Anemia Due to CKD May See First-in-Class Drug This Year
Chronic kidney disease (CKD) affects almost 40 million people in the United States. The condition can cause a variety of health complications, including anemia. Treatments for anemia of CKD consist of erythropoiesis...
New FDA Specialty Approvals
✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk...
News Briefs
✦ A magistrate judge recommended dismissing a lawsuit filed by Catalyst Pharmaceuticals, Inc. against the FDA, HHS and Jacobus Pharmaceutical Company, Inc. Catalyst filed the suit (Case No. 1:19-cv-22425-BB) last ...
CMS Proposes Medicaid Best Price Changes to Boost VBP Deals
As more and more high-cost therapies come onto the U.S. market, payers are looking for ways to be able to cover those treatments for their members who need them. Value-based purchasing (VBP) arrangements are an opti...
CMS Makes COVID-Wrought Changes to Oncology Care Model
As the COVID-19 pandemic continues to spur huge changes throughout the health care system, CMS’s current and future alternative payment models have not been immune. In early June, the Center for Medicare & Med...
NSCLC Gained Seven Approvals In May; More Are in Pipeline
When the FDA approved Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) on May 6, it was the first of seven approvals in non-small cell lung cancer (NSCLC) through May 29 (RSP 6/20, p. 8). While these will of...
Payers Say They Likely Will Cover METex14 NSCLC Agents
When the FDA approved Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) in early May, the tablet became the first treatment approved for a specific type of non-small cell lung cancer (NSCLC). Commercial payer...
Prime Signed Value-Based Deal With EMD Serono for Mavenclad
Prime Therapeutics LLC recently unveiled that it had signed a value-based agreement for a relatively new multiple sclerosis (MS) drug with a complicated treatment regimen and high price tag.
In early June, the PB...
Community Oncology Practices Are Feeling Pandemic Pressure
Community oncology practices already have been hit hard for a number of years, and the COVID-19 pandemic may make the situation worse. But as hospitals try to keep immune-compromised people out, this could result in...
New FDA Specialty Approvals
✦ May 29: The FDA expanded the label of Eli Lilly and Co.’s Cyramza (ramucirumab) to include, in combination with erlotinib, the first-line treatment of people with metastatic non-small cell lung cancer with EGF...