ROLLING MEADOWS, IL - In 2023, 9 in 10 employers (90%) increased their support for one or more core employee wellbeing dimensions, including physical, emotional, career and financial. As a result, total rewards investments made in 2023 are likely to be based on their potential to create stronger organizational attachment, according to Gallagher's 2023 US Physical & Emotional Wellbeing Report. The Gallagher report examined how employers are adjusting to top trends in employee physical and emotional wellbeing and using these trends to help improve employees' quality of life at and outside of work.

"Today's workforces consist of multiple generations and people from a variety of backgrounds, and this requires employers to analyze whether their benefit offerings are addressing a wide range of employee needs," said William F. Ziebell, CEO of Gallagher's Benefits & HR Consulting Division. "As organizations continue to focus on recruiting and retention as top operational and HR priorities, it's clear that they're paying closer attention to important issues, such as flexibility, burnout and inclusive medical coverage."

The Gallagher study, which is the second installment of the 2023 US Workforce Trends Report Series, was conducted from December 2022 to March 2023 and sourced data and insights from more than 4,000 organizations across the US. The study presents recent findings on current and emerging trends to help employers optimize their investments in employee physical and emotional wellbeing by covering medical, pharmacy and voluntary benefits, as well as absence management strategies.

Pervasive concerns about stress and burnout spark continued focus on emotional wellbeing.

The focus on emotional wellbeing in the workplace continues its upward trend with more than 7 in 10 employers (74%) increasing the importance of this area in 2023. While prioritization of wellbeing starts at the top, more meaningful interactions take place at the operational level. In fact, since last year, providing mental health training for managers, leaders or HR increased by 5 points to 22%.

Employers are investing in building morale, addressing these concerns through clinical care and designated time off for mental health. Roughly 7 in 10 employers (71%) offer clinical care such as virtual or telephonic mental health counseling, and 25% are allowing time off for mental health and burnout (up from 3 points in 2022).

Employers are updating PTO and leave policies that account for life outside of work.

Nearly all employers (96%) offer paid time off (PTO) to full-time employees, and more than 4 in 5 (81%) allow employees to carry over days into future years. The ability to help employees meet their work-life integration needs relies on flexible PTO policies. But less than half (47%) include separate vacation, sick or personal days and only 5% offer unlimited PTO.

The future of absence management is evolving as employers accommodate an aging workforce, mental health challenges and changing benefit expectations. As such, employers have developed strategies for administering leaves and disabilities (49%) or expect to do so in the next two years (15%).

Employers are increasingly adapting to align paid leaves with family-focused policies. For example, access to new child or parent bonding paid leave has increased 5 points from 2022 to 41%. And while just 13% of employers offer paid caregiver leave, of those who offer caregiver leave, the majority provide 11–12 weeks (40%).

Balancing demands for specialty drugs and treatments with rising healthcare plan premiums.

Median health plan premium increases at the most recent renewal were 5%–5.9%, up from 4%–4.9% in 2022, and nearly 4 in 5 employers (78%) believe a moderate or significant rise in healthcare costs is likely this year. Nevertheless, nearly 2 in 5 employers (39%) enhanced their medical benefits in 2023, up 6 points from 2022. After base salary and variable compensation, medical benefits received the most attention from employers (39%), up 6 points from 2022. As a result, the use of employee cost sharing and other cost-management tactics is likely to grow.

Coverage for infertility, autism or transgender services and other specialty treatments can show support for ranging employee populations. Though most of these benefits don't stabilize or lower costs, they often align with preferences that strengthen cultural inclusivity. However, their availability was uneven — autism (53%) and fertility services (46%) are offered by nearly half of employers, voluntary pregnancy termination by one-third (34%) and gender reassignment surgery by one-quarter (25%).

Challenges remain in managing specialty drugs (e.g., weight loss, gene therapies, biosimilars), and 48% of employers don't know or don't use tactics to manage their use and costs. Given the accelerating interest in weight loss drugs specifically, and the high costs associated, employers could quickly absorb expenses that exceed their budget limit and impose other strains on their pharmacy benefit plans.

