Image courtesy of
Bayer HealthCare

Special report: Contrast media

April 14, 2014
by Sean Ruck, Contributing Editor
Unlike injectors, which have a tradition of slowly evolving, contrast agents have the ability to leapfrog ahead with what they can do. Even with the advances, existing injectors are able to play their role and get the contrast media where it needs to go.

All that being said, contrast seems to have taken a breather from its leapfrogging. Tried-and-true agents like Bracco Diagnostic’s Isovue hasn’t changed much in the past 28 years even if Bracco has. (The company started off as a contrast media company and morphed into more of a one-stop full service vendor for contrast needs.)

The other elephant in a relatively small room is still Bayer HealthCare. When Bayer acquired Medrad in 2006 and integrated it into Bayer’s Radiology & Interventional business in 2012, they too became a one-stop shop and additional acquisitions of informatics companies like Radimetrics in 2013 and their associated products, only helped to strengthen their portfolio of offerings. With that acquisition, came the introduction of Bayer’s Total Dose Management System.

News of note
We reported in last year’s issue that Bracco was looking to break into a new section of the market with their ultrasound agent SonoVue sometime this year. That big move is still awaiting U.S. Food and Drug Administration clearance, keeping the agent available in 39 other countries, but not the U.S.

And big news about contrast, good, bad or otherwise has been light during the past 12 months with no major new approvals to note and the one exception regarding news of concern being a report issued at RSNA in December. The report detailed some research findings of a medical team from Japan that may establish a link between linear gadolinium- based contrast medium and certain brain abnormalities. However, the study’s patient pool was small, comparing just 16 patients who had received one to six gadolinium-enhanced scans to 19 patients who had received more than six. The study’s lead author, Dr. Tomonori Kanda, from Teikyo University School of Medicine in Tokyo and the Hyogo Cancer Center in Akashi, Japan stressed that there is currently no conclusive proof that the contrast is responsible for the abnormalities and that further research is needed, including research involving macrocylic gadolinium-based contrast medium.

Getting size wise
Surprisingly, the biggest news around contrast medium updates doesn’t involve a new indication or research. It involves packaging. Customers have been demanding repackaging of contrast supplies and manufacturers have responded.

“We’ve developed a new presentation size for Eovist,” says Dennis Durmis, head of the Americas region for Radiology & Interventional at Bayer HealthCare. Durmis says the contrast medium, which is used for imaging the liver in adults, is now available in a 15mL single-dose vial to image patients weighing more than 220 pounds. Gadavist, an MR-enhancing contrast medium used to image the central nervous system in adults and children older than 2, is now available in a 2mL single-dose vial- for imaging of pediatric patients weighing 44 pounds or less.

“It’s ultimately up to the hospital to decide how they want to leverage individual vial sizes or whether they want to go the pharmacy bulk package route,” says Durmis. “Both are still out there and being used in different ways, but it certainly has been a big topic of discussion.”

The demand from customers and the subsequent response from manufacturers does make sense. Contrast is fairly expensive as consumables go and while bulk packaging can save facilities money, contrast use is governed by the same rules and regulations surrounding pharmaceuticals. In the case of bulk packaging, it means any unused contrast has to be disposed of 24 hours after it’s opened. For facilities with a large volume of patients, it’s unlikely to be an issue, but for smaller hospitals, individually packaged single-dose solutions can be attractive.

“Our customers are often looking at ways that contrast use can be expanded based on new studies and literature,” said Melissa Layman, vice president of Global Marketing at Lantheus Medical Imaging in an emailed response. “In August of 2013, we added a new packaging option for DEFINITY. We heard from our customers about packaging waste and space constraints and developed a new 16-vial pack that is more compact, cost efficient, and sustainable. With our 16-vial pack option, one cold chain box can fit up to 64 vials.”

With fewer packages, Layman says customers can streamline processes and reduce paperwork, produce less waste and save space.

The smaller delivery sizes will likely gain in popularity as equipment continues to get more sophisticated and therefore require less contrast to obtain optimum results. “High-speed CT scanners today are more involved with reconstruction algorithms,” says Sandra Schaffer, product manager of CT for Bracco. “You need less dose volume now than you did 10 or 15 years ago,” she says.

For the foreseeable future, with noted exceptions like SonoVue waiting in the wings, it’s likely that efforts will be focused on efficiency and cost control when it comes to contrast.

“With the ACA’s continued pressure on reimbursement and the price pressure with that, it’s really forcing companies to drive more efficient, lower-cost solutions instead of newer, more novel concepts,” says Bayer’s Durmis. “It’s forcing us to shift from the way we’ve historically invested our resources.” Betsy Rose, head of marketing for MR & ultrasound at Bracco Diagnostics Inc., shares a similar sentiment. “We are working with customers who are anticipating having to respond to meaningful use criteria and they’re trying to manage accordingly,” she says. Those customers are consolidating and managing staff in a way that they can do more with less according to Rose. “We’re partnering with them to respond to the demands and needs of this environment,” she says.