Rising health care costs, including escalating drug prices, have led to an increased focus by payers on strategies to guide the use of health care resources. As payers search for ways to control the rising cost of care, they often employ “utilization management" (UM) policies, which are payer-imposed practices that may restrict, limit, or deny coverage for certain treatments.
ASCO’s 2017 position statement on the impact of UM policies in cancer care, identified common practices that public and private insurers use to control the use of cancer therapies including:
- Prior Authorization – which requires patients or prescribers to secure pre-approval as a condition of insurance coverage for a prescribed medication.
- Step Therapy (“Fail-First”) – which requires patients to use—and then fail to be effectively treated by—their insurer’s preferred drug treatment before the insurer will cover another drug, even if that other drug is preferred by the patient or treating physician.
- Lack of parity for oral chemotherapy – when payers impose higher patient cost-sharing requirements on oral chemotherapy agents than for intravenous or injectable anti-cancer drugs.
- Restrictive Formularies – when insurers limit coverage of prescription drugs to an approved list of drugs. This often restricts access to therapies that are not clinically interchangeable.
- Specialty Drug Tiers – when payers categorize prescription drugs into tiers by cost and/or by type. Medications in these tiers are typically high-cost, molecularly complex agents, or drugs that require special handling, administration and patient education. Patient cost sharing is also typically greater for these drugs than for others.
Prior Authorization’s Impact on People with Cancer and their Providers
Evidence is mounting that UM strategies are impeding the delivery of high-quality, high-value cancer care. Recent surveys conducted by the American Cancer Society Cancer Action Network (ACS CAN), the American Medical Association (AMA), and the American Society for Radiation Oncology (ASTRO) all raise significant concerns about the impact of UM policies on people with cancer and their physicians.
“Hilda’s” Experience with Prior Authorization:
Hilda had acute myeloid leukemia (AML), a cancer of the blood and bone marrow and a disease that usually gets worse quickly if it is not treated. At age 79, Hilda was too frail for conventional chemotherapy, so her physician ordered a non-infusion oral therapy (venetoclax), which is recommended for elderly patients. Her insurance company denied coverage of this treatment, unaware that new data on AML in the elderly pointed to the treatment her physician had recommended. Over the course of more than two weeks, her physician spent hours on the phone with the insurance company—mostly on hold waiting to speak with a company representative—to provide more information about the treatment plan and why it was the most appropriate in Hilda’s situation. By the time the treatment was approved, Hilda had died of her disease.*
ACS CAN’s survey shows that one in three of the patients and caregivers surveyed reported delays in cancer care because their physician was waiting for their health plan to approve a prescribed treatment, test, or medicine. Such treatment delays may have deleterious consequences to a patient with cancer that is progressing.
Additionally, 70% or more of the physicians surveyed by ACS CAN reported that utilization management techniques are having a significant negative impact on their practice of medicine by limiting their ability to provide high-quality care and imposing significant administrative burdens that divert precious time away from direct patient care.
Among AMA survey respondents, 75% report that prior authorization can lead to patients abandoning their recommended course of treatment, and 91% say that prior authorization has a “significant or somewhat negative impact” on patient clinical outcomes.
ASTRO’s survey found that prior authorization disproportionately burdens patients at community oncology clinics, with patients at community-based, private oncology practices experiencing longer delays than those seen at academic centers. Average treatment delays lasting longer than a week were reported by 34% of private practitioners versus 28% of academic physicians.
“Susan’s” Experience with Prior Authorization:
Susan has glioblastoma and was to start radiation therapy and oral chemotherapy (temozolomide). Concurrent administration of radiation and chemotherapy has been shown to be essential in managing this type of brain cancer. She missed 5 days of chemotherapy due to the prior authorization delay, which caused extreme frustration and family stress when also dealing with the loss of her spouse as a mother of two.*
Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medication before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, it potentially leads to irreversible disease progression and other significant patient health risks.
CMS began to allow step therapy for drugs within the Medicare program. ASCO believes that step therapy is generally inappropriate in oncology due to the individualized nature of modern cancer treatment and the general lack of interchangeable clinical options. Medically appropriate cancer care requires patient access to the most appropriate drug at the most appropriate time.
