SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, AGA convened a panel of payer medical directors to shed light on what it takes to get coverage and reimbursement for a new device or procedure. Data is king! Companies need to show durable and sustainable efficacy of their technology through relatively large, well-designed studies that include both commercial and Medicare patient populations, demonstrating an improvement in outcomes over several years duration, and publish the results in peer-reviewed journals.

Payer representatives included:

Arthur Lurvey, MD, FACP, FACE, Contractor Medical Director, Noridian Healthcare Solutions, LLC, which administers Medicare plans

John L. Fox, MD, MHA, Senior Medical Director and Associate Vice President, Medical Affairs, Priority Health, which administers Medicare, Medicaid, and private health plans

John S. Yao, MD, MPH, MBA, MPA, FACP, Staff Vice President of Medical Policy, Anthem Inc., which administers Medicare, federal employee, and private health plans

1) What should a device manufacturer be thinking about when trying to generate the evidence necessary to ensure coverage for a new device?

Dr. Yao

Clearly, we would all like to see well-designed, well-powered, randomized controlled trials with statistically significant results. But we recognize that this is not always possible in the real world. From the coverage perspective, we are looking for objective evidence, which includes not only analytical validity of the device, but also both clinical validity and clinical utility.

Dr. Lurvey

We look at journals, white papers, and technical assessments, particularly by parties who are not associated with the manufacturer – because we know if it comes from the manufacturer they are going to want to make it look good.

As far as publications, we want data published in reputable journals. There are plenty of journals that will publish anything for $500. This isn’t what we’re looking for. We want quality studies published in quality journals. We see a lot of noninferiority trials concluding that “My product is as good as everyone else’s,” but that is not helpful – you should be looking for equivalence at a minimum, or superiority. Another big problem is endpoints – we need clinically meaningful, primary endpoints, not secondary or tertiary endpoints. We look for input from specialty societies, such as AGA.

When we are looking at journal articles by impartial experts, we are influenced by their concluding remarks, especially if they recommend further study. If the experts don’t think it’s ready for prime time, then we don’t either.

We also like to see a wider patient population. Very few studies deal with people older than 65, so we don’t know how effective or harmful your device would be to the Medicare population, people who are older, or medically fragile.

Dr. Fox

Those who design studies need to design them around a clinically meaningful primary endpoint, and physicians will have to decide what that is. We can’t just have a statistically significant endpoint. It has to mean something to patients. We want evidence of outcomes that show this device is making a difference in patients’ lives – not just in patient scores. Do they feel better? Does it cut down on the need for additional procedures or treatments? Is there evidence that it’s a good alternative to a more expensive therapy? Does it produce a better outcome with a lower cost? How are physicians going to use the device, and how will it change their management of patients?

If you can’t come to the table with information like that, I’ll be playing defense against something that isn’t really helping patients and may be costing them more.

2) What do you look for in terms of durability of effect?

Dr. Yao

We want to see technology that can be replicated consistently in a real-world practice setting, not just in the ideal setting of a clinical trial or in tertiary care centers with strict protocols and ideal patient populations.

As far as long-term safety, we get a lot of requests from device manufacturers who have 6-month data. With a brand new innovation, we feel 6 months is not long enough. We would like to see at least 1-2 year follow-up data with good results and no adverse events. For example, there was a very highly anticipated implant for postprostatectomy urinary incontinence where the data initially looked very good. But as longer-term data became available, the reimplantation rate was about 25%, and this turned out to be a very invasive procedure. You don’t get this with only 6 months of observation.

msullivan@frontlinemedcom.com

Medical devices – the evidence for coverage