News Briefs
✦ On Aug. 17, 2018, the FDA gave accelerated approval to Bristol-Myers Squibb Co.’s programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) for the treatment of people with metastatic small cell lung cancer whose...
MFN Rule Likely Will Have Broad Impact on Health Care System
More than two years after first proposing the idea of pricing drugs on the U.S. market based on their prices in certain countries, the administration on Nov. 20 moved ahead with an interim final rule that would requ...
Biosimilars May Be at Risk Depending on Court’s ACA Ruling
As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus understandably has been on the millions of people who would lose health insurance coverage and protections for pre-existin...
Keytruda Brings New Option To Treatment of PD-L1+ TNBC
The FDA has approved only a few drugs to treat triple-negative breast cancer (TNBC), and last month saw Merck & Co., Inc’s Keytruda (pembrolizumab) gain accelerated approval for the condition. Commercial payer...
With Oxlumo Approval, Alnylam Unveils Value-Based Program
With its third FDA approval in less than two-and-a-half years, Alnylam Pharmaceuticals, Inc. is bringing another orphan drug for a rare condition to the U.S. market. And similar to the first two, Oxlumo (lumasiran) ...
International-Based Pricing Model Is Not New Focus
The most-favored-nation (MFN) interim final rule issued in late November is not the first time the current administration has attempted to implement some kind of drug pricing model based on prices in other countries...
New FDA Specialty Approvals
✦ Nov. 9: The FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne Liquid CDx to identify people with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may...
News Briefs
✦ HHS has moved ahead with its plan to eliminate rebates to PBMs and plans in Medicare Part D. The administration issued a final rule (85 Fed. Reg. 76666, Nov. 30, 2020) providing safe harbor to rebates given to b...
Anthem Oncology P4P Program Boosted Evidence-Based Care
A recent study of Anthem’s Cancer Care Quality Program (CCQP) treatment pathways found that an enhanced reimbursement to providers who adhere to on-pathway treatment regimens increased use of the drugs without cha...
Study: ‘Drug Super Spender’ Members Doubled in Four Years
The United States is seeing a surge of innovative specialty therapeutics coming onto the market, many of which offer potential treatments for conditions that previously didn’t have one. But many of these newer the...
