Here comes Obama's COMPARATIVE EFFECTIVENESS. Here's how it works (from BARRONS):
1- "Health insurers decried the overprescribing of the anti-clotting drug Plavix from Bristol-Myers, for preventing the recurrence of a stroke. Plavix costs $1,500 per year, noted one health-insurance trade group, but is only slightly more effective than $15-a-year aspirin. Medicare data for 2007 showed Plavix was the government's second-largest expenditure under the Part D drug benefit, after Pfizer's cholesterol drug Lipitor."
If a special research can demonstrate the above, the government will no longer pay for Plavix and neither will the HMOs.
2- "Health insurers complained further that proton-beam treatment for prostate cancer, as sold by Varian Medical Systems (VAR), costs four times as much as radioactive-seed implants, with little evidence for its comparative superiority."
If VAR can't prove COMPARATIVE SUPERIORITY, there will no GVT. or HMO payments for proton-beam treatment.
3- There are others who may have problems who are mentioned in the Barrons article including BSX and MDT.
4- IMO, this concept of COMPARATIVE EFFECTIVENESS will destroy monetary support for new drugs and devices R&D.
Hogwash? What do you think hospitals will do to get the money they have promised Obama? I am long THOR, but Thoratec is not immune to the overall political situation. Look at what is happening to cardiology under Obama. Below are sample quotes from an article on Heartwire (link
ACC aghast at proposed cuts to cardiology payments in Medicare physician fee schedule for 2010
Jul 3, 2009 | Lisa Nainggolan
"....The American College of Cardiology (ACC) predicts that under the new proposals as they stand, nearly all services that cardiologists perform would see cuts ranging from 10% to more than 40%—with certain imaging procedures being particularly hard-hit...."
"....Services that have improved countless lives by diagnosing and treating cardiovascular disease are scheduled to have payment cuts in the range of 25% to 42%...."
"....In a statement , the president of the ACC, Dr Alfred Bove (Temple University Medical Center, Philadelphia, PA) says: "The ACC is shocked. These proposed cuts are based on the incorporation of a few esoteric pieces of data into a complex formula . . . [that] completely ignores the very important issues of access that are certain to be created by these huge slashes in payment."
I really think all this talk about Obama and his effect on THOR is hogwash. As LVADs develop, particularly with newer generations and minimally invasive surgeries with the potential to throw 8-9 L/min of CO, they will reduce costs comparatively matched up to treating with OPTIMAL MEDICAL MANAGEMENT (Diuretics, Beta Blockers, ACE inhibitors, Inotropes) ----invariably these devices will prove to be more cost effective solutions economically speaking AND will have greater efficacy for treating/managing the CHF patient. Patient readmissions for heart failure are ridiculously high for CHF and medical management and if LVADs and the research going forward to improving them is stifled, well the loser in the long run is the tax payers, government, and ultimately patients.
I agree that the only comparison with the LVAD is OMM (Optimal Medical Management) which has been demonstrated in prospective clinical trials to be significantly inferior.
My view is that Destination Therapy will sharply change the equation for THOR's valuation because it includes a step-function potential to everyone who is not BTT eligible.
At that point no one can argue against a Multi-$BILLION potential revenue.
When you consider that the HeartMate II has already significantly bested the control-arm with the HMxve, think DT PMA within a year.
When the HeartMate II DT data is published, I think $50 or higher is not a stretch for THOR's stock price.
The October 2009 AMA meeting is set for a Breaking-News presentation.
Even Obama will have trouble withholding LVAD's after they become better known. From the Thoratec website:
Patient Stories: "I've had an LVAD now for six years, and six years ago, you know, they did not give me a chance." - Sherri
Grim, but realistic view. The insurance companies are already doing some of this today. I rarely am ill, rarely see a doctor and even more rarely am prescribed drugs, so my personal view is very anecdotal. Nonetheless, I have been pressured every time in recent years to take generics even though I experienced well known side effects (on a half dose--I always take 1/2 of anything, including vitamins, to see what happens before complying with prescribed amount)and had to fight for the brand name drug prescription. Don't let anyone tell you there is no difference between generics and brands. At the very least, generics have different (cheaper) binders and fillers--each with its separate potential for good or ill effects--and are manufactured in different facilities with different (less stringent) requirements. Children, smaller people, seniors, those taking multiple drugs, all may be more sensitive to these differences. Letting a bureaucrat (who is under pressure to reduce costs)decide who gets what will be a nightmare for many people.
But again, I remind that the U.S. is only one market, and we may become less and less important under the current administration at the same time that emerging markets are creating a new middle class along with new millionaires. THOR has international significance. Just read the Australian newspapers. A life saving device will have world wide appeal.
See the future of US medical care if King O's scheme goes through: it's on the editorial page of the WSJ today titled OF NICE AND MEN . It describes how the British system rations care by outright refusal to pay for drugs costing about a certain amount. You are BARRED from the benefit of taking these drugs. You already have the first inning of that now. It's called STEP THERAPY which you must take a couple of less effective drugs first to see if they work before the MD can prescribe the newer more effective drugs. medPAC King O's healthcare ration board will not be limiting just drugs. They are out to cut costs and procedures will come under attack as well. It is irrelevant that current procedures may allow THOR to come in under the radar. medPAC can and will write new procedures to cut costs. Best example of how the Govt works is to look at EPA. Thet can (and do) render farmland or oil drilling areas worthless simply by finding an endangered bug on the property. If the Govt. wants to get something done it will. Congress may write the laws, but the bureaucrats INTERPRET them.And they will interpret them the way King O wants. As a long, long time holder of THOR from the days of TMO I hope I am wrong, but that's what I see coming down the pike.
Personal experience without substantiation can be quite biased. I have two relatives in their mid-eighties who received triple bypasses, one of them also received a valve. Both were in their early 70's at the time of the operations. One of them is a caretaker for his younger wife, and in addition to all other sorts of activities, carries her from room to room. Along with members of their communities and other family members, I personally rely upon both of them for their wisdom and advice. It would have been a shame for these intelligent, lively seniors to have been dumped into a hospice to die. Obviously, I have a different impression of the value of these operations than you do based upon my relatives and my other anecdotal experience and the fact that I really, really enjoy people in their 70' and 80's and 90's. Hence the call for data in making assumptions about who should live and who should die. It is a rather serious decision to withhold medical treatment.
"The success rate of heart valve surgery is high. The operation can relieve your symptoms and prolong your life.
The death rate averages 2% to 5%, depending on the heart valve. About 2 of every 3 patients who received an artificial mitral valve are still alive 9 years after the surgery.
The clicking of the mechanical heart valve may be heard in the chest. This is normal.
You will stay in an intensive care unit for the first 2 or 3 days following the operation. Your heart functions will be monitored constantly. The average hospital stay is 1 - 2 weeks. Complete recovery will take a few weeks to several months, depending on your health before surgery.
Update Date: 5/15/2008
Updated by: Robert A Cowles, MD, Assistant Professor of Surgery, Columbia University College of Physicians and Surgeons, New York, NY. Review provided by VeriMed Healthcare Network. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.