more on the subject, and as you can see from the steady number of deals RelayHealth is signing up, interest in the conecpt is slowly taking shape.

Meanwhile, in what’s essentially the same space (sorry!), that of EMR access by patients, Geisenger in Pennsylvania has a success to report. Like Group Health Cooperative in Seattle, which has a similar system that also appends email connectivity to a patient’s view of its EHR, Geiseneger patients can go oline to get their health information from their physicians and also email them about administrative and clinical tasks. An article in JAMIA shows that Geisenger patients found EHRs easy to use. The authors noted that:

Patients preferred email communication for some interactions (e.g., requesting prescription renewals, obtaining general medical information) while they preferred in-person communication for others (e.g., getting treatment instructions). Telephone or written communication was never their preferred communication channel. In contrast, physicians were more likely to prefer telephone communication and less likely to prefer email communication.

Something tells me that this is a slow movement of attrition that will hit a tipping point. Perhaps a modest injection of funds as part of the 10 Year Plan might help push it along? Can the VA and DOD get on board first? We’ll see.

HEALTH PLANS: Group Health strike–ahh the irony

Here’s the AP report on the fact that the workers at Group Health Cooperative of Puget Sound, the nation’s most famous staff model HMO, (and no I have heard of Kaiser but I’m being a smartass here) are on strike because they are being asked to pay a greater share of their health care costs. Given that labor is about 70% of system costs there’s something circular going on here, but I won’t investigate it for fear that smoke will start coming out of my ears.

HOSPITALS/PROVIDERS: GPOs under investigation

There’s a long article in the NY Times this weekend suggesting that the next target for investigation by HHS and DOJ are the GPOs (Group Purchasing Organizations). The largest of these Novation (the GPO of the VHA a group of some 1400 hpsitals and the much smaller University Hospital Consortium) has received a supoena investigating its relationship with suppliers. The NY Times mole, a former Novation exec, likened the case to the “best price” issues that Medicaid and Medicare have had with the pharma companies:

The former Novation executive said he believed that the federal investigators might see similarities in those arrangements to payments that drug companies have made to doctors who prescribed their brands – payments that have led to multibillion-dollar settlements by some pharmaceutical companies.

“Pharmaceuticals are referred to in the press because the average reader can associate with them more,” the former executive said. “Consumers don’t buy operating-room tables or X-ray machines, or that kind of stuff, but you’ve got the same sort of thing going on. And it’s huge, huge money.”

GPOs have historically had some influence moving market share between different suppliers, but any member of the buying group has always been free to go around the group if they can get a better deal outside it. So because the GPO cannot force its members into buying supplies through it, they are always looking to deliver reasons to stay within the buying fold. The article suggests that the complexity of the GPO’s arrangements both in terms of rebates for volume purchases it gets from manufacturers, and dollars and services it delivers back to its memeber hospitals has ended up with either over complex or false real pricing. Hence Medicare and Medicaid may not have got the best prices, as they are legally supposed to.

It might also be worth keeping an eye on whether the same issues have been raised in some of the bigger chains practices, notably HCA or Broadlane (the buying group owned by Kaiser and Tenet). There’s no hint of that in the report, but if HHS is looking at one GPO you can assume that most of them have been following the same pattern.

Where this investigation goes will be interesting. The complexities of rebates and pricing in these cooperatives are mind-boggling. Some of the intricacies of the relationships between the big hospitals, the GPOs, the big wholesalers (like McKesson and Cardinal) are very complex. Add into that mix that some suppliers, notably GE as reported in the NY Times a while back, are rolling in consulting across a whole hospital’s operations as part of a wider business realtionship, and it becomes very difficualy indeed to figure out what the “best price” really is.

POLICY: Watching the politics of MMA

The devil is in the details and all politics are local. Cliches, but in the implementation of health care policy and payment in the US, true cliches. Two articles over the weekend bear this out. The AP reports that insurers and pharma companies are fighting over the details of whether therapeutic categories are broadly defined in the details of the the MMA’s new Part D drug benefit (as the insurers want) or more narrowly (as the pharmas want). What’s at stake here is the ability of the insurer or PBM to switch a patient from an expensive branded product to a generic or a cheaper older brand. If they are in the same category, it’ll probably be OK, but if it’s in a different category, it probably won’t be. So should Cox-2 inhibitors be in the same category as ibuprofen? In fact a trial underway is looking at that precise question, and if there’s no real difference perhaps Vioxx and Celebrex will only be available under some kind of step therapy within Medicare Part D. Well you see where this is going.

For those of you really interested, here’s the first draft of the US pharmacopoeia guidelines, which includes a series of steps for meetings and comments. Those of us who prefer to gloss over the details and look at the big picture just need to realize that over the next decade lots of lobbying dollars will be spent to change tiny line items in the resulting final document.

And talking of tiny details in new regulations it appears that the Bush administration is running into trouble by trying to create regional Medicare managed care plans when the nation’s health plans (especially the Blues of course) are actually 51 different plans, all operating under different local statutes, and are not too keen to develop the alliances or infrastructure required to compete regionally when they’re mostly happy with their monopolies infrastructure at home. Now if you want competition, you have to make the market big enough so that you can have a few plans with some scale compete in a region. But of course it makes no sense for any plan to go into, say, a North Dakota and take on the local Blues plan with its 80% market share. How this gets squared away I don’t know, but I suspect that you’ll see an exemption for the share of the population living outside the top 100 metro areas, which after all are the real units that matter in the business of America (think TV markets!).

Frankly the state-based health insurance system is an anachronism. But then the state-based system of electing Senators (and Presidents!) is an anachronism too. (Note that a senator from California represents 15 million people where one from Alaska represents 200,000, but as far as the law’s concerned their votes are equal). It might actually be easier and faster for HHS to abolish the states and come up with 10 regions! On second thoughts, maybe not. But what a great idea.

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