Can the ‘War on Cancer’ Be Lost to Money?

By Ruff, Kathy

Did you know that the death rates for the four most common cancers – prostate, breast, lung and colorectal – are declining?

That’s the good news.

What’s not so good is that, according to National Cancer Institute’s 2007 Cancer Trend Progress Report, the incidence rates of cancer of the liver, pancreas, kidney, esophagus, thyroid and other cancers are on the rise.

Cancer screening: It can’t save lives if people don’t use it

Screenings unquestionably have contributed to the downward trends in death rates, as diseases caught and treat, ed earlier tend to result in better outcomes. But lack of insurance, higher costs and fear counteract that success as people procrastinate or choose not to get screened.

“The biggest barrier to screening is patient fear and lack of understanding the value of screening, rather than cost,” says Samuel M. Lesko, M.D., MPH, director of research and medical director at the Northeast Regional Cancer Institute (NRCI), Scranton.”I don’t think cost is the primary barrier, at least for the insurance patient, the barrier is being afraid of the test itself, that it’s going to be uncomfortable – maybe even fear that they have a serious disease.Those seem to be more important barriers, as is – maybe for a few – the belief that screening doesn’t work. Perhaps people are not even aware of the option or the availability of screening tests.”

The institute’s mission includes advocacy for early detection and treatment. “It’s much better to detect these diseases earlier,” says Lesko. “It costs less to treat an early, small tumor than to treat a more advanced-stage disease. For an early-stage tumor, surgery may be enough. More advanced stages may require surgery and chemotherapy or radiation. That adds to the cost and also to the real burden of the disease on patients.”

Insurance companies today cover more costs for mammograms, Pap smears and prostate exams, all of which have been proven to pick up early cancers and reduce long-term treatment costs. Pennsylvania recently passed a new law that requires insurers to cover colorectal screenings.

“In the past, the insurance companies were not paying for as many screenings,” says Stacy Goetz, executive director of oncology for the Dale and Frances Hughes Cancer Center at Pocono Medical Center, Stroudsburg. “We are happy to say that more people are being covered by their insurance.”

For those without insurance, the cancer center and other community and public health programs offer events to educate people on the importance of cancer screenings and some provide free or low- cost screenings.

Yet in 2005, 67 percent of women aged 40 and older had a mammogram within the past two years, falling from 70 percent in 2003. For women aged 18 and older, in 2005, 78 percent had a Pap test within the past three years, down from 79 percent in 2003.

Costs and fear may be only part of the reason for these trends.

“When you look at a screening program, it’s almost from a public health perspective – Do you expend an excess amount of dollars to discover one case? And, was the one case that you discover, discovered early enough so that early intervention will influence outcomes?” says David Greenwald, M.D., president and founder of Medical Oncology Associates, Kingston. It s whether or not the screening itself is cost-effective. Where screening has been shown to he effective, we do it. A controversial area has always been chest X-rays for lung cancer because of the inability to demonstrate in large populations that screening has made the difference – that it picked up enough cases early enough so that one would think its a good procedure to do.”

Chemotherapy drugs: Doctors sometimes absorb the costs

Today promising new drugs are making the difference in cancer treatment outcomes, but costs and a lengthy FDA approval process have added additional burdens to the patients, the physicians and the health-care system.

“Oncology drugs for oncologists are not like any other supply – it’s a very unique supply that has a limited market,” says Steven Pierdon, M.D., executive vice president and chief medical officer of Geisinger Northeast. “You essentially pay for it and resell it to the patient or the payer as part of that transaction. The government has really ratcheted down the reimbursement process for oncology drugs and the costs have continued to go up significantly. For private-practice oncology, this is a big deal because these drugs are very expensive. For our organization, as a large health system, it all gets integrated in the overall business.”

Geisinger uses a team-oriented approach to care, with nurse navigators, social workers and oncologists who implement specific protocols.

“It’s not just about giving the medicine, which is expensive, but how you manage it,” says Pierdon. “There are very specific protocols for how to best manage those types of biologics for the treatment of patients with anemia secondary to oncology treatment We have established a protocol that maintains patients in a therapeutic range of blood count at a much greater frequency. By doing that in a very organized and coordinated way, we save somewhere in the range of $4,200 per patient per year.”

Geisinger also works with a larger buying consortium to help coordinate care, reduce costs and decrease the impact of financial strains caused by lower reimbursements and unpaid co-payments.

