Abiraterone Formulations for mCRPC: Effectiveness, Access, and Cost Implications

Opinion
Video

Dr. Christopher M. Pieczonka and Dr. Jose De La Cerda discuss the various formulations of abiraterone, including micronized and non-micronized forms in combination with prednisone or methylprednisolone, including safety and effectiveness. They share insights on the specific patient populations for whom micronized abiraterone is particularly beneficial, how patient specific needs or comorbidities influence treatment appropriateness. They also delve into the accessibility of these formulations, emphasizing the importance of proper diagnosis codes to enhance medication approval processes.

Transcript:

Christopher M. Pieczonka, MD: What I want to do is maybe shift gears a bit and now talk more specifically about some of the choices for medicine. So, you know, this is meant to be more of a focused discussion regarding certain of the oral therapies. And one of the things that I wanted to kind of get your take on is the difference between the original version of abiraterone acetate and the micronized formulation. And if you could maybe describe to the audience what is the difference in terms of the drug itself?

Jose De La Cerda, MD, MPH: Standard abiraterone typically is about four pills, 250-milligram tablets. You take four tablets a day, and it's in combination with prednisone 10 milligrams. The micronized version with the standardized abiraterone is typically taken fasting. So you'd have to take it without eating for two hours, take the medication, and then wait another hour to ensure absorption. Now, the micronized formulation is much smaller in diameter. The benefit is that you get a lower medication dose. This medication is about 125-milligram tablets. You take four of them, so a total of 500 milligrams of the micronized abiraterone, and this is taken with methylprednisolone, about four-milligram tablets twice a day. Because it's a smaller formulation, you can take it with or without food since the surface area is smaller, and absorption is higher due to dissolution. So there is a benefit for patients to get the smaller dose because they don't have to fast, and they get the same bioequivalence compared to standardized abiraterone. It's something I use pretty frequently in my practice. The main issue being cost. And I think that's one of the issues we have with something that's non-generic. Even though I think patients do well, particularly Hispanic patients, because there's a high rate of diabetes, hypertension, hyperlipidemia, they might not be the best patients to fast. So being able to prescribe a medication they can take with or without food really improves tolerability and compliance, making it easier for patients to go about their daily lives.

Christopher M. Pieczonka, MD: I guess two follow-up questions on that. The first question would be, how do you document or what kind of things do you need to get the patient access to, again, branded medicine versus generic medicine? That's the first question. And then the second question, if you could just touch on your experience regarding the effectiveness of the micronized formulation versus the original abiraterone acetate.

Jose De La Cerda, MD, MPH: The safety and efficacy seem to be pretty similar for both, so I really don't find a difference in that. The most important thing when it comes to documentation is making sure you're using the right CPT codes and why you specifically want to use a micronized form. For me, the reasons I choose that are for patients' inability to fast, the need to ensure better medication dissolution, and conditions like IBS, Crohn's disease, or absorption issues. I add these codes to the prior authorization request to increase the chances of approval.

Christopher M. Pieczonka, MD: So, in terms of interrupting, because I want to drill down on that. Are you actually putting that diagnosis code in your note, the patient is diabetic, or are you just putting it in your note without adding a specific diagnosis code? Walk me through what you're doing.

Jose De La Cerda, MD, MPH: So, C61 typically covers genitourinary malignancy, and if there's anything specific that needs to be on the prior authorization, then I'm adding that code.

Christopher M. Pieczonka, MD: Okay, got it.

Jose De La Cerda, MD, MPH: So I'm not adding a ton of codes, just something that would need to be seen to ensure that this gets approved. Because if it's not in the code, it may get lost, and a lot of the times they base their decision on the code. So, as long as something is there and it gets sent off that way, I think it'll ensure it gets approved or at least try to maximize approval.

Christopher M. Pieczonka, MD: Yeah, that's a good point. I'm going to start doing that.

Jose De La Cerda, MD, MPH: Regarding effectiveness, clinical trials have shown that bioequivalence is similar for both formulations. There's no superiority of one over the other. The side effect profile is also similar, mostly related to ADT like fatigue, hot flashes, and rash. The main concern is monitoring liver function due to the risk of hepatotoxicity.

Christopher M. Pieczonka, MD: You triggered my thought about something related to cost and toxicity. I've found in my practice that using the micronized formula, believe it or not, might actually be cheaper for the patient. Sometimes the more expensive medicine can be cheaper because there might be co-pay assistance available, which is not available for generics. Weird things can happen with generics, like the actual cost might be low, but the patient is expected to pay a co-pay because of outdated information. So sometimes the more expensive medicine is easier for the patient to get. The thing you taught me about using diagnosis codes is something I had not been doing, and I'm going to start implementing that.

Jose De La Cerda, MD, MPH: It takes a bit more time, but it can help get the medication covered. One thing we haven't touched on about generic abiraterone is that even though it gets covered, it might not be covered at the full dose. Insurance companies sometimes limit the dose, which can be frustrating. So it's important to be aware of these insurance-dependent issues and try to maximize approval.

*Video transcript AI-generated and reviewed by Urology Times® editorial staff.

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