Bulletin Today
Does biosimilar competition lower costs for patients?
Biosimilars have typically been viewed as cost-saving medications, but according to results of a study published on March 29, 2024, in JAMA Health Forum, biosimilar competition did not consistently lower out-of-pocket costs for outpatients who were commercially insured. In fact, in some cases, costs even increased.
“Prices for biosimilars are typically 15% to 35% lower than their respective brand-name reference biologic, and can prompt the brand name manufacturers to lower prices or offer discounts,” noted the study authors. What they wanted to find out was whether biosimilar competition lowers costs for patients.
The researchers conducted a cohort study using a national commercial claims database and identified the out-of-pocket costs for those who were commercially insured across 7 physician-administered biologics with a biosimilar available in the United States from January 2009 through March 2022. The biologics included filgrastim, infliximab, pegfilgrastim, epoetin alfa, bevacizumab, rituximab, and trastuzumab. The primary outcome included out-of-pocket costs for the patient, such as deductible, copayment, and coinsurance.
Researchers performed two analyses to measure the association between biosimilar competition and out-of-pocket costs. In the first analysis, two biologics, rituximab and trastuzumab, were the only ones that showed significantly lower mean nonzero annual out-of-pocket spending after 2 years of biosimilar competition. The other drugs were either higher in cost or did not yield significant changes. In the second analysis, researchers found that 28% of the reference biologic claims and 17% of biosimilars had nonzero out-of-pocket costs, but after adjustment, biosimilars were more likely to have nonzero out-of-pocket claims compared to the reference product.
An important takeaway for policymakers, said the study authors, is to advocate for more targeted policy interventions that make biologics and biosimilars affordable and accessible to patients who need them. ■
Some Medicare health plans to start paying for weight-loss drugs
CVS Health, Kaiser Permanente, and Elevance Health will be the first major insurers in the country to cover the GLP-1 receptor agonist semaglutide (Wegovy—Novo Nordisk) for a segment of the Medicare population. The announcement by the companies came in late March.
Medicare has been blocked from paying for weight-loss drugs, but CMS recently said exceptions might be made if a medication is approved for additional indications. On March 8, 2024, FDA cleared semaglutide to lower the risk of heart disease and stroke in patients with overweight or obesity.
To qualify for Medicare coverage, beneficiaries must be enrolled in Part D and have a BMI above a set threshold plus documented heart disease. Elevance Health said they will pay for the GLP-1 receptor agonist for patients in the commercial insurance space who match this profile.
Expanded coverage will come as a relief to many patients who often pay upwards of $1,000 out of pocket for semaglutide. However billions of dollars spent on semaglutide could be racked up even as health plans struggle to keep costs in check. ■
Hormonal contraception will be available without a prescription in New York pharmacies
The New York State Department of Health issued an order in late March to formally implement a new law establishing access to hormonal contraception from pharmacists without a physician’s order.
Both residents of New York and nonresidents can receive a 1-year supply of oral contraception, vaginal rings, or patches from participating pharmacies, which will provide consultation and counseling services.
State officials estimate that 85% of pharmacies will take up the new authority, which seeks not only to eliminate barriers to access, but to protect reproductive rights in the post-Roe landscape. More than 20 states have restricted or completely outlawed abortions since the U.S. Supreme Court repealed the landmark ruling that empowered women with a constitutional right to terminate a pregnancy. At least two dozen other states have preceded New York in granting pharmacists some capacity to dispense contraception without a prescription. ■
Study links heart failure risk to e-cigarette use
Data from an NIH-led study found that people who used e-cigarettes were 19% more likely to develop heart failure compared with people who never vaped.
Researchers used data from surveys and EHRs in the NIH-run All of Us study of 175,667 study participants. The average age of participants was 52 years, and over half were female.
In all, 3,242 participants developed heart failure within a median follow-up period of 45 months. The researchers accounted for demographic and socioeconomic factors, heart disease risk factors, and participants’ past and present use of other substances.
The connection between e-cigarettes and heart failure was not affected by participants’ age, sex, or smoking status, noted researchers.
“More and more studies are linking e-cigarettes to harmful effects and finding that it might not be as safe as previously thought,” said Yakubu Bene-Alhasan, MD, the study’s lead author in an American College of Cardiology (ACC) news release. “The difference we saw was substantial. It’s worth considering the consequences to your health, especially with regard to heart health.”
The findings were presented at the ACC’s Annual Scientific Session on Sunday, April 7, 2024, in Atlanta, GA. ■
Model sets out to tackle CVD disparities through pharmacy team partnerships
CDC, in partnership with APhA, has announced the teams that will be part of a project to advance health equity and prevent heart disease and stroke in the United States.
The Community of Practice Teams are part of the Advancing Health Equity and Pharmacy-Based Strategies, Pharmacists Patient Care Services and Support Services project. Through an application process, teams were selected from state and local health departments, state pharmacy associations, professional organizations, colleges of pharmacy, pharmacy practice settings, and community-based organizations.
Six teams in total have been selected to participate in the project based on their composition, qualifications, and commitment to CVD prevention. The teams have a goal to use pharmacy-based strategies to address racial and ethnic disparities in CVD risk factors, prevalence, and outcomes. ■
Semaglutide yields positive results for patients with obesity-related heart failure and T2D
Results of a study published in NEJM on April 6, 2024, found that semaglutide led to greater reductions in weight loss and heart failure–related symptoms in patients who had obesity-related heart failure with preserved ejection fraction and T2D compared with placebo.
In the trial, STEP-HFpEF DM, researchers randomly assigned 616 patients who had heart failure with preserved ejection fraction, a BMI of at least 30 kg/m2, and T2D to receive weekly injections of semaglutide 2.4 mg or placebo for 1 year.
With semaglutide, the mean change in the Kansas City Cardiomyopathy Questionnaire clinical summary score—a primary endpoint—was 13.7 points compared with 6.4 points with placebo. The second primary endpoint, the mean percentage change in body weight, was –9.8% with semaglutide versus –3.4% with placebo.
Data for the confirmatory secondary endpoints—the change in 6-minute walk distance, win ratio for a hierarchical composite endpoint, and the change in the C-reactive protein level—also favored semaglutide over the placebo. Additionally, semaglutide resulted in fewer serious adverse events compared with placebo. ■