President Trump recently signed a pair of bills into law aimed at increasing transparency with regard to drug prices in the United States. The Patient Right to Know Drug Prices Act (S. 2554) and the Know the Lowest Price Act (S. 2553) prohibit so-called "gag clauses," which prevent pharmacists from telling customers if they could save money by buying prescription drugs out-of-pocket rather than using their health insurance. S. 2554 applies to private health plans, while S. 2553 targets Medicare Part D and Medicare Advantage plans.
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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In the latest ASCO in Action Podcast, Dr. Ray Page, DO, PhD, FACOI joins ASCO CEO Dr. Clifford A. Hudis to discuss the impact that Pharmacy Benefit Managers (PBMs) are having on cancer care delivery and ASCO’s recent position statement on PBMs.
In a comment letter from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, to the Food and Drug Administration (FDA) Commissioner Scott Gottlieb, the society expressed appreciation for FDA’s efforts to gather stakeholder perspectives on enhancing access to biologic cancer therapies and ensuring greater availability of biosimilars, while retaining a balance between innovation and competition.
On September 27, 2018, the Food and Drug Administration approved dacomitinib tablets (VIZIMPRO, Pfizer Pharmaceutical Company) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
On Sept. 13, 2018, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (LUMOXITITM, AstraZeneca Pharmaceuticals LP), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
ASCO leaders recently met with representatives from the Trump Administration to discuss the delivery of high-quality, high-value cancer care as the Administration implements its “blueprint to lower drug prices and reduce out-of-pocket costs.”
In a new position statement, the American Society of Clinical Oncology (ASCO) warns that some of the practices of pharmacy benefit manager (PBM) companies use could hinder patient access to timely, high-quality cancer care. ASCO describes a range of PBM practices that, while they may be intended to help control costs in cancer care, might compromise physicians’ ability to provide the right treatment at the right time for people with cancer.
ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered drugs under Medicare Part B and Part D.
ASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration that the Risk Evaluation and Mitigation Strategy communication plan for ICLUSIG® (ponatinib) is no longer required.
ASCO submitted a response to the Request for Information (RFI) that was included in the Trump Administration's “blueprint to lower drug prices and reduce out-of-pocket costs.” In a letter to Secretary of the U.S. Department Health and Human Services (HHS) Alex Azar, ASCO recommends a value-based approach to address rising drug costs and makes specific recommendations regarding the 340B Drug Pricing Program, reviving the Competitive Acquisition Program (CAP), moving drugs from Medicare Part B to Part D, and site neutrality proposals.
In the latest ASCO in Action Podcast, Dr. Edward Kim, Chair of the Department of Solid Tumor Oncology at the Levine Cancer Institute, joined ASCO CEO Dr. Clifford A. Hudis to discuss eligibility criteria for cancer clinical trials.
On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. The FDA also accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
During the American Medical Association (AMA) House of Delegates (HOD) annual meeting, delegates approved several ASCO-led resolutions and incorporated them into the AMA’s policy agenda.
Right-to-try is the latest topic addressed in the ASCO in Action podcast series. ASCO CEO Dr. Clifford Hudis recently interviewed ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky to examine RTT legislation—now enacted as federal law—and discuss the Food and Drug Administration’s (FDA) expanded access program.
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda®, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.