The Safety Profiles of Novel Agents Are Likely to be Scrutinized by Both Clinicians and Payers, According to a New Report from Decision Resources
BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the continued need for more efficacious drugs to treat irritable bowel syndrome (IBS) is evident in surveyed physicians’ overall low opinions of the effectiveness of currently available therapies as a large majority of physicians believe conventional IBS drug classes are only somewhat effective in treating IBS-associated motility symptoms. Additionally, surveyed primary care physicians (PCPs) are significantly more likely than surveyed gastroenterologists to consider Sucampo/Takeda/Abbott’s Amitiza (40 percent), Prometheus’s Lotronex (50 percent) and Salix’s Xifaxan (38 percent) to be very effective for IBS motility symptom management.
The new U.S. Physician & Payer Forum report entitled How will the First-In-Class Launches of Linaclotide, Rifaximin, and Asimadoline Shape the U.S. Irritable Bowel Syndrome Market? A Physician and Payer Perspective also finds that 29 percent of surveyed gastroenterologists who prescribe Xifaxan consider the drug to be ineffective in treating motility symptoms. The report also finds that, with the exception of Amitiza, surveyed PCPs rely heavily on long-marketed conventional agents while most surveyed gastroenterologists use Xifaxan and many use Lotronex. Additionally, at least 85 percent of surveyed PCPs and gastroenterologists currently prescribe conventional IBS treatments such as laxatives, antidiarrheals and antispasmodics.
According to the report, while most surveyed clinicians expect to use Ironwood/Forest/Almirall/Astellas’s linaclotide at some point in the future, surveyed gastroenterologists (30 percent) are more likely than PCPs (16 percent) to use it as soon as it becomes available. A slightly greater majority of surveyed PCPs (72 percent) than gastroenterologists (59 percent) plan to begin prescribing linaclotide once it has accumulated a favorable postmarketing safety record.
“Physicians’ caution in regard to linaclotide may be prompted more by concerns about limited understanding of a drug offering a new mechanism than by clinical data published to date,” said Decision Resources Vice President Cynthia Mundy, Ph.D. “To date, no serious safety signals have appeared in linaclotide’s clinical trials, and the drug targets gut-specific receptors that may limit the risk of serious systemic effects.”
The report also finds that most surveyed gastroenterologists and PCPs are taking a conservative approach to Tioga/Ono's asimadoline, possibly because the drug’s mechanism of action is poorly understood. The majority (63 percent) of surveyed gastroenterologists and PCPs (58 percent) indicate that they plan to begin prescribing asimadoline once it has accumulated a favorable postmarketing safety record. The safety profiles of novel agents are likely to be scrutinized by both clinicians and payers as concerns about rare instances of ischemic colitis associated with Lotronex continue to weigh heavily on physicians’ minds, and surveyed clinicians frequently cite a desire for more long-term safety data as a reason for skepticism about new agents.
“Similarly, payers cite lack of long-term safety data or insufficient clinical benefit to outweigh safety risks as reasons for excluding branded agents or relegating them to non-preferred status,” Dr. Mundy said.
About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
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