Asthma

Atrial Fibrillation

Autoimmune Diseases

Biologics

Biosimilars

Blood Cancer

Breast Cancer

COVID-19

Cardiovascular Diseases

Depression

Dermatology

Diabetes

Digital Health

Drug Coverage

Eyecare

Friedreich Ataxia

Gene Therapy

Graft Versus Host Disease

Heart Failure

Hemophilia

Hypertrophic Cardiomyopathy (HCM)

Leukemia and Lymphoma

Liver Disease

Lung Cancer

Mental Health

Multiple Sclerosis

NSCLC

Neonatal Care

Obstetrics-Gynecology & Women's Health

Oncology

Opioids

PTSD

Pain

Pediatrics

Plaque Psoriasis

Population Health

Post-Acute Care

Prescription Digital Therapeutics

Pulmonary Arterial Hypertension

Reproductive Health

Respiratory Conditions

Safety & Recalls

Skin Cancer

Sleep Disorders

Solid Tumors

Spinal Muscular Atrophy

Substance Use Disorder

The Improving Patient Access Podcast

Type I Diabetes

Type II Inflammation

Ulcerative Colitis

Urology

Urothelial Carcinoma

Vaccines

Women's Health

News

Media

Between the Lines

Expert Interviews

K-Cast

Medical World News

Podcasts

Population Health Perspectives

Conferences

Partners

Publications

All Publications

MHE Publication

Formulary Watch Supplements

Formulary Watch Spotlights

Supplements And Featured Publications

Events

2024 PBMI Annual National Conference

PBMI MAP

Virtual Events

CME/CE

Resources

Emerging Leaders

Interactive Tools

PBM Leaders

Subscribe

Articles

A forecast for this year by Dan Parsons, chief experience officer of Thoughtful AI.


AI Davids and Goliaths | Predictions for 2025

U.S. approved the RSVpreF vaccine for adults 60 years and older in 2023, recommending it only based on individual’s decisions with their doctors.

RSV Vaccine Highly Effective in Preventing Severe Illness in Older Adults

Predictions for this year from Perry Cohen, Pharm.D., CEO of the TPG Family of Companies and Managed Healthcare Executive editorial advisory board member.


Dysfunction at the FDA, NIH, Elsewhere | Predictions for 2025

Predictions for 2025 by Tracy Baroni Allmon, J.D., vice president of Market Access and Policy at Magnolia Market Access.


Pressure on Patient Assistance Programs | 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.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do Not Sell My Personal Information

Managed Healthcare Executive

Facebook

LinkedIn

Resource Centers

Eye Care

Spotlight

ID Week 2024

AMCP Nexus 2024

AHIP

AIDS Conference

ATS 

Business

Business Strategy

Chronic Disease

Consumers

Drug Costs

Drug Pipeline

Formulary

Health Management

Health/Disease Strategy

Hospitals & Providers

Industry Analysis

Pharmacy

Politics and Policy

Practice Management

Reimbursement

Technology

1rem

Authors

The opportunity for health insurers is to implement a well-designed cost estimator tool that goes beyond compliance to the new CMS rule and meets member and health insurer market trends by integrating more quality and cost metrics with an easy-to-use member interface.

The Opportunity in CMS’s Price Transparency Rule

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.

Clinical

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.

Tevimbra (tislelizumab-jsgr) is a PD-1 inhibitor, which was approved on March 13 for unresectable or metastatic esophageal squamous cell carcinoma. The NCCN recommends the drug in the second-line or subsequent therapies for category one. The cost per 10 mL (100 mg) and per dose (200 mg) is approximately $5,204 an $10,408, respectively.

Amtagvi (lifileucel) received accelerated approval on Feb. 16 for unresectable or metastatic melanoma as a tumor-derived autologous T cell immunotherapy. The drug is recommended by the NCCN as a preferred tumor-infiltrating lymphocyte therapy.

And here are the cancer drugs mentioned by Boss that are likely to be coming up for FDA approval decisions soon.

A decision on zenocutuzumab, a bispecific antibody for NRG1-positive NSCLC and NRG1-positive pancreatic cancer, is expected in the fourth quarter of 2024. It has also been given fast track designation by the FDA.

