The latest casualty among drugs falling victim to over-promotion and under-testing is Bextra, Pfizer’s COX-2 inhibitor. This time around it is not just cardiovascular issues that are the problem.
Bextra appears to be linked to a significantly higher incidence of a serious skin reaction, a problem not found in the other COX-2s. This skin condition is what led the FDA to “request” that Pfizer pull the drug last week. Earlier, Pfizer was asked to add additional safety warnings to Bextra’s labeling, a move that fell short of a withdrawal request.
Reactions ran the gamut from shock and disbelief to “I told you so”; perhaps the most telling appeared in the New York Times:
Thalia Segal, a pain specialist at New York University, said, “We used to just put people on these drugs for life and not think about it, but we can no longer commit them to lifelong therapy with impunity. We have to use these medications judiciously and follow people more closely. We have to rely on a much more individualized approach” (O’Connor, New York Times, 4/8).
It is becoming painfully (no pun intended) obvious that the “side effects” of various medications can not only be quite serious, to the point where people die or suffer debilitating conditions, but also have been under-considered by administrators and big pharma alike. And, the treatment expense and other liability associated with these side effects will contribute to our rising health care costs. Over the short term, financial results of the pharmas will suffer (“Pfizer, which on Wednesday announced plans to reduce costs by $4 billion annually and restated 2005 earnings estimates, might have to make additional cost reductions to return to double-digit earnings growth by 2006
I’ve been in Arizona at the Pharmacy Benefit Management Institute annual conference for the last couple of days, and will be reporting back in more detail later. Here are a few of the interesting take-aways
HSA has completed the Second Annual Survey of Prescription Drug Management in Workers’ Compensation.
Respondents represented a wide range of payers, with annual prescription drug spends ranging from $772,000 to $156 million. Total estimated drug costs provided by the respondents amounted to $645 million, approximately 18% of the annual total workers’ compensation drug spend. Together, the carriers participating in the survey represent 35% of all private-payer workers’ compensation insurance in the United States.
If anything, awareness of this problem has grown significantly over the last year. In fact, 20% of respondents, mostly from larger payers, indicated that prescription drug costs were “much more” significant than other medical cost issues.
The results of this survey indicate a significant awareness of the importance of prescription drug costs in workers’ compensation, a focus on PBMs as the primary solution, but a lack of distinction among the PBMs themselves. Clearly, the workers’ compensation industry is looking for solutions that emphasize customer service, utilization control, seamless processes and assistance in working with and educating payer staff and their customers.
There is also a rapidly growing recognition that the treating physician is central to addressing this issue. This recognition has grown dramatically over the last year and although there is not consensus on how to address the issue, there is no mistaking the level of interest in doing so.
Copies of the Survey Report may be obtained by emailing me at jpaduda@HealthStrategyAssoc.com.
Merck announced last week that almost 1400 lawsuits have been filed related to Vioxx to date. Many of these have been consolidated in US District Court in New Orleans, including over a hundred that are class-action suits.
Over 20 million Americans have taken Vioxx, and Merck expects the volume of lawsuits to increase substantially.
In comparison, Wyeth Labs’ “Fen-phen” diet drug has resulted in over 60,000 lawsuits as the company has reserved over $21 billion to cover the litigation.
Source Insurance Journal
Two Republican Senators have introduced legislation that will cap annual Medicare drug expenditures. Here’s the article from “California HealthLine” –
Sens. Lindsey Graham (R-S.C.) and Jeff Sessions (R-Ala.) on Thursday introduced legislation that would cap spending on the Medicare prescription drug benefit to the original Congressional Budget Office estimate of $395 billion over 10 years, CongressDaily reports. The new CBO estimate for the benefit is $849 billion between 2006 and 2015.
The bill would establish annual spending caps for the benefit, and the president would be required to submit legislation to scale back the benefit if spending goes beyond that amount. Graham said, “I was always concerned the projected costs of the Medicare prescription drug benefit would turn out to be wrong. Even I was surprised at how quickly and dramatically the projected costs of the program spiked” (CongressDaily, 3/11).
This is rather significant, to say the least. There are clearly cracks in the Republican wall, cracks that appear to be generated by deep concern over the cost of this huge entitlement.
As one wag put it when talking about the Medicare drug bill, “I didn’t realize conservatives could be THAT compassionate!”
California HealthLine reports today that three studies indicate strong links between COX-2s and cardiovascular problems. In fact, the link is so strong that the studies, reported in the New England Journal of Medicine, may well lead to the complete withdrawal of COX-2s from the market.
The three studies investigated Vioxx, Celebrex, and Bextra; all had significant negative side effects, ranging from delayed wound healing to double the risk for heart attack and stroke to kidney damage.
