NCCN Roundtable: Clinical and Economic Issues Impacting Cancer Care Delivery

May 2010, Vol 1, No 1

Hollywood, FL—Clinical practice guidelines issued by the National Comprehensive Cancer Network (NCCN) are followed by conscientious oncologists in their everyday practice, but they are developed based on clinical efficacy and without regard to costs. At a roundtable held during the NCCN’s 15th Annual Conference, moderator Clifford Goodman, PhD, Senior Vice President at The Lewin Group, predicted, “The appropriate use of evidence-based guidelines is on a collision course with the financial nonsustainability of the healthcare system.”

Dr Goodman alluded to a level of frustration that has never been higher in cancer care. “Too many patients are still dying young. We need innovations and a cure,” he said. But the inadequacy of current treatments for cancer is no longer the main problem. Equally challenging, he suggested, is finding a means to pay for the ever-costlier care that threatens to bankrupt the healthcare system.

As society struggles to find solutions, “the ground is shaking beneath us,” Dr Goodman commented. The conflict between optimal cancer care and today’s economic environment was the issue tackled in a lively discussion. Panelists included physicians, patient advocates, third-party payers, and industry representatives.

Do Practice Guidelines Really Guide Practice?

Representatives from Aetna Inc and UnitedHealthcare said their companies use the NCCN guidelines to inform both clinical care and coverage decisions. Both payers cover all treatments given a category 2B or higher recommendation by the NCCN.

“It is extraordinarily rare that treatment is denied by Aetna in a lifethreatening illness,” said James D. Cross, MD, National Head of Medical Policy and Program Administration for Aetna. Adherence to evidence-based practice guidelines can also have an effect on the overall cost of treatment, according to Dr Cross, who described a recent report from Aetna that showed overall care to be 35% less expensive when treatment guidelines were followed.

“We encourage the use of evidence-based guidelines. In my mind that is the commonality that brings patients, physicians, and insurers together,” he said.

Lee Newcomer, MD, MHA, Senior Vice President of Oncology Services at UnitedHealthcare, said his company gauges its physicians’ compliance with the guidelines. The data are not used “to judge physicians, but for quality improvement,” one aim of which is to “close gaps in care,” he said.

Physicians on the panel, however, bristled somewhat at the use of the guidelines as a measurement of best practices. Joseph S. Bailes, MD, Chair of the Government Relations Council of the American Society of Clinical Oncology (ASCO), said that the UnitedHealthcare project “is not necessarily well received” by ASCO members.

“What is good care, or not good care, is not always determined by guidelines,” he maintained.

The other oncologist on the panel, Al Benson, MD, Professor of Medicine at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, agreed that the guidelines should not be “prescriptive,” as not every recommendation is suitable for every patient. “A 100% concordance cannot be expected,” he pointed out. He called the NCCN guidelines the most “well structured and user-friendly” among hundreds of others, as they allow the entire medical system to have immediate access to evidence-based recommendations.

The NCCN guidelines are certainly useful to the National Patient Advocate Foundation, said Nancy Davenport-Ennis, cancer survivor and President and CEO of the organization. Her case managers have used the guidelines daily to win more than 500000 preauthorizations and appeals for patients. In addition, guidelines serve as reassurance to patients that they are receiving the recommended care they deserve, she said.

After the Guidelines: Then What?

After patients have received the various interventions listed in the NCCN guidelines, they may desire further treatment. Without evidence to guide these choices, “isn’t this when you begin experimenting with expensive therapies that may do more harm than good?” Dr Goodman asked the panelists.

“In my area, colorectal cancer, this is an increasing problem as we improve survivorship,” Dr Benson acknowledged. “A clinical trial is often the appropriate choice, but unfortunately, there are challenges in finding and enrolling individuals in trials.” Ms Davenport-Ennis looks to “courageous” oncologists to find interventions that might control the patient’s disease without inflicting harm, she said.

But this did not sit well with Dr Cross of Aetna, who said physicians must not just “take things off the shelf when there are no known solutions” but should work harder to get patients into trials. Dr Bailes noted that clinical trials would be a more viable option for more patients if they were universally covered by all third-party payers.

Dr Benson reminded the panel that best supportive care is often the most appropriate choice for these patients and is integrated into the guidelines. He acknowledged that “it takes some work for people to grasp that there are limitations to what we can do for them.”

Expense of Cancer Care at the End of Life

Cancer care at the end of life is usually assumed to be inordinately expensive, but a study by UnitedHealthcare did not substantiate this, according to Dr Newcomer.

