Update: ASCO’s resolutions on step therapy, Medicare Part B drugs, a Competitive Acquisition Program (CAP), and clinical trial access were adopted or reaffirmed by the American Medical Association (AMA) House of Delegates, as well as an ASCO-backed resolution on Qualified Clinical Data Registries (QCDRs).
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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On November 9, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
On November 8, 2018, ASCO and the National Comprehensive Cancer Network® (NCCN®) held a meeting with key stakeholders with the goal of developing consistency and harmony among clinical practice guidelines for pain control in individuals with cancer-related pain, as well as to address the critical pain management needs of patients with sickle cell disease.
On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA®, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Leaders from the ASCO State Affiliate Council met to discuss pressing issues in oncology, including drug pricing, Medicaid work requirements, changes to the Medicare physician fee schedule, and the role of pharmacy benefit managers (PBMs).
The Centers for Medicare & Medicaid Services (CMS) released the final rule for the Medicare Physician Fee Schedule (MPFS) and Quality Payment Program (QPP) outlining reimbursement changes for 2019. CMS estimates that the overall impact will be a one percent reimbursement cut for the hematology/oncology and radiation/oncology specialties in 2019. Based on feedback from ASCO, significant changes were made, which helped to avoid an overall four percent reduction for the specialty. However, it is important to note that the actual impact on individual physician practices will depend on the mix of services the practice provides.
The Centers for Medicare & Medicaid Services (CMS) released its 2019 Hospital Outpatient Prospective Payment System (HOPPS) final rule. An initial evaluation of the rule found that CMS finalized provisions cutting Medicare reimbursement for certain visits to hospital outpatient clinics and to extend 2018 cuts to the 340B Drug Pricing Program.
On October 29 and 30, the initial sessions of the full six-month Quality Training Program are being held in Madrid, marking both the first time the program has been licensed outside of the U.S. and conducted in Spain.
Nearly four in 10 Americans believe cancer can be cured solely through alternative therapies, according to the American Society of Clinical Oncology (ASCO)’s second annual National Cancer Opinion Survey. This is despite research showing that patients who use alternative therapies instead of standard cancer treatments have much higher mortality rates. The survey also found that amid the ongoing opioid crisis, nearly three in four Americans are opposed to limiting access to opioids for people with cancer, and many cancer patients report difficulty obtaining these medications. In addition, just as many Americans say they are worried about the financial impact of a cancer diagnosis as about dying of cancer, with caregivers and rural Americans bearing the weight of cancer’s financial and access challenges. The National Cancer Opinion Survey is a large, nationally representative survey conducted online by The Harris Poll.
On October 30, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).
On October 25, 2018, CMS released the International Pricing Index Model for Medicare Part B Drugs, an advanced notice of a proposed rule that, if implemented, would establish a pilot program to test ways to lower the costs of drugs. Provisions in the proposal include benchmarking some part B drug prices against other countries and changing how providers get paid for administering drugs to patients. The proposal marks the most sweeping changes the Administration has put forth to implement the President Trump’s “blueprint to lower drug prices and reduce out-of-pocket costs.”
ASCO recently submitted two comment letters from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, to the Food and Drug Administration (FDA) Commissioner Scott Gottlieb related to the modernization of clinical trials.
This year we celebrate Healthcare Quality Week October 21–26, a time dedicated to celebrating the contributions professionals have made to improve health care quality. For 2018, ASCO is using this time to recognize practices—and the individuals on their oncology care teams—that have participated in offerings and expansions in several Society programs aimed at improving the quality of cancer care.
In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis highlights key studies from this year’s ASCO Quality Care Symposium, an annual meeting that brings together oncology leaders and members of the cancer care team to share strategies and methods for improving measurement and implementation of quality and safety activities in oncology.
ASCO’s Policy 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.