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Prior Authorization and Payer Test Coverage of SMA

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Peter L. Salgo, MD: Well, in the current state of the art—exclusive of new drugs on the market, exclusive of miraculous new therapies, whatever the cost—are there challenges that the clinicians face in getting the payers to listen and to authorize whatever the therapies are? Are you on the phone a lot looking for exceptions and overrides?

John Brandsema, MD: I spend a great deal of my time on the phone…

But I can understand because I look at it from the perspective of the person on the other end of the phone with me, who probably has never met a patient with the condition that I’m trying to advocate for. My first rule is trying to put something in a clinical context for them that they can actually have some appreciation of what the disease means for the patient, and then why what I’m trying to advocate for is going to make a difference for them. That is a very involved conversation and takes a good chunk of my time to do in terms of advocating for the patient. And the challenge as a rare disease specialist—you know I’m a neuromuscular specialist, so this is my wheelhouse—is that these new therapies are coming in my disease states that I take care of. But that multiplies this by dozens of times for me. For every patient who is going on these new therapies, it’s a big investment to try to get this to my clinic population, and our team spends a lot of time on that.

Peter L. Salgo, MD: How much of your time, and how much staff is dedicated, not to patient care but to massaging the insurance companies?

John Brandsema, MD: I think that’s the challenge—that’s nonreimbursable time by us, right? We try our best to come up with the clinical infrastructure to make this happen, but it involves having dedicated prior-authorization people, dedicated people who are involved in the clinical advocacy world in terms of coming up with the appropriate clinical outcome measures and other things that we might be sharing with payers when we’re trying to advocate on behalf of our patients. And then just the phone time to first of all get to the person who you’re trying to talk to, which can be an investment in and of itself. But then when you’re actually with them doing the education and getting the follow-through for your patients. It’s hard to estimate, but I can tell you that starting in 2016, when we had 3 different therapies approved in our disease area between SMA [spinal muscular atrophy] and Duchenne muscular dystrophy, there was a significant change in the overall culture of our clinics that was felt across the country and certainly a lot of discussion in our disease communities about how that impacted all of us.

Peter L. Salgo, MD: Do you feel his pain at all?

Maria Lopes, MD, MS: Well, I do. It’s certainly invested time that you could be putting to better uses in terms of patient care, right? In the end, it costs everybody something. I think a better approach—and I think we’re having more dialogue between payers and thought leaders—is to 1, help us understand the disease. Two, if you had the purse strings to the dollars, how would you define the prior authorization and the right patient? And on the reauth, what would you be looking for?

Peter L. Salgo, MD: Reauth is insurance company reauthorization.

Maria Lopes, MD, MS: Exactly.

Peter L. Salgo, MD: I knew that.

Maria Lopes, MD, MS: This is for continuous therapy. We want to understand some of these therapies are over half a million dollars a year.

Peter L. Salgo, MD: That’s a lot of money.

Maria Lopes, MD, MS: We want to understand from the clinician perspective, what does a clinically significant improvement look like? I think we all have to have this dialogue because ultimately this comes to a reaffordability issue.

Peter L. Salgo, MD: We have data we can collect. Part of that data are to help the patient and to help the family. Part of that data are to justify to you and your colleagues that this is what this is, and we’re going to go forward. So do you pay for the testing?

Maria Lopes, MD, MS: The testing is usually a laboratory test that’s under the medical benefit. Unfortunately, the answer is yes, but because of benefit design…

Peter L. Salgo, MD: Why is there always a but?

Maria Lopes, MD, MS: Sometimes, patients do have some out-of-pocket.

Peter L. Salgo, MD: For the testing.

Maria Lopes, MD, MS: For the testing, yes. But not only is the testing covered technically, but the testing is a requirement to be able to get the drug.

John Brandsema, MD: That’s been the trend recently that if there is a therapeutic intervention that seems to make an impact on a disease, a lot of times there will be a sponsored testing program for that disorder, which then takes the whole approval process out of the picture for us as clinicians. That is extremely helpful. If we can just have a test that if you have a clinical suspicion, it’s immediately done without any financial repercussions for the patient or the provider. That really helps getting those diagnostic incidents higher—being able to test more people without having to go through that process.

Maria Lopes, MD, MS: It benefits, obviously, the pharmaceutical company if you can identify more patients who would qualify for their therapy.


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