Check out what's new in this month's newsletter
- Breaking news: AMCP Dossier Format Version 5.0 is live
- Join us at AMCP Annual for Bubble Tea during the FormularyDecisions Snack & Learn
- Don't forget to sign up for our exclusive Cencora evening reception in New Orleans
- Check out all of our other events, thought leadership sessions, and award-winning research at AMCP
- Meet with us at Asembia in April
- New and enhanced features in FormularyDecisions
- Did you miss our most recent AMCP Webinar? Watch the recording now
Breaking news:
AMCP Dossier Format Version 5.0 is live
The AMCP Format serves as guidance for the development of dossiers as a comprehensive and standardized framework of clinical and economic evidence and information to meet the evidentiary needs of healthcare decision makers to support formulary consideration.
In April 2024, AMCP released Version 5.0 of the AMCP Format for Formulary Submissions. Key updates to AMCP Format 5.0 include the following:
- Special content considerations for digital therapeutics
- More robust language to include health disparities
- Increased emphasis on the inclusion of real-world evidence
- Brevity encouraged to streamline dossiers
- Add-on guidance for pre-approval information exchange (PIE)
The last AMCP Format revision (Version 4.1) was released in December 2019 and provided expanded guidance on pre-approval dossiers (for unapproved products and unapproved uses of approved products) to support PIE for early scientific dialogue between manufacturers and HCDMs.
As with other version updates to the AMCP Format, updates to existing product dossiers are recommended when new information becomes available. Click below for full details on the AMCP Format 5.0.
Our upcoming events in April
Attending AMCP Annual? Connect with us!
April 15-18, New Orleans
Join us for Bubble Tea at FormularyDecisions Snack & Learn
Title: The Role of Unapproved Product Dossiers in a Successful Product Launch
Time: Wednesday, April 17, 2024, from 2-2:45pm CT
Location: Ernest N. Morial Convention Center in Room 206
During this session:
- Discover the different types of dossiers that biopharma companies disseminate and their content and structure variations
- Gain insights into how healthcare decision-makers (HCDMs) can leverage FormularyDecisions to access and request these dossiers both pre- and post- approval
- Learn from case studies highlighting how biopharma companies are utilizing FormularyDecisions to expand their reach to HCDMs through nonpersonal communication tactics
- Explore the eDossier program, which allows biopharma companies to host their unapproved product and unapproved use dossiers effectively
Our expert speakers include:
- Elham Heidari, PharmD, MSc, Pharmacoeconomist, UMass Chan Medical School
- Ben Penley, PharmD, MS, Evidence Generation & Value Communications, Cencora
- Jasmine Knight, PharmD, MS, Digital Solutions Lead, Cencora
- Thai Young, MBA, Product Development & Strategy, Cencora
- Thomas Liberta, National Director Business Development, Cencora
Space is limited, so please, register here to confirm your attendance.
You’re invited to Cencora’s exclusive evening reception
Time: Tuesday, April 16. 7:45pm – 10:00pm
Location: Generations Hall, 310 Andrew Higgins Blvd, New Orleans
Our 2024 Innovation & Impact Award recipients will be announced live at the reception.
Charting the Biosimilars Beat Drop: The Latest Updates in the Landscape, Coverage, and Adoption in the US
Date/Time: Monday, April 29, 2024, from 2-2:45pm PT
Location: Wynn Convention Center
The long-awaited launch of self-administered pharmacy benefit biosimilars has marked a new beat to the ever-growing landscape of approved, launched, and pipeline products in the United States. Alongside recent launches have come innovative strategies from both industry disruptors and longstanding players to revolutionize patient access in an increasingly competitive marketplace. Coupled with ongoing regulatory/legislative considerations and the availability of real-world evidence, how are payers and providers responding to maturing and up-and-coming biosimilar products?
Join our expert faculty as they review today’s biosimilars landscape, explore trends in uptake, and report perspectives from key stakeholders through their latest primary market research.
Speakers:
- Tasmina Hydery, PharmD, MBA, BCGP, Associate Director of Digital Solutions, Cencora
- Lakesha Farmer, PharmD, MBA, Senior Director, ION Oncology Practice Network, Cencora
- Cate Lockhart, MS, PharmD, PhD, Executive Director, Biologics and Biosimilars Collective Intelligence Consortium
IRA One Year Later: IRA’s Evolution and How Biopharma Companies Can Strategically Position for 2025
Date/Time: Monday, April 29, 2024, from 3-3:40pm PT
Location: Wynn Convention Center
With one year of IRA regulations behind us, the industry is still grappling with key aspects of implementation. This session will:
- Review IRA regulatory guidance since 2023.
- Explore key lessons learned during the first round of drug price negotiations.
- Delve into payer reactions and insights in response to the Medicare Part D benefit redesign.
- Assess how biopharma companies across the industry are adapting to the IRA’s implementation
Corey Ford from Cencora will equip biopharma companies with a strategic roadmap to not only respond to regulatory and payer developments, but more importantly, to proactively prepare for the impact of the IRA.
Speaker: Corey Ford, VP of Reimbursement and Policy Insights, Cencora
Here's a sneak peek of some of the activities we have planned by conference in 2024:
- DIA (June 16-24, San Diego, CA): 1:1 meetings, Biosimilars podium presentation
- NASP (October 6-9, Nashville, TN): Healthcare decision maker networking event (closed event for healthcare decision makers only)
- AMCP Nexus (October 14-17, Las Vegas, NV): Biopharma Snack & Learn, Healthcare decision maker networking event (closed event for healthcare decision makers only)
Check back for additional details and to see where else we’ll be in 2024.
New & enhanced features in FormularyDecisions
eRequest update coming soon!
To complement our eDossier enhancements, the eRequest form is also under construction, with a launch date expected by Summer 2024. Improvements include:
- Disease state-specific eRequests
- Increased transparency for HCDMs around eDossier availability
- Clearer notifications about eRequest fulfillment instructions
Did you miss it? AMCP Webinar: Accelerate patient access with pre-approval information
Session: AMCP Webinar hosted by FormularyDecisions – Leveraging the pre-approval information safe harbor to accelerate patient access
Recorded on: March 14, 2024
Join Cencora thought leaders for an interactive, engaging, and informative discussion as they dive into the evolving landscape of PIE and explore opportunities and innovative solutions for leveraging PIE when collaborating with stakeholders.
Learning objectives:
- Understand how biopharma companies leverage PIE to communicate with healthcare decision makers through various channels
- Explore the impact of effective PIE strategies on stakeholder engagement and decision making
- Discuss potential solutions for challenging areas in PIE such as FDA expedited approval pathways and availability of economic/pricing data
- Understand how digital solutions can be leveraged for PIE and its implications for communication with stakeholders