Generic Contrast Agents

EP: 1.Imaging Modalities in Medical Diagnosis and Treatment

EP: 2.Role of Contrast Agents in Imaging

EP: 3.Contrast Agent Protocol

EP: 4.Role of Generics in Imaging

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EP: 5.Generic Contrast Agents

EP: 6.Contrast Media: American College of Radiology Recommendations

EP: 7.Unmet Needs in Imaging Modalities

Joseph Cavallo, MD, MBA: I want to turn our discussion to the 2 generic agents that are now available in the US for imaging. One of those is an iodinated contrast iodixanol injection, and the other is an iodine-based MRI [magnetic resonance imaging] contrast, gadoterate meglumine injection. Have you had any experience with either of these 2 agents?

Dushyant Sahani, MD: I have experience with the branded agents. I have used both of them extensively, and I even did research on the iodixanol, but I don’t have experience with the generic agents. My overall thought process is that these agents have been in use for several decades now. I don’t anticipate any different outcomes when it comes to safety or the effectiveness, but I don’t have experience in using the generic agents myself.

Joseph Cavallo, MD, MBA: I don’t either, yet. For those not aware, iodixanol generic was approved about a year ago, last July, and the gadoterate generic was approved less than a year ago, this past October. As you know, many hospital systems have vendor or supplier contracts that can be many months or even greater than a year. I imagine there will be a transition period as people would try to potentially move over and get first-hand experience with these.

Dushyant Sahani, MD: I completely agree with you. I think this space will evolve [and] people will gain trust. They will revisit their own contracts when it comes to contrast media. There might be changes in the pricing. More competitive pricing will be offered to the customer…. Some of these changes might start at other countries. And with more research, publication, and data on the cost effectiveness of some of the changes with or our use of generic agent, [that] will influence the future practices. I think it’s a matter of time. We are at the inflection point of those changes. If you look at what COVID[-19] has done to health care or practices, there is a bigger emphasis on operation, which is not only efficiency but also cost. All these factors will play a bigger role in decision-making in terms of the choice of contrast media and the contracts and how each practice would like to bring on those generic agents or not.

Joseph Cavallo, MD, MBA: We talked about the similarity of these generics with their branded counterparts. To your knowledge, would there be anything from a prescribing or administration point of view that technologists, diagnostic, or therapeutic radiologists themselves would have to know for effective utilization of these agents?

Dushyant Sahani, MD: When it comes to generic agents, as I mentioned, there is some tremendous similarity, meaning it’s the same molecule. The safety profile has been established for this these agents over decades, and there are millions of patients who have been scanned. Those elements are foundational to the use of contrast media. How you use it depends on individual preference and practices [and whether you have a] relationship with the vendors. ACR has a very clear position on this. ACR is important for the field of radiology because it sets up standards we need to adhere to, [to] ensure we practice high-quality diagnostic imaging and therapies to ensure we optimize care delivery. In that case, ACR has given some recommendations when it comes to the use of generic agencies. You want to make sure any generic agent meets a few expectations. One is the bioequivalence in terms of the pharmacokinetics—the contrast distribution, excretion—all those things are matches to the branded [agent]. Second is [whether] it [has a] similar safety profile. The third is effectiveness of the contrast media. Generally, most generics will meet those because they have been in use. They’re a similar type of molecule. It comes down to individual trust and confidence of practices or providers if you have the right motivation and needs to use the generic agents. I think some of the research that will come out with the use of generic might bridge some of the lack in confidence, if anyone has to decide [whether] generic agents are right for them, but it will come down to individual practices.

When it comes to protocols, I would say the protocols might be similar if you’re using a similar dose. I don’t anticipate [many] changes there. If the concentration or volume is similar, then the protocols might be similar. One point I want to emphasize is [that] if you want to make any changes to your practice, those changes, after one has piloted, [must] be system wide. Otherwise, this creates tremendous confusion. A well thought-out approach, where the stakeholders are aligned. That means not only the administrators and physicians but [also] the technologists who are in the trenches. You don’t want to create any confusion. How patients are scheduled on Epic or in your reporting templates, sometimes the older contrast agent to details are listed by default in those templates. A lot of changes have to be made to ensure there is a smooth transition from a branded agent to a generic agent.

Joseph Cavallo, MD, MBA: A lot of great points in there.

Transcript is AI-generated and edited for clarity and readability.