How to Leverage Health Outcomes to Successfully and Compliantly Market Medical Devices

The confetti has cleared the air, the champagne bottle is empty and the sun is shining on the day after your device has gained FDA clearance. You want to believe the hard-part is over and from here on it is smooth sailing into the sunset, with an umbrella drink in hand, and payers in line to beat down your door and sales are magically pouring in. It’s a nice picture anyhow. Now back to reality. Please read on.

In reality, you’ve jumped through the proof-of-concept, equity funding, intellectual property and regulatory clearance hoops, and now you find yourself defending your devices once again, this time for market access and utilization by CMS and other healthcare system payers. What happened? What to do next?

Health economics and comparative effectiveness are increasingly critical areas that many medical device and procedure companies should consider if the goal is to achieve the most advantageous product positioning for optimal patient utilization and product reimbursement.

Rules for access determinations and reimbursement are dynamic and continually changing, which means that your value proposition needs to change and keep up with the times too. No device or product is immune from this, despite any history of previous success in the marketplace.

The product development and clinical plan should include discussions on the strategic plan to combine clinical, medical and economic goals. These discussions would include capturing the necessary data to perform statistical and at a minimum, even some basic calculations to convincingly answer those tough questions that will be asked.

In no particular order, these questions could include: How does your device compare to what is currently available and/or being used? How does your device upset the ‘market basket’ in this therapeutic space? How can patients expect to benefit/to risk from your device? What utilization data do you have to share? What will be the payer’s expectation for an ROI and in what terms?

A true story from my days as Medicaid Director: A very enthusiastic national account director comes into my office one day to ‘offer’ me the opportunity to have his first-in-class medication on the State Medicaid formulary. After talking for about 10-15 minutes, he pointedly tells me “…you need to put this on your formulary because it’s the first medication to treat this condition in this way and doctors will write for it for their patients…”

My response: we care about our patients very much and want them to have access to all appropriate therapies, however, our patients ARE currently receiving standard of care treatment (SOC) and your first-in-class therapy is not currently SOC.
I then requested more information so I could fully understand the benefits AND risks to the patients and program. I asked: Did the clinical trials include cohorts that represented my patient population? What medical (not clinical) outcomes were studied and what were the results? What amount of market penetration does the company anticipate? How much of a sales promotion is being planned in our coverage area? Has a HEOR or CER analysis been done and if so, what are the results? How will this therapy affect the need to use other therapies that the patient may be taking or need to take? What is the impact on office, clinic and ER visits?

The end of the story was a happy one. The therapy was eventually placed on the formulary because of the additional information that was shared and the company’s responsiveness to address some critical data concerns. The company could have shortened the timeline had they been prepared with the necessary information or an acceptable substitute in the first place.

When bringing devices and procedures to market, consider what data is and will be available for use by your medical team under FDAMA Section 114 regulations for health economic promotion. In addition, consider what your economic and outcomes package will include for non-promotional, unsolicited requests, using an AMCP-type of dossier.

Stay tuned to upcoming discussions of FDAMA 114, healthcare economic and outcomes initiatives, Advamed code of ethics and how to optimize the use of your current clinical data to address your ‘data gaps’ in the short-term. There is light at the end of the tunnel….and it’s not a train!