With the growing burden of the cost of cancer therapy, for both payers and society as a whole, cost-effectiveness discussions are on the rise among all stakeholders—payers, providers, and patients. Organizations like the American Society of Clinical Oncology have joined the discussion and are developing a framework that could help physicians and patients reach treatment decisions together. While the healthcare system in the United States is struggling to balance access to care with the cost of that care, comparative effectiveness research (CER) could lead to better-informed healthcare decisions.
The value of CER was discussed by a group of payer representatives during the Peer Exchange convened by The American Journal of Managed Care in September 2014, Oncology Stakeholder Summit: Evidence-Based Decisions to Improve Quality and Regulate Costs. Participants included John L. Fox, MD, MHA, senior medical director and associate vice president of Medical Affairs at Priority Health; Ira M. Klein, MD, MBA, FACP, national medical director, Clinical Thought Leadership, Office of the Chief Medical Officer, Aetna Inc; Michael Kolodziej, MD, national medical director for Oncology Strategies, Aetna Inc; Bryan Loy, MD, physician lead—Cancer, Humana; and Irwin W. Tischler, DO, national medical director, Oncology, Cigna. The session was moderated by Peter Salgo, MD, professor of medicine and anesthesiology at Columbia University and associate director of surgical intensive care at NewYork- Presbyterian Hospital.
Kolodziej began the discussion with a comparison between the European healthcare system and that of the United States. While CER guides policy decisions in Europe, especially by Britain’s National Institute for Health and Clinical Excellence (NICE), it has not found widespread acceptance in the United States, with critics equating CER with rationing of healthcare to save costs. The Patient-Centered Outcomes Research Institute (PCORI), a product of the Affordable Care Act, was considered by many as a solution to tackling CER, but was prevented from considering the cost of care in its research, Kolodziej said. “So I think that this is a fertile soil. I don’t think the payers are going to do it, but I think they’re dying to use it,” he added.
He went on to cite a project that he is involved in, a project to identify the optimal drug sequence in breast cancer and renal cell cancer. Although this is a very challenging task, Kolodziej said that pointing out the worst sequence would be equally effective. Loy added that while CER has been used by pharmacies and pharmacy benefit managers for some time (as step therapy), it could have tremendous utility in the healthcare delivery model.
When Salgo asked the payers about CER in a clinical trial setting, several of them agreed that it would be a huge advantage to trials. CER works as the phase 4 of a clinical trial for the FDA, said Klein, “a post trial real-world analysis” that would provide a much clearer picture of a drug’s performance than an actual clinical trial with its highly controlled environment would.
When the discussion moved toward the importance of including quality-adjusted lifeyears (QALYs) in CER, Kolodziej emphasized the role of patient-reported outcomes in the QALY discussion. The real question, the panel agreed, is whether decisions should be made on a case-percase basis after evaluating a patient’s status and respecting patient opinion, or whether a general policy should be crafted after establishing cost-effectiveness of a therapy. As the discussion circled back to patient age and cost of care, Tischler suggested that in the case of
an older patient, the treating physician should be obligated to discuss the cost of therapy with the patient and the family. “Like I used to say to my patients, I could add a lot of years to your life or some years to your life, but I’m not going to add a whole lot of life to your years, and what price are you willing to pay for that? I think that’s where the discussion should go,” he added. While these extremely important discussions on cost of care are in their preliminary stages, Tischler said he could foresee them being a part of mainstream healthcare decisions in the near future.
Fox concurred, and emphasized the importance of communicating available options to the patients and family members, stating that the question of “rationing” care may not arise if the patient is well aware of the different ways to achieve the desired outcome. “In our experience in working with providers to do advanced care planning around patients who have terminal diseases, a lot of patients, once they fully understand the options, say, ‘You know, I don’t want more treatment. I want to be kept comfortable,’” added Fox.
While CMS is prohibited from considering CER to approve coverage for a particular treatment, Fox said that payers have a straightforward method of accounting for a very expensive drug: increased premium or co-pay. Klein added that these increases in patient cost-sharing lead to an informal rationing, with a steep decrease in adherence. “We’re creating a multi-tiered system in which rationing occurs by the financial burdens we put on people, and we put those burdens on people actuarially because we have decided not to fix the problem on the front end,” said Klein.