Payers want proof for medical treatments
In a tug of war over the skyrocketing costs of medical technology, the makers of implantable defibrillators are opposing a plan by Medicare to track the health outcomes of patients who get the devices.
The debate is centered on a plan to expand coverage for the defibrillators, which are designed to give a life-saving electrical jolt during a heart attack.
Medicare's announcement in September that it would cover implantation in 500,000 more patients was good news for manufacturers. But Medicare said it also wants to make sure the implants -- with a price tag of $25,000 to $30,000 per patient -- are used appropriately. As a condition of coverage, it wants to require that patients be enrolled in a national registry tracking patient outcomes.
The resulting data would help it make future decisions about coverage of the devices, which already constitute a fast-growing, $4.7 billion-a-year market. Medicare officials say they plan to expand the concept of evidence-based coverage to other treatments.
The negative response from industry emerged this week. The three largest manufacturers of implantable defibrillators -- Medtronic Inc., Guidant Corp., and St. Jude Medical Inc. -- dissented on Monday when a divided panel of industry and medical interests recommended that Medicare move forward.
Company representatives said in interviews this week that the proposed registry appears unnecessary. They said rigorous clinical trials have already proved that implantable defibrillators save lives. They cited a National Institutes of Health study this year that said the devices led to better survival rates for patients who have a weakened heart, not just those who have already suffered a previous heart attack.
''There is not much left to be studied," said Medtronic spokeswoman Valerie Lind.
Guidant's chief medical officer, Dr. Joseph Smith, said formal clinical trials that compare patients with implants to those without implants are the best measure, not broad-based sets of data gathered outside a controlled study.
''A registry that would include only those patients treated won't allow you to determine the benefit of a therapy," he said.
But cardiologists who support the Medicare proposal say it can help government regulators develop meaningful statistics about which treatments work best, and which are the most cost-effective. The American College of Cardiology and the Heart Rhythm Society support the initiative.
''Industry looks upon this as a possible barrier to physicians implanting their products, which will affect profitability," said Bruce Lindsay, a professor at Washington University School of Medicine in St. Louis, who was speaking on behalf of the American College of Cardiology.
Medicare's move is part of a broader effort by the agency to measure the quality of medical treatments at a time when the costs of America's technology-driven healthcare system are rising and Medicare budgets are facing close scrutiny in Congress.
The evidence-based approach is championed by Dr. Mark McClellan, head of the federal Medicare and Medicaid programs who is a healthcare economist and former head of the Food and Drug Administration.
The initiative is part of a trend: ''Payers" in the healthcare system -- namely, insurers and government -- are demanding more proof that treatments are effective as a prerequisite for coverage.
In another example, the agency wants patients who receive cancer drugs for unapproved uses to participate in clinical trials cosponsored by the National Cancer Institute. The drugs include Eloxatin, made by Sanofi-Synthelabo Inc.; Camptosar, made by Pfizer Inc.; Avastin, made by Genentech Inc; and Erbitux, made by ImClone Systems Inc. and Bristol-Myers Squibb Co. Medicare has a similar proposal for cancer patients undergoing diagnostic PET scans.
Medicare currently provides coverage for cancer drugs for FDA-approved indications, or indications listed in certain drug manuals. The agency until now has not routinely reimbursed for drug costs for ''off-label" indications not listed in the manuals.
McClellan told the Globe this week that Medicare intends to push the concept into other treatment areas in the future, although he declined to be specific.
''If you look at medical product development today, there is more going on than ever before -- and that's good," McClellan said. ''What we need to do is make sure the evidence base is moving along with that."
Industry representatives and doctors are still digesting the new approach. Nicholas Littlefield, a lawyer with Foley Hoag LLP in Boston who represents biotech firms in their discussions with Medicare over reimbursement rates, called the trend ''inevitable."
''No one should be surprised, with the increasing pressure from Congress to restrain healthcare costs, that Medicare wants to cover new products that are actually shown to help patients," he said.
But the proposed requirement to enroll cancer patients in clinical trials if they are treated ''off-label" is worrying some doctors.
Dr. George Demetri, director of sarcoma research at Dana-Farber Cancer Institute, said doctors frequently experiment with cancer drugs for small numbers of patients who suffer from rare forms of the disease. Those populations are too small for a full-blown clinical trial and would not be eligible for coverage under the proposed Medicare rules, he said.
The more researchers learn about cancer, the more they learn that the disease takes many forms, he said.
''The days of a broad approval, that a drug is approved for a single cancer as a whole such as breast cancer, may be antique. That is not the way the world is going."
Dr. Sean Tunis, chief medical officer of Medicare and Medicaid, said the agency is studying ways to make an exception for off-label uses of drugs to treat small populations with rare cancers where there are no clinical trials. But in general, he said, the demand for evidence and controlled studies will be the rule.
''It's not as if physicians have some special intuitive powers to learn about the risks and benefits of new uses of drugs in the absence of clinical trials," Tunis said.
Christopher Rowland can be reached at crowland@globe.com. 