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If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025.

FDA Accepts BLA for Leqembi Autoinjector 

Study authors Susan D. Reed, MD, MPH, MS, and Erin Dwyer, MPH, both at the University of Washington School of Medicine, attribute some of these different challenges to underlying health disparities.

Menopause Challenges Across Rural, Suburban and Urban Communities

Doug Mirsky, Ph.D., is vice president of healthcare development at the Digital Medicine Society.

A prediction of 2025 by Doug Mirsky, Ph.D., vice president of healthcare delivery at Digital Medicine Society.


Digital Lifeline | Predictions for 2025

A prediction for this year by Shawn Gremminger, president and CEO of National Alliance of Healthcare Purchaser Coalitions.

Show us Your Prices | Predictions for 2025

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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Women living in rural areas experience higher rates of menopausal symptoms — such as mood changes, sleep issues sand musculoskeletal pain — compared to women in urban and suburban communities.

A new, first-of-its-kind study published in 

 found that these symptoms occur particularly during the late menopause transition and post-menopause.

Women living in rural communities tend to face more health issues than those in urban communities, such as higher rates of anxiety, depression, obesity and heart disease.

However, there is limited research on how women in rural, suburban and urban communities experience menopause differently, according to study authors.

Menopause — a natural but sometimes burdonsome stage in a woman’s life — can greatly affect her health and well-being. Many women (80%) experience symptoms such as hot flashes and night sweats, which can lead to poor sleep, memory issues and depression.

Rural women may have a more difficult time during menopause as they are more likely to deal with challenges including higher stress, financial problems, smoking and lower levels of education.

Common menopause symptoms such as trouble sleeping, mood swings, memory issues and discomfort in the urinary area are well-known, but little is known about how often or how severely rural women experience them.

Researchers of the study compared how menopause affects rural women differently from those in suburban and urban communities, focusing on symptoms, treatments and attitudes toward menopause care, using data from a 2019 online survey by HealthyWomen and WebMD.

From September to October 2019, the survey gathered responses from 3,197 U.S. women aged 18 and older. Researchers focused on women aged 45 and older in the late menopause transition or postmenopause.

Data was divided by rural, suburban and urban residence, and age-weighted proportions of symptoms and treatments were analyzed using chi-square tests to identify differences between groups.

Out of 1,531 women, 45% were in the late menopause transition (average age 50) and 55% in postmenopause (average age 65). Rural women in late menopause transition reported higher rates of muscle aches (65%) and panic attacks (30%) compared with urban and suburban women.

In postmenopause, rural women experienced more mood swings (23%), urinary incontinence (23%) and vaginal dryness (37%) than those in urban and suburban communitues.

Hot flashes were common with 71% in late menopause transition and 20% in postmenopause, but only 11% of women used menopause hormone therapy, regardless of where they lived.

Access to menopause resources did vary by location.

Additionally, researchers found that rural, urban and suburban women use different ways to find health information.

To raise awareness about the risks and benefits of therapies such as menopause hormone therapy (MHT), it’s suggested that organizations should modify communication methods to fit the target audience.

Researchers found that rural women in the late menopause transition relied more on healthcare providers for information, while urban women used social media more often. Postmenopausal rural women were also less likely to engage with blogs or message boards compared to urban women.

Previous studies show that self-confidence, support and knowledge are key factors in helping rural women make informed decisions about MHT.

This study holds many strengths based on the range of findings. One includes using data from a large, diverse U.S. population and comparing rural, suburban and urban women.

However, there are limitations. The study relied on self-reported survey data, it did not track symptom duration and used categories for residence that were defined by the participants themselves.

Recruitment through WebMD provided diversity, but it also created a sample that might not fully represent all women's menopause experiences.

With the low use of menopause hormone therapy, researchers suggest that more education is needed about this treatment. This education should be designed to fit the needs and lifestyles of women in different communities.

A new, first-of-its-kind study found that these symptoms occur particularly during the late menopause transition and post-menopause.

Clinical

Rural Women Experience Worse Menopausal Symptoms and Limited Resources, Study Finds

It was found that those living with posttraumatic stress disorder (PTSD) who took a combination of Rexulti (brexpiprazole) and sertraline had much better improvements in their symptoms than those who took sertraline with a placebo, according to a new study published in 

People with PTSD experience four main symptoms: reliving the trauma, avoiding reminders of it, negative changes in mood or thinking and being easily startled or on edge.

The disorder is common in the U.S. and globally, with the highest risk associated to traumatic events involving violence, such as physical or sexual assaults. PTSD significantly affects people’s lives, leading to social and work challenges, poor quality of life and even suicide.

Currently, the only medications approved by the FDA for PTSD are the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine.

However, these medications don’t work for everyone. For example, in a previous analysis, about 42% of patients didn’t respond to the medications.

They are also less effective for specific symptoms such as reliving the trauma and heightened arousal.

