VerifiedRx

Alpha-gal Syndrome and Impact on Patient Safety

Alpha-gal syndrome is an emerging and often underrecognized allergy triggered by a tick bite that can cause delayed reactions to red meat and mammalian-derived products. In this episode, host Stacy Lauderdale is joined by clinical experts Zack Stacy and Kyna Henrici to unpack the science behind alpha-gal, its implications in healthcare settings, and the operational challenges providers face in managing this complex condition. 
 Guest Speakers:  Zachary Stacy, Pharm.D., MS, FCCP, BCPS Clinical Pharmacy Specialist, Surgery BJC Health  
Kyna Henrici, RN Medical Evidence Director - Cardiovascular Vizient, Inc. 
 Host:   Stacy Lauderdale, Pharm.D., BCPS AVP, Evidence-Based Medicine Vizient, Inc. 
 
00:05 – Introduction 
Podcast introduction and welcome to VerifiedRx 
00:14 – What is alpha-gal syndrome 
Overview of alpha-gal syndrome 
Delayed allergic reactions after eating red meat 
Often linked to tick bites 
00:48 – Meet the Guests 
 Zack Stacy, clinical pharmacy specialist 
Kyna Henrici, medical evidence director 
01:10 – Understanding the Allergy 
Alpha-gal is a carbohydrate in nonprimate mammals that can trigger an allergy in humans 
Key difference is delayed reaction timing 
Symptoms are not always easy to trace  
01:32 – How It Develops 
Triggered by tick bites 
Immune system produces IgE antibodies  
Oral exposure to alpha-gal leads to delayed reactions 
IV exposure to alpha-gal can cause immediate reactions 
02:17 – Prevalence and Diagnosis Challenges 
More common in Midwest and southern United States 
Likely underdiagnosed 
Often mistaken for general food allergies 
Allergy may fade over time 
03:07 – Risks in Healthcare Settings 
Patient safety concerns beyond food 
Mammalian components in medications and devices 
Examples include heparin and surgical materials 
03:44 – Hidden Medication Risks 
Inactive ingredients can be animal derived 
Examples include glycerin, lactose, amino acids, stearates 
Difficult to identify and track 
04:42 – Lack of Transparency 
No centralized ingredient database 
Sourcing can change frequently 
Variability across manufacturers and batches 
05:33 – Screening in Surgical Settings 
Medication review at NDC level 
Identification of active and inactive ingredients 
May require contacting manufacturers 
06:45 – Timing Challenges 
Urgent procedures limit investigation time 
Manufacturer responses may take days 
Alternative medications often needed 
07:14 – Identifying At Risk Patients 
Many patients are unaware they have alpha-gal syndrome 
Screening includes questions about dairy tolerance 
Three patient categories used for evaluation 
08:32 – Using Dairy as a Screening Tool 
 Dairy tolerance helps guide risk level 
Food exposure typically higher than medication exposure 
Determines need for deeper review 
09:12 – Managing Emergencies 
Focus shifts from avoidance to risk mitigation 
Use of team communication and clear documentation 
Preparation for unavoidable exposure 
10:03 – Prevention and Preparedness 
Stock alpha-gal safe medications when possible 
Prepare for allergic reactions with standard treatments 
10:47 – Team Based Care Approach 
Collaboration across care teams is essential 
Premedication strategies may be used 
Close monitoring for reactions 
11:11 – Gaps in Care 
Limited visibility into product ingredients 
Need for better labeling and transparency 
11:33 – Need for Standardization 
Call for clearer guidance and clinician education 
Desire for centralized resource for medication ingredients 
12:24 – Monitoring Challenges 
CDC tracking decreased after privatization of testing 
Cases likely still increasing 
12:53 – Closing Remarks 
 
Links and Resources: Alpha-gal Syndrome | Alpha-gal Syndrome | CDC 
 
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Efficiency to Excellence: AI’s Role in Modern Pharmacy Practice

AI is rapidly reshaping pharmacy practice, raising both concern and opportunity for healthcare teams. Vizient host Kerry Schwarz is joined by Dr. Jason Chou, Vice President of the System Pharmacy Service Line, and Dr. Catherine Oliver, System AVP of Clinical Pharmacy Services at Ochsner Health, to explore how AI is improving efficiency while redefining how pharmacy teams spend their time. They discuss where technology is already making an impact and where its limits still require human expertise.
 
Guest Speakers: 
Dr. Jason Chou, Pharm.D., MSVice President, System Pharmacy Service LineOchsner Health
 
Dr. Catherine Oliver, Pharm.D., BCPS, DPLA, CPGxSystem AVP, Clinical Pharmacy ServicesOchsner Health
Host Dr. Kerry Schwarz, Pharm.D., MPHSenior Clinical Manager, Evidence-Based Medicine and OutcomesVizient Center for Pharmacy Practice Excellence 
 
