http://www.curetoday.com/publications/cure/2018/winter-2018/changing-our-health-care-values
Changing Our Health Care Values

Andrew Smith

When doctors diagnosed Amy Berman with incurable stage 4 inflammatory breast cancer, they told her that the most life-maximizing treatment regimen was probably mastectomy follwed by radiation, all sandwiched between rounds of aggressive chemotherapy. But another oncologist suggested an alternative: a mild hormonal drug that is taken as a pill.

Berman weighed the statistically significant but small survival benefit that research demonstrated for the more aggressive regimen against the near certainty that it would bring debilitating side effects and huge copays. She decided that the “best” treatment wasn’t best for her.

“My primary concern was maximizing the quality of my remaining time by avoiding harsh treatments, but saving large amounts of money has also helped my quality of life by giving me more to do the things I enjoy,” says Berman, 58, a registered nurse who, as a senior program officer at the John A. Hartford Foundation in New York City, had already spent years advocating for less debilitating end-of-life care.

That decision saved Berman a huge amount of money over the past seven years. The aggressive chemotherapy and in-office infusions, she recalls, would have cost more than $100,000 a cycle. Her first actual treatment, generic letrozole taken once per day, retails for less than $30 a month; her subsequent medications, tamoxifen and zoledronic acid, have been nearly as cheap.

Berman’s decision-making process epitomizes the Choosing Wisely strategy adopted by organizations like the American Society of Clinical Oncology (ASCO). The idea is simple: Patients should always ask questions of themselves and their doctors — ASCO provides a basic starter list — to make sure their care is supported by evidence, free from harm and truly necessary, and does not duplicate previous tests or procedures. In some cases, that might mean that “aggressive” treatment is not the optimal path.

Berman’s initial decision preceded the Choosing Wisely initiative, but she has since used the list and other program resources to help clarify her thinking, saving her both money and pain. “When I developed severe bone pain, my doctors recommended 10 to 20 doses of radiation,” she says. “I did some research and found a very new Canadian study that supported the use of a single larger dose, so I requested that, saved myself a lot of treatment and got great results.”

Many patients take the opposite approach and maximize life span at any price, but rising cancer care costs may soon make Berman’s value-maximizing strategies more common.

It helps a bit that most pharmaceutical companies have patient assistance programs that offer discounted or free cancer medications to those eligible and, in some cases, navigators who can recommend other organizations willing to help defray the price of treatment or living expenses. Still, that is not nearly enough to control rising costs. Nationwide, expenditures for cancer care climbed from $72.1 billion in 2004 to $87.8 billion in 2014. Patients, private insurers and the government are all feeling the pinch and looking for ways to economize. Although possible political solutions get most of the news coverage, many experts expect more from efforts that don’t require new laws, but instead discourage counterproductive care, reduce hospitalization rates and cut drug dosages. These ideas are designed to cut long-run costs across the entire health care industry, but patients currently being treated for cancer can already use some of them, such as Choosing Wisely, to cut out-of-pocket expenditures.

“Many physicians don’t have the time, and in some cases the skills or knowledge, to talk with patients about weighing the medical benefits and financial costs of various diagnostic tests and treatment alternatives. Some patients thus begin on treatment plans they ultimately cannot afford and, when the costs overwhelm them, they begin endangering their lives by cutting their pills in half, failing to refill prescriptions or skipping treatments,” says ASCO Chief Medical Officer Richard L. Schilsky, M.D.

“Patients need to ask about costs before they start treatment, and need to consider this information in the context of their treatment goals and options. Doctors can sometimes offer a reasonable alternative to an expensive treatment if patients raise concerns about cost with their physicians.”

Indeed, a 2012 survey found that cancer costs had put onethird of all survivors into debt and that 55 percent of those survivors owed at least $10,000. Out-of-pocket costs for all cancer patients totaled nearly $4 billion in 2014, and both prices and copays keep rising.

In theory, it should be easy to put some downward pressure on cancer costs by at least eliminating genuinely useless care. In practice, such care is common, and the health care system has found it nearly impossible to take the next step and curtail unnecessary practices. Consider tumor imaging.

