On July 24, 2020, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL.
ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.
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Today President Trump signed four executive orders (EOs) aimed at addressing the high cost of prescription drugs. The EOs, as described by the White House, would: (1) address the price of insulin by requiring federally qualified health centers to pass along any available discounts to patients, (2) allow for importation of certain drugs from other countries, (3) pass manufacturer discounts on Part D drugs to patients at the pharmacy, bypassing pharmacy benefit managers, and finally (4) implement a “favored nations” policy to allow Medicare to purchase Part B drugs at the lower prices paid by foreign countries. The fourth EO will go into effect in 30 days unless drug companies lower their prices first.
COVID-19 data collection efforts by the American Society of Clinical Oncology (ASCO) were featured in three separate abstracts during the Association for Cancer Research (AACR) Virtual Meeting: COVID-19 and Cancer this week. Two of the abstracts highlighted COVID-19 data from PracticeNET, and one abstract that was selected for an oral presentation reported on the ASCO Survey on COVID-19 in Oncology (ASCO) Registry.
The American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC) today announced a new collaboration to foster participation in cancer treatment trials to more fully reflect the diversity of people at risk for or living with cancer.
The US Food and Drug Administration (FDA) recently finalized four new final Guidance for Industry documents for cancer clinical trial eligibility criteria that describe ways that clinical trials can safely include patients who have historically been excluded. The guidance documents complement ongoing work by ASCO and Friends of Cancer Research (Friends) to eliminate overly restrictive eligibility criteria that can exclude patients from trials without scientific or participant safety justification. Clinical trials provide patients with cancer access to promising investigational therapies – which are sometimes the only treatment option available – and advance clinical care by producing safety and efficacy data about new therapies.
The U.S. Department of Health and Human Services (HHS) is hosting Telemedicine Hack, a free 10-week learning community aimed at accelerating telemedicine implementation for ambulatory providers, and the American Medical Association (AMA) launched its Telehealth Impact Physician Survey as part of an effort to ensure appropriate telemedicine implementation during COVID-19.
The Association of Clinical Oncology congratulates the eighteen practices that prioritized the quality of care they provide by achieving the Quality Oncology Practice Initiative (QOPI®) Certification in the second quarter of 2020.
The Association for Clinical Oncology signed on to a letter from the American Medical Association and statements from the Council of Medical Specialty Societies and the American College of Physicians’ Council of Subspecialty Societies expressing concerns about the Trump Administration’s executive order suspending immigration on certain professional visas to the United States (U.S.). The groups state that such restrictions on health care professionals could hinder efforts to address the COVID-19 pandemic in the U.S. and urge the Administration to make health care professionals, researchers, and dependent family members exempt from the proclamation.
The Association for Clinical Oncology (ASCO) recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the FY 2021 Hospital Inpatient Prospective Payment System proposed rule.
Following the completion of the 2020 Merit-based Incentive Payment System (MIPS) reporting year, the American Society of Clinical Oncology (ASCO) will no longer offer MIPS reporting through the QOPI® Reporting Registry, ASCO’s Qualified Clinical Data Registry (QCDR).
The American Society of Clinical Oncology (ASCO) and the U.S. Food and Drug Administration (FDA) will be holding the 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop, which will be fully virtual. The goal of the workshop is to provide a detailed discussion for creating regulatory-grade patient-reported data on tolerability.
The National Cancer Institute (NCI) announced an opportunity for current NCI-funded Principal Investigators whose postdoctoral fellows have temporarily lost stipend support from a non-profit funder because of the COVID-19 pandemic to apply for a funding supplement to cover the fellow’s salary and applicable facilities and administrative costs for the time and effort devoted to the NCI-funded grant.
On July 7, 2020, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS).
The Centers for Medicare & Medicaid Services (CMS) published the Open Payments Program Year 2019 data, along with newly submitted and updated payment records from previous program years.
On June 23, 2020, The U.S. District Court for the District of Columbia upheld a Trump administration policy requiring hospitals and health insurers to publish their negotiated rates for health services. The policy, which aims to increase transparency in U.S. healthcare system, is scheduled to go into effect on January 1, 2021.