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OIG: One-third of Accelerated Approvals have Delayed Confirmatory Trials
OIG: One-third of Accelerated Approvals have Delayed Confirmatory Trials
OIG: One-third of Accelerated Approvals have Delayed Confirmatory Trials
October 6, 2022
Medicare and Medicaid spent more than $18 billion on drugs without verified clinical benefit.
 U.S. to Buy up to $10.7 Million of Monkeypox Treatment
 U.S. to Buy up to $10.7 Million of Monkeypox Treatment
U.S. to Buy up to $10.7 Million of Monkeypox Treatment
October 5, 2022
SIGA indicated that $5.1 million of oral Tpoxx is targeted for delivery in 2022.
Humana Updates Medicare Pharmacy Benefits
Humana Updates Medicare Pharmacy Benefits
Humana Updates Medicare Pharmacy Benefits
October 4, 2022
Humana’s 2023 Medicare pharmacy benefits updates include $0 copays, simplified access to prescriptions and Veteran’s focused-plans that add pharmacy benefits.
BioMarin Resubmits BLA for Hemophilia A Gene Therapy
BioMarin Resubmits BLA for Hemophilia A Gene Therapy
BioMarin Resubmits BLA for Hemophilia A Gene Therapy
October 4, 2022
If approved, valoctocogene roxaparvovec would be the first commercially-available gene therapy in the United States for the treatment of severe hemophilia A.
Kroger Health to Terminate Express Scripts Agreement
Kroger Health to Terminate Express Scripts Agreement
Kroger Health to Terminate Express Scripts Agreement
October 3, 2022
The retailer indicated that Express Scripts’ drug pricing model is unstainable for Kroger and its customers.
FDA Approves Amylyx’s ALS Therapy
FDA Approves Amylyx’s ALS Therapy
FDA Approves Amylyx’s ALS Therapy
September 30, 2022
Now with the brand name Relyvrio, the new therapy should be available within four to six weeks. It will have a wholesale acquisition cost of $158,000 per year.
IQVIA: Payers Increase Exclusions for Oncology Drugs
IQVIA: Payers Increase Exclusions for Oncology Drugs
IQVIA: Payers Increase Exclusions for Oncology Drugs
September 29, 2022
Jing Yang from IQVIA discusses how national payers are using formulary exclusions for oncology therapeutics.
New Report: Generics, Biosimilars Saved $373 Billion
New Report: Generics, Biosimilars Saved $373 Billion
New Report: Generics, Biosimilars Saved $373 Billion
September 28, 2022
In 2021, patients in the United States received 6.4 billion prescriptions, 91% of which were generic and biosimilar medicines.
Optum’s Efforts Combat Opioid Misuse and Abuse
Optum’s Efforts Combat Opioid Misuse and Abuse
Optum’s Efforts Combat Opioid Misuse and Abuse
September 28, 2022
Carl Black, pharmacist-in-charge at Optum Rx, talks about how the PBM has decreased dispensed opioids by 62% since 2018.
HHS ups COVID-19 Med Bebtelovimab Availability
HHS ups COVID-19 Med Bebtelovimab Availability
HHS ups COVID-19 Med Bebtelovimab Availability
September 27, 2022
Bebtelovimab is available under an emergency use authorization, and the HHS is making doses available to those who are uninsured and underinsured.
Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence
Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence
Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence
September 26, 2022
But researchers found that only a small percentage of plans use available real-world evidence studies and economic evaluations in their coverage policies.
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
September 26, 2022
Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
September 23, 2022
While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.
FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy
FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy
FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy
September 23, 2022
RBX2660 — now with the brand name Rebyota — is a potential first-in-class microbiota-based live biotherapeutic that aims to reduce recurrent C. difficile infection.
Report: Generic Drug Spending Rose Due to Formulary Placement
Report: Generic Drug Spending Rose Due to Formulary Placement
Report: Generic Drug Spending Rose Due to Formulary Placement
September 22, 2022
An Avalere review finds that the proportion of generic drugs covered on lower tiers (with generally lower out-of-pocket costs for patients) in Part D plans have decreased.
FDA Advisory Committee Votes Against Poziotinib for NSCLC
FDA Advisory Committee Votes Against Poziotinib for NSCLC
FDA Advisory Committee Votes Against Poziotinib for NSCLC
September 22, 2022
Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.
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