Many studies have found that cancer patients undergo far too many X-rays, CT scans and other imaging procedures. One fairly typicalanalysis of 40,000 patients whose low-risk cancers justified no imaging whatsoever found that doctors ordered at least one image — and often several — in more than 40 percent of cases. That was around five years after professional societies began trying to educate against such practices.

Excessive imaging isn’t the only problem. As part of Choosing Wisely, ASCO and the American Society for Therapeutic Radiology and Oncology have recommended against a wide range of common “low value” practices. Unfortunately, a 2017 study of Medicare claims data at 12 cancer centers found that poor physician adherence to those recommendations cost $19 million in a single quarter.

“These deviations don’t just waste money; they often hurt patients,” says the study’s lead author, Gabrielle Rocque, M.D. “Needless scans produce false positives, which necessitate painful biopsies and scare patients. The frequent overuse of Neulasta (to help prevent infection) in patients who only face a low risk of chemoinduced immunosuppression often produces needless bone pain.

“Why are such deviations so common? Some older doctors have never learned newer guidelines. Others may be used to pressure from some of their patients to order labs and scans more freely, so they extend this practice to other patients. Some got a few great results from a particular drug or procedure and started using that drug or procedure way too often.

Some lost a low-risk patient to metastatic bone cancer, and now they scan every patient. Some are just giving in to patients who want frequent scans to track their cancer,” Rocque explains. “At the level of the individual patient, improvement is possible. Patients who read treatment standards and question apparent deviations can save money. At a societal level, however, the understandable but irrational beliefs that drive needless care have proven very hard to overcome.”

Discouraging effective but overpriced care has proved even more difficult.

Most wealthy nations have some organization that measures the value of new medications in terms of cost per qualityadjusted life year (QALY) saved, and then bans “overpriced” medications. In England, for example, the National Institute for Health and Care Excellence typically lets the National Health Service use drugs that cost less than $27,780 per QALY (at dollarpound exchange rates in mid- January 2018), makes case-bycase calls on drugs that cost up to $41,671 per QALY and rejects most drugs that cost more. Given the fury over claims that the Affordable Care Act would lead to “death panels,” the creation of a system like England’s doesn’t seem imminent in the United States. Patients can, however, choose for themselves by looking at value estimates from groups such as the Institute for Clinical and Economic Review, which has found that at least one new drug costs more than $400,000 per QALY in a particular cancer type.

“Drugs that produce very marginal survival improvements — and sometimes no survival (or quality-of-life) improvements at all — come to market at astronomical prices. Neither Medicare nor private insurers want to be villainized for excluding them entirely, but they do pass some of the cost on to patients,” says Lowell Schnipper, M.D., clinical director emeritus of the Cancer Center at Beth Israel Deaconess Medical Center, in Boston. “Patients desperate for help will often be willing to take a chance on a new medication, despite a slim possibility it will confer meaningful benefit, and do so at great financial risk to themselves. The copays on such drugs can be enormous. Recent studies have confirmed that financial stress is a major factor affecting patients and families caring for a loved one with cancer.

“Our health care system is crying out for meaningful change,” Schnipper says. “We need to develop cost thresholds analogous to those extant in many developed countries, and not just for drugs, which account for a reasonably small fraction of all cancer spending, but for all of the elements that are essential to high-quality cancer care … We are particularly prone to overspending toward the very end of life. We have a cultural belief in fighting to the end and spending bankrupting sums in a futile quest for some miracle cure.”

Denying patients their small chance at a miracle, even one that costs many hundreds of thousands of dollars, wins little public support, which is why most cost-cutting efforts seek to improve outcomes or — at the very least — leave them unchanged.

One major effort to both reduce costs and improve outcomes involves what the Centers for Medicare & Medicaid Services calls the oncology care model. Several competing models are under evaluation, but they all work along similar lines: Insurers pay participating providers a flat fee for care of a patient throughout a single medical episode, such as chemotherapy treatment. In turn, the providers offer enhanced care and services, such as 24/7 telecare and next-day office appointments for problems that can’t be solved over the phone. The aim is to reduce emergency room (ER) visits and hospitalizations.

