Changes in prices and out-of-pocket costs for brand-name...
Using commercial claims data between 2009-2018, a paper in Health Services Research by Lalani et al (2024) finds that: Rebates are rising as a share of costFewer patients have $0 out-of-pocket...
View ArticleChanges to the FDA Advisory Committee process
It appears changes are coming to the FDA Advisory Committee process for evaluating new drugs. The FDA is planning significant reforms to its advisory committee process, as announced by Commissioner...
View ArticleFederal rules could streamline prior authorization decisions…but not for drugs
A CMS proposed rule would expedite the prior authorization approval process. CMS summarizes key provisions of the rule as follows: Proposals include requiring implementation of a Health Level 7®...
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Utilization management for biosimilars
When we think of utilization management (e.g., prior authorizations, step edits), we often think payers only use these for higher cost branded products including biologics. Generic drugs should have...
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Why Does the United States Pay, by Far, the Highest Prices in the World for...
That is the topic of a U.S. Senate hearing last week. One person testifying was an economist, USC Professor Darius Lakdawalla. While his full testimony is here, his key points of contention are worth...
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How will Medicaid pay for cell and gene therapies?
One approach CMS has is the Cell and Gene Therapy (CGT) Access Model. Under the CGT Access Model, CMS (at the federal level) will negotiates outcomes based agreements (OBAs) with manufacturers, which...
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A primer on formularies
Hydery and Reddy (2024) provide a nice primer on drug formularies. Below is a quick overview. What is a formulary? A formulary is a continually updated list of medications, products, and technologies...
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Medicaid Coverage and Reimbursement of Antiobesity Medications across States
Medicaid policies vary from state-to-state. With the advent of new, GLP-1 medications (and others) to treat obesity and overweight, there are potentially significant health benefits to be gained....
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Pharmacy quality metrics: An overview
A paper by Kogut (2024) has a nice overview of the organizations that develop pharmacy plan quality metrics. Pharmacy plan quality is vital since approximately 85% of the US population has...
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EMA and delays in drug launch
For patients with serious illnesses, timeline access to efficacious medications is paramount. The European Medicines Agency (EMA) was created in part to help expedite drug approvals and insure these...
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