Shownotes: 
00:05 — Introduction
Announcer welcomes listeners to VerifiedRx, produced by the Vizient Center for Pharmacy Practice Excellence.
 00:14 — Episode Overview
Host Kerry introduces the topic: the role of artificial intelligence (AI) in healthcare and pharmacy.
Key themes:
Addressing fears of job replacement
Identifying real-world use cases
Understanding limitations of AI
Practical strategies for adoption
Guests:
Dr. Jason Chou, VP, System Pharmacy Service Line, Ochsner Health
Dr. Catherine Oliver, System AVP, Clinical Pharmacy Services, Ochsner Health
 01:04 — Will AI Replace Healthcare Jobs?
Concern exists, but largely driven by misunderstanding
AI is expected to:
Augment, not replace, pharmacy roles
Improve efficiency in daily workflows
AI is not capable of:
Independent clinical judgment
Meaningful patient interactions
Human elements—trust, empathy, and nuance—remain essential.
 02:20 — Where AI Can Add Value Today
Focus should shift from fear to practical use cases
Ideal applications:
Reducing non-value-added tasks
Improving efficiency
Supporting clinical decision-making preparation (not replacing it)
 02:39 — Early Use Cases: Operational Efficiency
AI can reduce administrative burden such as:
Prior authorizations
Insurance-related communications
Data gathering and documentation
Opportunity to eliminate “busy work” and improve staff satisfaction
 03:31 — Clinical Workflow Support
AI can:
Summarize patient charts, labs, and notes
Organize large volumes of clinical data
Enables pharmacists to:
Spend less time preparing
Spend more time in patient care and provider interaction
 04:08 — Additional Opportunities: Supply Chain & Operations
AI can support:
Inventory management
Purchasing optimization
Multi-site coordination
Benefits include:
Cost savings
Improved efficiency
Better resource utilization
05:00 — Where to Draw the Line
AI should not replace clinical decision-making
Limitations include:
Lack of experience and judgment
Inability to incorporate patient values and preferences
Final decisions must remain with clinicians.
 05:42 — Preserving the Human Element
Patient care involves:
Trust
Empathy
Relationship-building
Over-reliance on AI risks eroding patient confidence.
 06:11 — Patient Interaction & Transparency
Patients want to know:
When AI is used
How it impacts their care
Transparency and communication are critical
 06:48 — AI in Direct Patient Care: Ambient Listening
AI tools can:
Capture conversations during patient visits
Reduce documentation burden
Important considerations:
Patient consent
Ability to opt out
Privacy concerns
 07:31 — Risks of Poor Implementation
Poorly designed AI interactions can:
Frustrate patients
Reduce trust
Healthcare AI must avoid:
Impersonal experiences
Inefficient automation
08:21 — AI as a Tool, Not a Replacement
Comparable to tools like:
Search engines (e.g., Google)
Enhances efficiency without replacing professional roles.
 09:12 — Early Success Stories
Prior Authorization Optimization
AI improves:
Data extraction
Documentation speed
Approval timelines
Benefits:
Faster patient access to therapy
Improved staff satisfaction
 10:07 — Clinical Decision Support Enhancements
AI-driven rule systems:
Identify high-risk patients
Reduce unnecessary chart reviews
Example outcome:
Reduction in time spent reviewing charts without intervention
Frees pharmacists for:
Medication reconciliation
Patient counseling
 11:11 — Impact on Workforce Engagement
Staff report:
Increased satisfaction
More time for meaningful work
AI seen as an enabler rather than a threat
12:03 — Vendor Landscape & Challenges
Rapid growth of AI vendors addressing niche problems
Key risks:
Data security concerns
Vendor quality variability
Overlapping or redundant solutions
 12:51 — Integration & Workflow Considerations
Successful AI tools must:
Integrate with EHRs
Align with pharmacy workflows
Avoid siloed systems
Poor integration leads to inefficiency and adoption barriers
 14:04 — Vendor Evaluation Considerations
Assess:
Clinical and operational expertise
Product maturity
Implementation effort
Risk vs benefit
Balance between:
Ready-made solutions
Custom-built tools requiring internal resources
 14:56 — Practical Advice for Health System Leaders
Develop a system-wide AI strategy
Collaborate across departments (not siloed decisions)
Engage:
IT
Legal
Ethics teams
Avoid duplicative solutions across service lines
 15:31 — Building Organizational Readiness
Be open to learning and experimentation
Ask questions and maintain healthy skepticism
Focus on:
Improving workflows
Enhancing patient outcomes
Supporting workforce engagement
 16:02 — Infrastructure & Speed of Innovation
AI vendors move quickly
Organizations must:
Be prepared to adapt rapidly
Avoid delays that hinder innovation
Balance speed with governance and safety
 16:27 — Closing
Kerry thanks the guests for their insights
Encourages continued exploration of AI’s evolving role in healthcare
Reminder to subscribe and engage with VerifiedRx.
 
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Inside the Medicare Transaction Facilitator: Early Wins and Growing Pains

In this episode of VerifiedRx, Carolyn Liptak is joined by Dr. Jennifer Tussey, Senior Specialty Pharmacy Manager at BJC Health, to discuss early experiences with the Medicare Transaction Facilitator (MTF) and the Medicare Drug Price Negotiation Program. From managing complex data flows and delayed payments to coordinating cross-functional teams and evolving workflows, they share practical insights from the first cycle of implementation. Tune in to learn what’s working, what’s challenging, and how health systems are adapting in real time.
 
Guest speaker:  
 Jennifer Tussey, PharmD, CSP, AAHIVP
Senior Specialty Pharmacy Manager
Specialty, Oncology, Mail Order
BJC Health East Region
 
Host:  
Carolyn Liptak, MBA, BS Pharm
Pharmacy Executive Director, Regulatory Compliance
Vizient Center for Pharmacy Practice Excellence  
Verified Rx Host 
 
00:05 — Introduction
Announcer welcomes listeners to VerifiedRx, produced by the Vizient Center for Pharmacy Practice Excellence.
 
00:14 — Episode Overview
Host Carolyn Liptak introduces the topic: early experiences with theMedicare Drug Price Negotiation Program (MDPNP) and the Medicare Transaction Facilitator (MTF).
Discussion focuses on:
Implementation planning
Early operational challenges
Payment and data flow issues
Lessons learned from initial rollout
Guest: Dr. Jennifer Tussey, Senior Specialty Pharmacy Manager at BJC Health.
 
00:14 — Key Program Definitions
Medicare Drug Price Negotiation Program (MDPNP):
Created under the Inflation Reduction Act (2022)
Allows CMS to negotiate prices for select high-cost drugs without generic/biosimilar competition
Establishes a Maximum Fair Price (MFP)
Medicare Transaction Facilitator (MTF):
Operational system supporting:
Data exchange
Payment processing
Coordination between CMS, manufacturers, and dispensers
Ensures Part D beneficiaries receive negotiated pricing
 
02:00 — Health System Context
Jennifer oversees specialty, oncology, and mail-order pharmacy operations within BJC Health’s east region.
Approximately 12 pharmacies impacted by MTF processes.
 
02:27 — Implementation Strategy
Initial steps:
Participation in CMS webinars
Formation of a multidisciplinary team
Key roles involved:
Pharmacy leadership
Data analyst
Business manager
Reconciliation technician
Revenue cycle team
Responsibilities include:
Tracking claims and payment status
Managing 340B eligibility
Reconciling payments across multiple systems (MTF, Beacon, internal systems)
 
03:54 — Enrollment Experience
Enrollment process was relatively straightforward:
Entity signatures
System setup for remittance processing
Complexity increased post-enrollment due to:
Data fragmentation across systems
Limited access for revenue cycle teams
Required strong coordination across departments.
 
05:09 — Data & Payment Flow Challenges
Data flow remains slow but improving.
Current timeline:
~19 days for payment finalization
Up to 45 days for resolution if inquiries are required
Early collection rates:
Initially ~10%
Improved to ~60%
 
05:09 — Operational Workflow Adjustments
Monitoring cadence evolved:
From daily tracking → now biweekly review cycles
Teams review claims approximately 45 days in arrears.
 
06:02 — Inquiry & Tracking Challenges
System limitations:
Inquiry submissions may not be saved reliably
Lack of built-in tracking tools
Requires manual documentation and tracking to monitor claim status and follow-ups.
 
06:18 — Managing Payment Inconsistencies
Payment discrepancies handled through inquiry process.
Key challenges:
Delayed initiation (must wait for processing window)
Extended resolution timelines (up to 45 days)
Requires proactive and continuous follow-up.
 
06:53 — Financial & Resource Challenges
Low reimbursement margins under standard refund amounts.
Even large systems with wholesale discounts experience tight margins.
Significant FTE investment required to manage the process.
Smaller systems may face:
Greater operational burden
Limited staffing capacity
 
07:33 — Operational Evolution
Processes are continuously evolving.
Key success factors:
Ongoing process refinement
Strong internal documentation
Rapid incorporation of lessons learned
Example:
Identifying system issues with inquiry tracking and adjusting workflows accordingly
 
08:14 — Key Advice: Patience & Persistence
Success requires:
Patience with slow-moving processes
Meticulous follow-up
Strong tracking systems (e.g., Excel-based workflows)
High claim volume (500+ scripts at a time) necessitates structured tracking tools.
 
