ASCO in ActionASCO 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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Showing results for Cancer Drugs

October 16, 2019

Issue Overview

Rising health care costs, including escalating drug prices, have led to an increased focus by payers on strategies to guide the use of health care resources. As payers search for ways to control the rising cost of care, they often employ “utilization management" (UM) policies, which are payer-imposed practices that may restrict, limit, or deny coverage for certain treatments.

October 1, 2019

Senators Lisa Murkowski (AK), Doug Jones (AL), and Bill Cassidy (LA) introduced S. 2546, the Safe Step Act of 2019, in the U.S. Senate. If enacted into law, the bill would ensure patients with private insurance have reasonable protections against harmful step therapy practices.

September 17, 2019

On September 17, 2019, the Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (KEYTRUDA®, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

September 17, 2019

On September 17, 2019, the Food and Drug Administration approved apalutamide (ERLEADA®, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.

September 10, 2019

ASCO joined 370 health care groups in urging members of the U.S. House of Representatives to support the Improving Seniors’ Timely Access to Care Act (H.R. 3107). The bipartisan bill would help protect patients from unnecessary care delays by streamlining and standardizing prior authorization under Medicare Advantage (MA) and providing program oversight and transparency for MA beneficiaries.

August 19, 2019

New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study demonstrate that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A mutated or deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma.

August 16, 2019

On August 16, 2019, the Food and Drug Administration approved fedratinib (INREBIC®, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

August 8, 2019

The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover Food and Drug Administration (FDA)-approved Chimeric Antigen Receptor T-cell (CAR T-cell) therapy for certain patients with cancer.

August 6, 2019

ASCO recently submitted comments to the Food and Drug Administration (FDA) regarding the agency’s draft guidance recommending specific approaches for sponsors of clinical trials to broaden eligibility criteria, redesign clinical trials, and remove patient barriers to increase enrollment of underrepresented populations in their clinical trials.

August 6, 2019

Precision medicine treatments (otherwise known as targeted therapies) have the potential to improve outcomes for patients with advanced cancer. Over the last 5 years, 20% of the U.S. Food and Drug Administration’s (FDA) drug approvals have been for precision medicine treatments. With so many treatments coming onto the market, it can be challenging for oncologists to navigate the options available to identify the right treatment for each patient.

August 2, 2019

On August 2, 2019, the Food and Drug Administration approved pexidartinib (TURALIO, Daiichi Sankyo) capsules for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT.

July 31, 2019

On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA®, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer.

July 31, 2019

ASCO submitted comments to a Senate Finance Committee markup on the “The Prescription Drug Pricing Reduction Act (PDPRA),” a package of proposals aimed at addressing the high cost of prescription drugs.

July 23, 2019

The American Society of Clinical Oncology (ASCO) recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards – Sterile Preparations and USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, which become official December 1, 2019 and may not apply to most U.S. oncology practices that administer and prepare oncological agents. However, as rules and regulations vary across states, practices should contact their respective state pharmacy board, medical board, regulatory agency, and/or accrediting organization to determine how the standards may apply to their specific situation.

July 23, 2019

In early July 2019, 14 out of the 16 members of the House GOP Doctors Caucus sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma requesting that their agencies reconsider a policy allowing Medicare Advantage plans to use step therapy.

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