Measuring the value of pharmaceuticals over time

Measuring treatment value is difficult. Costs are relatively easier to measure but benefits are often more difficult, particularly impact on caregiver burden, productivity, quality of life and other factors. Not only that, but the “benefits” that accrue to a person may vary by individual. Some individuals may prefer treatments that are more effective, but with…

FDA sets standards for Real-World Evidence

The 21st Century Cures Act, enacted December 2016, mandated that the FDA consider how to use real-world evidence (RWE) to bring innovative treatments to market faster. To meet this statutory requirement, the FDA has provided guidance outlining its policies for using RWE to support the approval of a new drug indication. What is real-world evidence?…

Payer coverage of FDA-approved drugs

Many people think that once a treatment is approved, your insurance automatically covers the treatment.  However, that is no longer the case.  Some health plans may keep certain drugs off of formularies.  Others health plans have drugs on formulary but may require step edits (failing another drug first before moving to the novel treatment) and…

Pharmacists as health care providers

Pharmacists are often seen as individuals who just dispense drugs.  However, pharmacists are increasingly considered as providers that are part of the broader health care team. My own research has shown that pharmacists are a more cost-effective and safe approach to getting vaccinations compared to primary care providers (see Fontanesi et al. 2009).  A Health Affairs Entry…

Competition matters

While the high price of branded drugs often gets a lot of attention in the public, few realize that after patent expiration, prices often plunge dramatically and high quality treatments are available for extremely affordable prices.  Granlund and Bergman (2018) estimate the size of this price reduction using data from Sweden. In the long term,…