As a result, doctors typically use multiple medications to treat a range of symptoms, highlighting the need for better treatment options

Rexulti is a medication used for other mental health conditions and has shown promise for PTSD. Early studies suggest that combining brexpiprazole with sertraline may effectively and safely reduce PTSD symptoms.

In this parallel-design, double-blind, randomized clinical trial, sponsored by Otsuka Pharmaceutical Development & Commercialization, researchers examined how well the combination of brexpiprazole and sertraline works for treating PTSD in adults compared to sertraline with a placebo. Researchers also reviewed its safety and efficacy.

The study took place at 86 locations in the U.S. from October 2019 to August 2023. Participants first took a placebo for one week, then, for the next 11 weeks, one group took a mix of two medicines: brexpiprazole (2-3 mg daily) and sertraline (150 mg daily). The other group took sertraline (150 mg daily) with a placebo.

To measure improvements, researchers used a tool called CAPS-5, which checks how severe 20 PTSD symptoms are. They also kept track of any side effects during the study.

Out of 1,327 participants screened, 416 joined the study and were split into the two groups. After 10 weeks, more folks in the brexpiprazole sertraline group (64%) finished the study compared to the sertraline and placebo group (56%).

The brexpiprazole + sertraline group showed a much bigger improvement in PTSD symptoms, as measured by CAPS-5 scores, compared to the placebo group.

On average, their scores dropped by 19.2 points, while the placebo group only dropped by 13.6 points, with a statistically significant difference.

Some side effects were reported, including nausea, fatigue and weight gain. These were slightly more common in the brexpiprazole + sertraline group but were generally manageable.

Fewer people in the brexpiprazole and sertraline group (3.9%) stopped the treatment due to side effects compared to the placebo group (10.2%).

This study has many strengths including participants with different types of trauma, making it more relatable of real-life PTSD patients. Most participants hadn’t used PTSD medications before, which helped received clear results.

Additionally, the study also used both doctor and patient reports to measure results.

Though there were limitations, including only monitoring U.S. participants, the study left results potentially only applying to a smaller audience.

The study also excluded people with depression, which is common in PTSD, making the findings less relevant for some patients.

Adding brexpiprazole to ongoing sertraline treatment works was also not tested, and the study didn’t show how long treatment should last. Researchers suggest further investigation is needed to understand long-term effects and safety.

Currently, the only medications approved by the FDA for PTSD are the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine. However, these medications don’t work for everyone.

PTSD Treatment Shows Promise with Brexpiprazole, Sertraline Combination

The patient engagement movement is set to advance significantly in 2025, with patients taking greater ownership of their health. This shift will empower individuals to be actively involved across their entire healthcare journey — from developing innovations, such as drugs and digital health tools, to decisions about the value and access of these interventions.

Patient involvement will begin earlier in these processes, ensuring their voices are integral to shaping healthcare solutions. Additionally, this participation will become more inclusive, reflecting the diverse populations the healthcare system serves. These trends highlight a growing emphasis on equity and patient-centered care, redefining how healthcare systems collaborate with individuals to achieve better outcomes.

A prediction for this year from Jason Spangler, M.D., M.P.H., CEO, Center for Innovation & Value Research.

Power to the Patients | Predictions for 2025

There have exceptions to their rule, such as glucagon-like peptide 1 (GLP-1) drugs and the COVID-19 vaccines. But drugs to treat cancer have been the dominant force in pharmaceutical innovation, clinical trials and drug expenditures for many years now, and nothing in Kaelyn C. Boss’ oncology drug pipeline talk yesterday at the 2024 Academy of Managed Care Pharmacy (AMCP) Nexus meeting suggested that is going to change any time soon.

Oncology represents a large portion of the drugs in development, with approximately 1,600 medicines and vaccines in the pipeline, Boss, a clinical consultant pharmacist at UMass Chan Medical School in Worcester, Massachusetts, told the AMCP Nexus audience. A large percentage of the cancer-fighting agents are treatments for rare cancers with a relatively small number of suitable patients, Boss said, while also noting that there are also a large number of agents in development for solid tumors that affect many more people, she noted.

Boss said that spending on cancer drugs worldwide is projected to increase to $409 billion by 2028. The price of novel agents is high at more than $200,000 per year on average. She said that biosimilars and generic medications may yield savings, but the money saved is no match for new agents and the trajectory of higher spending.

Boss’ encyclopedic overview of oncology drug development included drugs that the FDA has approved this year, some of which were for new indications of previously approved drugs that had been previously approved, as well those still in the wings, with FDA action expected later this year or in early 2025.

Sita Bhatt, Pharm.D., a clinical pharmacy specialist at Boston Medical Center, joined Boss in making a presentation during the oncology pipeline session. She spoke about the growing number of cell therapies for solid tumors, a group that that includes LN-145-S1 for head and neck squamous cell carcinoma (HNSCC) and melanoma; LN-145 Gen 3 for HNSCC, melanoma and NSCLC; letetresgene autoleucel for soft tissue sarcoma; ECT240 for liver cancer; ET140203 for liver cancer; and CARv3-TEAM-E for glioblastoma.