09:07 — Additional Financial Considerations
Low net margins combined with high operational workload.
Challenges amplified for:
Smaller pharmacies
Systems with fewer resources
Emphasizes importance of operational efficiency and resource planning.
 
09:36 — Final Takeaways
MTF implementation is:
Complex
Resource-intensive
Still evolving
Key themes:
Strong cross-functional collaboration is essential
Processes will require ongoing refinement
Financial sustainability remains a concern
 
09:46 — Closing
Carolyn thanks Jennifer for sharing insights and real-world experience.
Reminder to subscribe, provide feedback, and stay engaged with VerifiedRx content.
 
Links | Resources: 
Medicare Drug Price Negotiation Program: Click Here
 
Medicare Transaction Facilitator General Resources: Click Here
 
Pharmacy and Dispensing Entity Resources: Click Here
 
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Checkpoint Change: Rethinking How PD-1/PD-L1 Inhibitors Are Delivered

Immune checkpoint inhibitors targeting PD-1 and PD-L1 have transformed the treatment landscape across a wide variety of cancers, becoming foundational therapies in oncology. Dr. Stacey Sobocinski and Dr. Michele Rice join host Dr. Kerry Schwarz to discuss what the new subcutaneous PD-1/PD-L1 immune checkpoint inhibitors could mean for oncology practice. They cover the three agents that have become available in subcutaneous formulations, their advantages and disadvantages, other important operational, financial, clinical, and safety issues for health systems to consider.
 
Guest speaker:  
 
Stacey Sobocinski, Pharm.D., BCPS
Associate Director, Pharmacy Medication Management & Informatics
MD Anderson Cancer Center 
 
Michele Rice, Pharm.D., BCOP
Senior Consulting Solutions Director
Vizient Pharmacy Enterprise Solutions
Host:  
Kerry Schwarz, Pharm.D., MPH
Senior Clinical Manager, Evidence-Based Medicine and Outcomes
Vizient Center for Pharmacy Practice Excellence  
 
Show Notes:
00:05 — Introduction
Announcer welcomes listeners to VerifiedRx, produced by the Vizient Center for Pharmacy Practice Excellence.
00:14 — Episode Overview
Host Kerry introduces the topic: new subcutaneous formulations of PD-1 and PD-L1 immune checkpoint inhibitors.
These therapies have traditionally been administered intravenously (IV) in infusion centers.
Recently approved subcutaneous versions include:
Pembrolizumab (Keytruda Qlex)
Nivolumab (Opdivo Qvantig)
Atezolizumab (Tecentriq Hybreza)
Potential benefits include shorter administration times and relief for infusion centers operating at capacity.
Guests:
Stacy Sobacinski, Associate Director of Pharmacy Medication Management and Informatics, MD Anderson Cancer Center
Michelle Rice, Senior Pharmacy Enterprise Solutions Director, Vizient
01:39 — Clinical Data: Efficacy, Safety & Pharmacokinetics
Subcutaneous formulations were approved in combination with hyaluronidase, allowing full-dose subcutaneous administration.
Clinical studies demonstrated:
Comparable pharmacokinetics
Similar efficacy
Similar safety profiles compared to IV formulations
The main difference observed was local injection site reactions, expected with subcutaneous administration.
02:32 — Confidence in Clinical Comparisons
Although direct head-to-head trials are limited, extensive experience with IV formulations supports confidence in safety and efficacy.
Differences largely relate to administration method, not drug activity.
03:11 — Operational Impact: Changes to Workflow
Subcutaneous administration introduces new operational considerations.
Shorter injection times may appear advantageous, but real-world workflow impact is still being evaluated
Much of a patient’s visit still involves:
Waiting room time
Laboratory testing
Provider visits
Care coordination
 
04:06 — Chair Time vs Total Visit Time
For therapies previously requiring longer infusions, switching to subcutaneous injections can significantly reduce chair time.
For therapies previously infused over 30 minutes, the difference between IV and subcutaneous administration time may be less impactful.
 
04:24 — Administration Challenges
Subcutaneous doses are not small-volume injections.
Injection volumes may reach 10–15 mL
Nursing considerations include:
Patient tolerance for larger-volume injections.
IV infusions allow nurses to start the infusion and attend to other tasks.
Subcutaneous injections require continuous nursing presence during administration.
This may increase direct nursing time.
 
 
 
05:05 — Equipment Considerations
Some centers may use syringe pumps to administer subcutaneous injections.
Many adult infusion centers do not currently have pumps since chemotherapy is typically delivered via IV using infusion pumps.
Implementing syringe pumps could require additional equipment and associated procedures.
 
05:32 — Operational Complexity
Transitioning to subcutaneous therapy involves more than simply switching order sets.
Organizations must evaluate:
Staffing models
Nursing workflows
Equipment availability
Infusion center capacity management.
 
06:25 — Financial Considerations
Subcutaneous formulations are currently priced roughly at parity with IV versions.
Manufacturers may be incentivized to transition providers to subcutaneous formulations before biosimilars enter the market.
 
07:07 — Anticipating Market Dynamics
Over time, pricing strategies may shift to encourage broader adoption.
Biosimilar competition for these agents is expected within the next few years.
 
07:11 — Site of Care Considerations
Adoption may vary by care setting:
Hospital outpatient departments
Physician offices
Freestanding infusion centers
 
08:06 — Strategic Timing Decisions
Health systems may weigh:
Operational advantages of subcutaneous administration
Potential cost reductions from future biosimilars
Some organizations may delay adoption until biosimilar competition arrives.
 
08:24 — Infusion Center Optimization
Subcutaneous therapies could increase turnover.
Some centers may develop “express lanes” for subcutaneous administration.
 
09:01 — Payer Influence
If subcutaneous formulations are perceived as cheaper or operationally simpler, payers may:
Restrict site of care
Prefer administrations in physician offices or non-hospital settings.
 
09:45 — Key Questions for Health Systems
Organizations should consider:
What value does the new dosage form provide?
Which patients benefit most from subcutaneous administration?
How will payer policies evolve?
 
10:05 — Evaluating Clinical Value
Institutions often approach new dosage forms with caution.
Subcutaneous PD-1/PD-L1 inhibitors may not offer the administration time reductions seen with other biologics because there is not as large of a difference in administration times (30 minutes versus 5 minutes).
 
10:53 — Patient Selection Considerations
Subcutaneous formulations may be most beneficial for patients:
Receiving monotherapy
With difficult IV access
Patients receiving combination therapies may see less benefit since IV access is already required.
 
11:12 — Additional Patient Factors
Some patients have low body mass or cachexia, making high-volume subcutaneous injections more difficult.
Physicians may prefer individualized treatment decisions rather than blanket formulary changes.
11:33 — Final Thoughts
Transitioning to subcutaneous PD-1/PD-L1 inhibitors involves clinical, operational, and financial considerations.
Observation times, administration practices, and workflow models continue to evolve.
Ongoing monitoring of emerging best practices is encouraged.
12:15 — Closing
ongoing monitoring of emerging best practices.
Listeners are invited to subscribe and follow VerifiedRx for future episodes.
 
