ASCO submitted comments to the United States Pharmacopeia Convention (USP) concerning a proposed chapter on pharmaceutical compounding. ASCO is concerned that proposed chapter, General Chapter <797> Pharmaceutical Compounding– Sterile Preparations (USP <797>), as it is currently written, could create unnecessary confusion for providers, interfere with patient access to potentially life-saving drugs, and undermine FDA drug approval requirements.
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 December 6, 2018, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.
On November 28, 2018, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA®, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
While ASCO supports efforts to control drug prices, we are keenly aware that optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence.
On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI®, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
The Food and Drug Administration (FDA) recently announced new changes to expand and update the Expanded Access (EA) program, which allows very ill patients access to experimental treatments outside of clinical trials. The most recent updates include clarifications on safety data, a new navigation team, a new coordinating committee, and updated web resources.
On November 21, 2018, the Food and Drug Administration approved glasdegib (DAURISMO™, Pfizer Labs) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.
In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis reviews the results of ASCO’s 2018 National Cancer Opinion survey, which examined the views held by Americans on a wide range of cancer-related issues.
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).
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).
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.”
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.
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.