Results for 'medicare'
Mahnum Shahzad, BA, Huseyin Naci, MHS, PhD, Anita K. Wagner, PharmD, MPH, DrPH
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated
medicare spending, drug indications, AA, FDA, medicare, ODAC
Medicare Parts B and D spent at least $569 million between 2017 and 2019 on 10 cancer drug indications without confirmed overall survival (OS) benefit after accelerated approval (AA). Approximately $224 million was spent on drug indications that were either voluntarily withdrawn or recommended fo…
Oct 18th • 5 mins read
Eric Q. Konnick
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
Oncology, Regulation, Testing, LDTs, FDA, CLIA, CMS
The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions. Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests. There are ongoing …
May 22nd • 8 mins read
Jakub P. Hlávka, PhD, Pei-Jung Lin, PhD, Peter J. Neumann, ScD
Outcome measures for oncology alternative payment models: practical considerations and recommendations
This paper focuses on synthesizing existing research on quality measures in oncology, particularly outcome-based quality measures which are underutilized. A set of "core outcome measures" is proposed for future oncology alternative payment models (APM). The study design includes a literature rev…
Dec 1st • 10 mins read
Idine Mousavi, BA; Timothée Olivier, MD; Vinay Prasad, MD, MPH
Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022
anticancer drugs, adjuvant therapy, FDA approvals, cost per event averted, surrogate endpoints, oncology drug costs
Importance: Evaluating the cost-effectiveness of adjuvant therapies based on the cost per event averted. Objective: To assess the costs per event averted for anticancer drugs approved by the FDA between January 2018 and March 2022. Design, Setting, and Participants: Cross-sectional study of F…
Jun 10th • 30 mins read
Rachel E. Sachs, JD, MPH, Kyle A. Gavulic, BA, Julie M. Donohue, PhD
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
FDA accelerated approval, Medicaid spending, prescription drug costs, surrogate endpoints, cancer drugs, drug approval pathway
The study examines the impact of drugs approved through the FDA’s accelerated approval program on state Medicaid spending. From 1992 to 2020, 216 drug-indication pairs were granted accelerated approval, with a significant increase in cancer drug approvals in recent years. Although drugs wi…
Oct 8th • 25 mins read
Cheryl Ho, MD, Howard J. Lim, MD, Dean A. Regier, PhD
Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program
canada, oncology, malignant, hematology, HTC
Canadian regulatory approvals align with FDA decisions, but submission numbers to Health Canada (HC) and Health Technology Assessment (HTA) processes are lower in Canada. There is a nearly 3-year delay between Accelerated Approval (AA) and funded access to treatment for Canadians. HTA in Canada …
Jun 5th • 6 mins read