An article in a recent issue of the New England Journal of Medicine once again raises the question of how are we going to afford our cancer treatments now and in the years to come?
The report, written by Peter Bach MD who is currently on the faculty of Memorial Sloan Kettering Cancer Center in New York and in the recent past served as a special advisor for oncology to the Administrator of the Medicare program, highlights the difficulties that the Medicare program has controlling the increasingly substantial costs of new cancer drugs.
As acknowledged in the article, we have made advances in the treatment of advanced cancers, such as colorectal cancer. But these advances have come at huge costs.
For example, the costs to Medicare of injectable cancer drugs given in doctors’ offices increased from $3 billion in 1997 to $11 billion in 2004, an increase of 267% at a time when the costs for the entire Medicare program increased 47% (which itself is not exactly chump change).
Dr. Bach goes into great detail about how Medicare could control chemotherapy drug costs, such as only paying for the least expensive effective drug, or averaging out the costs of drugs that are similar. But he also points out that the newer cancer drugs are “sole source” for specific diseases, which essentially means that Medicare must pay the costs for whatever drugs the doctor chooses.
The article also comments on the huge reduction in Medicare expenses that occurred when the off-label use of ESAs—which are drugs used by medical and radiation oncologists to increase the red blood cell counts of patients either undergoing active treatment or if they have anemia related to their disease process alone—was found to actually cause harm to patients. The net result was that use of these drugs quickly dropped and the costs to Medicare dropped from over $1 billion a year to just $200 million.
What Dr. Bach did not point out was that these drugs—which are for supportive care, not the active treatment of cancer—were the leaders in outpatient drug costs for cancer patients in the Medicare program. You would have been wrong until recently if you thought that typical chemotherapy drugs led the pack when it came to Part B Medicare chemotherapy expenses. In fact, it was the ESAs.
The article does review several of the options available to the Medicare program to control costs, such as bundling all the charges for cancer care into a single payment and let doctors and patients decide how to best spend that money. Another would be to fund a comparative effectiveness program to assess whether or not these newer treatments (based for the most part on targeted therapies) are really better than older treatments.
And, then, there is always the possibility that Medicare could be given responsibility to determine which treatments are acceptable, based on cost-effectiveness criteria.
None of these options is particularly appealing to doctors and patients, who in the United States have been generally unencumbered by financial constraints in making cancer treatment decisions if the patients have excellent insurance and unlimited finances.
For the rest of us, decisions about what cancer treatments we actually use are being made every day across the country based on whether or not people can afford the drugs. Some people simply don’t have any insurance, others have inadequate insurance, and those who thought they had enough insurance find out quickly that they have outspent the limits of their health insurance policy. And few have the additional savings to pay for the high deductible and co-pay costs of these drugs.
There are some additional points that should be considered in this analysis, some of which are unique to the Medicare program and some that are broadly applicable to insurance in general. All reflect the difficulties we face as a nation going forward as we seek to craft solutions for this very vexing problem.
For example, you probably think that cancer drugs used for Medicare patients are “approved” for payment by a central Medicare office based on a detailed analysis of their effectiveness for a particular cancer treatment regimen.
Well, that is not the case. Many of the decisions made to cover medical procedures and treatments for Medicare patients are made by companies around the country that have contracts to administer the Medicare program in different locations. These companies used to be regional and fairly large in number. Over the past number of years, there has been consolidation in these carriers and some of them are no longer regional but may cover many different states, even in different parts of the country.
These “local medical review policies” have the potential to create different rules in different parts of the country as to what drugs and procedures will be covered for some Medicare patients and not covered for others. Instead of this catch-as-catch can approach to cancer treatment, some experts have recommended—especially for very expensive cancer treatment drugs—that the coverage decisions be made centrally rather than locally.
I’m not going to comment on which approach is better—there are arguments on both sides of this one—but only say that we must have consistency in the decision-making process when it comes to cancer treatments. There is simply too much at stake.
Recently, Medicare has decided to use four resources called compendia to determine which drugs cancer drugs should be covered for payment. These are the guides that the regional/national carriers are now supposed to use to make these coverage decisions.
The reason this is so important is because many of the drugs used in treating cancer are “off-label.” That means they were not evaluated or approved by the FDA to be used as they are today in various combinations or doses for the treatment of a particular cancer.
The problem is that much valid cancer treatment which is state-of-the-art and perfectly appropriate is “off-label.” The compendia are supposed to evaluate these off-label uses and keep the data up-to-date so that patients aren’t denied access to necessary and appropriate treatment. (Why the drug companies don’t seek these additional approvals from the FDA is a topic for another day.)
But what happens when a lot of the use of a particular drug used in treating cancer patients for a particular disease or condition—such as ESAs in the anemia of cancer, which led to premature deaths—is beyond FDA oversight and approval? How do we find out whether those treatments are in fact acceptably safe and effective?
Maybe what we need to do is continue to monitor these drugs and how they are used after approval, and if there is a significant increase in off-label usage perhaps they should be reviewed through some process that can in fact evaluate their effectiveness and safety.
If we don’t do something to keep an arm around off-label use to be sure there is some rationale to use a particular drug to treat a particular patient with a particular cancer-- especially with very expensive targeted therapies-- then the money will run out while we offer treatments to patients that have no basis in science and little expectation of meaningful success.
Another interesting point is that the Medicare part B program—which is where the payments for chemotherapy drugs given in the doctors’ offices come from along with payments for physician services and durable medical equipment—is “budget neutral.”
“Budget neutral” means that if money needed to pay for expensive cancer drugs and other outpatient medicines under Part B goes up, then payment for something else in Part B must go down.
Where does that money come from? It comes from payments to doctors for services to Medicare patients.
Because of these budget neutrality rules—which are supposed to be very strict but in fact have been “broken” by Congress every year for the past several years—payments to physicians are projected to decline 21% beginning January 2010. That in turn will impact access to care for Medicare patients.
Already in my hometown in Southwest Georgia no primary care internist or family physician will take a new Medicare patient. And this is a community that has been touted in several magazines recently as a desirable place to retire, in part because of its high quality medical care. If these proposed cuts go into place, there is a virtual certainty in my personal opinion that access problems for Medicare patients are going to increase dramatically nationwide.
The costs of chemotherapy drugs in the Medicare program are not solely responsible for the problem of finding a primary care physician in Thomasville, Georgia. But this is an example of how so many of these seemingly unrelated issues are in fact intertwined, not only in Medicare but in Medicaid and private insurance as well.
The complexities of Medicare drug costs are simply a metaphor for what we face as a nation when it comes to the costs of medical care. The net result is that we need to take a hard look at how we are going to solve the problems of access to quality, affordable medical care in this country, a cause that has been vigorously championed by the American Cancer Society.
This is not something that is going to be solved by waving a magic wand and hoping it will go away. It will take hard work and hard compromises to find solutions that are equitable for all.
Yes, there are momentary urgencies that require our immediate attention, but we cannot ignore our responsibilities to address this fundamental and very necessary issue.
Feedback
