Over the past years there has been increasing emphasis and criticism focused on re-evaluating the US healthcare system. We know the expenditures are outweighing the benefits when comparing our statistics with ex-US countries. The ACA was supposed to help provide care for more people, but it has also put an increased burden on the system, which will result in a greater cost of care. One of the solutions spoken about for many years is to consider the value of drugs in addition to safety and efficacy.
The challenge with value is defining what it means to the different stakeholders in the healthcare equation; it means vastly different things to payers, patients, providers, and caregivers/families. A way has not been identified to incorporate the various stakeholder definitions of value into a ‘fair’ evaluation of value that works for all. Quality Adjusted Life Years (QALYs) are used in Europe, but have been termed death panels here in the US, so there has to be another way to evaluate the value of drugs.
American College of Cardiology/American Heart Association (ACC/AHA) Value Guidelines 2014 (http://tinyurl.com/kg4q36r) were released in March 2014, but have not gained much attention or buy-in thus far. These guidelines propose classifying drugs into high, intermediate, low, and uncertain value categories based on the systematic analysis of published studies on cost-effectiveness of the drug. The overall measurement proposed is a QALY, which the ACC/AHA believe is the preferred measure for clinical effectiveness for health economic measurements.
The lack of uptake around the use of a measurement like that proposed by ACC/AHA causes one to question the ability to actually integrate this into the evaluation criteria for drugs. A compounding factor is that the study designs for new drugs coming to market are not built to be analyzed in this manner. This brings up the question of what will be done to manage the new drugs until outcomes data are available.
Hopefully, within the next few years, similar organizations will try to do a similar value assignment as ACC/AHA. The American Society of Clinical Oncology (ASCO) has already stated they will focus on modifying their guidelines to include value measurement. With a concerted effort by a number of groups, we may eventually see an effective way in which to measure whether a new, additional, or different treatment is really going to bring greater value to the patient than additional cost to the system.
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