CONTACT: Aimee Frank
AGA Members Also Cite Insurance Company Impact on Biologic Drugs Prescribing
Bethesda, MD (July 29, 2015) –The American Gastroenterological Association (AGA), the leading voice of the gastrointestinal community, today released the findings of a national survey of gastroenterologists on biologics and biosimilars. Regularly prescribed for inflammatory bowel disease (IBD), biologics are treatments made from biological materials and are more difficult to produce and manufacture than traditional chemical-based drugs. Biosimilars are therapies similar to, but not exact copies, of innovator biologics. The survey of 180 AGA members examined their prescribing practices and explored their views on the safety and quality standards needed as biosimilars enter the U.S. marketplace.
The survey revealed that almost all respondents currently prescribe biologics to their patients, and a majority has, at some point, had to switch a treatment due to their patients’ insurance plan. It also demonstrated that rigorous clinical testing proving efficacy was important for nearly all respondents when deciding to prescribe a biologic. Approximately two-thirds of respondents favored a policy similar to Health Canada that would not allow indication extrapolation in the approval of biosimilars for IBD.
“Many gastroenterologists successfully use biologics to treat their IBD patients and are comfortable with their knowledge to prescribe the agents to induce remission,” said James Lewis, MD, AGAF, professor of medicine at the University of Pennsylvania, Philadelphia. “Our members welcome access to new therapies like biosimilars, particularly if they can lower costs to patients without compromising the effectiveness and safety of our therapies.”
As biosimilars come on the market, AGA advocates that biosimilar drug names be distinguishable nonproprietary names and that patients should not be forced to switch their biologic treatments without prior notification of their health-care provider.
The AGA survey was broken up into two sections: one regarding biologics and the other on the approval process for biosimilars. Notable findings of the survey include:
- 96 percent of respondents prescribe biologic medicines to their patients.
- 81 percent of respondents believe strong evidence of effectiveness of biologic drug therapy from well-designed clinical studies is a very important factor when starting a patient on a biologic — nearly half of respondents say this is the most important factor.
- Almost 60 percent of all respondents said they have had a patient’s biologic treatment switched due to insurance company rules. 87 percent of respondents are concerned about pre-authorization for biologics, including 61 percent who are “extremely” or “very” concerned. Delay in treatment (39 percent) was the top concern about the need for pre-authorization approvals.
Biosimilar standards, quality & safety section:
- 40 percent of respondents felt they were extremely or very familiar with biosimilars while 51 percent were somewhat or slightly familiar with biosimilars.
- 72 percent of respondents report that they would be likely to prescribe biosimilars if they became available in the U.S., with 49 percent “extremely” or “very” likely to prescribe.
- 71 percent and 59 percent of respondents said they would be likely to prescribe an interchangeable and non-interchangeable biosimilar, respectively.
- 67 percent of respondents favored a policy whereby the FDA would not allow indication extrapolation in the approval of biosimilars for inflammatory bowel diseases relative to a policy that allowed for indication extrapolation.
When considering a biosimilar:
- 80 percent of respondents say they are very concerned with the level of clinical similarity in terms of effectiveness and safety to the reference biologic and the biosimilar efficacy.
- 78 percent of respondents are very concerned about biosimilar safety/immunogenicity.
- Among respondents who are unlikely to prescribe biosimilars, 69 percent report that they would be unlikely to prescribe biosimilars because they do not have experience with biosimilars.
- 66 percent of respondents who are unlikely to prescribe biosimilars believe there will not be enough clinical data on biosimilars.
- 65 percent of respondents who are unlikely to prescribe biosimilars say they need time to evaluate the effectiveness of biosimilars.
- 55 percent of respondents believe that pharmacy-level substitution of interchangeable biosimilars should only be allowed with prescriber notification.
- 35 percent of respondents believe that pharmacy-level substitution should never be allowed.
Physicians and patient groups have called on FDA to issue further rules and guidance documents concerning the implementation of biosimilars.
This survey was conducted by AGA with support from AbbVie. The survey sample has been weighted to match the demographics of AGA’s membership based on region and length of time practicing medicine. The standard margin of error for the survey at the 95 percent confidence level is 7.3 percent. These survey findings do not constitute a formal policy of the AGA and do not necessarily reflect the opinion of the AGA Governing Board members or Dr. Lewis.
About the AGA
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org.