Personalized, targeted therapies
A new treatment, called immune effector cell therapy, allows physicians to harvest a patient’s T cells (a type of white blood cell), re-engineer them to target cancer cells by equipping them with receptors—proteins placed on the surface of T cells that allow them to bind more effectively to cancer cells—and then reintroduce them into that patient’s immune system, says Richard R. Barakat, MD, MBA, physician-in-chief and director of cancer, Northwell Cancer Institute. The institute is part of Northwell Health in Lake Success, New York, which is the state’s largest healthcare provider and private employer and treats 2 million patients annually. The engineered cells multiply in the patient’s body and recognize and kill cancer cells that harbor the receptor.
The most advanced therapy in clinical development in this space is chimeric antigen receptor T-cell (CAR T-cell) therapy.
The FDA has approved two CAR T-cell therapies:
- Yescarta (axicabtagene ciloleucel), manufactured by Kite Pharma (which was recently acquired by Gilead), is approved for patients with refractory diffuse large B-cell lymphoma.
- Kymriah (tisagenlecleucel), from Novartis, is approved to treat acute lymphoblastic leukemia in patients under age 25 years.
“These two treatments target small populations who have limited to no further treatment options, but [the treatments] pose challenges to the U.S. healthcare system due to their high upfront costs, uncertainty of effectiveness, and potential adverse events,” says Brian Duffant, vice president, BluePath Solutions, a market access and health outcomes consulting firm.
CAR T-cell therapy is intended to be delivered as a one-time treatment. The cost of therapy for Yescarta (with a wholesale acquisition cost of $373,000—the list price set by the manufacturer) and Kymriah ($475,000) is front-loaded. “This may result in short-term budget impact challenges, which are particularly acute for smaller payers and employers,” Duffant says. “The current U.S. healthcare system doesn’t have existing infrastructure for this type of cost dynamic, and will require innovative solutions such as payment over time, risk-share agreements, and indication-specific pricing.”
Although expensive, Amit Kumar, PhD, CEO and president, ITUS Corp., a cancer diagnostics and therapy company and board member of the American Cancer Society, says the overall impact of CAR T-cell therapies to the healthcare system is modest right now due to the small number of conditions it can treat. “Payers, including Medicare, are already working with providers and therapy developers to evaluate and institute new models for reimbursement,” he says. For example, CAR T-cell therapies may not be reimbursed unless there is an objective measure of efficacy.
Barakat says some payers already have policies for these two treatments. “Inpatient costs will likely be bundled into the total cost of the hospital stay,” he says. “While many institutions will likely launch their CAR T therapies in an inpatient setting due to the potential of significant toxicities … these therapies could possibly be performed in an outpatient setting as a pretreatment with an interleukin-6 (IL-6) receptor blockade—which could potentially result in less toxicity.”
Social determinants of health
Social determinants of health include economic stability, education, health and healthcare, neighborhood and built environment, and social and community context, according to Healthy People 2020, which provides 10-year national objectives for improving Americans’ health. “These are the conditions in which people are born, grow, live, work, and age, as well as the circumstances that impact their health,” says Lori Tremmel Freeman, MBA, CEO, National Association of County and City Health Officials, which advocates for local health departments. “Social determinants of health undergird many current healthcare challenges, including obesity, heart disease, diabetes, and depression.”
While genetics plays a role in an individual’s overall health, most health outcomes are the result of circumstances outside the healthcare system. “The conditions in which someone lives, whether they have transportation to a clinic when needed, their support network, and other factors beyond the doctor’s office are as important to an individual’s overall health and well-being as being treated for an illness,” says Joseph Valenti, MD, board member, The Physicians Foundation, an organization that seeks to help physicians deliver high-quality care. “As the healthcare system effectively addresses these issues, the overall price of healthcare in the United States will decrease and people will generally be healthier.”
Some states, insurers, and hospitals are already factoring social determinants into healthcare by doing things like ensuring patients have adequate housing and access to needed resources and programs.
Freeman says more attention to social determinants would provide a more balanced approach to health.
From a public health perspective, she says healthcare can be categorized at three levels:
- Primary, focused on disease prevention;
- Secondary, treating disease in the early stages; or
- Tertiary, treating the effects of a disease or illness.
Considering diabetes as an example, primary care would include a focus on healthy lifestyle, secondary care would involve monitoring of blood levels and medication, and tertiary care could include amputation.
Primary, secondary, and tertiary care can be targeted at the individual, interpersonal, organizational, community, or public policy level, Freeman says. Naloxone, a medication designed to rapidly reverse opioid overdose, for example, is tertiary care at an individual level. On the other hand, given that unemployment is thought to contribute to patterns of opioid use, a strategy of increasing job opportunities becomes primary care at a community level. By focusing on the social determinants, organizations can better address population health problems.
Social determinants of health could impact how the healthcare industry conducts business. Instead of concentrating on tertiary care for patient populations only, healthcare could participate more in community health, Freeman says. Eventually, as social determinants of health become a greater part of the healthcare portfolio, tertiary care spending would decrease while quality of life would increase for affected communities.
In many places, this has already begun, as hospitals and health insurers work with local health departments around community health concerns, she says. By law, providing community benefit has been central to the tax-exempt status of nonprofit hospitals. The ACA’s explicit requirement for nonprofit hospitals to consider input from those with public health expertise in the development of hospital community health needs assessment and implementation strategies has increased local collaborations around social determinants of health.