Unbiased Analysis of Today's Healthcare Issues
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 products are save and effective. As stated in a paper by Grünwald and Stargardt (2024): The EMA [European Medicines Agency] was founded in 1995 primarily to…
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 prescription drug coverage through public (e.g., Medicare , Medicaid) or commercial (e.g., employer-provided) pharmacy plans. A helpful summary table is below. Quality measures are…
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. However, are State Medicaid Agencies actually covering these medications? This is the question asked by Liu et al. (2024). They use data from public state Medicaid formulary…
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 supported by current evidence-based medicine, as well as the judgment of physicians, pharmacists, and other relevant experts in the diagnosis and treatment of disease…
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 will include pricing terms and outcomes to be evaluated. Then states can elect to participate in the contract terms negotiated by CMS or…
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 reading. These include: The challenge for public policy is to sustain the pace of medical innovation while ensuring that valuable new…
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 low cost sharing and limited utilization management. One question, however, is whether payers’ utilization management practices for biosimilars mirror those of biologic products, or small-molecule generics,…
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® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) standard Application Programming Interface (API) to support electronic prior authorization. They also include requirements for certain payers to include a specific reason…
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 Rob Califf. While specifics are scarce, these changes are spearheaded by Namandjé Bumpus, the FDA’s chief scientist, and newly appointed deputy commissioner.Califf noted improvements in…
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 cost Fewer patients have $0 out-of-pocket cost Patient out-of-pocket costs growth was 2.9x as large as net drug cost growth Specifically: List prices increased 4.4%/yr (interquartile range [IQR], 1.1%…