Evidence-Based Oncology August 2019
Evidence-Based Oncology August 2019
Ellen Matloff, CGC, MS; Danielle Bonadies, CGC, MS; Meagan Farmer, CGC, MS, MBA
COTA Collaboration: Helping FDA Figure Out What's Possible and What's Not in Embrace of Real-World Evidence
L. Patrick James, MD
Kelly Owens, PhD; Lisa Schlager; and Piri L. Welcsh, PhD
Conference Coverage: NCCN Policy Summit
Laura Joszt, Mary Caffrey, Jaime Rosenberg, and Alison Rodriguez
Joseph Alvarnas, MD
Conference Coverage: NCCN Policy Summit
Coverage from the National Comprehensive Cancer Network Policy Summit held June 27, 2019, in Washington, DC.
How Are States Dealing With Challenges Facing Patients With Cancer?High costs of care, particularly for prescription drugs, dominated a discussion of cancer care at the state level during the June 27, 2019, National Comprehensive Cancer Network Policy Summit in Washington, DC.
With authority from CMS, states have looked at different ways to address needs for their specific populations while containing costs, explained Jennifer Carlson, associate vice president of External Relations and Advocacy at The Ohio State University Wexner Medical Center.
For example, states like Louisiana and Washington have adopted the “Netflix” subscription model, which allows the states to negotiate prices with manufacturers of hepatitis C virus (HCV) drugs. Under the model, states can pay a fixed amount per year for an unrestricted amount of HCV drugs.1 States are also dabbling with value-based purchasing models, where the states pay different amounts based on the efficacy of the drug, Carlson explained.
While most of the focus has been on high drug costs, it’s important to keep in mind that these are not the only costs affecting patients with cancer, said Lee Jones, MBA, a patient advocate and cancer survivor from Arlington, Virginia. Patients are also affected by the cost of radiation, computed tomography scans, and ongoing testing.
Offering a unique perspective, Anne Levine, MEd, MBA, vice president of external affairs, Dana-Farber Cancer Institute, discussed how Massachusetts controls healthcare spending by tying that spending to the state’s economy. In 2006, the state passed legislation that led to 97% of the commonwealth’s residents having insurance coverage by 2008.2 Of those covered, 25% are enrolled in the state’s Medicaid program, which accounts for 40% of the entire state budget, explained Levine.
With rapid growth in healthcare spending, the state in 2012 passed another piece of legislation to put healthcare spending in line with the growth of the state’s overall economy by setting a healthcare cost growth benchmark set by the state’s Health Policy Commission (HPC).3 Total healthcare costs account for growth in all medical expenses paid to providers by private and public payers, all patient cost-sharing amounts, and the net cost of private insurance. Between 2013 and 2017, the benchmark was set equal to the potential gross state product of 3.6%.
Beginning in 2018 and ending in 2022, the benchmark is set to 3.1%. While overall healthcare spending must also be monitored, Massachusetts has found that pharmaceuticals account for a large part of healthcare spending growth, explained Levine. Between 2016 and 2017, overall healthcare costs grew 1.7%, but pharmacy expenditures increased by 4.1%.4
To try and rein in drug prices, the state is moving toward allowing MassHealth, the commonwealth’s Medicaid program, to allow the program to negotiate directly with drug companies for high-priced drugs. When the plan was initially introduced in January, if the negotiations were not successful, the governor’s office could propose a price, hold public hearings, or refer the drug price to the HPC.5 In the final version, drug manufacturers would not be forced to negotiate prices, attend public hearings, or be referred to the Massachusetts’ attorney general. While innovative, the model could negatively impact patients with cancer, warned Jones.
“If you start capping expenditures on healthcare, it eventually ends up getting down to the patient, and the patient is not able to have access to the quality or quantity of care that they need,” said Jones. “And if you end up capping it significantly enough, you may end up getting drug makers not being willing to sell drugs to that state if they can’t earn whatever they consider to be a reasonable profit.”
Moving the conversation outside of costs, the panel also discussed their frustrations with utilization management strategies, including prior authorization and step therapy.
“I think the intentions behind it are good in that we’re trying to promote value and decrease waste, but I think the concerns most practitioners have is that limits our ability to individualize care and also, most importantly, causes delays in our patients’ care,” said Shiven B. Patel, MD, MBA, FACP, assistant professor in the Division of Oncology in the Department of Medicine at the Huntsman Cancer Institute at the University of Utah.
In the most extreme cases, said Patel, patients die waiting to get certain drugs approved. He gave the example of patients he’s seen with lung cancer who have metastasis in the brain and need oral chemotherapy but have died waiting sometimes 4 to 6 weeks to get them approved.
