Potential savings, uncertain access
Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.
Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.
The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.
However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.
“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.
Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
Reasons to lift regulations
“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.
Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”
Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.
“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.
The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.