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Winter 2026 Spend Management Outlook

Dr. Jeni Hayes, Senior Clinical Manager, Strategic Clinical Intelligence, and Dr. Heather Pace, Senior Clinical Manager, Ambulatory Care, join host Carolyn Liptak to discuss the Vizient Winter 2026 Spend Management Outlook, with a focus on pharmacy projections and key changes from prior outlooks. The episode also covers ambulatory care and self-administered drugs, biosimilar therapeutic insights, and dynamic pharmacy market forces.
 
Guest speaker: 
Jeni Hayes, PharmD, BCPS  
Senior Clinical Manager, Strategic Clinical Intelligence
Vizient Spend Management Solutions
 
Heather Pace, PharmD  
Senior Clinical Manager, Ambulatory Care
Vizient Center for Pharmacy Practice Excellence  
 
Host:  
Carolyn Liptak, MBA, BS PharmPharmacy Executive Director, Regulatory Compliance & Revenue IntegrityCenter for Pharmacy Practice Excellence (CPPE)Vizient
 
Show Notes:
00:05 — Introduction
Announcer welcomes listeners to Verified Rx, produced by the Vizient Center for Pharmacy Practice Excellence.
00:14 — Episode Overview
Host Carolyn Liptak, Pharmacy Executive Director at Vizient, introduces the Winter 2026 Spend Management Outlook (SMO).
Focus areas:
Pharmacy inflation projections
Acute vs ambulatory care trends
Provider-administered vs self-administered drugs
Biosimilar therapeutic insights
Dynamic pharmacy market forces shaping 2026–2030
Guests:
Jeni Hayes, Senior Clinical Manager, Strategic Clinical Intelligence
Heather Pace, Senior Clinical Manager, Ambulatory Care
01:09 — What Is the Spend Management Outlook (SMO)?
Biannual Vizient publication projecting price trends across healthcare spend categories.
Pharmacy headline:
Inflation slightly lower than last edition
Total spend still rising, driven by utilization growth and new technologies
01:49 — Top-Line Pharmacy Inflation Projection
2.84% projected drug inflation for purchases between July 2026 – June 2027.
Down from 3.35% in the prior edition.
Based on October 2024 – September 2025 wholesaler data.
Heavily weighted toward highest-spend drugs.
Contracted products show lower inflation; non-contract drugs still ~70% of spend.
02:45 — Inflation by Site of Care
Acute Care
3.03% projected inflation
Driven by:
Sugammadex
Kcentra
Clotting factors
Ambulatory Care
2.85% overall, but with key divergence:
Provider-administered drugs: 3.35%
Self-administered drugs: 2.43%
04:02 — Provider-Administered Drugs: What’s Driving Growth
Oncology infusions are the main drivers.
Key agents:
Keytruda
Darzalex Faspro
Continued growth due to:
Expanded indications
Increased outpatient infusion utilization
Oncology split by site of care:
Inpatient: High-cost CAR T (e.g., Yescarta)
Outpatient: Infusions, bispecifics, emerging cellular therapies
Emphasizes importance of site of care strategy.
05:14 — Self-Administered Drugs: Utilization Over Inflation
Five key drivers:
Autoimmune / inflammatory: Skyrizi, Dupixent, Rinvoq
Diabetes / metabolic / weight loss: Ozempic, Wegovy, Mounjaro, Zepbound
Spend growth fueled by:
Media exposure
Expanded indications
Increased patient demand
Opportunity for:
Retail & specialty pharmacy optimization
Margin capture
Patient support (adherence, counseling, benefits investigation)
06:45 — New Section: Dynamic Pharmacy Market Forces (2026–2030)
Seven strategic forces influencing pharmacy practice:
Growth in specialty and cell & gene therapies
Expansion of value- and outcomes-based contracting
Siteofcare shifts toward ambulatory and home
Digital transformation & automation
Supply assurance and resilience
Expanded pharmacist clinical scope & workforce models
Regulatory and policy efforts to lower drug prices
340B changes
IRA Medicare Part D negotiations
09:37 — Practical Takeaways for Pharmacy Leaders
Use 2.84% inflation as a baseline — then customize using Vizient Pharmacy Analytics.
Leverage segmented views to prioritize:
Acute vs ambulatory strategies
Provider-administered vs self-administered drugs
Identify top spend movers and align them with long-term market forces.
Consider:
Specialty pharmacy expansion
Site of care optimization
10:48 — Biosimilar Therapeutic Insights: 2025 Recap
Heather Pace highlights:
Shift from biosimilar approval to active adoption management.
Ustekinumab (Stelara) as defining example:
Multiple biosimilars
Uptake driven by payer and PBM strategy
Utilization varies widely based on:
Formulary design
Benefit alignment
Biosimilars now actively steered, not passively adopted.
11:50 — Why Stelara Was a Turning Point
PBM-developed, private-label biosimilars drove adoption.
Net cost and copay design outweighed:
Interchangeability status
Manufacturer differentiation
Sets expectations for future biologic launches.
12:25 — Operational Impact for Health Systems
Expect payer-specific product preferences.
Frequent switching will become routine.
Key considerations:
Siteofcare mandates
Product presentation
Supply chain logistics
Billing & reimbursement complexity
Clinical barriers are decreasing; workflow flexibility is critical.
13:09 — What to Expect From Biosimilars in 2026
Faster adoption timelines
Earlier payer-driven switching
Fewer preferred products
Less reliance on reference product trial periods
13:45 — Biosimilars With Major 2026 Impact
Eylea — multiple launches expected post-litigation
Xolair — expansion into asthma/allergy and retail specialty
Perjeta — oncology pathway disruption expected late 2026 / early 2027
15:01 — 2025 Biosimilars Impacting 2026
Ustekinumab (Stelara): broader formulary shifts
Denosumab (Prolia, Xgeva): full year of impact; all interchangeable
Eculizumab (Soliris): first rare-disease biosimilar entry
15:58 — FDA Biosimilar Guidance to Watch
Late-2025 FDA guidance:
Reduced reliance on clinical efficacy trials
Greater emphasis on analytical similarity
Aims to:
Reduce development cost
Accelerate market entry
16:26 — Interchangeability: Where Things Are Headed
Moving toward expectation that all biosimilars are interchangeable.
Shifts responsibility to:
Payers
Health systems
Pharmacists managing transitions and education
17:17 — Biggest Shift in the Biosimilar Landscape
Faster launches
Larger scale adoption
Payer strategy more influential than timing of approval
Success depends on:
Formulary fit
Channel alignment
Operational simplicity
17:41 — Final Biosimilar Insight
Biosimilar strategies must be molecule-specific.
One-size-fits-all approaches are no longer effective.
18:13 — Final Thoughts on the SMO
Inflation projections are a starting point.
Leaders should:
Focus on top spend drugs
Understand siteofcare and specialty drivers
Translate projections into actionable budgets
18:40 — Resources
Winter 2026 Spend Management Outlook available on Vizient’s SMO Hub.
Includes current and prior editions and related insights.
18:58 — Closing
Carolyn thanks Jeni and Heather.
Reminder to subscribe, like, and share feedback.
Verified Rx is produced by the Vizient Center for Pharmacy Practice Excellence.
 
