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 Sob...
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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