“Stephen’s” Experience with Step Therapy:
Stephen was being treated for chronic myelogenous leukemia (CML), a cancer that affects a person’s blood cells and bone marrow. When he began to have severe side effects from the treatment, his physician switched him to an alternative medication, and he was doing very well. When Stephen switched insurance plans, his new insurer refused to pay for the medication he was already on, stating that it was not on the plan’s “first tier” for that category of medication. The insurer wanted him, according to their policy, to "fail" on another medication before approving the medication he was taking—and which had been effective in treating his cancer. Stephen agreed, but severe side effects forced him to stop the required “fail first” treatment. During the time that he was not taking medication, Stephen’s disease progressed severely and he eventually died.*
“Ellen’s” Experience with Step Therapy:
A 52-year old mother of 3, Ellen was about to undergo chemotherapy for colon cancer. She hoped for a cure, but was very anxious about the side effects, especially nausea since she had had bad nausea with her pregnancies and wanted to avoid that while undergoing her chemotherapy. Her physician prescribed a potent nausea medication (Emend) to ensure that her first cycle of therapy was without an otherwise avoidable complication. Ellen’s insurance company refused to cover the nausea medication since she had not yet demonstrated that she had "failed,” despite having horrible nausea and vomiting with the less effective medication that was on their approved list. She did not have the means to pay for the medication without the insurance coverage and was forced to start chemotherapy without the more effective nausea medication. As expected, she had terrible nausea with the first cycle of therapy and was subsequently able to get the approval for the nausea medication with future doses of therapy, but at the expense of realizing her fears, demoralizing her efforts at staying healthy, and having great anxiety with every cycle of therapy thereafter that the medications for nausea may not work for her.*
Recent scientific advances have led to increased availability of orally administered medications to treat individuals with cancer, enabling many patients to undergo treatment outside of a hospital or doctor’s office and go about their daily lives with minimal disruption. Oral cancer drugs can provide significant clinical advantages over intravenous (IV) and injected anticancer medications, and in some instances, oral cancer drugs may represent the only or best treatment option.
However, some health insurance plans impose significantly higher cost-sharing requirements on cancer patients for oral cancer therapies than for traditional infusion cancer drugs that are delivered intravenously. This often presents significant financial barriers to optimal treatment, some of which may have the potential to lower the overall cost of care.
Read ASCO’s oral parity-specific issue brief for more information.
Clinical Pathways – A Better Way Forward
Well-designed, high-quality clinical pathways should be payers’ first choice to ensure the appropriate utilization of anti-cancer drugs and the delivery of high-value care.
Appropriately designed and implemented clinical pathways are evidence-based treatment management tools that deliver high-quality cancer care for specific patient presentations. Payers, institutions, and clinicians can use pathways to reduce variabilities in treating specific conditions and control costs. Evidence suggests that well-designed clinical pathways could address the cost of cancer care without compromising patient access to medically appropriate treatments, even when the cost of treatment is high. Learn about ASCO’s criteria for high-quality pathways in oncology.
ASCO will continue to oppose any utilization management policies that restrict patient access to high-quality cancer care, and the society stands ready to work with other stakeholders to develop and implement policies that better serve people with cancer.
For more information about utilization management, visit:
- Media Issue Brief: Oncology Clinical Pathways
- ASCO Utilization Management Statement (pdf)
- Drug Pricing, Medicaid Waivers, Clinical Trials, Step Therapy in Focus at ASCO Meetings with Federal Agencies
- As 116th U.S. Congress Begins, ASCO Focuses on Policy Priorities for Coming Year
- Some Pharmacy Benefit Manager Practices May Erode Patient Access to Cancer Care, ASCO Analysis Finds
- ASCO Opposes Payer Utilization Management Approaches that Curb Access to High-Quality, High-Value Cancer Care
ASCO’s Media Issue Briefs provide succinct overviews and relevant data on major policy issues impacting patients with cancer and the physicians who care for them. These briefs are designed to be especially helpful for journalists, offering background information on key issues across health policy today. Access ASCO’s full collection of Media Issue Briefs. For requests to speak with an ASCO expert on any cancer-related policy issue, please contact email@example.com.
*Patient stories are factual cases based on patient experiences shared by ASCO members. Patient names and certain identifying aspects of the stories have been changed to protect patient privacy.