Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Pharmaceuticals' Category

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 […]

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The AMA on value-based drug pricing

The American Medical Association released a statement yesterday in support of value-based pricing of pharmaceuticals.  However, AMA claims that value-based pricing should follow the following core principles. Value-based prices of pharmaceuticals should be determined by objective, independent entities. They also should be evidence-based and the result of valid and reliable inputs and data that incorporate […]

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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 […]

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Drugs from the sea

My daughter recently went to the Aquarium of the Pacific in Long Beach.  Not only did she enjoy seeing all the marine life, but she learned that the oceans also help humans in many ways.  For instance, many pharmaceutical firms are looking to the ocean to see if there are compounds created by sea plants, […]

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How are payers tackling value-based drug pricing?

A growing number of value-based drug pricing arrangements are tying the price of treatments to outcomes. While these payment models are far from prominent now, is it likely that drug makers will have a greater share of the risks and rewards associated with value-based care moving forward? This is what is written in a feature […]

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Dismal Arithmetic of Hepatitis C Treatment?

The American Journal of Managed Care has an interesting special issue on treatment for the hepatitus C virus (HCV).  Jay Bhattacharya provides the introductory commentary, and starts off with the following. Although the medical prospects facing patients with hepatitis C virus (HCV) have never been better, the prospect of gaining access to a cure is another […]

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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 […]

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Impact of Brexit on Pharma

There is a lot of talk that Brexit will be a disaster.  While I believe that much of this disaster talk is overblown, there are clear business implications.  Pharmafile provides an example of how Brexit would affect a small pharmaceutical company conducting clinical trials in the UK. In the latter case, UK-based pharmaceutical companies with no other […]

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Incentives for investing in “off label” trials

Aaron Carroll of the Incidental Economist draws on a column from his colleague Austin Frakt in The Upshot to explain why there is not more research into off-label uses of patented or generic drugs.  

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Off Label Drug Use

Approximately one in five prescriptions for drugs in the US are for off label use.  In some cases, this may be inapprorpiate as there is typically limited clinical evidence supporting off label use.  In other cases, off label use is approrpiate.  Clinical trials rarely enroll children or pregnant women and thus medictions are often not […]

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