"It is essential to recruitment, retention and the overall wellbeing of employees to serve diverse needs," said Ziebell. "As such, employers should determine what approaches to coverage and utilization will provide the best results for their employee populations, without driving excessive costs."

FDA is announcing two compliance policy guidances establishing a 1-year stabilization period to accommodate additional time that trading partners in the pharmaceutical supply chain may need to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level.

Under the DSCSA, trading partners – primarily manufacturers, wholesale distributors, dispensers, and repackagers – are subject to certain requirements for enhanced drug distribution security.

The DSCSA, enacted in 2013, outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S. The DSCSA requires trading partners to provide, receive and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser as the drugs are distributed in the U.S. supply chain. Currently, these entities can choose to provide such information either electronically or in paper format.

Those DSCSA requirements are scheduled to change on November 27, 2023, and will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically. The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems. The stabilization period is intended to avoid disruption to the supply chain and ensure continued patient access to drug products as trading partners work to fully implement the enhanced drug security requirements.

“FDA is committed to successful implementation of interoperable systems required under the DSCSA,” said Leigh Verbois, director of CDER’s Office of Drug Security, Integrity and Response. “We have heard concerns about supply chain readiness, and we believe that some flexibility will support successful implementation and lead to a stronger and safer drug supply chain.”

As explained in the guidance, FDA does not intend to enforce the enhanced drug distribution security requirements under section 582(g)(1) of the the Federal Food, Drug, and Cosmetic (FD&C) Act during this stabilization period to help trading partners transition to full implementation. Additionally, FDA does not intend to enforce section 582(g)(1)(B) of the FD&C Act with respect to drug product that is introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024, and for subsequent transactions of such product through the product’s expiry.

FDA expects trading partners to use this stabilization period to build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients. This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA.

The compliance policies support trading partners’ use of current methods to exchange and store documentation about products and their chain of ownership, investigate and report suspect or illegitimate product, and handle saleable returns.

The two guidances FDA issued are:

• an immediately-in-effect compliance policy guidance, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies. This guidance describes FDA’s compliance policies regarding enforcement of requirements for enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act.
• a revised final compliance policy guidance, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product  —Compliance Policies. This guidance describes FDA’s compliance policies regarding enforcement of requirements for wholesale distributors and dispensers to verify a product’s product identifier in certain circumstances under sections 582(c)(4) and 582(d)(4) of the FD&C Act.

STOUGHTON, MS & CHATTANOOGA, TN - Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced today that it has partnered with Tennessee-based Erlanger to establish a new specialty pharmacy program. The collaboration with the nationally-acclaimed, multi-hospital health system will provide patients who have complex, chronic conditions increased access to specialized pharmacy services developed to lower costs, bolster treatment options, improve medication management, and enhance overall health.

The partnership will initially serve three disease states: neurology, rheumatology, and gastroenterology, with the intent to expand to additional patient populations. With the new partnership, specialty pharmacy liaisons will guide patients and caregivers who fill prescriptions with Erlanger, working with patients on-site. Among other tasks, these liaisons can assist patients and families with navigating barriers to care including health insurance, prior authorizations, or securing financial assistance.

Expanded patient support services in conjunction with access to recently approved and newly available specialty medications, will offer Erlanger patients greater availability for on-site treatment options. Shields currently partners with nearly 80 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery — often within two days — and improved medication adherence greater than 90 percent on average.

“The newly formed specialty pharmacy at Erlanger marks a commitment to expanding the reach of the health system’s services and providing superior patient care in the Chattanooga area,” said John Lucey, CEO at Shields. “Our partnership will increase access to affordable care and improve therapy management and care coordination for Erlanger’s patients. Shields leverages our access to 90 percent of the limited distribution drugs to provide complex patients with the therapy they need and help them navigate restricted payer networks.”

