FDA Hedges

Pharmaceutical companies face major risk.  There is risk that the drugs they are researching don’t work (e.g., lack of efficacy) or are not safe.  There is risk that health insurers or government payers will not cover their treatment.  And there is risk that the FDA will not approve a drug after a Phase III clinical trial.…

Drug approval and reimbursement when clinical trials use surrogate endpoints

An interesting paper from some of my colleagues at Precision Health Economics: Approval of new drugs is increasingly reliant on “surrogate endpoints,” which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of…

Which cancer treatment is best?

This seems like a straightforward question, but clearly depends on what you mean by “best”.  Some drugs will be more efficacious and have more adverse events; other drugs may be less efficacious but have fewer adverse events.  What if a one drug shows an 80% improvement in progression free survival (PFS), but a 50% improvement in overall…

Geographic Variation in the Quality and Cost of Care for Patients with Rheumatoid Arthritis

This is the title of my latest article in JMCP co-authored with Arijit Ganguli,  Yuri Sanchez Gonzalez, Jin Joo Shim, and Seth A. Seabury.  The paper’s abstract is below. BACKGROUND: There is considerable push to improve value in health care by simultaneously increasing quality while lowering or containing costs. However, for diseases that are best…