These models work by preventing patients from ignoring small problems until they become big ones and discouraging ER visits when small issues arise at odd hours. Such programs are too new to have definitively succeeded or failed, but they have produced good results in small pilot programs. An initial analysis of the Community Oncology Medical Home (COME HOME) model found a reduction of 10 ER visits, three ambulatory care hospitalizations and four hospital readmissions per 1,000 patients in three months. That translated into a $224 savings per patient per month, so experts say it may behoove patients who would like to save some of their own money (and avoid the ER) to seek out a practice that has adopted some flavor of the oncology care model.

Another promising but even more premature effort to reduce the cost of cancer care is to look for ways to safely reduce the dosages, frequency and/or duration of cancer treatments.

When clinical trials begin, pharmaceutical companies have no real way of knowing when doses will become ineffectively small, so they tend to maximize the chances of therapeutic efficacy by using the largest tolerable dose of an experimental drug. In many cases, bigger doses are more beneficial, but in many other cases, subsequent analysis finds that lower doses would work just as well.

The Value in Cancer Care Consortium hopes to slash costs (and needless side effects) by conducting trials to see which drugs really can be used at lower doses. The group already scored what it considers a triumph with a 72-patient trial of the oral chemotherapy Zytiga (abiraterone acetate). In the trials that led to the standard dosing, patients with prostate cancer took the drug on an empty stomach, but later research results showed that the drug is absorbed up to 10 times better when taken with food. The consortium, therefore, ran a trial that compared the normal dose on an empty stomach and a quarter of that dose with food, and findings revealed that the quarter dose worked just as well.

“Research performed after initial approvals strongly suggests that many cancer drugs are given too often or for too long or in doses that are too large. We know, for example, that the targets of many targeted drugs are saturated by just a fraction of the medication (doses) we actually use,” says Allen Lichter, M.D., chairman of the Value in Cancer Care Consortium.

“The abiraterone trial was a nice start, but it was arguably too small to definitively vindicate the smaller dose,” says Lichter, who also served as ASCO’s CEO from 2006 to 2016. “We believe that trials with 300 to 400 patients will be incontrovertibly definitive, that these trials will cost $4 million to $5 million, that each successful trial will save many billions of dollars and that most trials will succeed. The only problem is that we don’t have money to start, so if anyone reading this would like to do many billions of dollars of good with a $5 million charitable donation, I’d invite them to reach out to me.”

The maker of Zytiga, Janssen Pharmaceuticals, does not agree, however, that it’s safe to alter the medication’s recommended dosage. “According to the prescribing information, Zytiga must be taken on an empty stomach,” says Bernadette King, leader of oncology communications for Janssen. “Do not take Zytiga with food. Taking Zytiga with food may cause more of the medicine to be absorbed by the body than is needed, and this may cause side effects. No food should be eaten two hours before and one hour after taking Zytiga.

“The use of food as a way to increase bioavailability in patients with cancer could present problems and risks,” King continues. “Given the variation in the content and composition of meals, the recommendation is to take Zytiga exactly as described in the prescribing information.”

Despite the relatively small size of the Zytiga trial, at least a few doctors and patients consider the evidence strong enough to proceed with the lower dose. Last year, a 63-year-old Toronto man, who asked to remain anonymous to protect his privacy, decided to take the lower dose — with food — as part of a multidrug regimen for prostate cancer that was first diagnosed in 2003 and has since been treated with half a dozen regimens.

His oncologist recommended the standard dosage, but Canada’s pharmacy benefits program wouldn’t cover Zytiga for a patient whose prostate cancer wasn’t castration-resistant, and the man balked at the idea of bankrupting his family with $5,000 monthly payments.

He learned of the lower dose not from his oncologist but from his wife, who spent much of the past 14 years following prostate cancer research. “I would have sold the house in a heartbeat if I thought the larger dose was much better than the smaller one — and I would have forced him to spend the money to save himself — but having looked at the research and talked to some of the people who did the research, I think the smaller dose is the better option in every way,” the patient’s wife said in a phone interview. “Not only does it seem to provide the same benefit at a quarter the price, it also produces far fewer of the serious side effects that are so common at the higher dosage.”
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