A decision on zolbetuximab, a CLDN18.2-targeted antibody for HER2-negative, CLDN18.2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, is expected on Nov. 9.

 a CAR-T therapy for relapsed or refractory adult B-cell acute lymphoblastic leukemia, is expected on Nov.16. If the FDA approves it,obecabtegene autoleucelwould be the third CAR-T cell for this disease.

A decision on zanidatamab, a HER2-targeted bispecific antibody for previously treated, unresectable, locally advanced, or metastatic HER2-amplified biliary tract cancer, is expected on Nov. 29.

Decisions on datopotamab deruxtecan, an antibody drug conjugate for advanced nonsquamous NSCLC and metastatic HR-positive, HER2-negative breast cancer, are expected on Dec.20 and Jan. 29, 2025, respectively.

A decision on revumenib, a menin-KMT2A inhibitor for relapsed or refractory KMT2Ar acute leukemia, is expected on Dec. 26. If it gets the FDA’s OK, revumenib would be the first menin inhibitor approved. Other menin inhibitors in development are either in phase 2 (ziftomenib) or phase 1 trials (JNJ-75276617, DSP-5336, BMF-219, BN104, and balamenib.)

A decision on cosibelimab, a PD-L1 inhibitor, is expected on metastatic or locally advanced cutaneous squamous cell carcinoma, on Dec. 28. In December 2023, the FDA issued a complete response letter for the drug, and it was resubmitted in July 2024.

A decision on ensartinib, an ALK inhibitor for ALK-positive NSCLC, is expected on Dec. 28. The drug is also being studied for pediatric patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that are recurrent or relapsed.

A decision for the subcutaneous formulation of Opdivo (nivolumab), a PD-1 inhibitor for many oncology indications, is expected on December 29, 2024.

A decision for mirdametinib, a MEK inhibitor for neurofibromatosis type 1-associated plexiform neurofibromas, is expected in the first quarter of 2025. It has been granted orphan drug designation by the FDA and the European Commission. It is also being studied in combination with lifrafenib for advanced or refractory solid tumors.

A decision for remestemcel-L, a stem cell therapy for acute GVHD, is expected on January 7, 2024. The drug was issued two CRLs, with one due to lack of potency data and one for additional data on highest risk population.

A decision on tabelecleucel, an allogenic T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease, on Jan. 15, 2025.

A decision for the subcutaneous formulation of Rybrevant (amivantamab), a bispecific antibody for NSCLC, is expected in the second quarter of 2025.

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.

Cancer’s Reign Over the Drug Development Pipeline Continues| AMCP Nexus 2024

William Shatner talked poignantly, with flashes of his trademark humor, about being diagnosed and treated for stage 4 melanoma at the annual meeting of the American Academy of Dermatology (AAD) meeting in San Diego this weekend.

It is apparently the first time that Shatner has discussed the skin cancer episode in public. He did not say when it occurred.

Shatner, who is 92, is famous for having played the role of Captain James T. Kirk in the 1960s “Star Trek” television series and subsequent movies. He has gone on to write books, star in commercials and make many public appearances like this one at the AAD meeting, which set an attendance record of nearly 20,000 dermatologists. A documentary about him titled  “You Can Call Me Bill” is scheduled to be released on March 20, two days before he turns 93. While trading on a celebrity status derived from “Star Trek,” Shatner has become almost as well known for his sense of fun, down-to-earth candor and lighthearted self-deprecation as for the Kirk role and the phrase , “Beam me up, Scotty,” a line from the television series that the Kirk character never actually said, although there are several lines that approximate it.

In a chatty, interview format with the academy president’s, Terrence A. Cronin Jr., M.D., at the meeting’s plenary session Sunday morning, Shatner joked about his short-term memory, sources of vigor and appearance. 

When Cronin asked him how he keeps going so strong, Shatner deadpanned, “I have no idea.”

As part of the same exchange, Shatner showed that comic timing and a keen sense of his audience. “Why do I look so good?” he asked rhetorically and paused. “It’s ointment!”

The 92-year-old "Star Trek" star said the skin cancer was treated surgically and with immunotherapy. It was apparently the first time he had discussed his melanoma in public.

Hannah Bowlin

Articles

Latest Updated Articles