The region’s only academic teaching hospital, Erlanger serves a broad patient population across portions of Tennessee, Georgia, North Carolina, and Alabama. It is the tri-state region’s only Level I Trauma Center and treats more than a million patients annually. Erlanger is comprised of seven total hospitals, including one pediatric facility, a behavioral health hospital, and a stroke center that has received recognition for its exhaustive stroke and neurosciences program.

“Our partnership with Shields and the new specialty pharmacy program will permit us to enhance the premium care we provide to our communities,” said Rob Maloney, COO at Erlanger. “We are delighted to join Shields’ network of premier health systems and leverage insights and experience from the foremost experts in the health system specialty pharmacy industry.”

Advance Market Analytics published a new research publication on "Pharmacy Automation Market Insights, to 2028" with 232 pages and enriched with self-explained Tables and charts in presentable format. In the Study you will find new evolving Trends, Drivers, Restraints, Opportunities generated by targeting market associated stakeholders. The growth of the Pharmacy Automation market was mainly driven by the increasing R&D spending across the world.

Some of the key players profiled in the study are:
Becton, Dickinson, and Company (United States), Omnicell, Inc. (United States), Cerner Corporation (United States), Capsa Healthcare (United States), Parata Systems LLC (United States), Baxter International, Inc. (United States), ScriptPro LLC (United States), KUKA AG (Germany), TCGRx Pharmacy Workflow Solutions (United States), RxSafe, LLC (United States), ARxIUM Inc. (United States), Talyst Systems, LLC (United States).

Scope of the Report of Pharmacy Automation
Pharmacy automation refers to the integration of advanced technologies and automated systems within a pharmacy environment to streamline and enhance various aspects of medication management, dispensing, and patient care. This innovative approach aims to optimize workflow efficiency, improve medication accuracy, reduce human errors, and ensure the safe and timely delivery of pharmaceutical products and services. Pharmacy automation encompasses a range of solutions that span from robotic dispensing systems to electronic health record (EHR) integration. Key components of pharmacy automation include robotic prescription dispensing systems, which accurately count, package, and label medications, minimizing the risk of errors and ensuring precise dosing. Automated medication storage and retrieval systems enable efficient inventory management and quick access to the required medications, improving the speed of dispensing and reducing wait times for patients.

The titled segments and sub-section of the market are illuminated below:
by Type (Automated Medication Dispensing Systems, Automated Packaging and Labeling Systems, Automated Storage and Retrieval Systems, Automated Medication Compounding Systems, Table Top Tablet Counters), End User (Inpatient Setting, Acute-Care, Long-Term Care, Outpatient Setting, Retail Pharmacy Chains, Outpatient/Fast-Track Care, Hospital Retail, Pharmacy Benefit Management Services, Other (Mail-Order Settings))

Market Drivers:
Rising Geriatric Population
Growing Need to Minimize Medication Errors
Rapid Decentralization of Pharmacies

Market Trends:
Upsurging Demand and Consumption has Led to Continues Enhancements in the Industry

Opportunities:
Healthcare Cost-reduction Measures
Increasing Awareness Among Pharmacists
Emerging Markets

Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.

Strategic Points Covered in Table of Content of Global Pharmacy Automation Market:

• Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Pharmacy Automation market
• Chapter 2: Exclusive Summary - the basic information of the Pharmacy Automation Market
• Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges & Opportunities of the Pharmacy Automation
• Chapter 4: Presenting the Pharmacy Automation Market Factor Analysis, Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.
• Chapter 5: Displaying the by Type, End User and Region/Country 2015-2020
• Chapter 6: Evaluating the leading manufacturers of the Pharmacy Automation market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile
• Chapter 7: To evaluate the market by segments, by countries and by Manufacturers/Company with revenue share and sales by key countries in these various regions (2021-2027)
• Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source
  
  Finally, Pharmacy Automation Market is a valuable source of guidance for individuals and companies.
  
  Read Detailed Index of full Research Study at @ https://www.advancemarketanalytics.com/reports/69554-global-pharmacy-automation-market-1#utm_source=OpenPR/Suraj 

Brewton, AL – D.W. McMillan Memorial Hospital announced that Amy Holland has been selected as the Pharmacy Director. In her new position, she will be responsible for the overall operations of the hospital pharmacy dispensing functions for inpatient and outpatient medications. She will assume the role previously held by Phillip Parker.