The Huntsman Cancer Institute has hired a pharmacist whose sole job is to deal with the prior authorization process and patient assistance programs, “so our institutional costs are going up because we’re hiring people just to help our patients access these meds,” said Patel.
With stories like this and others, states around the country have taken the initiative to regulate these utilization management strategies. John Cox, DO, MBA, FACP, FASCO, medical director of Oncology Services at Parkland Health and Hospital System, University of Texas Southwestern, explained that the legislature recently passed several bills dealing with step therapy, one of which prohibits step therapy in metastatic breast cancer.6
Levine said Massachusetts currently has a bill pending that would implement a series of guardrails for step therapy, including allowing an exemption if it’s part of an approved clinical guideline, allowing physicians to override the step therapy in certain instances, and implementing tight time frames for utilization management decisions to be made.
1. DiGrande S. Louisiana chooses Asegua to partner for Netflix subscription model for HCV treatent. The American Journal of Managed Care® website. ajmc.com/focus-of-the-week/louisiana-chooses-asegua-to-partner-fornetflix-subscription-model-for-hcv-treatment. Published March 27, 2019. Accessed July 24, 2019.
2. McDonough JE, Rosman B, Phelps F. Shannon M. The third wave of Massachusetts health care access reform. Health Aff. 2006; (suppl 1) doi.org/10.1377/hlthaff.25.w420.
3. Health Care Cost Growth Benchark. Mass.gov website. mass.gov/info-details/health-care-cost-growth-benchmark. Accessed July 24, 2019.
4. Massachusetts Health Policy Commission. 2018 annual health care cost trends report. Mass.gov website. mass.gov/files/documents/2019/02/20/2018%20Cost%20Trends%20Report.pdf. Published February 2019. Accessed July 24, 2019.
5. Bebinger M. Massachusetts moves to negotiate Medicaid drug prices. wbur.org/commonhealth/2019/07/22/massachusetts-budget-drug-price-controls. Published July 22, 2019. Accessed July 24, 2019.
6. Patt D. Prohibit step therapy in metastatic breast cancer. Texas Medical Association website. www.texmed.org/Template.aspx?id=50261. Published April 2, 2019. Accessed July 24, 2019.
Shifting Regulatory Action to States: Implications for Patient Access to High-Quality Cancer CareSince President Donald Trump took office, his administration has been granting states greater flexibility in how they address healthcare for their populations. This involves Medicaid work requirements, block grants, and short-term, limited duration (STLD) health plans.
On June 27, a panel of diverse stakeholders gathered at the National Comprehensive Cancer Network Policy Summit in Washington, DC, to discuss how shifting regulatory signals from both the federal government and from states has implications for patient access to high-quality cancer care. Panelists kicked off the discussion by outlining how states have leveraged Medicaid Section 1115 waivers to initiate different types of demonstration and research projects, such as Medicaid expansion and, more recently, Medicaid work requirements for certain populations.1
“I think it’s a larger trend of states looking at really beginning to diversify the Medicaid population more and to say, ‘We want to look at populations differently,’” said Nina Owcharenko Schaefer, senior research fellow at The Heritage Foundation. “Rather than having Medicaid as one program where we deliver [healthcare] to everyone, I think what we’re seeing is states taking a very active role in understanding the needs of the patients in Medicaid are very different from one another, and
that not every…Medicaid patient is the same as another Medicaid patient.”
A number of states have looked at different ways to diversify their programs, such as by examining cost sharing for some of the higher income levels in Medicaid, addressing behavioral health, and looking beyond the medical scope to alternative services. “From the patient perspective, flexibility is important and innovation is important; however, the concern—and we try to make sure there’s a clear balance—is the fact that you have to have flexibility but also make sure that patient access and access to quality care is not harmed,” said Keysha Brooks-Coley, MA, vice president of federal advocacy and strategic alliances at the American Cancer Society
Cancer Action Network. She noted that Medicaid work requirements, in particular, could hinder access for patients with cancer.
The panel also discussed block grants, which have not yet seen as much uptake as work requirements. In March, Trump released his budget for fiscal year 2020, which called for converting Medicaid to a system of block grants.2 On July 1, a law went into effect in Tennessee that directed the governor to submit a waiver to CMS to turn the state’s Medicaid program into a block grant. If approved, Tennessee would become the first state to make the transition.3
Block grants represent the concept that states should figure out what best serves the needs of their populations, said Ronald S. Walters, MD, MBA, MHA, a professor of clinical medicine in the Department of Breast Medical Oncology, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, Houston. The idea makes sense as long as guardrails are built to make sure essential health benefits are protected, he added. “States balance their budgets, so they are squeezed in figuring out how to take that dollar and make it spread everywhere,” Schaefer said. “You know where they don’t balance their budget? Here in Washington.”