Patient Safety Org Says it is Time to Review New Evidence for FDA-Approved Weight Loss Drugs

ECRI report identifies reasons medications have been underutilized and urges action to help combat America's obesity epidemic

PLYMOUTH MEETING, Pa., Jan. 10, 2023 /PRNewswire/ -- With rates of obesity and diabetes at record highs, the nation's largest nonprofit patient safety organization is calling on healthcare leaders to change their approach and fully embrace FDA-approved weight-loss drugs. A report from independent nonprofit ECRI outlines a series of myths about weight-loss medication—such as their perceived inconsequence for losing weight and long-term ineffectiveness for keeping it off—that have led to them being dramatically underused. A large body of evidence shows that these drugs are beneficial as an adjunct to diet, exercise, and counseling and should be considered for first-line treatment in many patients, says ECRI.

"Obesity is epidemic and we need comprehensive evidence-based solutions," says Marcus Schabacker, MD, PhD, president and chief executive officer of ECRI. "By shining a spotlight on promising new evidence for weight-loss medications, we hope healthcare stakeholders and policymakers will adopt policies that better reflect current evidence-based conclusions on obesity."

ECRI researchers identified several reasons for the low rate of weight-loss drug use, including widespread skepticism of drugs' efficacy, unrealistic expectations of rapid weight loss, and personal beliefs that individuals should lose weight through their own efforts alone.

They say the key barrier, however, is financial. Subcutaneous, monthly injections list for around $1,200 for one dose. Oral medications can cost up to $250 for a one-month supply.

"Initial evidence is favorable for the effectiveness of weight-loss drugs, but insurance coverage is extremely limited, discouraging doctors from prescribing them and patients from using them," says Schabacker. "Insurers' unwillingness to cover weight-loss medication puts it out of reach, especially for people with low incomes who experience obesity disproportionately."

Weight-loss drugs are excluded from Medicare Part D plan requirements, and most Medicaid state plans and private plans qualifying for Affordable Care Act subsidies do not cover weight-loss drugs.

While ECRI identifies price as the main barrier, the researchers say many physicians have negative opinions of weight-loss medication based on out-of-date evidence or personal beliefs that people who are overweight or obese should lose weight through willpower and behavior change alone, leading to low prescribing rates for weight-loss drugs.

"The United States has struggled to follow an evidence-based approach to reduce obesity," says Dheerendra Kommala, MD, chief medical officer of ECRI. "The case of weight-loss drugs illustrates the need for continuous reevaluation in evidence-based medicine to prevent outdated perceptions from taking root, address evidence gaps, and evaluate emerging interventions."

ECRI urges stakeholders to follow the FDA's evidence-based decisions in approving the use of weight-loss medicines, which can improve population health and decrease downstream costs. According to the Centers for Disease Control and Prevention, over 70% of Americans are considered over-weight or obese, and the annual cost of obesity on the U.S. healthcare system is estimated at $173 billion.

"Millions of people in America resolve to live healthier lives in 2023, possibly including weight loss among their goals," says Schabacker. "Physicians must set aside the misinformation about weight-loss drugs, and personal biases about whether and how people can recover from obesity. Every person who loses excess weight improves their health, decreases the likelihood of future medical issues, and cuts healthcare costs. We need to use every tool in our arsenal to help them."

ECRI notes that stakeholder coordination and communication, including with manufacturers, is critical to maintain a sufficient supply of drugs able to meet current and future demand, especially for those who rely on the medications for diabetes management.

ECRI's position paper, Outdated Notions and Persisting Misconceptions Bar the Way to Effective Obesity Treatment, and evidence assessments on weight loss medications are available at www.ecri.org.

NOTE: ECRI received no funding from manufacturers of weight-loss drugs in preparing this independent research assessment.

ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on technology evaluation and safety, ECRI is respected and trusted by healthcare leaders and agencies worldwide. Over the past fifty-five years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the U.S. Department of Health and Human Services. The Institute for Safe Medication Practices (ISMP) formally became an ECRI Affiliate in 2020. Marcus Schabacker, MD, PhD, President and CEO of ECRI, has been recognized by the Philadelphia Business Journal as a Healthcare Leader in 2021. Visit www.ecri.org.

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SOURCE ECRI