The Food and Drug Administration has approved the use of MRI contrastagent Magnevist for whole-body applications, making the productthe first agent to be cleared for use outside the central nervoussystem. The FDA's action will improve Magnevist's
The Food and Drug Administration has approved the use of MRI contrastagent Magnevist for whole-body applications, making the productthe first agent to be cleared for use outside the central nervoussystem.
The FDA's action will improve Magnevist's position againstcompeting gadolinium-based agents from Bristol-Myers Squibb andSterling Winthrop as MRI expands into new clinical areas. Magnevistis marketed in the U.S. by Berlex Laboratories, the U.S. subsidiaryof Germany's Schering.
About 25% to 30% of all MRI scans are of areas outside thecentral nervous system, and the potential for growth outside theCNS is great. Some MRI applications, such as breast and kidneyimaging, are impractical without contrast.
"Renal imaging is almost a waste of time without contrastMRI. With contrast it's as least as good as CT," said Dr.Jeffrey C. Weinreb, director of MRI at New York University Schoolof Medicine.
Some radiologists have already been using contrast agents forwhole-body MRI on a practice-of-medicine basis. The FDA's action,delivered in late August, gives the green light to the rest ofthe radiology community and sets the stage for widespread Medicarereimbursement of whole-body contrast.
Medicare reimburses for whole-body contrast on a case-by-casebasis, according to Berlex. Berlex is working with the HealthCare Financing Administration to develop current procedural terminology(CPT) codes for whole-body contrast reimbursement.
The FDA's move comes as welcome news for Berlex. The companyhad the MRI contrast agent market to itself for four years butmust now contend with two competitors, Sterling Winthrop's Omniscanand ProHance from Bristol-Myers Squibb (SCAN 1/27/93 and 12/2/92).
Since Omniscan and ProHance hit the market, Magnevist's sharehas fallen to about 70% to 75% of all contrast used, accordingto the company. Having the whole-body segment to itself couldallow Berlex to reclaim some of the market share it has lost,at least until Sterling and Squibb win whole-body approval fortheir agents. Both companies have applied for approval for useoutside the CNS.
"(Whole-body approval) creates a larger market, and Berlexwill dominate that market for a period of time because it hasthe only product approved," said David S. Talbot, an analystwith Arnhold and S. Bleichroeder of New York City. "It'simportant from a competitive standpoint, now that it has to sharethe market."
Breast imaging is one of the most promising new areas for MRIcontrast use, and Berlex and Schering have capitalized on theFDA's go-ahead to establish a beachhead in this area. The companiesare participating with multimodality vendor Siemens in an internationalresearch study to assess the use of contrast-enhanced MRI in diagnosingbreast cancer.
The project began in September at eight research institutionsin Sweden, the Netherlands, Germany and the U.S., and will studyabout 2000 women over a two to three-year period. It is beingconducted by the Medical Engineering Group of Siemens A.G.
Advisors to the study include Dr. Laszlo Tabar of Central Hospitalin Falun, Sweden; Dr. Edward Sickles of the University of Californiaat San Francisco; and Dr. Roland Holland of the National BreastScreening Center in Nijmegen, the Netherlands.
The study is attempting to determine whether Magnevist-enhancedMRI scans provide radiologists with enough information to recognizeand differentiate between benign and malignant lesions, accordingto Siemens.
The study is being conducted with Siemens' dedicated bilateralbreast coil, which was released last year (SCAN 7/15/92).
Studies like the Magnevist-Siemens project could lay the academicfoundation for a surge in use outside the CNS.
"MRI is not being applied for whole body very broadly," Weinreb said. "The increase in whole-body applications willdepend on radiologists being educated, gaining experience, learningnew techniques and having the equipment that allows them to dogood whole-body MRI. For those people, contrast is going to improvediagnostic quality and increase the number of cases they are doing."