Higher co-pays add to the dilemma. For example, Medicare has 20- percent co-pay and, although many patients have supplemental insurance to pick up the co-pay, some do not.

For those not on Medicare, the co-pays can run into hundreds or thousands of dollars, a reality Medical Oncology Associates’ Greenwald sees as a problem for some patients.

“We just absorb the 20 percent,” he says. “It just puts a strain on us. You wind up where you make either no money or you lose money in treating people. In general, patients get the drugs that they need somehow, some way. I don’t know of any patient in the Wyoming Valley that we have ever taken care of who didn’t get a drug that they needed, whether they had insurance or didn’t have insurance.”

But that practice may threaten not only the financial viability of the healthcare entities that provide care, but also accessibility to patient treatment if the situation continues to worsen.

What worsens the situation and causes exorbitant administrative costs on the system is the need for a professional staff focused on finding financial resources for patients and pursuing slow or disallowed insurance reimbursements.

According to the American Medical Association, the inefficient and unpredictable system of processing medical claims adds unnecessary costs to the health insurance system, estimated at as much as $210 billion annually, without creating value. Physicians divert as much as 14 percent of their total revenue to ensure accurate insurance payments for their services.

“We have three people that deal all day long with different insurance companies, different plans within insurance companies and fighting constantly to get paid because they do everything they can to not pay you,” says Greenwald. “It’s a terrible system, we are spending that much money to administer.”

That trend permeates today’s healthcare industry nationwide.

“With some of the oncology drugs, there are patient assistance programs that are available, so whenever we can, we try to tap into those and use the resources that are out there to help patients get whatever medications they need,” says Lynn Heller, oncology social worker at Pocono Medical Center. “If it’s a challenge, we are looking for other resources, like the American Cancer Society, like the Leukemia Lymphoma Society, who can help patients who qualify financially with some of those out-of-pocket costs. We really work hard to try to find people the resources that they need in order not to have a delay in their care. It may get a little more tricky with the way the economy is going.”

Those organizations also assist in finding other resources to help patients get the drugs they need, and patient assistance programs through the drug companies represent one alternative.

“We don’t hold treatment based on people’s lack of insurance or if they have insurance,” says Goetz. “We proceed with all the patients in the very same way. We tell them this is the situation, how much it costs and we work with the patient to try and find other ways to fund these programs. The drugs and the costs of care are extremely expensive but it does not keep people away from getting their treatments.” Another agency works to help people finance their treatments.”

Another agency works to help people finance their treatments.

“We serve as an information and referral research, including looking for financial assistance” says Laura Toole, LCSW, director of education and outreach at the Northeast Regional Cancer Institute. “Although the Cancer Institute is not in a position to directly offer financial situation, we funnel them to the appropriate local or, in more and more cases, national organizations that may be able to assist.”

Toole sees more demand for financial assistance beyond calls from people who don’t have health insurance.

“It’s certainly becoming increasingly common,” she says. “Over the past couple of years, we increasingly are receiving calls from individuals that have insurance, but they are finding that their co- payments for medications are increasing and they are looking for assistance to cover the cost of those co-payments.”

Toole estimates over half of the calls the institute receives every year relate in some way to financial assistance.

“I know that the quality of life is being affected by this concern on top of being faced with a serious illness, but I can’t say whether it impacts on the care that they receive,” says Toole. “The problem is the amount of uncovered expenses related to, say, pharmaceuticals. Where 10 years ago it was somewhat of a manageable amount, now it’s becoming unmanageable.Of the national organizations that are able to offer assistance, that assistance – while it’s much appreciated – in some cases is not enough. In some cases, it’s not making a dent in the amount of debt that patients are going into for their cancer care.”

The institute helps individuals exhaust every potential resource available to alleviate some of the financial burden that only adds additional stress to the cancer diagnosis.

Drug therapies and the FDA

Promising new drugs give hope to patients, but the system and the FDA approval process add to the cost and availability of those drugs.

“The problem reminds me of the perfect storm, because a couple things hap pened simultaneously,” says Dr. Greenwald. “The FDA came under great criticism 10, 15 years ago because it would take 10 years to bring a drug to market. To try to speed up that process, the FDA said, ‘All we are going to require from the pharmaceutical company is that a drug is effective against one cancer. We’ll approve it and then we’ll allow doctors to figure out where else it works.’ “

While the FDA worked on speeding up the process, insurance companies cracked down on reimbursements, allowing reimbursements only for “FDA approved” uses.

