Hologic is already looking ahead to reimbursement and training requirements for its Selenia Dimensions 3D three-dimensional digital mammography system as it works with FDA on final pre-market approval issues, the company says.

The firm continues to anticipate FDA approval in 2011 following a unanimous endorsement of safety and efficacy data from FDA's Radiological Devices Advisory Panel Sept. 24 (¹ Also see "Hologic Selenia 3D Digital Mammography System Gets Panel Nod" - Medtech Insight, 27 September, 2010.).

Reimbursement from both Medicare and private payers will likely be the most significant factor in achieving widespread adoption of the first-of-its-kind 3D mammography system, once approved, market watchers say.

"We do have plans in place" for achieving Medicare reimbursement, Hologic VP of Regulatory Affairs and Quality Assurance Arthur Friedman told "The Gray Sheet" in a post-panel interview.

The firm also will work individually with private payers on reimbursement, Friedman said. However, "predicting the reimbursement is almost as challenging as predicting FDA approval."

Reimbursement Could Take Until 2012 - Analysts

Achieving reimbursement for the Hologic 3D tomosynthesis technology "is likely a year or two away" from when FDA approval is granted, Susquehanna analyst David Turkaly said in a Sept. 20 report. "And a premium will probably be required to drive meaningful adoption" of the technology, he said.

"Reimbursement remains a 2012 event and meaningful revenue contribution [from 3D sales] will not accrete until that time," Morgan Stanley analyst David Lewis echoed in a Sept. 24 report.

For "broad-spectrum reimbursement ... the earliest estimation is in the back half of 2012," Lewis noted. "Obtaining reimbursement will take additional time and data."

Hologic also is negotiating with FDA on the details of a training program for radiologists to use the 3D system.

Training emerged during the FDA panel review as a prominent issue to help ensure appropriate use of the technology by radiologists. The panel generally agreed that the device can help radiologists reduce unnecessary follow-up visits for cancer-free patients without missing true cancer cases, with proper training.

Radiologist Workflow Will Change With 3D

During a Sept. 27 Morgan Stanley conference call on commercialization expectations for Selenia Dimensions 3D, two radiologists discussed their experiences with training and reimbursement for current-generation two-dimensional digital mammography systems and their expectations for the 3D system.

Both Linda Moy, New York University Medical Center, and Joseph Lo, Duke University associate professor of radiology, acknowledged that the 3D system would offer many benefits to physicians and their patients. However, they also described the potential for the device to interfere with current workflow patterns at their practices, and the need for appropriate reimbursement and training.

Although 3D can enable fewer patient call-backs to boost productivity down stream, it can take up to 10 minutes to read a 3D image versus two minutes for a 2D digital image, the radiologists said. The resulting decline in throughputs "could slow adoption initially and increase the reimbursement premium physicians desire" to perform the 3D imaging, analyst Lewis said.

Hologic's Friedman countered that while reading a 3D image might take slightly more time than reading 2D, "I don't think it will be significantly more." While Hologic has not yet disclosed its pricing expectations, analyst Turkaly estimates that the 3D upgrade for existing Selenia Dimensions 2D systems would cost $100,000 to $150,000.

"The training is going to be really critical," as it was with 2D implementation, and "reimbursement is a big issue," Moy noted. But pressure from patients and hospital administrators likely will require her practice to purchase at least one of the systems in the near term, she said.

- Sue Darcey ( ² s.darcey@elsevier.com )

Hologic Looks Ahead To Reimbursement, Training For 3D Mammography

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