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 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,…

Federal 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® (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…

Changes 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 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…

Strong year for drug discovery

2023 was a strong year for drug discovery. Mullard et al. (2024) report: The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, as the small molecule and biologic pharmacopoeia continues to grow. This cohort is nearly 50% bigger than the new approval class of 2022, which fell below the…