The NEJM editorialized that, based on the results of the studies, “physicians are dismayed, pharmaceutical companies are embarrassed and financially threatened, and patients are injured.”
If the physicians had seen fit to prescribe COX-2s only for those patients who clearly could not take other drugs, the scope of this problem would have been drastically dimished. But one cannot point the finger only at physicians; Merck, Pfizer et al spent hundreds of millions promoting these drugs.
The war between payers and pharmacies just got nastier. In a pre-emptive move, GM anounced that Walgreen’s would no longer be allowed to fill prescriptions for its insureds. It appears that GM made this move after Walgreens got into a dispute with Toyota over Toyota’s efforts to increase the use of a mail-order pharmacy by its employees. (Mail order pharmacies are generally significantly less expensive than retail. Retail pharmacies want people to come into their stores, buy drugs, and pick up other goods on the way to check out, thus they really do not like mail order) As a result of the Toyota-Walgreen’s dispute, Walgreen’s cut Toyota out.
Perhaps Walgreens hoped Toyota’s employees would rise up in arms and demand Toyota include the chain, or perhaps Walgreen’s just could not afford to participate on Toyota’s terms. Regardless, GM decided to pre-empt any similar move by Walgreen’s towards the GM employee benefit plan. As one of the largest private payers, GM represents significant dollars for many health care providers.
According to Reuters, “GM provides health care coverage for 1.1 million workers, retirees and their families in the United States. Last year, GM spent $5.2 billion on health care in the United States, including $1.5 billion on prescription drugs.”
GM’s move is a clear indication of how seriously large employers take this issue. And with prescription drug costs leading the inflationary charge, don’t expect them to back down.
The announcement last week that the Medicare Drug benefit will cost $724 billion over ten years, instead of the Administration’s original forecast of $400 billion, may be the long-awaited trigger for fundamental reform. Perhaps this is wishful thinking, perhaps not.
Three recent reports from prominent media outlets present rather compeling arguments that the sticker shock may well cause Congress to rethink its approach to prescription drugs.
In an article labeling the issue “sticker shock and awe, the Christian Science Monitor reports that the price tag is “focusing the minds of many lawmakers” on confronting the rising cost of drugs in Medicare.
The San Francisco Chronicle quotes a Heritage Foundation spokesman who claims the drug cost issue, along with the seemingly unstoppable rise in other entitlement programs will “cast a shadow over the entire conservative domestic agenda.”
National Public Radio on Thursday featured a segment with Dan Schorr commenting on Medicare costs and the potential fallout from same.
Among the suggested fixes to the problem are the reimportation of drugs from Canada (a non-answer, as discussed in previous postings here) and the negotiation of prices by the government with drug companies. The former is no answer at all, but the latter may well offer some hope. Almost every other country negotiates directly with pharma manufacturers, and receives much better pricing than does Medicare. In addition, the US Veteran’s Administration negotiates drug prices directly and has done a very effective job in containing prescription drug costs.
While this may offer scant hope for commercial payers, it is important to recall that many physician, hospital, and ancillary reimbursement arrangements are based on Medicare rates (Workers’ comp fee schedules, DRGs, RBRVS, etc.). Therefore, it is possible that any Federal pricing standard would replace the much-maligned Average Wholesale Price as the basis for pricing drugs.
And that would be great news.
DR. R Centor’s DB’s Medical Rants weblog has a great piece about an MD’s decision to stop meeting with drug reps and accepting gifts from same. The piece is short and well worth the read.
Timing is everything; I am just finishing the second annual survey of prescription drug management in WC. One of the notable changes from last year to this is the recognition by WC payers of the key role of the treating MD in prescription drug cost. There is what can only be characterized as wide-spread recognition on the part of large WC insurers that the most important single stakeholder in this is the treating physician.
Kudos to the Cedar Rapids docs for showing the way.
DB’s Medical Rants has an interesting discussion re why MDs prescribe Vioxx, Celebrex, etc. As MDs are the ones ultimately driving prescription volume, it bears reading.
HSA (my firm) is completing a study of prescription drug management in Workers’ Comp – one of the very preliminary findings is the strong opinion among WC payers that MDs are in large part responsible for Rx cost inflation.
Payers are frustrated that MDs are prescribing drugs patients don’t need, driving up short term costs with no attendant benefit to patients. Meanwhile, these decisions may very well lead to additional costs, as patients suffering cardiovascular events who also took COX-2s for WC injuries seek compensation from their WC payer.
The net – payers see MD prescribing behavior as abdicating responsibility, and increasing payer costs. Frustration is rampant.