How to avoid being approved by the FDA but shunned by Medicare

The FDA and Medicare have different priorities. Getting the twain to meet sometimes takes a third party to show what is safe and effective can also be a value, too.   

The FDA serves as the gatekeeper of the drugs and devices in the U.S. by presiding over their approval. It continues to monitor these products once it allows them to enter the marketplace.

The Centers for Medicare & Medicaid Services holds the purse strings, deciding what services and products it will reimburse and for how much. Other payers sometimes follow its lead, making it a de facto gatekeeper as well. A product may survive the journey through the FDA but languish in the marketplace if Medicare and commercial insurers refuse to cover its costs, at least in part.

While the FDA focuses on the safety and efficacy of a drug or device under review, others who want to see innovations gain traction in the healthcare system are building cases for worth. One late-breaking clinical trial at the recently concluded Society for Cardiovascular Angiography and Interventions (SCAI) conference is a case in point.

Jeffrey Chambers, MD, director of the Cardiac Catheterization Laboratory at Mercy Hospital in Minneapolis, presented the two-year results of ORBIT II at SCAI’s 2015 scientific sessions in San Diego. The study assessed the safety and efficacy of Cardiovascular Systems’ Diamondback 360 Orbital Atherectomy System in severely calcified coronary lesions. Results were generally promising.

The study includes an economic analysis, using Medicare patients as a comparator. In this way the researchers could show that in an average case, savings using this approach offset the cost of the device. Best cases offered a cost savings.

A long-term analysis of MI FREEE, on the other hand, went straight to the source. MI FREEE is a pragmatic policy trial with a clever randomization scheme that showed providing full coverage of statins, beta-blockers, ACE inhibitors and ARBs improved adherence and some outcomes in patients who experienced a first MI.

Using conservative modeling, researchers recently demonstrated that full payment was cost-effective over a long term, meeting a willingness to pay threshold of $100,000 in 88 percent of cases. Aetna, the carrier used in the trial, now is sold on MI FREEE’s full payment protocol. As lead researcher Niteesh K. Choudhry, MD, PhD, of Brigham and Women’s Hospital in Boston, said in an interview, Medicare has the most to gain, though, since it assumes lifetime care after a patient turns 65.

Evaluating cost and cost-effectiveness is becoming increasingly critical with new drugs and devices, and more trials proactively include a cost component to facilitate their uptake. It may be beyond the scope of what the FDA requires, but it is a wise investment in the long run.

Candace Stuart

Editor, Cardiovascular Business