The Official Medicare Set Aside Blog And Information Resource

Osteoarthritis Drug Receives Fast Track Designation from FDA

FDA, MSAs, Rx/Pharmacy on February 21, 2019
Posted by Leah King, PharmD, JD and Marilyn J. Larrimer, RN, BSN, JD

In late November 2018, the FDA announced that it was granting Fast Track designation to an investigational drug for the treatment of osteoarthritis (OA). The drug, developed by Galapagos, is known by its identifier GLPG1972/S201086.  This drug is one to watch, since it has a novel mechanism of action for this therapeutic category. GLPG1972/S201086 is […] Continue

The Opioid Crisis: What is the Government Doing About It? Part 4 – Increasing the Availability of Overdose-Reversing Drugs

FDA, Opioids, Rx/Pharmacy on December 17, 2018
Posted by Complex Claims Division

This blog series is devoted to better understanding the efforts our Federal government is undertaking to combat the opioid epidemic in America. Earlier this year, the Department of Health and Human Services (HHS) announced a five-part strategy that will be utilized to combat the opioid epidemic. In previous posts, we have focused on the first […] Continue

FDA Awards Six-Month Patent Extension for Lyrica

FDA, MSP News, Rx/Pharmacy on November 30, 2018
Posted by Complex Claims Division

You may recall our earlier blog this week about Lyrica in the News.  Once again, the spotlight is on Lyrica.  First, after Pfizer was awarded a six-month patent extension based on a new pediatric indication for the drug.  Earlier this month, the Supreme Court in the United Kingdom ruled against Pfizer in a longstanding patent […] Continue

FDA Issues Safety Communication Regarding Medications Utilized in Intrathecal Pumps

FDA, MSP News, Rx/Pharmacy on November 20, 2018
Posted by Erin O'Neill, PA-C, JD

On November 14, 2018, the Food and Drug Administration (FDA) issued a safety communication to all patients with implanted intrathecal pumps, their caregivers and health care providers, and medication compounding companies warning of the dangers of utilizing medications in intrathecal pumps that have not specifically been approved for intrathecal pump use. Intrathecal pumps are programmable devices that […] Continue

FDA Approves Consensi™: A Novel Combination but a Conundrum for the Medicare Set-Aside

FDA, Medicare Set-Asides, Rx/Pharmacy on September 11, 2018
Posted by Complex Claims Division

On May 31st, the FDA approved Kitov Pharma’s application for Consensi™. Consensi is a unique combination product containing amlodipine, a calcium channel blocker used for the treatment of hypertension, and celecoxib, a non-steroidal anti-inflammatory used for the treatment of osteoarthritis. The product’s labeling will include a single indication for patients for whom treatment with amlodipine […] Continue