Articles related to BUSINESS OF MEDICINE

Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.

To gain access to its primary experimental medication for a rare blood cancer and complement Blenrep, currently indicated as a treatment for patients with relapsed or refractory multiple myeloma who received at least four prior therapies, the company decided to purchase American pharmaceutical company Sierra Oncology in April. However, in patients with relapsed or refractory multiple myeloma, Blenrep did not achieve the primary endpoint of progression-free survival, according to a statement from GSK, which saw its shares fall 3% upon the announcement.

In a three-page letter, Kathryn A. Coleman, director of the agency’s Medicare Drug and Health Plan Contract Administration Group, stated that CMS is immediately stepping up its examination of marketing materials, which are required to be submitted in accordance with its legal “File and Use” authority for Medicare Advantage and Part D drug plans, and “may exercise its authority to prohibit” their use. As of right now, Medicare Advantage marketing materials are allowed to go live five days after being submitted, as long as the company submitting them “certifies the material complies with all applicable standards.” Starting January 1, 2023, however, no television advertisements will be eligible for submission under its “File and Use” authority, meaning that the advertisements will not air until CMS approves them.

All eligible Medicare beneficiaries who received treatment at Mayo facilities in Arizona and Florida over the previous three years were sent letters this past fall urging them to sign up for original Medicare and a supplement. When asked about the purpose of the letters, Kevin Punsky, the Mayo communications manager, said that they are meant to act as “a courtesy reminder” at the start of the annual Medicare re-enrollment window, which started on October 15.

The pandemic forced hospitals to quickly become more flexible. They were challenged to find ways to invent new space for ICUs and ERs within existing facilities. Virtual critical care and virtual specialty care were implemented. Outside spaces were re-envisioned for clinical purposes and physicians and other HCPs were to reimage and expand care space within the hospital walls.

The experts seem to say “yes,” although the shortage of oncologists and a growing number of cancer patients will require that oncologists treat a broad range of cancers is challenging that direction.