Days are long gone when you can make a claim without solid proof.  Everyone knows that every promotional point must be supported by clinical trials and be referenced in the package insert, but today we need to go even further.  We need to deliver and prove value to the market if our brands are going to be utilized.

Take a look at this opinion piece in the New York Times that discusses the need to thoroughly test those things we have taken for granted over the years.  The overarching issue is the fact that we in the U.S. spend approximately twice per person on healthcare than other developed countries and our results are often mediocre at best.  Are we spending money on things that really don’t result in value to the system?  Are we testing too often?  Are we treating things without considering the impact on morbidity or mortality?  Just because we have always done things one way doesn’t automatically mean we are doing it the right way.

Part of the concern is around the need to practice defensive medicine.  How often are blood and other tests really needed?  Are they done just to protect the physician rather than the patient?  Are procedures and tests done because the current reimbursement system rewards physicians for doing more rather than less?  Are patients demanding more intense care even if there is no evidence that there is value?  The bottom line is we need to constantly be challenging the things being done and have an open mind for change if the results go against current practice.

The Affordable Care Act deals with these issues in numerous ways, but in reality the Patient-Centered Outcomes Research Institute can only go so far.  This is where the pharmaceutical industry must continue to do its part.  Is the industry about putting new drugs on the market or delivery of healthcare solutions?  I would argue that if the industry is to prosper in the future it must really concentrate on the solutions concept.  By definition, a solution requires that there is a problem in the first place.  These problems or gaps in therapy can be great or small.  Solutions are needed for all gaps if the system is going to move forward.

Companies need to be very realistic about the products they are bringing to market and the points of differentiation from what is already being used.  The problem is that products seem to always look more promising when they enter the clinic than when they come out.  When phase III is complete and the product looks more like everything else than unique, it is tough for the commercial team to face reality.  They rationalize that the product will still be a success if they just out-detail and out-spend their competition.  In order to do that a premium price is needed.  This used to work in the old days when physicians were able to spread their prescriptions around for every rep who called on them.  Today the world is quite different.

The model today requires solid clinical proof that a product is better than what is currently being used.  This is not a feel and not some obscure piece of data that may or may not have an impact on patient outcomes.  When a difference is proven then an economic analysis must be done to determine what this is worth to the system.  The price should only reflect the incremental value.  Looking at the other side of the coin is just as important.  Price can be the great differentiator.  Lower prices with equal clinical value is a huge point of differentiation.  Obviously, when looking at this it is important to consider the price issue from the perspective of payers, patients and providers.  Each is important.

Economics in medicine is becoming big business.  It is no longer a side discussion between physicians and reps as an afterthought after a reminder detail.  The practice of medicine has become much more standardized and it is becoming even more so by the day.  Using a drug not on formulary or one that is not preferred is becoming a rarity.  Pricing work and formulary discussions must be held with the top of the decision tree not at the bottom.  This requires a completely new skill set.  I hope we are ready to really prove the value we know our products bring to the market.