Medical Device Daily

MINNEAPOLIS – A panel at the IBF Med-Tech Investing conference here last week discussed the role of evidence-based medicine and comparative effectiveness in developing medical policy. The panel that consisted largely of medical directors also discussed the challenges that medical directors face today and the best strategies for communicating with them and what should be avoided.

Expressing a hope that no audience members would be throwing "stone and sticks," Brent O'Connell, panel moderator and chief medical officer at Argenta TEC Advisors (Woodbury, Minnesota), acknowledged he and the other panel members were the people responsible for making the policy and making technology evaluations for health insurance companies, "we're the people that actually have a lot to do with your success as investors and in the success of your products."

As an example of how an insurance company decides to cover new products, Elizabeth Brown, MD, a board-certified pathologist in Woodbury, Minnesota, described the five technology evaluation center criteria used by Blue Cross Blue Shield (Chicago) to assess whether a technology improves health outcomes such as length of life, quality of life and functional ability.

The criteria are:

The technology must have final approval from the appropriate governmental regulatory bodies.

The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

The technology must improve the net health outcome.

The technology must be as beneficial as any established alternatives.

The improvement must be attainable outside the investigational settings.

Brown noted that nowhere in these Blue Cross criteria is there any mention of cost. She said that once the organization decides to prioritize something and look at it through its technology evaluation, "cost goes out the window."

Fiona Wilmot, a principal at the Glas Group (San Francisco) and a former medical director for Blue Shield of California, stressed that while an FDA approval is important in making a coverage decision, it doesn't mean that the product is assured of coverage by Blue Shield. FDA approval "is considered a floor, not a ceiling," for the coverage decision, she said.

At the health plan, Wilmot said, "we look at the bigger picture." By this, she said other options available to the patient are looked at. She also noted that sometimes good evidence is lacking when it comes time to evaluate the benefit of new technology on health outcomes. However, she acknowledged that when CMS makes a coverage decision "it's very hard to be in opposition to that unless the evidence is very at odds with that."

Brown concurred that many new product candidates vying for coverage often fail the good scientific evidence test. "You have to define the outcome of what is going to be of the greatest interest to the plan and the payer and define what type of data are going to be required to meet that outcome."

As to the data itself, Wilmot acknowledged that much of it comes from company sponsored trials and that is unavoidable until there becomes a way for more government involvement in the process via heightened sponsorship in trials. However, she noted that the data still need to be "appropriately powered" in order for it to be taken seriously for a positive coverage decision.

O'Connell concurred with Wilmot's assessment of corporate sponsorship of trials. "When I see a study where every one of the 12 authors is an officer of the corporation an investor in the corporation or has done the research as a paid employee of the corporation that's involved, it really raises some doubts." He said it would be a good idea to get some academicians in the mix of the study that don't have any vested interest. "When you go to publish, if everyone has to release their associations, it's a very difficult sell from our perspective as reimbursement advisors to the insurance companies."

An audience question touched on the difficulty of applying these technology criteria to diagnostics, and Brown acknowledged that diagnostic technologies are always a challenge "because you have to define what the outcome is, and a lot of times payers will try to tie the therapeutic outcome to the diagnostic technology."

She said that if a company has a novel diagnostic technology, "it's quite likely that plans are going to want to see that not only does the product change the management of the patient but that the change in management will improve health outcomes, which is obviously very challenging if you don't expect the health outcome to improve for several years."

O'Connell discussed the comparative effectiveness agenda of the Obama administration and noted that most of the money committed to it so far is being used to study how to implement it. "There's a lot of work to be done between now and time we adopt such a radical change in the way that we look at evidence. He added that he thinks comparative effectiveness on a national level is going to be a "slow moving train with changes along the way, but it's still moving down the track and sooner or later we will have something that's acceptable to most people involved."

Brown noted that comparative effectiveness "has always been with us," and insurance companies have already been doing it for years, as evidenced by the Blue Cross technology criteria. "I think the issue is that hopefully we're going to have better data," with more direct vs. indirect data.

Fredrik Tolin, MD, a medical director for Chicago Commercial Market (Chicago), said "cost effectiveness and comparative effectiveness are a very important part" of fixing a broken healthcare system. "As physicians, we would like to think that we look at things totally independent of cost in caring for our patients. The truth is you can't practice that way anymore and we can't approach technology that way anymore."

Wilmot said she sees comparative effectiveness as a good thing and that it will accelerate rather than squelch innovation. "The way I see it is that it's actually going to channel innovation so that there's more successes. I think in the best possible world, it will make the criteria evidentiary standards very clear and that way you'll know where you are along the way with that."

Wilmont mentioned that it's possible to game the system to avoid the technology review. Some examples she cited included high volume, low-cost diagnostics testing products and testing done in doctors' offices. "One of the ways to keep things moving is to stay under the radar," by avoiding all the reviews.

If something is low cost, it's not worth going to the trouble of reviewing it, Brown concurred. "If it's low cost and fits under an existing CPT code that's not going to draw their attention, then it's just going to be under the radar and payers aren't going to choose to try and manage it under any normal mechanisms."