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,…

How do HEOR studies handle missing data?

That is the questioned answered in a paper by Mukherjee et al. (2023). The authors define an “HEOR study” for this paper as …real-world evidence studies that conducted a secondary/post-hoc analysis using randomized controlled trial (RCT) data, and a within-trial cost-utility analysis in which the outcome of interest was costs or PROs including preference-based utilities…

Valuing treatments for rare disease

That is the topic of a recent white paper from the Innovation and Value Initiative titled “Valuing Rare Disease Treatments in Healthcare: Real Experience, Real Impact“. The report notes a number of challenges in assessing treatment value in rare disease (see my white paper “Challenges in Preserving Access to Orphan Drugs Under an HTA Framework”…

Mid-week Links

ABIM on physician certification. 70.4% of physicians worked while on vacation on a typical vacation day Is Science a public good? Healthcare job growth reached three-decade high. Is there a future for digital therapeutics?

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…

Are We Valuing Prescription Drugs Appropriately?

That is the title of a new Health Affairs Forefront article by Peter Neumann and Joshua Cohen. An excerpt is below: One reason economic analyses may yield estimates that are too low is that they ignore the downstream declines in drug prices that occur when competitors enter the market and especially with the introduction of…

Friday Links

No cervical cancer cases in HPV-vaccinated women. Neuroimaging and mental health care. Syphillis cases on the rise. Dengue Fever vaccine soon to arrive? School spending: “Spending on basic infrastructure (such as HVAC) or on the removal of pollutants raises test scores but not house prices; conversely, spending on athletic facilities raises house prices but not…

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…