Would you choose to live a few weeks longer if it cost your family upwards of $10,000? What about a longer lifespan with a price tag that came in the form of difficult side effects?
A new decision guide, published Monday by the American Society of Clinical Oncology, seeks to help patients facing these types of devastating decisions by providing more clarity on the impact of new cancer drugs on health outcomes, side effects and finances.
The proposed methodology aims to make it easier for patients and providers to make more-informed decisions about care.
“This project is responding to patient concerns, as well as society’s concerns, about the rising costs of medical care, specifically cancer care, that make optimal care challenging at best and prohibitive in other cases,” said Dr. Gary Lyman, co-director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch and member of the ASCO Value in Cancer Care Task Force that created the framework.
The ASCO Value Framework assigns a score, called a “Net Health Benefit,” to new drugs based on how they’ve stacked up against the current standard of care in randomized controlled trials. A new drug gets points for helping patients survive longer than the old therapy and for having less-severe side effects.
The framework provides the drug costs along with the Net Health Benefit so patients and their doctors can consider medical benefits side by side with the financial impact when choosing a course of therapy.
The framework’s authors demonstrated its use in metastatic lung cancer, advanced multiple myeloma, metastatic prostate cancer and HER2-positive breast cancer. As currently published, it is geared more toward physicians than for use by patients (with published results from a clinical trial in hand, users fill out a worksheet to derive a drug’s Net Health Benefit). But eventually, ASCO said in a statement, the goal is for the framework to serve as the basis for user-friendly tools that physicians and patients could use together to choose treatments based on the patient’s individual values and preferences for care. In fact, Lyman said, the task force envisions an electronic tool that integrates up-to-date information on benefits, harms and costs seamlessly into electronic health records.
“When all three elements are considered” — clinical outcomes, toxicity and cost — “distinct differences in the available options often emerge,” Lyman said. “It’s not telling people to take one agent or another, but rather to enhance the discussion between patient and provider.”
The task force developed two versions of the framework: one for patients with early-stage cancer (in which the goal of treatment is to eliminate the disease) and another for patients with advanced, incurable disease who are seeking to improve survival while maintaining quality of life. The two versions of the framework measure clinical benefit in different ways to take these varied treatment goals into account. The version for advanced disease also assigns “bonus points” to a drug’s score if it greatly reduces symptoms or prolongs the amount of time before additional treatment is needed.
In each of the four test cancers, different drugs’ Net Health Benefits and costs diverged wildly.
A combination chemotherapy incorporating pemetrexed (Alimta), a new lung cancer drug, earned a Net Health Benefit score of just zero when compared to an older combination for first-line treatment of metastatic non-small-cell lung cancer ― despite having a price tag more than 11 times higher.
In contrast, the addition of trastuzumab (Herceptin) to a three-drug cocktail for HER2-positive breast cancer had a Net Health Benefit of 48, a relatively high score. The new drug cut the risk of death by more than one third compared to the three-drug combination alone, while maintaining the same level of toxicity.
However, adding the newer, fourth drug to the combo also caused the cost to skyrocket from just $3,400 to over $73,000.
Lyman emphasized that these numbers will mean different things to different patients as they consider their treatment options for their disease together with their oncologists.
“For many patients, optimizing efficacy even if it’s a matter of weeks or a couple months may be the choice they take, but others, who may be more concerned about the ravages of high cost and the impact on family and the next generation, may want to maximize efficiency,” Lyman said.
The issue of cancer drug prices is increasingly on the radar of patients and doctors around the country.
The issue took center stage at last month’s ASCO annual meeting, where plenary speaker Dr. Leonard Saltz of Memorial Sloan Kettering Cancer Center told his peers, “these drugs cost too much.” Several weeks later, researchers at his institution released an interactive calculator, DrugAbacus, which adjusts drug prices based on the drugs’ effects on lifespan and side effects.
“If you look at what’s happened in the last five years, there’s been an increase in the price of new agents coming on the market, with cancer being on the high end,” Lyman said. “Part of this is the technology,” he said, referring to the high-tech methods used to develop today’s molecularly targeted drugs. But, he added, the “disconnect” between these high costs and net benefit some drugs’ provide — sometimes just a few more weeks of life — “just doesn’t make much sense,” he said.
He said that he has been part of a growing chorus clamoring for change in drug pricing.
“Many of us have been calling on industry and the government and the payers to rein in these steeply rising prices that are making these drugs unaffordable and often catastrophic for patients,” he said. He cited the prohibition against price negotiation by the Centers for Medicare & Medicaid Services — the nation’s largest cancer drug purchaser — as one area for change.
Through HICOR, Lyman and his colleagues also seek to make a difference through research. “What we’re doing now with HICOR is testing out different strategies to improve the quality of care and reduce costs within the Northwest among our partners,” he said. “And it gives us real opportunities to test different models and see what works and what doesn’t work.”
The framework is a work in progress. “This is just the first iteration,” Lyman said.
ASCO is seeking feedback from patients, providers and others on the framework to guide the development of future versions. To provide feedback, visit the online survey. The public comment period is open through Aug. 21.
Lyman cited quality of life and patient-reported measures as important outcomes that could potentially be included in future versions of the framework. Future versions might also provide information on the out-of-pocket costs that a patient would experience in their specific circumstances, he said.
Susan Keown, a staff writer at Fred Hutchinson Cancer Research Center, has written about health and research topics for a variety of research institutions, including the National Institutes of Health and the Centers for Disease Control and Prevention. Reach her at firstname.lastname@example.org.