John L. Fox, MD: In the state of Michigan, where our health plan operates, we’re required by state legislation to cover any FDA-approved cancer drug as long as it’s FDA approved for that indication, as long as it’s listed in an approved compendium, or as long as the provider can produce 2 peer-reviewed articles supporting that indication. That’s not true in every state. There are about 26 or 27 states that have legislation mandating the coverage of drugs. So, clearly, listing in the NCCN compendium is critical. Medicare lists 3 additional compendiums. That requires us to cover those drugs for Medicare Advantage and traditional Medicare patients, if they’re listed in those compendiums. It varies state by state, but for us, a listing in the compendium is a critical aspect.
Having said that, we don’t have to cover without limitations. So, at our health plan, we say that we’ll cover category 1 and 2A indications before we cover category 2B, and we’ll cover 2B if there are no appropriate category 1 or 2A options. We don’t cover category 3 at all. We’ve never been tested on that. There aren’t too many category 3 listings in the NCCN guidelines. I think the point is that while the compendium guide covers what types of therapies we have to cover, it doesn’t necessarily restrict our ability to manage those therapies that are listed in the compendium to ensure that they’re medically appropriate and consistent with the label and the evidence.
There are several sources of guidance on how we decide what drugs to cover for ovarian cancer. Foremost are the NCCN guidelines that have been used for a number of years to help us decide which therapies to cover and in which order. But certainly, Medicare also has rules around what drugs we can cover. In fact, oncology drugs are a protected class, which means we’re required to cover all of them. None of that means we have to cover them in any circumstance. We can still apply medical appropriateness criteria, but those are the 2 primary sources we use.
There are a number of other tools that are available to health plans to help evaluate therapies and their place in the management of ovarian cancer and other conditions. For example, the DrugAbacus from Peter Bach of Memorial Sloan Kettering is an interesting tool, but is probably more for testing the relative weighting of different factors influencing your willingness to pay. The ICER (incremental cost-effectiveness ratio) is another tool that’s available. The challenge with ICER from a payer perspective is really a practical one. The results aren’t available in a timely fashion to help us make a decision, and the breadth of the analyses that they do is not very wide. They can’t be relied upon to provide information to help us make decisions because of the number of them that are done.
The ASCO value framework is something that we’ve evaluated as a plan, and there have been a number of enhancements in that that have increased its utility. First, there has been the addition of the hazard ratio instead of the overall survival or the progression-free survival, which is more reflective of the actual benefit of a therapy. The addition of all types of side effects, not simply those serious adverse side effects, has also improved it. The primary challenge with the value framework right now is that you have to calculate the results yourself, or that has been our experience.
The NCCN evidence blocks are helpful, but they have their own limitations. There are 5 different elements in the evidence blocks. There’s efficacy, safety, consistency, quality of evidence, and then affordability. It was very interesting. When they first came out, we were looking at multiple myeloma, and they had a comparison of bortezomib/dexamethasone, lenalidomide/dexamethasone, and thalidomide/dexamethasone. They were all equal on efficacy, safety, quality, and consistency of evidence. The only difference was in the affordability, where thalidomide was the most affordable. So, while it’s helpful to compare across those 5 different domains, there are still some overall limitations in our ability to use that in a decision-making format.