“We busted that myth,” he said, as the UnitedHealthcare study found that from disease recurrence until death “expenditures remained constant” in all malignancies but leukemia and lymphoma. “The end-of-life costs you keep hearing about turned out to be primarily associated with hospitalization for complications of disease,” he reported. “We did not see a sudden surge in chemotherapy at the end.”

But when anticancer treatment is desired at the end of life, expenditures can appear irrational, he added. The cost of chemotherapy for advanced lung cancer patients has been found to add $60000 to cost of care, while rendering just 10 extra days of survival, he said.

Avoiding aggressive treatment at the end of life may not only reduce costs but may improve quality of life, Dr Newcomer suggested. “Costs aside, let’s not expose patients to harm with little chance of benefit. We know patients will have toxicities, yet we have no confidence that they will get better,” he pointed out.

Is Innovation Being Sacrificed?

Concerns over costs are now contaminating the most sacrosanct of areas—drug development, said 2 panelists who work in that field.

Douglas Lind, MD, a managing partner in the venture-capital firm GBP Capital, said investors are now greatly interested in the likelihood of compounds being covered, once approved. “Companies used to innovate without concerns about cost but the table has turned,” he said. “The first question is not whether a phase 1 or 2 clinical trial will be positive, and not even if a product will become FDA-approved, but whether it will be reimbursed.

“If our investors cannot predict what will happen down the road in terms of a drug being cost-neutral or cost-saving, then they think ‘why bother?’ For the first time this is the central question,” he said, adding that this question actually begins on the industry level. “They are equally asking this question.”

Considerations about reimbursement are not intended to suppress innovation but to direct it, and this is a positive concept, he maintained. “Reimbursement is where the rubber should meet the road.”

Financial Crises Already at Hand

For patients already dealing with cancer, the crisis is occurring now. For many, medical insurance is simply unaffordable, Dr Newcomer emphasized. “In 1970, if you were a minimum wage worker in California you could buy a healthcare plan for your family of 4 for 15% of your income. In 2007, that same plan would cost you 102% of your income,” he noted. “And we are about 4 years away from telling that same story about a middle class worker. We are spending far more on medical care than the economy can sustain.”

The National Patient Advocacy Foundation has witnessed an 87% increase in the number of families filing for bankruptcy as a result of non-reimbursed medical expenses, according to Ms Davenport-Ennis. This parallels the findings from a 2009 study showing that nearly two-thirds of all bankruptcies are due to medical-related debt and that most debtors have health insurers (Himmelstein DU, et al. Am J Med. 2009; 122:741-746). This represented a rise of 50% over 2001 medical-related bankruptcies, the authors reported.

“Be aware that the American consumer is bellying up to the bar to try to pay for healthcare and is slipping into bankruptcy,” she told attendees. Dr Newcomer took exception with this notion. “Are we living in the same country?” he responded. “I can’t think of any FDA-approved drug that we don’t pay for. If the drug has FDA approval, the patient can recover the cost,” he maintained. Ms Davenport-Ennis pointed out that the problem is not necessarily with insurance reimbursement, but the high copayments the insured now face. “And while UnitedHealthcare may be generous in covering costs,” she added, “not all insurance companies are alike.”

Jason Slotnik, Esq, an attorney with the Washington, DC–based legal firm Foley Hoag, who represents pharmaceutical and biotech companies, noted that regardless of public perception, economic hardships are being felt by industry. Built into the emerging payment model, he said, must be a means for industry to recoup its expenditures for drug development that are only becoming greater as a result of new demands.

“Doing health economics studies to demonstrate cost-effectiveness for a new drug, for example, adds another $200 million to the cost of bringing a drug to market,” he pointed out.

Ms Davenport-Ennis put the different perspectives together to conclude that reining in healthcare costs will be the responsibility of all stakeholders, including employers who “make arbitrary decisions about coverage” and a government system that imposes regulatory burdens within the clinical trials system. “All this drives up cost,” she stressed, “and reduces the opportunity for the patient to obtain innovative care.”

Patients can and should be part of the discussion about their cost of care. “They can participate in making wise decisions,” she insisted.

Dr Newcomer agreed that patients need to better appreciate the consequences of the current payment model. “From diagnosis to death from breast cancer, our company spends an average of $160,000 per patient,” he noted. “Would the conversation change if the patient were not spending someone else’s money? If we said, ‘Do with this money as you wish’?”

Such conversations might be more likely to have their intended effect, Dr Lind added, if they are not postponed until the end of life when patients and their families are desperate and emotional.

“We are all complicit in this upward spiral,” Dr Goodman concluded, “and we are stuck with a collision course.”

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