On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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Applications are now being accepted for the 2020-2021 cycle of ASCO’s Health Policy Leadership Development program. The Health Policy Leadership Development Program is a one-year program that gives ASCO members the opportunity to develop expertise in health policy, advocacy, and grassroots activity while learning valuable leadership skills.
“We applaud the National Academies of Sciences, Engineering, and Medicine for its recommendations on cancer control in the United States. The report examines the oncology community’s efforts over the past 10 years and lays out a comprehensive path for addressing the complex issues facing the entire cancer care continuum, from government agencies to the individual physician.
On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to update and streamline the prior authorization process under Medicare Part D. The proposal aims to improve access to prescription medications for Part D beneficiaries and alleviate administrative burden for providers. Under the proposal, clinicians would be able to complete prior authorizations for Part D prescriptions online and through a more streamlined process. ASCO supports efforts to improve the prior authorization process for patients and providers, including electronic prior authorizations.
ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the 2020 Hospital Inpatient Prospective Payment System (IPPS) proposed rule. ASCO’s comments focus on appropriate coverage and reimbursement for Chimeric Antigen Receptor T-Cell Therapy (CAR-T) therapies, the need to address disparities between rural and urban hospitals, and implementation of meaningful quality measures to improve cancer care for patients and providers.
ASCO is seeking 10 oncology practices in rural or urban centers in the U.S. that primarily treat underserved populations to participate in its Quality Oncology Practice Initiative (QOPI®) and Quality Training Program (QTP) offerings for a three-year period, with training and funding support provided.
A recent American Medical Association (AMA) report on opioids highlights how provider mandates—on training, prior authorizations—have not had a significant impact on curtailing the opioid epidemic. According to the Opioid Task Force 2019 Progress Report, prescription opioid-related mortality may be leveling off, however deaths from heroin and illicitly manufactured fentanyl and fentanyl analogs are at an all-time high. Instead, the report calls on policymakers to address the opioid epidemic with policies to promote evidence-based treatment.
ASCO submitted comments to the House Ways and Means and Energy and Commerce committees on draft legislation to address rising out-of-pocket costs in the Medicare Part D program. The draft legislation proposes capping out-of-pocket costs for Part D beneficiaries. The society supports such caps and suggests other ways to reduce out-of-pocket costs for Part D beneficiaries with cancer including lower patient cost sharing requirements for self-administered cancer treatments and addressing unnecessary costs caused by utilization management policies.
On June 17, 2019, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
The Quality Oncology Practice Initiative (QOPI®) Round 2 is now open for registration (as of June 17), and data abstraction will open on July 1.
ASCO joined more than 120 other organizations in signing on to a letter urging Congress to introduce several improvements to ensure the continued success of efforts to implement the Medicare Access and CHIP Reauthorization Act.
The American Medical Association’s (AMA) House of Delegates (HOD) successfully passed three resolutions that were led by the ASCO delegation during their recent Annual Meeting, as well as a resolution calling on the Centers for Medicare & Medicaid Services to ensure additional patient protections for step therapy in Medicare Advantage this plan year. The HOD also reaffirmed existing policy stating that physicians who have proven adherence to high quality clinical pathways physicians should be exempt from prior authorization requirements.
ASCO’s Center for Research and Analytics (CENTRA) is now accepting research applications from ASCO members who wish to conduct surveys of ASCO members for research purposes.
ASCO submitted comments to Senate Health Education, Labor and Pensions (HELP) Committee leadership regarding draft legislation to address rising out-of-pocket costs for patients in the United States. ASCO’s comments focus on improving patient access to cancer care by reducing prescription drug prices, improving transparency around pharmacy benefit manager (PBM) practices, and improving public health and the exchange of health information.