“We can see a shift towards cell therapies for solid tumors,” Bhatt said. “44% of all trials initiated in 2023 [were] for solid tumor indications . . . this is really where we're seeing the trend in the oncology pathology space right now.”

Here are the cancer drugs that Boss discussed that have been approved by the FDA this year.

Itovebi (inavolisib), a PI3K inhibitor for HER2-negative breast cancer with a PIK3CA mutation, was also approved on Oct. 10. It was studied in combination with fulvestrant and palbociclib following progression on at least one endocrine-based regimen or within 12 months of adjuvant therapy. It is also being studied in combination with fulvestrant for HR+/HER2- breast cancer and in combination with dual HER2 blockade and endocrine therapy.

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) is a PDL-1 inhibitor that was approved on Sept. 12. for multiple indications, including nonsmall cell lung cancer (NSCLC). It is formulation of Tecentriq that will allow for subcutaneous administration. Tecentriq was orginally approved in 2016.

The combination of Lazcluze (lazertinib) and Rybrevant (amivantamab) was approved on Aug. 19 as a first-line treatment NSCLC with epidermal growth factor receptor (EGFR) mutations.

Niktimvo (axatilimab) is an anti-CSF-1R antibody approved for chronic graph versus host disease (GVHD) on Aug. 14.

Lymphir (denileukin diftitox-cxdl) is an IL2-receptor-directed cytotoxin approved on Aug. 7, for relapsed or refractory cutaneous T-cell lymphoma. The drug is a reformulated version of Ontak (denileukin diftitox), which was withdrawn due to manufacturing errors. National Comprehensive Cancer Network guidelines recommend the drug as preferred for stage 2B mycosis fungoides with generalized tumor disease and useful for some situations with other stages of mycosis fungoides with limited tumor disease.

Voranigo (vorasidenib) is an IDH1 and IDH2 inhibitor that was approved on Aug. 6 for treatment of grade 2 IDH-mutant glioma. The drug is also being studied in combination with Keytruda (pembrolizumab0 for recurrent or persistent IDH-1 astrocytomas. Of note, the cost per 40 mg tablet is $1,329 and $29,881 per 30 count bottle.

Tecelra (afamitresgene autoleucel) is a MAGE-A4-directed genetically modified autologous T-cell immunotherapy that received accelerated approval on Aug. 2 a as treatment for unresectable or metastatic synovial sarcoma. It is one-time intravenous therapy that modifies T cells to attack cancer cells. The drug was launched with a list price of $727,000.

Augtyro (repotrectinib) is a kinase inhibitor that was granted accelerated approval on June 13 as a treatment for solid tumors with a neurotrophic tyrosine receptor kinase gene fusion that are locally advanced or metastatic, positive solid tumors. It had been previously approved in November 2023, as treatment for locally advanced or metastatic ROS1-positive NSCLC. The estimated cost per 120 count of the drug is $14,500.

Rytelo (imetelstat) is an oligonucleotide telomerase inhibitor that received approval on June 6 as a treatment for low- to intermediate-1 risk myelodysplastic syndrome (MDS) with transfusion dependent anemia. Rytelo is priced to cost approximately $385,000 a year (based on a patient weighing 70 kg), which is almost four times more than an Institute for Clinical and Economic Review assessment said it should cost based on common cost-effectiveness thresholds. 

Imdelltra (tarlatamab-dlle) received accelerated approval on May 16 as a bispecific T-cell engager for extensive stage small cell lung cancer. The estimated cost of the drug is $15,000 per 10 mg, $31,500 for cycle one and step-up dosing, and $30,000 for cycle 2 and beyond. According to NCCN recommendations, Imdelltra is preferred for small cell lung cancer as subsequent systemic therapy in chemotherapy free intervals of 6 months or less.

Ojemda (tovorafenib)accelerated approval on April 23 as a Pan-RAF kinase inhibitor for relapsed or refractory pediatric low-grade glioma with BRAF fusion or rearrangement, or BRAF V600 mutation. The estimated cost per 16, 20 or 24 count bottle is $33,916 and $8,479 per 12 mL bottle. The drug is also being studied in combination with nivolumab for the treatment of craniopharyngioma.

Anktiva (nogapendekin alfa inbakicept-pmln) received approval on April 22 as an IL-15 receptor agonist for Bacillus Calmette-Guérin-unresponsive, nonmuscle-invasive bladder cancer. The cost of induction is estimated at $214,800 and patients can receive up to two courses. For maintenance therapy at month four to 19, the estimated cost is $537,000 and an estimated $322,200 for months 25 to 27. The maximum total course for the full 27 months, including two induction courses, is estimated to be $1,288,800.

The FDA has already made more than a dozen cancer drug approval decisions this year and more expected in the next several months and in early 2025, according to Kaelyn Boss, who gave an oncology drug pipeline talk at the 2024 AMCP Nexus meeting this week.

Doug Mirsky, Ph.D.

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