Links | Resources: 
Vizient Spend Management Outlook webpage
Vizient Winter 2026 Spend Management Outlook
Vizient Biosimilars Therapeutic Insights
 
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CDC Childhood Immunization Schedule Updates (January 2026)

John Schoen, Senior Clinical Manager of Evidence-Based Medicine and Drug Information in Vizient's Center for Pharmacy Practice Excellence and Vizient's vaccine subject matter expert, joins host Stacy Lauderdale to discuss key updates to the CDC's childhood Immunization schedule and what they mean for practice.
 
Guest speaker:  
John Schoen, PharmD, BCPS  
Senior Clinical Manager of Evidence-Based Medicine and Drug Information   
Vizient Center for Pharmacy Practice Excellence  
 
Host:  
Stacy Lauderdale, PharmD, BCPS  
Associate Vice President 
Vizient Center for Pharmacy Practice Excellence  
Verified Rx Host 
 
Show Notes:
00:00 — Introduction
Announcer welcomes listeners to Verified Rx, produced by the Vizient Center for Pharmacy Practice Excellence.
00:14 — Episode Overview
Host Stacy Lauderdale introduces the topic:updates to the CDC’s U.S. Childhood Immunization Schedule, revised January 20, 2026.
Goal of the episode: explain what changed, what didn’t, and what it means in practice for providers, pharmacists, and families.
Guest: John Schoen, Senior Clinical Manager of Evidence-Based Medicine and Drug Information at Vizient and vaccine subject matter expert.
01:16 — What Changed in the CDC Immunization Schedule
CDC reorganized the schedule into three recommendation categories.
Vaccines were reclassified, not removed.
Number of diseases covered under “routine” recommendations decreased from 17 to 11 due to recategorization.
01:50 — Stated Rationale Behind the Changes
Rationale provided in executive summary of scientific assessment.
The supporting scientific assessment is available online and referenced for transparency (link in resources below).
03:19 — Were Any Vaccines Removed?
No vaccines were removed from the CDC schedule.
Some vaccines were shifted into different recommendation categories.
03:40 — Category 1: Routine Childhood Vaccinations
Vaccines still routinely recommended for all children include:
MMR (measles, mumps, rubella)
Polio
Tdap / DTaP
Hib (Haemophilus influenzae type B)
Pneumococcal
HPV
Varicella (chickenpox)
04:27 — Category 2: Vaccines for High-Risk Populations
Vaccines recommended for children who meet specific high-risk criteria:
RSV monoclonal antibodies (mAb)
Hepatitis A
Hepatitis B
Quadrivalent meningococcal
Meningococcal group B
Dengue
05:19 — What Changed vs. Stayed the Same
Hepatitis A, Hepatitis B, and quadrivalent meningococcal moved from routine to high-risk
RSV mAb recommendations are effectively unchanged, as high-risk infants are defined as those born to mothers who did not receive the maternal RSV vaccine.
Dengue remains risk-based.
Meningococcal group B remains a mix of risk-based and shared clinical decision-making.
06:31 — Category 3: Shared Clinical Decision Making (SCDM)
Defined by ACIP as an individualized decision made jointly by provider and parent/guardian.
Allows vaccination when risk-based criteria are not met but benefit is still considered.
06:52 — Vaccines Under SCDM
Vaccines now include:
Influenza
COVID-19
Rotavirus
Hepatitis A
Hepatitis B
Quadrivalent meningococcal
Meningococcal group B
08:05 — What’s New in SCDM
Influenza and rotavirus moved from routine to SCDM.
Hepatitis A, hepatitis B, and quadrivalent meningococcal also shifted.
COVID-19 moved to SCDM in September 2025 for individuals ≥6 months.
08:28 — Insurance Coverage Implications
No expected changes in coverage.
Vaccines recommended by CDC as of December 31, 2025 remain:
Covered without cost-sharing under Affordable Care Act (ACA) plans.
Covered by Medicaid, Children’s Health Insurance Program (CHIP), and Vaccines for Children (VFC) program.
09:14 — Impact on Pharmacy Vaccine Access
Pharmacists are considered healthcare providers under CDC SCDM definitions.
Authority to administer vaccines primarily determined by state laws.
Standing orders, protocols, and collaborative practice agreements may need to be updated, as applicable, to address language related to ‘routine’ immunizations for children.
10:27 — Recommendations for Providers & Organizations
For providers:
Become familiar with schedule changes.
Be prepared for patient and parent education.
Recognize differences between CDC and other professional guidelines.
For organizations:
Review EHR documentation and order sets.
Consult local state regulations to ensure compliance with vaccine administration practices. Review standing orders/protocols and collaborative practice agreements to determine if revisions are needed. Monitor vaccine utilization and adjust inventory accordingly.
11:24 — Resources & Closing
Additional CDC and Vizient resources will be linked in the show notes.
Announcer closes with subscription and feedback reminder.
Links | Resources: 
HHS press release on changes to childhood immunizations schedule
Assessment of US childhood and adolescent immunization schedule
HHS fact sheet: CDC childhood immunization schedule
Revised CDC child and adolescent immunization schedule
ACIP shared clinical decision-making recommendations
 
Vizient resource
Minute Market Insight
 
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2026 OPPS Final Rule: What Hospitals Need to Know

The Centers for Medicare and Medicaid Services has finalized the 2026 Outpatient Perspective Payment System (OPPS) rule, with most policies taking effect on January 1, 2026. Jenna Stern, Vice President of Regulatory Affairs and Public Policy at Vizient, joins host Carolyn Liptak, Pharmacy Executive Director in Vizient's Center for Pharmacy Practice Excellence, to discuss key updates to payment policies, payment rates, and quality provisions affecting Medicare beneficiaries receiving care in hospital outpatient departments and ambulatory surgical centers.
 
