What We're Reading: FDA Clears Breast Cancer Drug; ACA Numbers Steady; Sutter Settles Case

December 23, 2019

The FDA approved [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu; preliminary CMS numbers show that 8.3 million people enrolled in coverage under the Affordable Care Act (ACA) from November 1 to December 17, about 2% fewer than last year; Sutter Health agreed to pay $575 million to settle claims of anticompetitive behavior brought by the California state attorney general as well as unions and employers.

FDA Clears Trastuzumab Antibody Conjugate for Advanced Breast Cancer

The FDA approved [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu, The Center for Biosimilars® reported. [Fam-] trastuzumab deruxtecan is an antibody-drug conjugate (ADC) designed to delivery cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker. The approval, granted to AstraZeneca and Daiichi Sankyo, is for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2—based regimens.

ACA Enrollment Numbers Hold Steady

Preliminary CMS numbers show that 8.3 million people enrolled in coverage under the Affordable Care Act (ACA) from November 1 to December 17, about 2% fewer than last year, The Associated Press reported. The final number will be higher after states that run their own sign-up periods report results, with national totals not expected until March.

Sutter Health to Pay $575 Million to Settle Lawsuit With California

Sutter Health agreed to pay $575 million to settle claims of anticompetitive behavior brought by the California state attorney general as well as unions and employers, The New York Times reported. Sutter will also be prohibited from engaging in several practices that the state attorney general and others said the hospital system used to ensure its dominance in northern California. It will be required to limit what it can charge patients for out-of-network services, which the state said would prevent surprise medical bills, and will be barred from requiring insurers to include all of Sutter’s medical facilities if they wanted to include some of the system’s hospitals.