The U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma.
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.
To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.
On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC who received no prior chemotherapy for extensive stage disease and had ECOG performance status 0 or 1.
ASCO recently submitted comments in response to a request for information (RFI) on reducing health care costs from the Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee.
Two of the world’s leading cancer organizations have released national strategies for meeting the needs of the growing population of cancer survivors in the United States while addressing provider shortages and rising costs. ASCO and the American Cancer Society convened a summit in January of 2018 focused on developing and implementing care that addresses these issues by treating patients in personalized follow-up care pathways depending on the type and level of resources needed for their long-term care. The strategies from that summit were published on March 8, in CA: A Cancer Journal for Clinicians.
Members of Congress recently introduced oral parity legislation to ensure patients have access to the highest-quality cancer treatment.
On April 10, ASCO will convene some of the nation’s top physicians, advocates and rural health experts for a discussion on the challenges facing Americans living with cancer in rural areas and promising opportunities to improve outcomes.
The 116th Congress is in full swing, and ASCO is advocating on a number of cancer-related policy priorities, including federal funding for cancer research, patient access to clinical trials, oral parity legislation, and potential barriers to care such as the high cost of cancer drug treatment, step therapy, and prior authorization policies. ASCO members can support these advocacy efforts by engaging local lawmakers to ensure they are aware of patient access challenges, as well as legislation that can improve the delivery of the highest quality cancer care.
On February 11-12, the National Cancer Policy Forum hosted a workshop at the National Academy of Medicine in Washington, DC, entitled “Developing and Sustaining an Effective and Resilient Oncology Careforce.” Over the course of the two-day workshop, ASCO volunteer and staff leadership and several other ASCO members gave presentations and participated in panel discussions. ASCO President-Elect Howard “Skip” Burris, MD, FASCO, discussed his institution’s experiences leveraging organizational culture and leadership to promote change in the oncology careforce.
Acreditar Oncology has become the third practice in Brazil to receive Quality Oncology Practice Initiative (QOPI®) certification through QOPI Certification Program, LLC, and the tenth practice internationally to receive this accreditation.
"We strongly oppose the White House budget proposal for Fiscal Year (FY) 2020, which would stall our nation’s progress against cancer and impede access to needed care for the millions of Americans dealing with cancer. The proposal would make drastic, unprecedented cuts to the U.S. Department of Health and Human Services—which houses the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Centers for Medicare & Medicaid Services (CMS)."
On March 11, the Journal of Oncology Practice (JOP) published, “State of Cancer Care in America: Reflections on an Inaugural Year,” which highlights key takeaways from the 2018 State of Cancer Care in America series. The JOP series, which examines trends and critical challenges in the delivery of cancer care, used the findings from the 2017 ASCO Practice Census (the Census), a survey of U.S. oncology practices, as its starting point to identify the most pressing issues in cancer care. The series includes articles on trending topics on cancer care, along with commentaries from payers, oncologists, and regulators.
On March 8, 2019, the Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.
Registration is now open for the 4th Annual FDA Clinical Outcome Assessments in Cancer Clinical Trials (COA-CCT) Workshop, which will take place on July 12 at the FDA White Oak Campus in Silver Spring, Maryland.
In late January, ASCO notified members that some oncology practices and providers in the Merit-Based Incentive Payment System (MIPS) received inaccurate 2019 payment adjustments as a result of Medicare Part B drug costs incorrectly being included in the adjustments. CMS is now working to correct the payments. ASCO is in contact with the agency and will keep members informed as a solution is implemented. No action is required from MIPS participants at this time.
March 4 is International HPV Awareness Day, which aims to promote education about HPV, raise awareness about prevention methods, and encourage governments and individuals to take advantage of the HPV vaccine and screening for cancer. ASCO is again a supporter of the important initiative.