Guest speaker: 
Jenna Stern Vice President of Regulatory Affairs and Public Policy
Vizient
Host:  
Carolyn Liptak, MBA, RPh 
Pharmacy Executive Director
Vizient 
 
Show Notes:
00:05 — Introduction
Announcer welcomes listeners to VerifiedRx.
Host Carolyn Liptak, Pharmacy Executive Director at Vizient, introduces the episode focus: the 2026 CMS Outpatient Prospective Payment System (OPPS) Final Rule.
Guest: Jenna Stern, VP of Regulatory Affairs and Public Policy at Vizient.
01:12 — Overview of the OPPS Final Rule
OPPS sets Medicare payment for most hospital outpatient services.
Published annually (typically November), effective January 1.
Covers payment rates, policies, quality programs, and compliance requirements.
Note: CMS delayed enforcement of hospital price transparency requirements until April 1, 2026.
01:34 — Key Takeaways From the 2026 Final Rule
Jenna’s high-level insights:
Hospitals will continue facing financial pressure in 2026.
Modest payment rate increase combined with reimbursement-reducing policies.
Expansion of site-neutral payment policies will be particularly impactful.
Rule reflects emerging administration priorities shaping future policy.
02:21 — OPPS Payment Rate Update for 2026
CMS finalized a 2.6% OPPS schedule increase factor for hospitals meeting quality reporting requirements.
02:40 — What the 2.6% Increase means
Based on:
3% market basket update
–0.7% productivity adjustment
Results in a modest net increase.
Slightly better than the proposed 2.4% increase, though still viewed as inadequate.
CMS estimates $8 billion increase in total OPPS payments compared to 2025.
03:37 — 340B Remedy Offset: Background
From 2018–2022, CMS paid for 340B drugs at ASP –22.5%.
Prior Supreme Court decision from 2022 found that CMS lacked authority to vary rates as finalized in prior rulemaking (e.g., without using drug acquisition cost surveys to inform policy).
04:13 — 340B Remedy Offset in the 2026 Final Rule
CMS considered increasing the remedy offset from 0.5% to 2%.
Stakeholders strongly opposed the increase due to hospital financial strain.
05:10 — Final Outcome
CMS retained the 0.5% offset for 2026.
CMS signaled that larger offsets may be proposed for 2027.
This marks the first year the remedy offset takes effect,
06:00 — Site-Neutral Payment Policy: What It Is
Concept: same service = same payment, regardless of site of care.
Hospital concern: policy reduces hospital reimbursement without accounting for site of care differences, patient acuity, overhead, or service complexity.
06:15 — Site-Neutral Expansion in the 2026 Rule
CMS expanded site-neutral payment to include drug administration services at excepted off-campus provider-based departments.
07:08 — Financial Impact
Reimbursement aligns with Physician Fee Schedule rates.
CMS estimates $290 million reduction in outpatient spending for 2026.
$220 million of savings accrue directly to Medicare.
Not implemented in a budget-neutral manner.
08:14 — Non-Opioid Pain Management Payments
Temporary additional payments began January 1, 2025.
Authorized under the NO PAIN Act (Consolidated Appropriations Act of 2023).
08:28 — What’s New for 2026
CMS finalized the renewal of:
5 drugs
13 medical deviceseligible for separate payment in HOPD and ASC settings.
Per statue, payments available through December 31, 2027.
09:32 — Process Improvements
CMS will allow more frequent consideration of new qualifying products (not limited to annual updates).
Quality criteria unchanged; timing flexibility added.
CMS released guidance on how stakeholders can engage for inclusion.
10:58 — OPPS Drug Acquisition Cost Survey
CMS finalized plans to survey hospitals on acquisition costs for separately payable OPPS drugs.
11:21 — Why CMS Is Advancing the Survey
Addresses Supreme Court requirements from prior 340B litigation.
Aligns with White House Executive Order on lowering drug prices.
Positions CMS to use survey data for 2027 rulemaking.
12:47 — OPPS Packaging Thresholds for 2026
Drugs and biologics: Threshold remains at $140.
Diagnostic radiopharmaceuticals: Increased to $655 (from $630).
Products below thresholds retain Status Indicator “N” (packaged payment).
13:26 — Why Billing Packaged Drugs Still Matters
Even though not separately payable, hospitals must bill for packaged drugs.
Billing data feeds cost reports used to calculate future bundled payments.
Failure to bill can result in inaccurately low reimbursement.
14:14 — Elimination of the Inpatient-Only (IPO) List
CMS finalized a three-year transition to eliminate the IPO list by January 1, 2029.
14:32 — Why This Change Is Significant
IPO list historically ensured certain services were provided inpatient only.
CMS emphasizes provider judgment in determining site of care.
Raises concerns about:
Patient safety
Payer coverage changes
Pressure to move services outpatient
16:28 — ASC Covered Procedure List Expansion
CMS expanded the ASC Covered Procedure List.
Enables more Medicare covered services to be performed in the ASC settings.
16:48 — Price Transparency: Still a Priority
No major overhaul, but continued refinement.
CMS exploring new uses of price transparency data beyond patient comparison.
17:46 — Most Critical Policies to Watch
Jenna highlights:
Modest OPPS payment increase
Site-neutral payment expansion
340B remedy offset
Drug acquisition cost survey
Broader regulatory activity beyond OPPS
18:43 — Available Vizient Resources
OPPS Final Rule Summary
Government Relations & Public Policy Summaries
 Advocacy
19:20 — Closing
Carolyn thanks Jenna for her insights.
Reminder to subscribe, like, and share feedback.
VerifiedRx is produced by the Vizient Center for Pharmacy Practice Excellence.
 
Links | Resources: 
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots: Click Here
CMS fact sheet on the Final Rule: Click Here
Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey: Click Here
Vizient Office of Public Policy and Government Relations final rule summary:  Click Here
Final List of Qualifying Products for Separate Payment for non-opioid pain medications: (Table 136, pgs. 1138-1140)
 
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The GOAT of GPO’s

Pharmacy buyers play a critical role in keeping hospitals running—and their partnership with a GPO can make all the difference. In this episode of Verified Rx, Jackie Stokes sits down with Theresa Brown and Michelle Crump, two powerhouse pharmacy buyers and members of Vizient’s Pharmacy Technician Committee, to talk about the tools, programs, and peer networks that help them thrive in their roles. From leveraging pharmacy analytics to navigating shortages, maximizing NovaPlus value, and strengthening buyer-to-buyer collaboration, this episode is packed with insights to help pharmacy teams work smarter, save money, and support better patient care.
 
Guest speakers: 
Theresa Brown National Pharmacy Purchasing Specialist
Prospect Medical Holdings
 
Michelle Crump, ASBA, CPhTNational Certified Pharmacy Technician Buyer
Pharmacy
Host:
Jackie Stokes
Program Services Manager
Center for Pharmacy Practice Excellence (CPPE)
Vizient
 
Show Notes:
[00:48] — Guest Introductions
Theresa
National pharmacy purchasing specialist
Background: inventory control, home infusion startup, pharmacy technician educator
[01:14] — Michelle
Nationally certified pharmacy technician since 2016
Pharmacy buyer at a small independent county critical access hospital
Transitioned from accounting into pharmacy purchasing
 
[01:26] — The Role of Vizient in Supporting Pharmacy Buyers
Theresa:
Biggest benefit: relationship with pharmacy executive & sourcing team
Uses Pharmacy Analytics (formerly VSAP) to evaluate spend and inventory control across 63 facilities
 
[02:16] — How Pharmacy Analytics Supports Buyers
Theresa:
Data mining on spend increases/decreases
Tracks product returns
Identifies sharing opportunities to prevent waste
[02:59] — Michelle’s Experience
Analytics helps mitigate waste
Collaboration with other buyers has been essential — especially for someone new to the buyer role
Learns navigation of Vizient systems and how to work with the local GPO
Peer support helps demystify a “diverse and complex” buyer role
 