“Amy is an outstanding leader and we are excited to have her step into this leadership role.” stated Stacy Hines, Hospital Administrator. “We are very thankful to Mr. Parker for over 44 years of dedication to D.W. McMillan Memorial Hospital where he has served as pharmacist and administrator,” stated Hines. “We are happy to have him remain on staff as a pharmacist as part of this transition.”

Prior to joining D.W. McMillan Memorial Hospital, Amy has worked as a pharmacy tech and as a pharmacist in Monroeville, Opelika, and Brewton. She has also worked for various health related entities such as Monroe County Hospital, Winn Dixie Pharmacy, Rite Aid, Wal-Mart and Monroe Drugs.

Amy earned her Doctorate of Pharmacy (PharmD) in 2011 from Auburn University’s Harrison School of Pharmacy. She is also a graduate of Monroe Academy. Amy lives in Castleberry with her husband, Randy and their two children.

WOONSOCKET, RI - CVS Health® (NYSE: CVS) today announced that it has launched Cordavis, a wholly owned subsidiary that will work directly with manufacturers to commercialize and/or co-produce biosimilar products (an FDA approved biologic medication that is highly similar to, and has no clinically meaningful differences from, a biologic medicine already approved by the FDA) for the U.S. pharmaceutical market. The Cordavis products will be FDA approved, high quality and easy for patients to use and will help ensure consistent long-term supply of affordable biosimilars.

As the U.S. pharmaceutical environment continues to evolve, biosimilars represent one of the biggest opportunities for reducing drug costs for employers and consumers. Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products. The biosimilars market in the U.S. is projected to grow from less than $10 billion in 2022 to more than $100 billion by 2029.

As its first product, Cordavis has contracted with Sandoz to commercialize and bring to market Hyrimoz® (adalimumab-adaz), a biosimilar for Humira®, in the first quarter of 2024 under a Cordavis private label. The list price of the Cordavis Hyrimoz® will be more than 80% lower than the current list price of Humira®.

“CVS Health has a history of bringing innovative solutions to the market that lower the cost of drugs and ensure people have access to the medications they need to stay healthy,” said Shawn Guertin, Chief Financial Officer, CVS Health. “Cordavis is a logical evolution for us and will help ensure sufficient supply of biosimilars in the U.S. and support this market now and in the future, while ultimately improving health outcomes and reducing costs for consumers.”

“Biosimilars are crucial to creating competition and reducing costs for specialty pharmaceuticals where drug prices are rising the fastest,” said Prem Shah, Chief Pharmacy Officer and Co-President of the Pharmacy and Consumer Wellness segment. “Through our direct involvement, we will expand the supply chain and ensure biosimilar availability in the market. We have assembled a talented team at Cordavis and look forward to the value this business will deliver to patients and payors.”

A leader with vast pharmacy experience in academic health systems has been appointed as the VCU Health System’s first chief pharmacy officer (CPO). Matthew Jenkins, Pharm.D., M.S.H.A, will begin in his new role on September 17.

In this newly created role, Jenkins will lead the direction, planning and strategy of pharmacy services across the health system. The CPO will collaborate with VCU Health team members to improve clinical outcomes and patient safety, while shaping organizational strategy for inpatient and retail pharmacy programs — increasing medication access for patients.

The CPO will also work closely with Kelechi “K.C.” Ogbonna, Pharm.D., M.S.H.A., the dean of the VCU School of Pharmacy, to foster an environment of excellence in research, education and clinical care.

“Matthew brings 14 years of pharmacy experience in academic medical center environments, including 12 years in leadership positions,” said Michael Roussos, president of VCU Medical Center. “In his new role with VCU Health System, Matthew will oversee VCU Medical Center, VCU Health Tappahannock Hospital and VCU Health Community Memorial Hospital pharmacy services, including pharmacy services at our ambulatory locations.”

