On June 15, 2018, the Association of Community Cancer Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's opening of a National Coverage Analysis (NCA) for CAR T therapies for cancer. Currently, two CAR T-cell therapies are approved the U.S. Food and Drug Administration, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel). In comments its to the agency , ACCC urged that CMS:
Additionally, ACCC expressed concern that the outcome of the NCA process may be stifling to innovation of CAR T therapies in the pipeline.
Read ACCC Comment Letter
At the 2018 ASCO Annual Meeting, we had the opportunity to connect with many ACCC members and engage a wide audience! Oncology Business Review, OncLive, and ASCO Post sat down with a number of ACCC advocates and leaders to discuss pressing issues in cancer care.
ACCC Immuno-Oncology Institute Executive Committee Member Ivo Abraham, PhD, RN, speaks about value in cancer care:
ACCC Past President Jennie R. Crews, MD, MMM, FACP, describes how care coordination in immunotherapy is engaging new providers with the cancer care team:
Dr. Abraham shares his perspective on hurdles to adoption of biosimilars in oncology:
Watch more from Dr. Abraham on:
Key features of a biosimilar - via OBR
Biosimilars approved and nearing approval for oncology - via OBR
Biosimilar pricing and reimbursement - via OBR
Dr. McBride Discusses financial toxicity in oncology with OncLive:
Lee S. Schwartzberg, MD, FACP, discusses how the ACCC Immuno-Oncology Institute is evolving to support integration of IO in the community through new working groups, resources for cross-specialty care coordination, and team education for this rapidly expanding field. - ASCO Post
Dr. Zibelman discusses managing immune-related adverse events with OncLive:
On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
Read the full FDA announcement here.
The Trump administration's U.S. Department of Justice (DOJ) on June 7, stated it will not defend the Affordable Care Act from litigation spearheaded by 20 conservative Republican-led states that aims to invalidate the ACA. Rather than defend the law, the DOJ has asked a Texas court to overturn the ban on denying insurance coverage to those with pre-existing conditions. The Texas lawsuit, filed in February, argues that the recent congressional action to eliminate the individual mandate should result in other key provisions of the ACA being overturned.
Essentially, the 20 GOP-led states are reviving the 2010 lawsuit argument over the constitutionality of the ACA.
According to news reports, Attorney General Jeff Sessions explained the decision in letters to House Speaker Paul Ryan (R-WI) and Minority Leader Nancy Pelosi (D-CA), indicating that Congress’ action repealing the individual mandate means that ACA provisions banning insurers from denying coverage or charging more to those with pre-existing health conditions are now invalidated.
While the ACA remains the law and there is no immediate threat to pre-existing coverage protection, legal experts are noting that it is extremely far from precedent that a sitting administration would not argue the constitutionality of a sitting law.
Sources: InsideHealthPolicy, Politico, Bloomberg BNA, New York Times
The National Academies of Sciences, Engineering, and Medicine (NASEM) has published the proceedings of a workshop on improving the effectiveness of patient navigation in cancer care. The Establishing Effective Patient Navigation Programs in Oncology workshop, held on November 13 and 14, 2017, addressed where patient navigation programs should be deployed in cancer care and which patients should be prioritized to receive navigation services when resources are limited. The workshop also discussed who should serve as navigators, the benefits of navigation, and current gaps in the evidence base.