[04:02] — Value of the Vizient Pharmacy Technician Committee
Provides national peer networking
Helps buyers learn from subject matter experts
Even highly experienced buyers (35+ years) learn from every call
 
[04:41] — Vizient Programs: NovaPlus, NES, Forum Calls, Hot Info
Bimonthly Forum Calls
Provide regulatory updates
Help expand buyer knowledge in real time
Hot Info Weekly Updates
Keeps users informed on inventory, shortages, spend impacts
[05:31] — Michelle on Program Impact
Calls and shared expertise were critical when she was new
NovaPlus program especially valuable in critical access settings
 
[06:32] — Deep Dive: How the NovaPlus Program Works
Michelle explains:
NovaPlus (Y-label) aligns with manufacturer-labeled products (M-label)
Quarterly rebates provide significant savings
Critical access hospitals benefit via 340B optimizer software that extracts outpatient utilization to qualify for discounted M-label purchasing
Can result in “significant savings” depending on contract structure
 
[08:38] — What If NovaPlus Pricing Isn’t the Best Price?
Michelle:
Buyer’s responsibility to identify price discrepancies
Communicates with Vizient representative to reassess contracting needs
Often resolved through rebates or future price adjustments
[09:30] — Theresa:
Price challenges taken seriously
Many result in price reductions visible in Hot Info the next week
Demonstrates importance of strong GPO relationships
 
[10:07] — Understanding NES: NovaPlus Enhanced Supply
Theresa:
Her hospitals are exploring NES participation
Requires 90% compliance (higher than standard 80%)
Benefits include prioritized product access during shortages
Critical when national backorders exceed 200+ items
Ensures better patient care continuity
 
[11:34] — Supply Assurance & Mitigation Strategies
Michelle:
During the North Carolina hurricane, Vizient’s mitigation strategy was “imperative”
Vizient engaged Baxter directly to resolve critical fluid shortages
Small hospitals especially reliant on support in crisis situations
[12:36] — Theresa:
Shortage team provides substitution guidance and clinical appropriateness information
Vizient recommendations support discussions with local clinical teams
Crucial during COVID start date — her first day in national role
 
[13:23] — Continuing Education (CE) Programs
Theresa:
Vizient CE programs help maintain technician licensure
Webinars are interactive, engaging, and more informative than generic CE resources
 
[14:07] — Networking and Pharmacy Aggregation Groups (PAGs)
Theresa:
PAGs offer cost savings and peer collaboration
Ability to share information and bring value back to her own network
[14:44] — Michelle’s Example of System-to-System Collaboration
Shared compounded syringes (from a 503B facility) with another hospital to prevent waste
Highlights real-world benefits of PAG networking
 
[15:52] — Addressing National Challenges Together
Theresa:
PAG roundtables help uncover shared struggles (e.g., DSCSA serialization issues)
Members provide actionable advice on what’s working in their systems
Reinforces “we’re all in the same boat”
 
[16:50] — Supporting and Elevating Pharmacy Technicians
Jackie’s goal:
Support technicians and recognize the value they bring
Committee exists to uplift and empower pharmacy buyers/techs
[17:05] — Michelle:
Worked with leadership to create a tiered technician level system
Helps techs gain skills, feel valued, and earn raises
Improves career satisfaction and retention
 
[17:46] — Closing Reflections
Theresa:
Being part of Vizient is “an honor and a privilege”
Values shared knowledge and strong relationships
[18:00] — Michelle:
Gratitude for collaboration and guidance over the years
Vizient connections were vital for adapting to the buyer role
 
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Return of Pipeline 2026 – Cell and Gene Therapies

In Part 2 of the 2026 pipeline series, host Carolyn Liptak welcomes Dr. Amanda Frick, Senior Clinical Manager, Strategic Clinical Intelligence at Vizient, to explore the advanced therapies pipeline: cell therapies, gene therapies, tissue-engineered products, and combination advanced therapy products.
The discussion explores major pipeline trends, six leading products to watch, and the growing innovation expected to shape clinical practice in 2026.
 
Guest speakers: 
Amanda Frick, PharmD, BCPSSenior Clinical Manager, Strategic Clinical Intelligence
Spend Management
Vizient
Host:
Carolyn Liptak, MBA, BS Pharm
Pharmacy Executive Director
Center for Pharmacy Practice Excellence (CPPE)
Vizient 
 