Jenkins joins VCU Health System from the University of Virginia Health System, where he most recently served as senior director of pharmacy services. In that role, he was responsible for multi-hospital health system pharmacy services integration with a 720-bed academic medical center, including clinical and operational services for acute care and post-acute care pharmacy settings, operational contracts, operational services supporting 340B integrity and financial performance, pharmacy informatics, regulatory compliance and personnel oversight.

Jenkins is active in several professional associations, including the American Society of Health System Pharmacists and Virginia Society of Health System Pharmacists. He has served as a clinical assistant professor and professionalism committee member for the VCU School of Pharmacy since 2014.

The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis,” said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

Tyruko is approved to treat the following relapsing forms of MS:

• Clinically isolated syndrome – a single, first occurrence of MS symptoms;
• Relapsing-remitting disease – a type of MS that occurs when patients have episodes of new neurological symptoms followed by periods of stability; and
• Active secondary progressive disease – when, following a relapsing-remitting course, patients experience gradual disability worsening with continued relapses.

Biological products include medications for treating many serious illnesses and chronic health conditions, including MS. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product. All biological products are approved only after they meet the FDA’s rigorous approval standards. The approval of Tyruko, a biosimilar to Tysabri (natalizumab), is based on evidence that showed there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness).

“Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of acquired neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability.

The Prescribing Information for natalizumab products (including Tyruko and Tysabri) contains a boxed warning to inform health care professionals and patients about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies (antibodies to the JC virus, a typically harmless virus carried by most humans), longer duration of therapy and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML.

Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program, under a risk evaluation and mitigation strategy (REMS). The REMS requires health care professionals who prescribe natalizumab products, and pharmacies that dispense them, to be specially certified in the REMS, and that patients be enrolled in the REMS. As part of the REMS requirements, prescribers must evaluate patients three and six months after the first infusion, every six months thereafter, as well as immediately and six months after discontinuing treatment.

Additional warnings in the Prescribing Information include risks regarding herpes infections, thrombocytopenia (low blood platelet count), immunosuppression (an increased risk of certain infections), serious hypersensitivity reactions such as anaphylaxis and hepatotoxicity (significant liver injury). The most common side effects associated with natalizumab products are headache and fatigue. Other common side effects are arthralgia (pain in a joint), urinary tract infection, lower respiratory tract infection, gastroenteritis (stomach flu), vaginitis (infection or inflammation of the vagina), depression, pain in extremity, abdominal discomfort, diarrhea and rash.

The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

IRVING, TX - A Vizient white paper released today demonstrates how the lack of information about medication access across the supply chain is exacerbating the shortage of seven oncology drugs used to treat a multitude of cancers. In survey results included in the paper, more than 94% of respondents reported an impact on pharmacy operations and patient care due to carboplatin and cisplatin shortages. View “Evaluating the impact of the oncology drug shortage.”

Six antineoplastic oncology medications are in short supply in the United States due to the December shutdown of a manufacturing plant in India — capecitabine, carboplatin, cisplatin, docetaxel, fluorouracil and methotrexate; a seventh, fludarabine, has been in short supply since 2019. The total number of units of the seven drugs sold to Vizient Pharmacy Program participants, which includes 60% of the nation’s acute care hospitals, increased 12% January through May 2023 compared to the same time during the previous year, according to Vizient data. At the same time, the Vizient Clinical Data Base showed relatively flat growth (1.5%) during that time for patient volumes that would receive antineoplastics as part of their oncology medications.

“Providers are naturally concerned about delivering the appropriate treatment to their patients. During a disruption providers have no awareness of production by alternate manufacturers or re-openings of facilities,” said Carina Dolan, associate vice president, clinical oncology, pharmacoeconomics and market insights. “The lack of transparency and trust in information coming from manufacturers and distributors leads to over-ordering, which can leave some hospitals without the necessary medications needed to deliver care.”

