Comprehensive insight regarding the cost and timing of peripherally acting mu-opioid receptor antagonist therapy in opioid-induced constipation.
David Wang, MD: One issue that's come up several times already is the idea of how payers will cover this and whether this will put any sort of economic burden on our patients who are living already with a chronic illness. Steve, as we all know, the emergency department [ED] tends to see patients from all walks of life at various pivot points in their illnesses. What have you come across in terms of the financial implications of being on a peripherally acting mu-opioid receptor antagonist [PAMORA] or needing to be on one?
Stephen Anderson, MD, FACEP: Long ago, I learned you had to ask the patient the questions about the economics, because they'll nod to you and then not fill things if the economics come into play. Clearly, patients with chronic pain unfortunately have a higher incidence of being on Medicare and Medicaid and managed care programs in which this clearly comes into play, whether it is authorized or isn't authorized. I say one pass down aisle B is going to be cheaper than a PAMORA by a long shot. Jeff pointed out quickly to me, yes, but the 15th and 16th pass down aisle B that isn't working is a lot more expensive, especially if you add in the 2 emergency department visits that nobody figured out.
Economically they clearly make sense, but there is a price difference, particularly between, at least at my institution, the injectable and the oral. There's a big price difference, to the point that my hospital system actually took the injectable off as one of the options in the outpatient setting because of the cost. Working within your system to have all the options available is important, but recognize that you have to ask the patient and work with the payers to figure out what is and what isn't covered, because it's a sizable difference between some of them.
Jeffrey Fudin, BS, PharmD, DAIPM, FCCP, FASHP, FFSMB: Sure. When you think about it, I've seen patients who are on 6 or 8 senna tablets a day plus docusate. That costs a lot of money.
Stephen Anderson, MD, FACEP: Out of their pocket.
Jeffrey Fudin, BS, PharmD, DAIPM, FCCP, FASHP, FFSMB: Out of their pocket.
Stephen Anderson, MD, FACEP: Correct.
Jeffrey Fudin, BS, PharmD, DAIPM, FCCP, FASHP, FFSMB: When you think about it, if a patient is in a long-term care [LTC] facility that is actually paying for all of the over-the-counter medications [OTCs] out of their pocketbook and Medicare Part D is paying for the prescriptions, that's consideration from a financial impact on the LTC facility.
David Wang, MD: There's almost a noneconomic burden too, going back to what we were saying. Allowing somebody to leave an inpatient setting earlier and obviating an ED visit or admission is extremely valuable to the patients. I agree with what everyone said here about the negotiation with payers to recognize the value of this and what it brings to not just one episode of care but the totality of the experience with the illness. Rick, you started us off by talking about the landscape and all the different agents. Where in your workflow do you start considering augmenting your treatment with a PAMORA?
Richard Rauck, MD: Right. I think it's really simple for me, David. The best thing is if you have a patient on an OTC, it's going to be lack of efficacy, which is more often a problem. Jeff brought out a good point earlier, that it can also be adverse events. If somebody maybe gets on psyllium, which it OTC, they may get an adverse event from the OTC, so it's not always just lack of efficacy with OTCs. Clearly, that's a problem with them. As we've talked about, they don't reverse the problem, being activation of the mu receptor from the opioid the patient is taking. To correlate to that, I always tell my fellows, if they're a little asleep at the switch, if a patient is not on an opioid, don't ever prescribe a PAMORA. It's not going to do anything. Every once in a while, maybe it's a resident who comes down and says, "Hey, let's put this person on this, he's got bad constipation." I ask, "Is he taking any opioid? I don't see it." He goes, "No."
Jeffrey Fudin, BS, PharmD, DAIPM, FCCP, FASHP, FFSMB: Even though he's really euphoric.
Richard Rauck, MD: Yes, exactly. I think though, once, if they fail those OTCs—and mainly it is efficacy, occasionally it's an adverse event to them—that's when I look to the PAMORAs. Again, in my own practice, I don't think you have to do this, I usually will stop the OTC. It gives me a better feel of how the PAMORA is doing, so I'll start the PAMORA. Then again, if it gives effect but maybe not quite as much as the patient wants, I might go to the OTC.
The last thing I'd say to that is it's important when evaluating both the OTC products that it's not just lack of efficacy. They may tell you, "I'm having 4 or 5 bowel movements a week," but you've got to explore just a little more and say, "What's the quality of those bowel-movement experiences?" Make sure they're not having incomplete evacuation or terrible straining, as we've said. I think you have to look at those different qualities, not just quantity, to how the OTCs perform. It's been my overwhelming experience that they really fall short most of the time in patients who are on opioid medications, chronically at least.
David Wong, MD: Theresa, if I might ask you, in your practice, let's say you've managed to help a patient have a bowel movement on the inpatient setting. How then do you handle their discharge pain or recommendations for laxatives?
Theresa Mallick-Searle, MS, NP-BC, ANP-BC: Well, one of the nice things about when we discharge patients if they're on chronic opioids is that I get to see them back in the chronic pain clinic, so it's a nice continuity. I want to be good to myself, so usually we'll send them out with recommendations for whatever was working for them on the inpatient side. If it is the injectable PAMORA, then it's giving them again the option of do we send you out with the injectable form or do we send you out with something oral? What will your insurance cover? It starts with educating just about all those other things we talked about in terms of behavioral management, stress reduction, fluid intake, dietary importance, exercise. Then making sure if they don't come back to my clinic, that I've reached out to the accepting provider—whether it's the primary care, or the surgeon, or the oncologist—with the recommended treatment plan.
David Wang, MD: Brett, do you have any words of wisdom for us in terms of how to navigate the addition of PAMORA to your regimens?
Brett B. Snodgrass, FNP-C, CPE, FACPP, FAANP: It's always just coverage. IN the outpatient setting, I'm always hinging things on coverage, unfortunately. Oftentimes we're met with step therapy. I'd love to go this route now, but I've got the steps to go through, and likely they're not effective and oftentimes we do that. Again coverage and lack of coverage are factors, so the comfort of having samples in the office is important. Oftentimes we're getting away from that, which I think can inhibit the patient. Is that the best practice for the patient? Sometimes we have to use samples. There is an unmet need there, but we're definitely making strides in it with this class of drug.
Theresa Mallick-Searle, MS, NP-BC, ANP-BC: Often, one of the nice things about being able to see these patients in the hospital is that you've gone through that trial step-wise. They come in, and they're already on a laxative of some sort, and they're already on a stool softener, and you've usually already tried something in addition to that. Being able to make the argument at discharge—it's important for documentation to meet the insurance recommendations or requirements.