Medical management of miscarriage reduces costs and maintains quality of care
Medical management of early pregnancy loss costs less and provides a similar quality of life to uterine aspiration, based on data from an analytical model.
Early pregnancy loss (EPL) occurs in more than one million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance. , Mass., and colleagues.
A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased efficacy and reduced the need for additional medications or subsequent uterine interventions, but the cost of mifepristone is perceived to be a barrier, and the cost-effectiveness of its use, compared to surgical or expectant management, has not been well studied, the researchers noted.
“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” said co-author Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, in an interview. “Procedural uterine aspiration is also very effective, so patients and providers can consider cost when deciding on a treatment strategy,” she added.
“If medication management is preferred by many patients, reduces the need to access in-person clinical care during a pandemic, and proves cost-effective, clinicians and policymakers should redouble their efforts to improve the availability of mifepristone and reduce access loads,” the researchers wrote.
In a study published in the American Journal of Obstetrics & Gynecology, researchers created a decision analysis model using data from the published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare the In-office uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.
The PreFaiR study randomized 300 women who underwent EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment with 200 mg oral mifepristone. The average age of participants was 30.7 years and demographics were similar between the groups.
The researchers used PreFaiR data for medical management and patient-level data from the published literature for uterine aspiration.
The primary endpoint was the cost per quality-adjusted life-year (QALY) gained. QALY was based on a utility score modified from published literature. Efficacy was based on QALY gained and rate of complete expulsion of the gestational sac without additional intervention.
Overall, the average costs per person were significantly higher for uterine aspiration, compared to medical management ($828 versus $661, P = 0.004). Uterine aspiration was significantly more effective for complete expulsion of the gestational sac (97.3% versus 83.8%, P = .0001). However, QALYs were significantly higher for medical management, compared to uterine aspiration (0.082 vs 0.079, P
Cost-effectiveness was higher for medical management from a healthcare sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.
They also assessed the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost-effective, compared to uterine aspiration, even though uterine aspiration procedures decreased in cost and that mifepristone was increasing in cost, and even if medication management had a reduced completion rate. and utility score, compared to uterine aspiration.
“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the upper willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the results. .
Potential savings, uncertain access
Despite the potential cost savings and patient benefits, access to mifepristone remains a barrier, the researchers said.
Although the FDA lifted some restrictions on mifepristone in 2021 as a result of the ongoing COVID-19 pandemic, the effect of the new restrictions related to abortion remains to be seen.
The study results were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, although actual costs vary by region and payer, noted Researchers. Other limitations include variations in the cost of mifepristone by region and time and differences in data sources between the uterine aspiration and medical management groups. Further research is needed to assess QALYs for early pregnancy loss to establish standard measures and assess the societal perspective of ALS as well as the healthcare perspective, they added.
However, the current findings support the medical management of PE with pretreatment with mifepristone followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Expanding access to mifepristone and removing unnecessary restrictions will improve care in early pregnancy,” they concluded.
“Given the efficiency of procedure management, we were slightly surprised that medical management remained profitable,” Schreiber said in an interview.
In the run-up to new restrictions on abortion, “patients may have difficulty accessing medical or procedural care for early pregnancy loss,” 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 the regulation
“Given the recent reversal of Roe vs. Wadeall medications associated with abortion are under increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used to manage early miscarriages,” said Sarah W. Prager, MD, from the University of Washington, Seattle, in an interview. “Demonstrating that drug management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is another reason to deregulate mifepristone so that it can also be more accessible for the management of EPL” , said Prager, who was not involved in the study.
Prager said she wasn’t surprised by the results because an effective drug should be cheaper than a procedure. “I would caution that the increase in QALYs found in this study should not be interpreted as a reason to restrict the surgical management of EPL, but also to increase access to medication management, even though drugs have a slightly lower rate of complete expulsion of the gestational sac,” she added. Noted. “The 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 the power to remove REMS, which would immediately make mifepristone a drug that can be prescribed in pharmacies and therefore be much more available,” Prager said. “Restrictions for both drug and surgical management of EPL will likely increase in states where abortion is illegal, and this could eventually lead to patients having fewer choices about how they are managed” , she explained.
“There are numerous studies showing that all modes of EPL management are safe and effective and should be supported when it comes to patient choice,” Prager noted. “There is also substantial data supporting the overall safety of mifepristone, and there is no scientific or medical data to suggest that REMS increases safety in any way. Frankly, there are no good evidence-based reasons to continue to keep REMS in place,” she says.
The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Mid-Career Mentorship Fellowship from the Society of Family Planning Research Fund. The researchers had no financial disputes to disclose. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. New.
This story originally appeared on MDedge.com, part of the Medscape Professional Network.