Diabetes-Related Complications: A Focus on Diabetic Macular Edema - Episode 16

Diabetes-Related Eye Diseases: Making Coverage Decisions

Kenneth J. Snow, MD, MBA: Over the past several years, we have fortunately noticed a significant drop in the number of people who are getting into the system too late. Some still come in later than we would like or later than their physician would like, but, certainly, [it is] nowhere near the problem that it used to be.

Coupled with that has been a steady improvement in disease treatment programs that ophthalmologists have at their disposal. Even for those patients who are coming in later than desired, there’s still options for them. The good news is that even folks coming in later than we would like still have opportunities to make sure that the disease is treated and [we can] protect their vision.

We see people come in at all [disease] stages. Fortunately, people are coming in much earlier with no disease or with early disease, and many times, those folks just need to be monitored. They need to manage their diabetes as effectively as possible. By doing so, their eye disease may not progress or may not progress significantly to the point that it actually impacts their eye health.

For those who come in at a further [later] point [in terms of disease stage], they may need very tight follow up to make sure that they don’t progress. Some folks do come in to the system and do need treatment [right away], and fortunately, as I said, we do have good treatments available for many of these folks to prevent them from losing their vision.

In terms of coverage decisions, we look at a number of things. First of all, we look at FDA decisions. If we’re talking about a medication, we need to look at if it has been FDA-approved for a use. We look at the literature. What has the professional world studied, looked at, and published so that we understand the value of these agents?

We also look at the recommendations from professional societies. As an example, we know that most professional societies recommend a yearly eye exam. As such, our policies reflect that, so that we encourage yearly eye exams. Then, our plan coverage reflects the need for that eye exam. We try to make that as painless as possible. With devices or with types of procedures, we follow roughly the same process. We look at if the procedure is approved or cleared by the FDA, as the therapy has been shown to be not only safe, but also effective. How does it compare to other processes that are out in the marketplace already? Does this add an advantage? How does it fit into the entire care of this patient? When should it be used, and how do we make sure that it’s used appropriately and not misused and provided to patients who don’t need therapy?

When there are competing therapies, let’s say in any condition where there might be 2 different drugs to treat the condition, one of the first things we look at is if they are both approved. What does the literature say about them? Has one been approved while the other one may be used a lot but has not been approved? We feel a lot more comfortable with a drug that’s been shown in clinical trials to be safe. It’s effective and the FDA has signed off that they agree.

For 2 agents that have both been approved and there’s different options, then we start to look at the efficacy of the therapies. Do they differ? Does one therapy provide greater benefit for a particular patient and the other one less so? Is that greater therapy needed? Just because it may provide a greater level of care, the patient may not need that greater level of care. Who would it be appropriate for? Is it appropriate for everybody or for certain groups who need that level of care?

Finally, we look at cost. If 2 therapies are equally effective, then yes, we’ll try the less-expensive before we go to the more-expensive therapy. But, in order of preference, the cost is the last issue we look at. The clinical care is the issue that we look at first. If we have 2 therapies and one is more effective, one of the first questions is, in what way is it more effective? Does it treat the disease state better or is it treating equally well but more people respond? Those are going to be dealt with differently. If it treats the disease state better, then we need to know if everyone should get that therapy or if there are subgroups who need it. That may drive who it gets approved for.

If it’s a matter of treating more people effectively—that this therapy is more likely to result in a success—we have to ask the question of, what’s the downside of having a failure? If it’s simply a matter of trying it and moving to the next therapy—as an example, maybe a blood pressure pill in somebody who doesn’t have severe high blood pressure, but needs therapy—if one drug doesn’t work, it’s easy enough to move and try a different one. But if this is a disease state where that delay would lead to a significant harm, then we look much more seriously and much more stringently at the issue of how many people will succeed versus how many will fail with a therapy. We don’t want anybody failing without therapy. That’s a significant benefit that we wind up looking at.