Adding the patient perspective to health technology assessment

Health technology assessments (HTAs) aim to measure the cost effectiveness of a given treatment or set of treatments for a specific patient populations.  Often, these assessments are conducted from the point of view of the payer–either a national health system or the individual insurer perspective.  This payer focused perspective can often focus largely on treatment costs rather…

Falsification Test for Instrumental Variables

Should instrumental variables (IV) be used for real-world evaluation of the comparative effectiveness of different studies?  It depends on who you ask.Garabedian et al. (2014) state Although no observational method can completely eliminate confounding, we recommend against treating instrumental variable analysis as a solution to the inherent biases in observational CER studies. On the other hand, Glymour,…

CEA for EBP

How do you implement a cost effectiveness analysis (CEA) for the implementation of evidence-based practices (EBP)?  This is the topic Fortney et al. (2014) address.  They review four types of CEAs. Trial based CEA. Relies on traditional randomized controlled trials (RCT).   Because RCTs are expensive, they are typically run on a small sample of the…

CER Around the World

Both the stimulus bill (i.e., The American Recovery and Reinvestment Act of 2009 [ARRA]) and Obamacare (the Affordable Care Act [ACA]) contain provisions to increase funding for compariative effectiveness research (CER).  According to a Deloitte Issue Brief, ARRA provided the foundation for the ACA’s newly mandated and immediately effective CER entity, the Patient-Centered Outcomes Research Institute…

Setting FDA Standards

To what standard should the FDA hold new drugs?  The FDA has a number of choices.  Drugs companies could be required to prove that the drugs they make: Do no harm. Are more effective than placebos Are more effective than existing drugs Are more cost-effective than existing drugs, or Are both more effective and more…