Mark McClellan on the future of the ACA & Healthcare Reform

This week, Marc McClellan was at the Drug Delivery Partnerships Conferncee and shared a few of the insights he had into the future of healthcare with the coming changes of the 2012 Election.  We'd like to share that with you.

Will it Help or Hurt? The Impact of Healthcare Reform on Drug Delivery Innovation, Reimbursement, and Patient Compliance
Mark McClellan, Engelberg Center for Healthcare Reform, Brookings Institute, Centers for Medicare and Medicaid Services

The healthcare world is anxiously awaiting the the decision from the Supreme Court as to whether or not the ACA is legal. McClellan believes that some of the Act will be overturned, but not the whole thing. No matter the individual mandate to buy healthcare insurance will be delayed or repealed entirely. A lot of the other aspects are directly impacted by the 2012 Election. Since it is unpopular, Congress will delay the implementation. McClellan believes that this whole process will take longer and won’t be implemented on schedule in 2014. What won’t change? The insurance market will change, and those with chronic conditions will be covered. Republicans can’t repeal the whole law should they win the 2012 Election. The challenge is how to figure out how to cover more and more people who aren’t covered by insurance.

Rising healthcare costs that are coupled with a lot of rules to restrict spending means it will be very difficult to find a way balance the budget.
 As for FDA Drug Approvals, they are up. This includes more personalized treatments. The process of developing new treatments is very long and uncertain. So success rates are still running around 11-13% for approval. Pharma is moving towards targeting therapies and innovative develop methods require new ways for the FDA to approve them.

Quick approval methods currently from the FDA: Fast track, Priority review, Accelerated approval. There were 8 drugs over the past few years approved this way. It’s hard to set up post approval success measures to get the drugs approved as well.

In the future, McClellan believes that there will be an evidentiary standard (Progressive approval), Targeting , better regulatory guidance and premarket development science

McClellan believes that personalized medicine will have a huge impact on health care in the future, but only if the reimbursement structure is changed from its current structure.