How reimbursement affects innovation

Below are some excerpts from seminal papers examining how changes in reimbursement or market size affect pharmaceutical innovation. Acemoglu and Lin (2004): Our estimates suggest that a 1 percent increase in the size of the potential market for a drug category leads to a 6 percent increase in the total number of new drugs entering the…

What do drugs cost in the long run?

That is the question that Lakdawalla et al. (2017) attempt to answer in the latest edition of the American Journal of Managed Care (AJMC).  The long-run average cost (LAC) of a pharmaceutical includes not only initial branded drug price, but also subsequent prices increases and decreases, especially those that occur after a treatment’s patent has expired…

Too many trials, not enough patients

As research in new cancer treatments has grown, scientists may have run into a serious roadblock: there many not be enough patients to fill the needed clinical trials.  As the New York Times reports: There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on. The logjam…

Predicting Real-World Effectiveness of Cancer Therapies Using OS and PFS Clinical Trials Endpoints

Clinical trials for cancer treatments aim to demonstrate whether one treatment is better than another. What is of most interest to patients, providers and payers, however, is which treatment works best in the real-world, not in a randomized controlled trial. Further, clinical trials often use progression free survival to measure treatment outcomes rather than overall…

Does drug detailing affect prescribing patterns?

The obvious answer seems to be ‘yes’.  Why would pharmaceutical companies spend billions of dollars on drug detailing (i.e., visits by pharmaceutical representatives to physicians to explain drug benefits) and drug samples if they don’t work?   When I say billions, I mean billions: A new study by Datta and Dave (2017), however, finds that drug…

How to regulate precision medicines

Currently, pharmaceutical treatments that are used in the U.S. need to gain an approval from the FDA.  The FDA’s approval is contingent on a demonstration of efficacy and safety in a randomized controlled trial (RCT).  However, precision medicine makes the standard FDA approval problematic. As described in Breckenridge et al. (2016), in the precision medicine…

Cancer drug pricing in Europe

How do Euroepan countries reimburse for pharmaceuticals? A paper by Pauwels et al. (2014) provides an nice summary. I review that article today. With the exception of Germany, most countries had a national and/or regional drug budget.  Germany is also unique in that only Germany and the UK allow for free pricing, whereas other countries…

How to prevent another EpiPen controversy

Dana Goldman–my colleague at PHE and a professor at USC–offers three suggestions on how to prevent generic products from increasing their prices drastically as occurred in the EpiPen saga.  In Stat News, he makes three recommendations: First, Congress should mandate that the Federal Trade Commission report on the availability of all such drugs and devices…