Starting in December, aggregated demand for the seven drugs spiked over 136% compared with historical purchase patterns and remained elevated at the time of this press release. Despite implementing various procurement strategies to ensure patient care needs are being met, the proportion of Vizient Pharmacy Program participants receiving less than 50% of their historical order quantities reached 57% as of May 2023.

“The fulfillment data we reviewed highlights challenges with how product availability and demand fluctuate considerably when a shortage occurs. As an industry, we must look at every link in the supply chain and determine how we can work collectively to improve transparency and the flow of information to quickly and more evenly implement product access and mitigation strategies that help ensure equitable distribution of medications when disruptions occur,” said Dolan.

Survey results: Provider and patient impact

In April, Vizient conducted a survey of its pharmacy program participants with 32 unique oncology network provider customers responding. Respondents reporting an impact from the shortage ranged from 72% to 97%, depending on the drug, with 56% of respondents implementing some type of mitigation strategy for cisplatin, used for a variety of cancers. The most common substitute was carboplatin, also impacted by the disruption.

Providers reported several procurement strategies to mitigate the shortage, including buying from alternative sources or sourcing alternative presentations and vial sizes and shifting inventory across the health system; conservation strategies, including restricting administration of certain indications and omitting a drug from regimens when possible; patient prioritization strategies, including delayed treatment; and overall increased communications during the shortage.

NEW YORK - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

“ABRYSVO’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available. Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger – when they are at greatest risk of possible serious consequences from RSV – has been achieved.”

The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy), a randomized, double-blinded, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and immunogenicity of the vaccine against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy. These results were published in The New England Journal of Medicine in April 2023.

“Newborns and young infants – whose immune systems are still developing and are not yet strong enough to defend against infections – may now be protected from RSV from the moment of birth through maternal immunization,” said Eric A.F. Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora. “The approval of Pfizer’s ABRYSVO is a major triumph as it helps ensure no delay in potential RSV protection during an infant’s most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV.”

RSV is a contagious virus and a common cause of respiratory illness worldwide.1 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.2,3,4 The disease burden of RSV in young children is staggering with virtually all children getting an RSV infection by the time they are two years old.5 In the United States, approximately 500,000 to 600,000 infants experience LRTD due to RSV each year and it is a leading cause of hospitalization in children less than one year of age. 6,7

About ABRYSVO

On March 2, 2022, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ABRYSVO for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women. This decision was followed by the FDA’s acceptance of ABRYSVO’s Biologics License Application (BLA) under priority review for infants in February 2023.

Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as help protect infants through maternal immunization. In May 2023, the U.S. Food and Drug Administration (FDA) approved RSVpreF under the name ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. The approval was followed in June by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) official recommendation for the vaccine for use in adults 60 years of age and older.

In July 2023, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the granting of a marketing authorization for the RSV vaccine candidate, PF-06928316 or RSVpreF, to help protect older adults and infants through maternal immunization from RSV. The CHMP’s positive opinion is being reviewed for each indication by the European Commission (EC). The EC will decide whether to approve RSVpreF, whose European Union (EU) trade name will be ABRYSVO.

In February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVPreF as a maternal immunization to help protect infants against RSV. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.

Pfizer has initiated two additional clinical trials evaluating ABRYSVO. One trial is being conducted in children at higher risk for RSV disease ages 2-<18.8 A second trial is evaluating adults ages 18-60 at higher risk for RSV due to underlying medical conditions, such as asthma, diabetes and COPD, and adults ages 18 and older who are immunocompromised and at high-risk for RSV.8 Pfizer also plans post-marketing studies and surveillance programs to further describe the safety of the vaccine.

INDICATIONS FOR ABRYSVO

ABRYSVO^TM is a vaccine indicated for:

• the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
• pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

IMPORTANT SAFETY INFORMATION FOR ABRYSVO

• ABRYSVO should not be given to anyone with a history of severe allergic reaction (eg, anaphylaxis) to any of its components
• For pregnant individuals: to avoid the potential risks of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
• In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, nausea
• In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo

View the full Prescribing Information. If maternal immunization details are not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.