Show Notes:
[00:05] — Introduction
Announcer opens the episode.
Host Carolyn Liptak introduces the focus on advanced therapies:cell & gene therapies, tissue-engineered products, and combination products.
Guest: Dr. Amanda Frick, Senior Clinical Manager, Strategic Clinical Intelligence at Vizient.
[01:07] — Defining Advanced Therapies
FDA groups cell and gene therapies within advanced therapies.
Total FDA-approved advanced therapies: 46.
Amanda monitors 29 drug-like therapies within that group.
[02:01] — Pipeline Size and Approval Activity
S. pipeline: 264 agents in development.
About 10 agents approach FDA decision annually.
Actual approvals: 5–7 per year on average.
[02:56] — Big-Picture Trends in Cell & Gene Therapy
Oncology dominates
40–50% of all CGTs in development.
Expanding into autoimmune, neurology, and earlier-phase therapies for diabetes, angina, osteoarthritis.
Movement toward allogeneic ("off-the-shelf") therapies
Designed to overcome limits of autologous cell manufacturing.
Reduces wait time and manufacturing failures.
Resurgence of therapeutic vaccines
Currently 3 approved (Sipuleucel-T, Talimogene, Papzimeos
).
20+ vaccines in the pipeline, largely targeted to cancer.
CE program coming Jan 29.
[06:13] — Therapy #1:  Tabelecleucel or Tab-cel (Allogeneic EBV-Specific T-Cell Therapy)
First allogeneic T-cell therapy expected in the U.S.
For EBV-positive post-transplant lymphoproliferative disorder (PTLD).
“Off-the-shelf” and donor-derived.
[07:07] — Clinical Need & Outcomes
Currentstandard of care: rituximab.
After relapse, survival <1 month (HSCT) or <4 months (solid organ).
Phase 3 data: 90% one-year survival.
Regulatory Status
Prior FDA CRL due to manufacturing (third-party issues).
Expected approval: January 10, 2026.
[09:00] — Therapy #2:  Kresladi  (Autologous Gene Therapy for LAD-I)
Treats severe leukocyte adhesion deficiency (LAD-I), typically diagnosed in infancy.
Could eliminate need for stem cell transplant (often limited by lack of matched donors).
[11:39] — Clinical Outcomes
Phase 1/2 data (n=9):
100% survival at one year
Major reduction in hospitalizations
Discontinuation of prophylactic antibiotics
Regulatory Status
Multiple delays due to CMC (chemistry, manufacturing, controls) questions.
Resubmitted Oct 2025; anticipated approval March 28, 2026.
[13:27] — Therapy #3: ORCA-T (Enhanced Allogeneic Stem Cell Transplant)
Allogeneic hematopoietic stem cells + regulatory and conventional T cells (Tregs + Tcons).
Designed to improve:
Graft-versus-tumor effect
Graft-versus-infection protection
Reduction in graft-versus-host disease (GVHD)
[14:31] — Clinical Significance
Could markedly improve quality of life after transplant.
Regulatory Status
Anticipated approval: April 6, 2026.
[15:01] — Therapy #4: Vusolimogene oderparepvec (RP1) (RP1 — Oncolytic HSV-1 Virus)
Off-the-shelf genetically modified HSV-1 oncolytic virus.
For advanced melanoma after prior PD-1 inhibitor therapy.
[16:17] — Why It Matters
Currently, poised to compete with Amtagvi (TIL therapy).
TIL therapy is autologous and slow to manufacture; RP1 is ready-to-use and combines with nivolumab (Opdivo).
Regulatory Status
PDUFA: April 10, 2026.
[16:34] — Therapy #5: INO-3107 (Therapeutic Vaccine for RRP)
Targets HPV 6 and 11, which cause recurrent respiratory papillomatosis (RRP).
Patients can require several surgeries per year to remove papillomas.
[17:34] — Vaccine Mechanism
DNA plasmid (vs viral vector in PAP).
Lower insertional oncogenesis risk.
Potentially improved durability of response.
Regulatory Status
Manufacturer aims to finish BLA by end of 2025.
Expected approval (with priority review): mid–late 2026.
[19:17] — Therapy #6: Clemidsogene lanparvovec (Intracerebral Gene Therapy for Hunter Syndrome)
One-time treatment for MPS II (Hunter syndrome).
Designed to deliver therapy directly into the brain to address neurological progression.
[21:21] — Competing Agent Emerging
New enzyme therapy tivedenofusp alfa crosses the blood-brain barrier — unlike current ERT (idursulfase).
Expected approval: April 5, 2026.
Raises payer & clinical sequencing questions:
One-time gene therapy vs repeat annual enzyme therapy
Durability vs cost (ERT ~$500K/year)
Regulatory Status
Clemidsogene lanparvovec anticipated approval: February 8, 2026.
[22:45] — Cost, Value, and Durability Considerations
Gene therapies may reach multi-million-dollar cost brackets.
Durability becomes critical for payer adoption.
Hospitals face long onboarding timelines for advanced therapies and must choose which to implement.
[22:56] — Where to Learn More
Spend Management Outlook (formerly Pharmacy Market Outlook)
Oncology and pediatric Vizient therapeutic web pages
FDA cell/gene therapy webpage
CE session on therapeutic vaccines (Jan 29)
[23:46] — Closing
Carolyn thanks Amanda.
Reminder to subscribe, send comments, and explore further resources from Vizient.
 
Links | Resources: 
Spend Management Outlook: Click here
Therapeutic class insights: Click here
FDA webpage: Click here
 
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Pipeline 2026: The Movers, the Shapers, & What Matters

If you're wondering which therapies may influence care delivery, budgets, and decision making in 2026, the pipeline offers an early preview and it points to a year defined by innovation. We're seeing new first in class treatments, thoughtful next generation agents, and a biosimilar market where fewer launches are offset by important competitive shifts driven by recent approvals. John Schoen and Heather Pace from the Center for Pharmacy Practice Excellence join Stacy Lauderdale, Associate Vice President of Evidence-Based Medicine and Drug Information and your Verified RX program host to highlight pipeline agents worth watching and discuss what they may mean for care delivery and spend management in the year ahead.
 
Guest speakers: 
John Schoen, PharmD, BCPS  
Senior Clinical Manager of Drug Information   
Vizient Center for Pharmacy Practice Excellence 
 
Heather Pace, PharmD
Senior Clinical Manager of Drug Information   
Vizient Center for Pharmacy Practice Excellence   
 
Host:  
Stacy Lauderdale, PharmD, BCPS  
Associate Vice President 
Vizient Center for Pharmacy Practice Excellence
 
Show Notes:
[01:01] — Episode Scope
The focus is non-CGT therapies; CGT pipeline will be covered in Part 2.
[01:50] — Therapeutic Areas With the Most Approvals
Oncology leads the pipeline.
Others include infectious disease, neurology, rare disease, endocrine, hepatology, dermatology, and rheumatology.
[02:37] — Biosimilars in 2026: Momentum or Headwinds?
Discussion of potential “biosimilar void”—only 10% of expiring biologic patents have biosimilars in development.
Emerging role of PBM private-label biosimilars.
[03:51] — FDA Draft Guidance on Interchangeability
FDA exploring interchangeable designation for all biosimilars.
Potential shift away from clinical efficacy studies in favor of analytical comparisons.
Guidance still in draft and open for public comment.
[05:34] — John’s Top Picks for First-in-Class Agents
06:11 — Orviglance
First manganese-based, oral MRI contrast agent.
Advantages for patients with kidney impairment.
Used for liver imaging.
[06:20] — Why Non-Gadolinium Matters
Lower risk of nephrogenic systemic fibrosis.
[06:46] — Tabelecleucel
First allogeneic EBV-specific T-cell therapy.
For EBV-positive PTLD post-transplant.
Could become new standard of care.
[07:42] — Tanruprubart
First therapy specifically for severe Guillain-Barré Syndrome (GBS).
Shows improved outcomes over IVIG and plasma exchange.
[08:20] — Comparing to Standard of Care
Review of improved real-world data outcomes.
[09:03] — Therapies That May Shift Care Delivery
[09:32] — Icotrokinra: First oral IL-23 antagonist for plaque psoriasis.
[10:00] — Insulin Icodec
First once-weekly basal insulin for type 2 diabetes.
Resubmitted after safety concerns in type 1 diabetes.
[10:59] — Honorable Mentions
Camizestrant
SERD for ER+/HER2– metastatic breast cancer.
Ensitrelvir (COVID-19)
Oral option for pre-exposure prophylaxis.
Also being evaluated for treatment.
Doravirine + Islatravir (HIV)
Introduces new NRTTI class.
Cefepime + Zidebactam
Active against metallo-β-lactamase–producing organisms.
14:05 — Key Biosimilar Launches
Omalizumab (Xolair)
First biosimilars in asthma/allergy space.
Aflibercept (Eylea)
High competition expected pending litigation.
Pertuzumab (Perjeta)
First biosimilar anticipated in oncology.
[15:31] — Biosimilars Approved in 2025, Impacting 2026
Ustekinumab (Stelara): first full year of competition
Denosumab (Prolia/Xgeva): 10–15 biosimilars expected
Eculizumab (Soliris): notable for rare disease market entry
[17:17] — John’s Closing Thoughts
Strong mix of first-in-class advances and next-gen convenience therapies.
[17:36] — Heather’s Closing Thoughts
2026 will focus on speed and scale after the 2025 biosimilar wave.
Pharmacists pivotal in ensuring smooth patient transitions.
 
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