Federal spending on the Medicare program for people with high drug costs has dramatically increased over the past five years, which is largely due to the soaring costs of expensive specialty medications, according to a January 2017 report from the Department of Health and Human Services. As the Wall Street Journal has noted, federal payments for Medicare Part D catastrophic coverage, which pays 80% of drug costs after a beneficiary has spent a certain amount annually, surpassed $33 billion in 2015, more than triple the amount paid in 2010. Most of this rise is due to increased spending on drugs that cost $1,000 or more a month, several of which came on the market in the last few years.
These high cost specialty drugs impact a range of stakeholders form payers, pharma, physicians, patients, and policymakers, and present complex legal issues ranging from Fraud & Abuse to compliance with FDA Marketing & Communications.
This course, presented by Rujul Desai, Vice President of Avalere Health, is designed to help attendees understand the unique dynamics of the specialty drug market in order to better advise clients on the legal, regulatory, and policy risks in today’s evolving healthcare landscape.
Understand the impact of high cost specialty drugs on overall healthcare spending trends
Outline the market access and distribution process for specialty drugs
Review recent attempts to address some of the cost pressure through innovative contracting
Identify key areas of legal risk for various stakeholders associated with the unique dynamics of the specialty drug marketplace
Discuss recent enforcement trends focusing on the specialty drug market
Rujul Desai advises clients on drug pricing, market access, reimbursement, strategic contracting, and regulatory solutions for drugs, biologicals, devices, and diagnostics. He brings deep experience with biopharma, specialty pharmacy, and pharmacy benefit management (PBM) companies.
Mr. Desai has held a number of leadership roles in the biopharma, PBM, and specialty pharmacy industry, including with CVS Caremark, UCB, and most recently as Vice President at Avalere Health. He has led engagements across a wide range of U.S. and global market access and reimbursement issues, including optimizing new product launches, pricing, PBM and payer formulary access, value-based contracting, distribution network design, patient access and hub services, affordability programs, e-prescribing, digital health, and the use of health economic data and modeling.
Mr. Desai is an author of the U.S. chapter of a global treatise on drug pricing and reimbursement.
Mr. Desai was a Captain in the Medical Services Corps of the U.S. Army Reserves, and served in active duty in Iraq.
Excellent introduction to a complex and increasingly important area; thank you!
Very informative and helpful discussion of major stakeholder interests and interplay in the area of specialty drug pricing. Thanks.
Course was outstanding. Great job of explaining complicated issues in a digestable way.
Best teacher I have seen on lawline and many of your teachers are excellent
Watch this program to better understand the subtleties of the specialty drug market as well as any associated legal, regulatory, and policy risks.