menu toggle

FormularyDecisions Insider Biopharma Edition Newsletter

Browse new features, discover platform releases, learn about upcoming events, and stay up to date on all the latest insights.

 

Breaking news:

Abstract

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. 

newsletter

Our upcoming events in April

abstract

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.  


Cencora logo

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

Cencora logo
It is our pleasure to personally invite you for an exclusive reception in a stunning venue that will transport you to the enchanting vibes of old New Orleans. This will be a wonderful opportunity to forge new connections, network with industry experts and create lasting relationships with your peers. 

Our 2024 Innovation & Impact Award recipients will be announced live at the reception.
Cencora logo
NOLA

Our events at AMCP

Check out all of our other events, thought leadership sessions, and award-winning research at AMCP in New Orleans. 

Meet with us at Asembia

April 28-May 2, Las Vegas

Mark your calendars for our thought leadership sessions. See what we have planned below!

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: 

  1. Disease state-specific eRequests 
  2. Increased transparency for HCDMs around eDossier availability 
  3. 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 
Customer Service Female

 

Have questions about your subscription?

Your Subscription Engagement Team is here to assist with an array of activities—from setting up your subscription, digitizing your eDossier, providing technical support, as well as helping address any other questions that may arise. FormularyDecisions Subscription Engagement Team is your personalized support backed by a broad, cross-functional team, and a suite of self-service tools.
Survey image_JPG

 

Let us know your thoughts

We value your input. Please take 2 minutes to jump into this 3-question survey and provide your feedback. What’s your favorite thing about FormularyDecisions? Do you have any recommendations for us?

Connect with us

FormularyDecisions Subscription Engagement Team is your personalized support backed by a broad, cross-functional team, and a suite of self-service tools. Connect with us today!