Facts Are Stubborn Things: The Medicare Part B Experiment, a Patient Advocate's Perspective (Part III)

Why this patient advocate is concerned about the newly proposed Medicare Part B model regarding its level of transparency and the evidence.

In Part II, Ms Madden discussed her concerns regarding the reaction of some to CMS' proposed approaches to "value-'" or "indications-based" pricing for specific drugs based on their different levels of effectiveness for different disease indications. In the conclusion to this series, she focuses on the troubling financial struggles many cancer and chronic disease patients are facing and the new initiatives that many groups are now establishing to bring a more informed awareness and increased level of science to considerations of overall value of care.

As citizens and patients in this country, the fact is that a majority of us worry about the extent of our healthcare coverage, whether or how long we’ll continue to have access to high-quality care, and the continued escalation of out-of-pocket costs, including insurance premiums, deductibles, specialty visit co-pays, and prescription drug co-pays. And for those of us with cancer or chronic conditions, such as multiple sclerosis, the medications required to treat us account for a significant percentage of spending on prescriptions. With the introduction of new, increasingly expensive drug agents, particularly the novel therapies that are emerging for many cancer types, treatment with just one of these medications—and many of us require combination therapies—can cost up to tens of thousands per month. Per Gary Lyman, MD, MPH, oncologist at Fred Hutchinson Cancer Research Center in Seattle and codirector of the Hutchinson Institute for Cancer Outcomes Research, “For many, the indirect and out of pocket expenses for cancer care are more than they can handle, leading to interruption or even cessation of potentially lifesaving treatment.…We know that cancer is one of the most, maybe the most, common causes of bankruptcy in the country.”

To come full circle, as so many of us are struggling to cover the costs of our medications and making extremely serious decisions concerning whether to continue with treatment, to face bankruptcy, to take on extra hours even when we’re at our sickest, shouldn’t one of the most important questions that we discuss be, “What is the clinical effectiveness of these medications that are costing us so much?” In other words, is it possible that some of these agents, despite being extremely expensive, may be no more effective than another much less expensive medication, or may add only a few additional weeks of life yet with substantial adverse effects that greatly impact quality of life?

In his role as HICOR’s codirector, Lyman noted that “We’re trying to bring a greater awareness and a high level of science to the discussion of the cost and overall value of cancer care.” He explained that in many cases, oncologists and their patients frequently have choices concerning which specific cancer treatment can be used. “We may have 2 treatments that give you the same overall benefit, but one is much less costly,” he stressed. “Therefore, it has a great value in the sense that you’re going to get to the same place, but you don’t need to go into bankruptcy or create enormous financial distress for yourself or your family.”

In fact, in addition to ICER, several groups are facing the reality of financial toxicity head on and developing value frameworks and tools, including the American Society of Clinical Oncology (ASCO)’s Value Framework and the National Comprehensive Cancer Network (NCCN)’s Evidence Blocks, where the costs and affordability of treatment are included in addition to the NCCN Guidelines’ standard measures of efficacy, toxicity, and quality of associated clinical research data. In addition, a growing number of oncologists have begun to push back concerning the prohibitively high costs of new cancer drugs, such as by being vocal about not prescribing new “me too” cancer drugs that are extremely expensive yet provide little or no added benefit for patients. Peter Bach, MD, MAPP, and 2 colleagues publically announced the following in a New York Times editorial, “At Memorial Sloan-Kettering Cancer Center, we recently made a decision that should have been a no-brainer: we are not going to give a phenomenally expensive new cancer drug to our patients. The reasons are simple: the drug, Zaltrap, has proved to be no better than a similar medicine we already have for advanced colorectal cancer, while its price—at $11,063 on average for a month of treatment—is more than twice as high.” They stressed that when determining specific treatment protocols for patients, it’s critical for clinicians to take into account the financial strain that could result in addition to the treatment’s benefits.

So in conclusion, my fear is that the importance of ICER’s contributions and those of other groups like those described above are being overshadowed by or inappropriately drawn into the discussion concerning the many flaws in the first portion of the proposed CMS Part B Payment Model. Rather, I’d suggest that CMS would gain much by eliminating the first portion of the proposal, which appears to be solely cost-driven and formulated without any critical stakeholder input, and/or potentially replacing it with a voluntary, transparent, stakeholder-driven demonstration project, such as based on the model described by Newcomer et al, above. And further, my hope is that an increasing number of patients, clinicians, advocacy groups, and clinical specialty societies will recognize and support the need for independent, transparent, evidence-based, and patient-centered analyses of value such as those driven by ICER, ASCO, and NCCN as a firm foundation for evidence-based practice for optimal patient care and outcomes. I leave you with David Sackett’s and his colleagues’ well-known description of evidence-based practice, which perhaps best describes what should be at the heart of care for all of those who are patients—in other words, for us all.

Evidence-based practice is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient…[It] is the integration of clinical expertise, patient values, and the best research evidence into the decision making process for patient care.”

~David Sackett

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