For example, when Taxol was first approved for ovarian cancer, insurance companies would only pay for the drug for that use. So- called “off-label” uses of the drug for other cancers resulted in denied payments.

“As it turns out, Taxol is very effective for lung cancer, uterine cancer, stomach cancer and a whole variety of other cancers, but we couldn’t use it for lung cancer for about six years after it came out, because the data wasn’t collected,” says Greenwald. “It’s not what the FDA originally intended. It’s just that the insurance industry came up and said, ‘You can’t use it. The FDA didn’t approve it for that.’ “

Today similar hurdles delay use of another promising drug, Avastin.

“The mechanism in Avastin prevents new blood vessel formations, blood vessels that are recruited from the normal tissues around, that’s where the blood vessel comes to fuel a cancer growth,” says Greenwald. “The cancer itself has no blood vessels, but it creates vessels from the surrounding tissues and that supports the growth of cancer. Avastin prevents new blood vessel formation. The truth is, it’s not cancer-type-specific. It doesn’t matter which cancer you have, Avastin does the same thing.”

Doctors were restricted from using the drug for colon cancer until, after three years of additional study, data showed Avastin worked in lung cancer Data also now shows it works in breast cancer. “In truth, it ought to be used in all cancers,” says Greenwald. “Why is it not? It’s because insurance companies won’t pay for it because of the fact that the FDA hasn’t approved it for all cancers and the FDA can’t because no one has the data. It has nothing to do with whether it will work. All it means is that the FDA hasn’t considered it for other cancers.”

The ongoing battle with insurance companies continues. Greenwald finds if he can show an early report on the promise of a drug, Medicare will almost always approve it. Most insurance companies will not.

“The FDA is very inefficient,” says Greenwald. “I don’t think they do as good a job as they can. I’m not in their shoes, but I know that sometimes it’s obvious and they still nit-pick over certain things and then other drugs seem to zoom right through and they are of very little benefit.”

Other factors add to the costs of promising new drugs.

“One additional thing that contributes to the cost in cancer drugs in particular, is that we don’t have a history of high participation rates in these studies. Of patients who are eligible to participate in a cancer-drug clinical, only about 3 or 4 percent of the eligible participate,” says Dr. Lesko of the Northeast Regional Cancer Institute. “As a consequence, it takes longer to get the number of patients that are needed to either test safety or show benefit, and that delays the process of getting the data that leads to approval. All of that in the overall mix can contribute to relatively higher costs for some of these products.”

The challenge of enrollemtn in clinical trials delays the process of getting new drugs to market, reducing the patent time for pharmaceutical companies to recoup their investment.

“Oncology drugs and cancer are a very frightening thing and people do not wish to have those medicines delayed or have the thought that they even could be delayed enter into it,” says Geisinger’s Dr. Pierdon. “There are substantial risks to them and the FDA is using the best possible size and most detail they canto manage the process. It’s just a very difficult balancing act.”

Some see no negative change as a result of the FDA-approval process for oncology drugs.

“There are many, many studies out there in development and currently going on right now for newer, promising drugs and also using a standard drug in different ways for treatment,” says Melanie Humphrey, clinical data manager at the Pocono Medical Center, who works with clinical trials at the center. “We have not seen a withdrawal of any medications that we have used or really a slowdown in the number of new promising drugs that are coming out. I have actually seen an increase in the drugs being processed. Some of them might be not new drugs, but drugs that are being utilized in different ways, trying to get them to be used for as many types of different conditions as they can. I can’t see any decrease or slowing down from the FDA.”

PMC participates in both local and national clinical trials, working in conjunction with Thomas Jefferson University.

While national situations may differ, care by health-care organizations in northeastern Pennsylvania boils down to traditional medical ethics.

“I hope costs never factor into a decision, from the physician first, then the patient” says PMC’s Goetz. “It does not factor into decisions here. We look at the patient and their problem and we try and choose the very best treatment and layout options for them. We definitely don’t look at it from a financial point of view. I hope we are never in a time where we can’t offer you the treatment you need because of money.”

Copyright Northeast Pennsylvania Business Journal Sep 2008

(c) 2008 Northeast Pennsylvania Business Journal. Provided by ProQuest LLC. All rights Reserved.