An Introduction of a New Class for the Treatment of Bone Health - Episode 11
Peter L. Salgo, MD: Now, something you said rang a bell, because Tom mentioned something, too. You said it’s a chronic disease and you’re never going to get cured, and yet there’s a time limit on bisphosphonates. People stop them. They stop prescribing them after what, 5 years?
Thomas P. Olenginski, MD, FACP, CCD: Typically, 5 years. Even in the FDA’s language, the optimal duration of treatment of bisphosphonate therapy is unknown.
Peter L. Salgo, MD: OK. So you stop the bisphosphonates, the practitioner. After 5 years, during year 6, boom, fracture. Now what?
Thomas P. Olenginski, MD, FACP, CCD: If somebody fractures, we are probably, number 1, going to make sure that there’s not some reason that we can modify biochemically. Does that patient have hyperparathyroidism? Do they have hyperthyroidism in excess that could be treated? Are they profoundly vitamin D deficient? Do they have celiac disease? We make sure that’s the case. If we rule that out, we’re going to probably move to something else. There was another consensus panel, but these were very good people who looked at the bisphosphonate data. The bisphosphonates are tremendous as a class of medicine. They, across the board, reduce the risk of fracture, if you take them correctly, 40% to 50% across most skeletal sites.
Peter L. Salgo, MD: That’s an astounding number when you think about it.
Thomas P. Olenginski, MD, FACP, CCD: That’s really good.
Peter L. Salgo, MD: Yes.
Thomas P. Olenginski, MD, FACP, CCD: The problem is, with the more severe patients, like this one, it’s not enough and we’ve got to go to something else. If we’re going to go to something else, do we go to an anabolic drug? There are some reasons we might, and some reasons we wouldn’t. Would we use a drug called denosumab, a RANKL inhibitor, or would we consider using this new class, this anti-sclerostin medicine?
Peter L. Salgo, MD: We’re going to get to that. Let me ask a simple question. Why not just restart the bisphosphonate?
Thomas P. Olenginski, MD, FACP, CCD: Because in that case, we’re going to expose a patient to some unusual, very unlikely event, and it’s not the right drug.
Peter L. Salgo, MD: What’s the event?
Thomas P. Olenginski, MD, FACP, CCD: Basically, bisphosphonates stun osteoclasts, but we don’t want to put them to sleep. Osteoclasts really cause bone to be reformed, and they repair the microdamage. Now, our drugs are pretty safe. In exceptional circumstances, and by reasons other than a drug, sometimes we see unusual fractures. So in a patient who’s been on a bisphosphonate and has a fracture or has multiply fractured, that’s typically a patient for whom I think most of us are going to use an anabolic agent or consider one of these newer drugs.
Andrea J. Singer, MD, FACP, CCD: But you were talking about the patient fracturing once they’ve been off therapy.
Peter L. Salgo, MD: You stop bisphosphonates. You fracture. Do you start the bisphosphonate or not?
Andrea J. Singer, MD, FACP, CCD: You could. I want to come back to something that I think is really important, and is often a misperception out there. There’s not an absolute limit. Nowhere is it written that after 5 years one must stop bisphosphonates. The guidance is really that you want to relook at the patient. After 5 years of treatment, and that was somewhat arbitrary based on some of the data we had, limited data, albeit, if the patient has been fracture-free, their bone density may be somewhat better, risk is OK because bisphosphonates have a really long half-life and stay around in the bone. So even if you stop giving them, they’re sort of like the gift that keeps on giving. They’re still there. You may be able to take somebody off and still have some of those residual benefits, not because they don’t work, but to reduce the risk of rare event. But in high-risk patients, some of the task force guidance from the ASBMR [American Society for Bone and Mineral Research] task force in high-risk patients was, you might continue the bisphosphonate for 10 years. The key message is that there isn’t an absolute that’s right for every patient. We have to look at it on an individual basis.
Peter L. Salgo, MD: Now, from a payer perspective, what do you hear? “You’re not following the guidelines. We’re not going to reimburse.”? Or are they a little more open? What are you guys hearing?
Thomas P. Olenginski, MD, FACP, CCD: The bisphosphonates are the standard of therapy, initially, for many patients. I think they want to see that that’s been tried. Or if they’ve had trouble, or the severity of the problem; I think if payers see the severity of the problem and you document that today, they’re willing to allow, within reason.
Peter L. Salgo, MD: But you’ve got to ask for an override?
Thomas P. Olenginski, MD, FACP, CCD: Absolutely, correct.
Claire Gill: I would say the feedback we hear a lot from patients, specifically, is that they and their doctor might want to try a specific drug and they cannot get that drug.
Peter L. Salgo, MD: So money is playing a role?
Claire Gill: That’s right.
Peter L. Salgo, MD: I knew you were going to say that.
Andrea J. Singer, MD, FACP, CCD: Part of the problem is that there are multiple guidelines for us to process out there. They don’t all say the same thing, in terms of which therapies to start with. So I’m not sure the payers know which guideline to look at, nor do providers.